A Single-blind, Multi-centre, Randomised, Controlled, Non-inferiority, Clinical Study to Assess the Safety and Performance of the Neurotech Vital Compact Device Compared to the Itouch Sure Pelvic Floor Exerciser for the Treatment of Stress Urinary Incontinence in Female Patients
Phase: NA
Conditions: Stress Urinary Incontinence
Sponsor: Atlantic Therapeutics

                   Study No: BMR-13-1001 
 
 
Study Ref: Neurotech Vital Compact RCT 
 
 
Version: 2.0 FINAL 27 March 2015 
 
CONFIDENTIAL                                                     Page 0 of 132 
 
 
 
Protocol Approval Page 
 
Study No: BMR-13-1001 
 
A single-blind, multi-centre, randomised, controlled, non-inferiority, 
clinical study to assess the safety and performance of the Neurotech 
Vital Compact device compared to the itouch Sure Pelvic Floor 
Exerciser for the treatment of stress urinary incontinence in female 
patients 
 
Version 2.0 
 
 
The undersigned have read this study protocol and hereby confirm that, to the best of their 
knowledge, it accurately describes the study to be conducted. 
 
Sponsor Representative: 
Barbara Powers 
Managing Director 
__________________________   __________ 
Expedite Research 
 Signature 
 
 
 
Date 
 
 
Sponsor’s Representative: 
Conor Minogue 
Technical Director 
__________________________   _________ 
Bio-Medical Research Ltd 
 Signature 
 
 
 
Date 
 
 
Quality/Regulatory Affairs: 
Brendan McCormack 
Quality Manager 
 _______________________    _________ 
Bio-Medical Research Ltd 
 Signature 
 
 
 
Date 
 
 
Statistician: 
  
Diane Tipping 
  
Senior Director, Biostatistics 
 ________________________   _________ 
Prosoft Clinical, Inc. 
 Signature 
 
 
 
Date 
 
 
 
 
 

                   Study No: BMR-13-1001 
 
 
Study Ref: Neurotech Vital Compact RCT 
 
 
Version: 2.0 FINAL 27 March 2015 
 
CONFIDENTIAL                                                     Page 1 of 132 
 
 
Study Protocol 
 
 
A single-blind, multi-centre, randomised, controlled, non-
inferiority, clinical study to assess the safety and performance of 
the Neurotech Vital Compact device compared to the itouch Sure 
Pelvic Floor Exerciser for the treatment of stress urinary 
incontinence in female patients 
 
 
Study No: BMR-13-1001 
 
 
Version 2.0 27 March 2015 
 
Sponsor 
 
Bio-Medical Research Ltd 
Parkmore Business Park West 
Galway 
Ireland 
 
Telephone No: 00353 91 77 4300 
Fax No: 00353 91 77 4301 
 
 
This study is considered a Nonsignificant Risk Device Study and is being 
conducted in accordance with the abbreviated Investigational Device 
Exemption (IDE) requirements set forth in 21 CFR 812.2(b). 

                   Study No: BMR-13-1001 
 
 
Study Ref: Neurotech Vital Compact RCT 
 
 
Version: 2.0 FINAL 27 March 2015 
 
CONFIDENTIAL                                                     Page 2 of 132 
 
Table of Contents 
1 
Study Synopsis ........................................................................................................7 
2 
Introduction ..........................................................................................................18 
2.1 
Background ..............................................................................................18 
2.2 
Rationale of Study Population .................................................................19 
2.3 
Rationale of Neurotech Vital Compact Device .......................................19 
2.4 
Rationale for Using the itouch Sure Pelvic Floor Exerciser ....................20 
2.5 
Rationale of a Single-Blind Study Design ...............................................20 
2.6 
Risk/Benefit of the Neurotech Vital Compact Device .............................21 
2.7 
Risk/Benefit Rationale .............................................................................21 
2.8 
Risk/Benefit of the itouch Sure Pelvic Floor Exerciser ...........................22 
3 
Objectives ..............................................................................................................23 
3.1 
Primary Objective ....................................................................................23 
3.2 
Secondary Objectives...............................................................................23 
4 
Study Design .........................................................................................................24 
5 
Trial Endpoints ....................................................................................................25 
5.1 
Primary Endpoint .....................................................................................25 
5.2 
Key Secondary Endpoints to Support Indication for Use ........................25 
5.3 
Secondary Endpoints - Other ...................................................................25 
6 
Trial Population ...................................................................................................27 
6.1 
Number of Subjects..................................................................................27 
6.2 
Inclusion Criteria .....................................................................................27 
6.3 
Exclusion Criteria ....................................................................................27 
6.4 
Withdrawal Criteria .................................................................................28 
6.5 
Monitoring for Subject Compliance ........................................................28 
7 
Study Treatments .................................................................................................30 
7.1 
Description ...............................................................................................30 
7.2 
itouch Sure Pelvic Floor Exerciser ..........................................................32 
7.3 
Device Storage and Accountability .........................................................33 
7.4 
Device Training/Experience ....................................................................34 
7.5 
Randomisation and Blinding....................................................................34 
7.6 
Concomitant Medication and/or Treatments ...........................................34 
7.7 
Treatment Compliance .............................................................................34 
7.8 
Unblinding/Breaking the Blind ................................................................34 
8 
Study Procedures .................................................................................................36 
8.1 
Ethical and Regulatory Considerations ....................................................36 
8.2 
Regulatory Considerations .......................................................................36 
8.3 
Informed Consent.....................................................................................36 
8.4 
Study Start and Training ..........................................................................37 
8.5 
Study Recruitment ...................................................................................37 
8.6 
Study Duration .........................................................................................37 
8.7 
Subject Eligibility ....................................................................................37 
8.8 
Randomisation .........................................................................................38 
8.9 
Screening Assessments – Visit 1 .............................................................38 
8.10 
Baseline Assessments – Visit 2 ...............................................................39 

                   Study No: BMR-13-1001 
 
 
Study Ref: Neurotech Vital Compact RCT 
 
 
Version: 2.0 FINAL 27 March 2015 
 
CONFIDENTIAL                                                     Page 3 of 132 
 
8.11 
Assessments During 12-Week Treatment Programme – Visit 3 and Visit 4
.................................................................................................................41 
8.12 
Pelvic Floor Exercises – Visit 4 Only ......................................................42 
8.13 
Assessments Following Treatment Programme – Visit 5 ........................42 
8.14 
Adverse Event Reporting – All Visits .....................................................42 
9 
Adverse Events and Device Deficiencies ............................................................44 
9.1 
Adverse Events Definitions .....................................................................44 
9.2 
Anticipated Adverse Events .....................................................................44 
9.3 
Reporting to Bio-Medical Research Ltd ..................................................45 
9.4 
Institutional Review Board (IRB) Reporting ...........................................45 
9.5 
Food and Drug Administration (FDA) Reporting ...................................46 
10 
Statistical Analysis ...............................................................................................47 
10.1 
Analysis Populations ................................................................................47 
10.2 
Sample Size ..............................................................................................47 
10.3 
Statistical Methods ...................................................................................47 
11 
Investigator Responsibilities ...............................................................................53 
11.1 
Investigator Responsibilities ....................................................................53 
11.2 
Data Collection ........................................................................................54 
11.3 
Review and Return of Completed Documentation ..................................54 
11.4 
Retention of Documentation ....................................................................54 
11.5 
Maintenance of Randomisation and Blinding ..........................................54 
11.6 
Data Management ....................................................................................55 
12 
Sponsor Responsibilities ......................................................................................56 
12.1 
Indemnity .................................................................................................56 
12.2 
Study Monitoring .....................................................................................56 
12.3 
Final Report .............................................................................................57 
12.4 
Publications ..............................................................................................57 
12.5 
Quality Control and Quality Assurance ...................................................57 
12.6 
Termination Procedure.............................................................................57 
13 
References .............................................................................................................58 
14 
Appendices ............................................................................................................59 
14.1 
Appendix I.  Schedule of Events..............................................................60 
14.2 
Appendix II. itouch Sure Pelvic Floor Exerciser 510k Summary ...........61 
14.3 
Appendix III.  Stress Test Protocol ..........................................................62 
14.4 
Appendix IV.  Pelvic Floor Exercises ......................................................63 
14.5 
Appendix V.  Incontinence Quality of Life (I-QOL) Questionnaire .......64 
14.6 
Appendix VI.  PISQ-IR questionnaire .....................................................71 
14.7 
Appendix VII.  Medical, Epidemiologic and Social Aspects of Aging Urinary 
Incontinence (MESA) Questionnaire ......................................................77 
14.8 
Appendix VIII. 7-Day Voiding Diary and Device Record ......................78 
14.9 
Appendix IX.  Patient Global Impresssion of Improvement – Incontinence 
(PGI-I) .....................................................................................................80 
14.10 
Appendix X.  Sample Informed Consent .................................................81 
14.11 
Appendix XI. Neurotech Vital™ Compact Instructions for Use and Quick Start 
Guide .......................................................................................................92 
14.12 
Appendix XII.  itouch Sure Pelvic Floor Exerciser Instructions for Use117 
 

                   Study No: BMR-13-1001 
 
 
Study Ref: Neurotech Vital Compact RCT 
 
 
Version: 2.0 FINAL 27 March 2015 
 
CONFIDENTIAL                                                     Page 4 of 132 
 
Tables 
Table 1.  Parameter Specifications on the Neurotech Vital Compact Controller ......31 
 
Figures 
Figure 1. The Neurotech Vital™ Compact device Controller .....................................30 
Figure 2. The Neurotech Vital Compact device connected to the garment ................32 

                   Study No: BMR-13-1001 
 
 
Study Ref: Neurotech Vital Compact RCT 
 
 
Version: 2.0 FINAL 27 March 2015 
 
CONFIDENTIAL                                                     Page 5 of 132 
 
Investigator Approval Page 
 
I, the undersigned, have read and understood the clinical study, and agree on the contents. The 
Study Protocol and the Investigator’s Agreement will serve as a basis for cooperation in the 
clinical study. 
 
Site No: 
  
 
 
 
Site Address: 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
Principal Investigator: 
   
 
Name: 
_____________________________________ 
 
 
 
 
 
 
Title: 
_____________________________________  
 
 
 
 
_____________________________   ________ 
Signature 
 
 
 
 Date 
 
 
 
 
 
 
 

                   Study No: BMR-13-1001 
 
 
Study Ref: Neurotech Vital Compact RCT 
 
 
Version: 2.0 FINAL 27 March 2015 
 
CONFIDENTIAL                                                     Page 6 of 132 
 
Abbreviations 
 
AE 
 
Adverse Event 
ALARP 
As low as reasonable possible 
CE-mark 
Certified in Europe  
cm 
 
Centimeter 
EC 
 
Ethics Committee 
ES 
 
Electrical stimulation  
FMEA  
Full Failure Mode Effects Analysis 
FDA  
Food & Drug Administration 
g 
 
Gram 
GCP  
Good clinical practice 
Hz 
 
Herz 
IDE 
 
Investigational Device Exemption 
I-QOL  
Incontinence Quality of Life 
IRB 
 
Institutional Review Board 
ITT 
 
Intent-to-treat population 
Kg 
 
Kilogram 
LOCF  
Lost observation carried forward 
mA 
 
Milliampere 
MAUDE 
Manufacturer and User Facility Device Experience 
MESA 
Medical, Epidemiologic and Social Aspects of Aging Urinary Incontinence 
Questionnaire 
µs 
 
Micro second/milli second 
NMES  
Neuromuscular electrical stimulation 
PF 
 
Pelvic floor 
PGI-I  
Patient global impression of improvement  
PISQ-IR 
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire 
PP 
 
Per Protocol population 
rms 
 
Root Mean Square 
SAE 
 
Serious Adverse Event 
SAP 
 
statistical analysis plan 
SD 
 
Standard deviation 
SUI 
 
Stress urinary incontinence 
TENS  
Transcutaneous electrical stimulation 
UADE  
Unanticipated adverse device effect 
W 
 
Watt 
 
 
 
 
 
 
 
 
 
 
 
 

                   Study No: BMR-13-1001 
 
 
Study Ref: Neurotech Vital Compact RCT 
 
 
Version: 2.0 FINAL 27 March 2015 
 
CONFIDENTIAL                                                     Page 7 of 132 
 
1   Study Synopsis 
 
Title:  
A single-blind, multi-centre, randomised, controlled, non-
inferiority clinical study to assess the safety and 
performance of the Neurotech Vital Compact device 
compared to the itouch Sure Pelvic Floor Exerciser for the 
treatment of stress urinary incontinence in female patients. 
Regulatory Status: 
 
The itouch Sure Pelvic Floor Exerciser is cleared by FDA 
through the 510 (k) premarket notification process 
(K103698) in the USA. 
 
The study is classed as a Non-Significant Risk Device 
Study and the study will be conducted in accordance with 
the abbreviated Investigational Device Exemption (IDE) 
requirements set forth in 21 CFR 812.2(b). 
Objectives: 
To demonstrate that the safety and performance profile of 
the Neurotech Vital Compact (delivering electrical 
stimulation through external electrodes) is equivalent to the 
itouch Sure Pelvic Floor Exerciser (delivering electrical 
stimulation through an internal vaginal probe). 
Primary Endpoint: 
The primary endpoint is defined as the proportion of 
subjects considered to have achieved at least a 50% 
reduction in pad weight following a provocative pad 
weight test at 12 weeks compared to baseline.  
Key Secondary 
Endpoints: 
The following key secondary endpoints will each be 
analysed, for superiority, at a 5% two-sided significance 
level with a view to support labelling. In order to control 
the type I error rate the endpoints will be analysed in the 
following hierarchy (Statistical Plan will supply further 
details).  If any endpoint in the sequence fails to show a 
statistically significant difference then the inference is that 
there is insufficient evidence both for that endpoint and the 
subsequent endpoints in the hierarchy. 
 
1. Between group comparison of mean change, with 
respect to baseline, in urine leakage in a 
provocative pad weight test at Week 12; 
2. Within Neurotech Vital Compact group estimate of 
mean change, with respect to baseline, in urine 
leakage in a provocative pad weight test at Week 
12; 
3. Between group comparison of mean change, with 
respect to baseline, in urine leakage in the 24-hour 
pad weight test at Week 12; 
4. Within Neurotech Vital Compact group estimate of 
mean change, with respect to baseline, in urine 
leakage in the 24-hour pad weight test at Week 12; 
5. Between group comparison of mean change, with 
respect to baseline, in the number of incontinence 

                   Study No: BMR-13-1001 
 
 
Study Ref: Neurotech Vital Compact RCT 
 
 
Version: 2.0 FINAL 27 March 2015 
 
CONFIDENTIAL                                                     Page 8 of 132 
 
episodes/day recorded using a 7-day voiding diary 
at Week 12;  
6. Within Neurotech Vital Compact group estimate of 
mean change, with respect to baseline, in the 
number of incontinence episodes/day recorded 
using a 7-day voiding diary at Week 12;  
7. Between group comparison of the mean 
improvement, with respect to baseline, in 
Incontinence Quality of Life Questionnaire (I-QOL) 
score at Week 12; 
8. Within Neurotech Vital Compact group estimate of 
mean improvement, with respect to baseline, in 
Incontinence Quality of Life Questionnaire (I-QOL) 
score at Week 12; 
9. Between group comparison of mean change, with 
respect to baseline, in the number of pads used/day 
recorded using a 7-day voiding diary at Week 12; 
10. Within Neurotech Vital Compact group estimate of 
mean change, with respect to baseline, in the 
number of pads used/day recorded using a 7-day 
voiding diary at Week 12; 
11. Between group comparison of the proportion of 
subjects achieving dryness at Week 12 (<1g on the 
provocative pad weight test). 
 
Other Secondary 
Endpoints: 
Other secondary endpoints that will be evaluated at 4 
weeks and 26 weeks are as follows: 
 
 Proportion of subjects considered to have achieved 
significant improvement, defined as a greater than 
50% reduction in pad weight, from baseline on the 
provocative pad weight test. 
 Urine leakage on the provocative pad weight test 
(following standardized bladder-filling protocol). 
 Urine leakage experienced by the subject at home 
in the 24-hour pad weight test; 
 Incontinence episodes/day recorded using a 7-day 
voiding diary; 
 Proportion of subjects achieving dryness (<1g on 
the provocative pad weight test)  
 Improvement in quality of life assessed using the 
Incontinence Quality of Life Questionnaire (I-
QOL); 
 Number of pads/day recorded using a 7-day voiding 
diary; 
 Dryness, defined as a pad weight of less than 1.3g 
on the 24-hour pad weight test (including an 
evaluation at 12 weeks); 
 Proportion of subjects considered to have achieved 

                   Study No: BMR-13-1001 
 
 
Study Ref: Neurotech Vital Compact RCT 
 
 
Version: 2.0 FINAL 27 March 2015 
 
CONFIDENTIAL                                                     Page 9 of 132 
 
significant improvement, defined as a greater than 
50% reduction in pad weight, from baseline on the 
24-hour pad weight test (including an evaluation at 
12 weeks). 
 
Other data that will be evaluated are as follows: 
 
 Proportion of subjects achieving dryness at Week 
12 in each group (<1g on the provocative pad 
weight test). 
 Within Neurotech Vital Compact group estimate of 
mean change, with respect to baseline, in sexual 
function as measured by the Pelvic Organ 
Prolapse/Urinary Incontinence Sexual 
Questionnaire (PISQ-IR) at Week 12; 
 Between group comparison of mean change, with 
respect to baseline, in sexual function as measured 
by the Pelvic Organ Prolapse/Urinary Incontinence 
Sexual Questionnaire (PISQ-IR) at Week 12; 
 Within Neurotech Vital Compact group estimate of 
patient response to the Patient Global Impression of 
Improvement (PGI-I) at Week 12. 
 Between group comparison of patient response to 
the Patient Global Impression of Improvement 
(PGI-I) at Week 12; 
 Safety in relation to adverse events and device 
deficiencies reported; 
 Evaluation of reduction in urine leakage on the 
provocative pad weight test in relation to the mean 
intensity of the stimulation delivered during the 12-
week treatment programme; 
 Evaluation of the reduction in urine leakage on the 
provocative pad weight test at Week 12 in relation 
to the BMI category 
(underweight/normal/overweight/obese) of the 
subjects; 
 Evaluation of the reduction in urine leakage on the 
provocative pad weight test at Week 12 in relation 
to the baseline severity of stress urinary 
incontinence of the subjects; 
 Device compliance of the Neurotech Vital Compact 
device with the treatment protocol during the 12-
week treatment programme; 
 Device compliance of the itouch Sure Pelvic Floor 
Exerciser with the treatment protocol during the 12-
week treatment programme; 
 
Indication: 
Stress urinary incontinence defined as ‘complaint of 
involuntary leakage on effort or exertion, or on sneezing 

                   Study No: BMR-13-1001 
 
 
Study Ref: Neurotech Vital Compact RCT 
 
 
Version: 2.0 FINAL 27 March 2015 
 
CONFIDENTIAL                                                     Page 10 of 132 
 
and coughing’ (International Continence Society). 
Inclusion Criteria: 
 
Subjects who are female and at least 18 years of age, 
and not more than 65 years of age. 
 
Subjects who have signed an informed consent form 
prior to any study related activity.  
 
Subjects who have previously tried and failed to 
improve their condition using Kegel exercises. 
 
Subjects who have been clinically diagnosed with 
stress urinary incontinence and demonstrate a greater 
than or equal to 3g urine leakage and a less than or 
equal to 90g urine leakage (>3g and < 90g) following 
a bladder-filling protocol and then a standardised  
stress test (provocative pad weight test) at the baseline 
assessment. 
 Subjects who score 9 or less (<9) out of 18 for the 
Urge Incontinence Questions and are confirmed as 
having predominant stress urinary incontinence on the 
Medical, Epidemiologic and Social Aspects of Aging 
Urinary 
Incontinence 
(MESA) 
Questionnaire 
completed at the screening assessment. 
 Subjects with a Body Mass Index of ≤ 35 kg/m2. 
 Subjects of child-bearing potential who are using a 
highly effective contraceptive method (established use 
of oral, injected, implanted hormonal method of 
contraception or barrier method of contraception with 
spermicide). 
 Subjects who are willing not to seek any other 
treatment for stress incontinence during the study 
period. 
 Subjects who are able to give voluntary, written 
informed consent to participate in this study and from 
whom consent has been obtained. 
 Subjects who are able to understand this study and are 
willing to complete all the study assessments. 
Exclusion Criteria: 
 Subjects who have an existing medical condition that 
would compromise their participation in the study,  
e.g. reduced sensory perception in the contact area of 
the stimulation electrodes; scars or vaginal tissue 
wounds,  lesions or inflamed/infected areas in the 
contact area of the stimulation electrodes; vaginal 
bleeding between menstrual periods; uncontrolled 
diabetes.  
 Subjects who have a physical condition that would 
make them unable to perform the study procedures, 
e.g. pelvic or hip surgery within the past 6 weeks. 
 Subjects who have been diagnosed with Chronic 
Obstructive Pulmonary Disease (COPD).  
 Subjects with a history of an underlying neurological 
condition, e.g. Multiple Sclerosis, Parkinson’s disease, 

                   Study No: BMR-13-1001 
 
 
Study Ref: Neurotech Vital Compact RCT 
 
 
Version: 2.0 FINAL 27 March 2015 
 
CONFIDENTIAL                                                     Page 11 of 132 
 
epilepsy.  
 Subjects with any bladder abnormality that would 
affect the urinary flow through the lower urinary tract 
including symptoms of a urinary tract infection, 
abnormal bladder capacity (e.g., >300 cc), post void 
residual volume >200 cc, spastic bladder, vesico-
ureteral reflux or bladder stones.  
 Subjects with a blood clotting disorder or who are 
taking anti-coagulant medications. 
 Subjects who have previously had any uro-
gynaecological related surgery that would affect the 
pelvic floor muscles or urinary flow through the 
urethra (excluding hysterectomy). 
 Subjects who have previously had pelvic floor 
radiation. 
 Subjects who have previously been treated for stress 
incontinence with injectable bulking agents and/or 
vaginal probes within the past 6 months. 
 Subjects with a clinical diagnosis of prolapse greater 
than Stage 2. 
 Subjects who are pregnant or could be pregnant. 
 Subjects who are less than 6 months post-partum or 
who are lactating. 
 Subjects who have any conductive intra-uterine 
devices or metal implants in the pelvic area, including 
hip and lumbar spine. 
 Subjects with pelvic pain or fibromyalgia or 
paravaginal defect. 
 Subjects with an active implanted medical device (e.g. 
pacemaker, insulin pump) or conditions that may be 
adversely affected by electrical stimulation (e.g. 
cardiac arrhythmias). 
 Subjects with a current or active history of pelvic 
cancer and/or subjects with a life expectancy of less 
than 12 months. 
 Subjects who are currently involved in any injury 
litigation claims. 
 Subjects who have participated in a clinical study in 
the last 3 months or any previous clinical study with 
Bio-Medical Research Ltd. 
 Subjects who have been committed to an institution by 
virtue of an order issued either by the courts or by an 
authority. 
Study Sites: 
Approximately 12 USA sites  
 
Number of subjects 
planned: 
Approximately 180 subjects (90 subjects per group). 
Target population: 
The patient population will be females with stress 
incontinence.  

                   Study No: BMR-13-1001 
 
 
Study Ref: Neurotech Vital Compact RCT 
 
 
Version: 2.0 FINAL 27 March 2015 
 
CONFIDENTIAL                                                     Page 12 of 132 
 
Study duration: 
Subjects included in the clinical study will be evaluated at 
screening, on enrolment into the study (baseline) and 
during the 12-week treatment programme at 4 and 12 
weeks. Telephone calls will be made at 1 week to check on 
the patient’s progress during their initial use of the device. 
Subjects will also be evaluated at 26 weeks following the 
commencement of the treatment.  
 
The recruitment period is estimated as 12 months with an 
anticipated study duration of 28 months.  
Study 
device/procedure: 
Neurotech Vital Compact device is CE approved as a Class 
IIa Device in Europe, in line with Medical Device 
Directive 93/42/EC as amended by 2007/47/EC. 
 
FDA has determined that Neurotech Vital Compact is a 
Non-Significant Risk device.  The study is therefore 
classed as a Non-Significant Risk Device Study and 
accordingly  it  will be conducted in accordance with the 
abbreviated Investigational Device Exemption (IDE) 
requirements set forth in 21 CFR 812.2(b) in the USA. 
Comparator 
device/procedure: 
The itouch Sure Pelvic Floor Exerciser (manufactured by 
TensCare Ltd., UK) is cleared by the FDA through the 510 
(k) premarket notification process (K103698) in the USA. 
Device treatment 
program: 
Subjects who are considered eligible to participate in the 
clinical study and give consent will be randomised to 
complete either a 12-week treatment programme with the 
Neurotech Vital Compact or a 12-week treatment 
programme with the itouch Sure Pelvic Floor Exerciser.  
 
The 12-week treatment programme will be completed by 
the subjects at home with the device in accordance with the 
device Instructions for Use. The Neurotech Vital Compact 
is used for five days each week (each daily session of 30 
minutes) with two rest days taken within a 7 day week 
period, for the 12-week period.  
 
The itouch Sure Pelvic Floor Exerciser is used once per 
day (each daily session of 20 minutes) during the 12-week 
period. 
Performance 
assessments: 
Performance will be assessed by: provocative  pad weight 
test following a standardized bladder-filling protocol 
verified by ultrasound bladder scanning; 24-hour pad 
weight test; Incontinence Quality of Life Questionnaire (I-
QOL); incontinence episodes/day and number of pads 
used/day from 7-day voiding diary; and assessment of 
‘dryness’ and ‘significantly improved’.  
Safety assessments: 
Safety will be assessed in terms of severity, frequency and 
seriousness of any adverse events or adverse device effects. 
Concomitant 
Medication and/or 
 Subjects may use any medication that has an effect 
upon urinary output function if a) the medication has 

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CONFIDENTIAL                                                     Page 13 of 132 
 
Treatments: 
been used for at least 4 weeks prior to study enrolment 
and b) the medication regimen is not changed during the 
12-week device treatment program 
 No device re-treatment will be allowed during the 
subject’s participation in the study. 
Single-Blind Status: 
The study is considered single-blind as the subjects will be 
randomised to the Neurotech Vital Compact device or the 
itouch Sure Pelvic Floor Exerciser (ratio 1:1). Since the 
two devices will be described in detail in the patient 
information sheet, the patients will know which device 
they have been randomised to i.e. the Neurotech Vital 
Compact device delivers electrical stimulation through 
external electrodes and the itouch Sure Pelvic Floor 
Exerciser delivers electrical stimulation through an internal 
vaginal probe. It is not believed this will introduce any bias 
since patients would not have an expectation that either 
device is better than the other. 
 
The site personnel who allocate the devices, perform the 
device training at baseline and monitor the device 
compliance at the follow-up visits will not be blinded, but 
the personnel who perform the follow-up assessments will 
be blinded. The statistical analysis will be blinded until 
data base lock 
 
Verification to ensure that this blinding is maintained will 
be assessed at the monitoring visits. 
STUDY 
ASSESSMENTS  
Visit 1: Screening 
 
 
 Demographic data including height and weight. 
 Medical history including details of stress urinary 
incontinence, previous bladder/kidney infections and 
any current/previous urological treatments.  
 Physical examination including a detailed urological 
examination to assess urinary symptoms and symptoms 
of bowel function, sexual function and pelvic organ 
prolapse.  
 Details of all medication (over-the-counter and 
prescription) and dietary/herbal supplements in the 
previous 6 months. 
 Urine pregnancy test to confirm subject is not pregnant 
(women of child-bearing potential only). 
 Complete the Medical, Epidemiologic and Social 
Aspects of Aging Urinary Incontinence (MESA) 
Questionnaire (patient quality of life questionnaire). 
 Complete a standardized stress test to evaluate amount 
of urine lost following a standardized bladder-filling 
protocol verified by ultrasound (provocative pad weight 
test). The data from this test will not be used for 

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Study Ref: Neurotech Vital Compact RCT 
 
 
Version: 2.0 FINAL 27 March 2015 
 
CONFIDENTIAL                                                     Page 14 of 132 
 
analysis purposes, it is only to allow patients to practise 
the stress test. Further details are provided in Appendix 
I. 
 Record any cough or cold symptoms. 
 Record any adverse events. 
 
Prior to leaving the clinic, subjects will also be provided 
with the  following: 
  A 7-day voiding diary to complete prior to Visit 2 
(baseline) appointment.   
 Pre-weighed incontinence pads in a sealed bag to 
complete the 24-hour pad collection for three days prior 
to the Visit 2 (baseline) appointment. Any subjects 
menstruating during this time will also be asked to 
record this on the voiding diary. Any subjects who have 
sexual intercourse during this time will be asked to 
expel any fluid post-intercourse and will be asked also 
to record this on the voiding diary.     
Assessments Visit 2: 
Baseline 
 Complete 
the 
Incontinence 
Quality 
of 
Life 
Questionnaire 
(I-QOL) 
(patient 
quality 
of 
life 
questionnaire). 
 Complete 
the 
Pelvic 
Organ 
Prolapse/Urinary 
Incontinence Sexual Questionnaire (PISQ-IR) 
 Complete a standardized stress test to evaluate amount 
of urine lost following a standardized bladder-filling 
protocol verified by ultrasound bladder scanning 
(provocative pad weight test). This is used to determine 
eligibility to participate. Further details are provided in 
Appendix I. 
 Number of incontinence episodes/day from 7-day 
voiding diary. 
 Number of pads used/day from 7-day voiding diary. 
 Mean weight of urine lost during three consecutive 24-
hour periods at home (difference in post- and pre-
weight incontinence pads) (24-hour pad weight test).  
 Record any medication use since the last visit. 
 Record any cough or cold symptoms since the last visit. 
 Record any adverse events since the last visit. 
 Subject training on use of device and complete one 
session in clinic 
 
Prior to leaving the clinic, subjects will also be provided 
with the  following: 
  A 7-day voiding diary to complete prior to Visit 3 
appointment.  
 Pre-weighed incontinence pads in a sealed bag to 
complete the 24-hour pad collection for three days prior 
to the Visit 3 appointment. Any subjects menstruating 
during this time will also be asked to record this on the 

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voiding diary. Any subjects who have sexual 
intercourse during this time will be asked to expel any 
fluid post-intercourse and will be asked also to record 
this on the voiding diary.     
Telephone call: 1 
week 
 
 Telephone call to check the patient is happy with the 
treatment set up and using the device as per the 
instructions and to assess if there any adverse events 
and/or changes to medication. 
Assessments Visit 3: 
4 weeks 
Assessments Visit 4: 
12 week 
Assessments Visit 5: 
26 week 
 
 
 Urine pregnancy test to confirm subject is not pregnant 
(pre-menopausal subjects only) (Week 4 assessment 
only). 
 Complete 
the 
Incontinence 
Quality 
of 
Life 
Questionnaire 
(I-QOL) 
(patient 
quality 
of 
life 
questionnaire). 
 Complete Pelvic Organ Prolapse/Urinary Incontinence 
Sexual Questionnaire (PISQ-IR) (Week 12 assessment 
only). 
 Complete Patient Global Impression of Improvement 
(PGI-I) (Week 12 assessment only). 
 Complete a standardized  provocative stress test to 
evaluate amount of urine lost following a standardized 
bladder-filling protocol (provocative pad weight test)  
 Number of incontinence episodes/day from 7-day 
voiding diary. 
 Number of pads used/day from 7-day voiding diary. 
 Mean weight of urine lost during a three day 24-hour 
period at home (difference in post- and pre-weight 
incontinence pads) (24-hour pad weight test).  
 Record any medication use since the last visit. 
 Record any cough or cold symptoms since the last visit. 
 Record any adverse events since the last visit. 
 Data from the device will be downloaded to determine 
stimulation intensity and duration of treatment were 
completed 
according 
to 
the 
planned 
treatment 
programme (Week 4 and 12 assessment only and 
completed by unblinded study personnel). 
 
At Visit 4, subjects will also be provided with training and 
an instruction flyer for pelvic floor exercises (Kegel 
exercises). Participants will be advised to perform Kegel 
exercises from 12 weeks to the 26 weeks follow-up. 
 
Prior to leaving the clinic at Visit 3 and 4, subjects will 
also be provided with the  following: 
  A 7-day voiding diary to complete prior to next 
appointment.  
 Pre-weighed incontinence pads in a sealed bag to 
complete the 24-hour pad collection for three days prior 
to the next appointment. Any subjects menstruating 

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during this time will also be asked to record this on the 
voiding diary. Any subjects who have sexual 
intercourse during this time will be asked to expel any 
fluid post-intercourse and will be asked also to record 
this on the voiding diary.     
 
 

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Personnel Involved in the Study 
 
Role 
Name 
Sponsor/Manufacturer: 
Bio-Medical Research Ltd 
Parkmore Business Park West 
Galway, Ireland 
 
US Study Director: 
Dr Barbara Powers 
President 
Expedite Research, LLC 
 
Technical Director: 
Dr Conor Minogue 
Technical Director 
Bio-Medical Research Ltd 
 
Regulatory Affairs: 
Brendan McCormack 
Quality Manager 
Bio-Medical Research Ltd 
 
Sponsor Medical Advisor: 
Dr Patricia Smith 
Chief Executive Officer (CEO) 
Bio-Medical Research Ltd 
 
Statistician: 
Diane Tipping, MS 
Senior Director, Biostatistics 
Prosoft Clinical 
 
Data Management: 
Jeff Harbaugh 
Senior Manager, Data Management 
Prosoft Clinical 
 
 
 
 
 
 
 

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2   Introduction 
 
2.1 
Background 
 
The International Continence Society (ICS) defines urinary incontinence as the involuntary loss 
of urine that is a social or hygienic problem and one that is objectively demonstrable. Stress 
urinary incontinence (SUI) is urinary incontinence during physical activities that increase intra-
abdominal pressure such as coughing, sneezing or lifting. Stress urinary incontinence often 
leads to patients limiting their participation in social activities, which in turn has a subsequent 
impact on a person’s quality of life. While some seek surgical intervention, physical therapy is 
seen as the first treatment option in this often under-reported condition. There are a number of 
treatments available to the therapist. Most women treated for stress urinary incontinence will 
have been introduced to pelvic floor muscle training exercises however adjunctive approaches 
such as biofeedback, vaginal weights and electrical stimulation are also treatment options. 
 
Bo (2004) described the goal of physical therapy in the treatment of stress urinary incontinence 
as an attempt to improve pelvic floor muscle function by increasing strength, coordination, 
speed and endurance. The effect of these training adaptations is the maintenance of an elevated 
position of the bladder neck during raised intra-abdominal pressures and a subsequent adequate 
urethral closing force as described by Ashton-Miller et al. (2001).  
 
Castro (2008) reported a significant decrease in urine lost during pad tests and in the number of 
stress urinary episodes, as well as a significant improvement in the quality of life, in subjects 
who underwent a programme of pelvic floor exercises, electrical stimulation or use of vaginal 
weights compared to a control group. In this study there was no observed difference between 
treatment groups suggesting each intervention to be equally effective. While it is reported that 
these interventions can be effective in the treatment of stress urinary incontinence the issues of 
technique, comfort of treatment and compliance with treatment are often limiting factors that 
impact patient outcomes. This has motivated the search to identify an electrical stimulation 
treatment modality that ensures satisfactory recruitment of the pelvic floor muscles and that is 
easy to administer and more comfortable for the patient. This resulted in the development of a 
novel electrical stimulation (ES) device that includes a wired garment which locates a set of 
skin contact electrodes around the pelvic area.  
  
A pilot study (n=9) with this novel ES system (first generation device called UCD RS device) 
conducted at  University College Dublin has shown improved outcomes (Maher and Crowe, 
2008) following an 8 week treatment programme. In particular, subjects using the ES system 
achieved a significant decrease in symptoms when compared to the control group. At Week 1 
all subjects could perform appropriate volitional contractions of their pelvic floor muscle in 
standing but more importantly there was a reported 87.43% decrease in leakage. At Week 8, 
subjects reported a 97.71% decrease in leakage (P<0.01) and the IIQ-7 and Modified Oxford 
scores also changed significantly (P<0.01). 
 
A pilot study (n=19) has recently been completed in Germany at St. Hedwig Krankenhaus 
(Soeder and Tunn, 2013) which looked at a 12 week treatment programme with the second 
generation device (called Inko RS device). Sixteen subjects completed baseline measurements 
while 14 and 13 subjects completed the 12-week and 26-week assessments, respectively. Mean 
(SD) urine leakage on the 1-hour and 24-hour pad weight tests improved (p<0.05) from 41.6g 
(43.92) to 5.8g (13.19) and 21.8g (19.41) to 5.6g (5.16) respectively after completion of the 12 
week programme. These improvements were substantially retained at the 26 week point. In 

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addition, 57% of subjects were classified as dry at the 12 week point, based on a 1-hr stress test 
result of less than 2g. This coincided with enhanced quality of life scores during and following 
the intervention period.  Secondary measures also identified a reduction (p<0.05) in the number 
of leakages experienced per day, from 2.5 (2.81) at baseline to 1.2 (2.28) at 26 weeks with an 
improvement in the modified Oxford scale.  One patient suffered an allergic skin reaction to the 
hydrogel electrodes. 
 
A randomised study (n=51) is currently ongoing in Germany at three sites with the third 
generation device (Neurotech Vital device). The purpose of this study is to test whether a 12-
week programme with the Neurotech Vital device significantly improves the symptoms of 
stress incontinence in female subjects compared to a modified Neurotech Vital device (sham 
device). In addition, the long term effects of a 12-week treatment with the Neurotech Vital 
device will be evaluated.  
 
The purpose of this proposed study is to conduct a pivotal study comparing the Neurotech Vital 
Compact device (fourth generation device) to an FDA 510(k) approved predicate device (itouch 
Sure Pelvic Floor Exerciser) to generate clinical date to submit to the FDA to obtain regulatory 
clearance. 
 
2.2 
  Rationale of Study Population 
 
The clinical study is designed to be prospective to ensure that the population is representative of 
the type of population for which the Neurotech Vital Compact device is intended to treat. 
Subjects will be drawn from clinics focusing on this type of treatment.  These clinics may 
advertise using an approved advertisement to recruit additional subjects. 
 
The patient population will be female patients identified by the clinic as seeking treatment for 
urinary stress incontinence. These patients will have previously tried volitional pelvic floor 
muscle exercises and have been unsuccessful in their attempts to alleviate their symptoms. 
 
2.3 
  Rationale of Neurotech Vital Compact Device  
 
The research evidence supporting the use of electrical stimulation (ES) in pelvic floor 
neuromuscular rehabilitation for stress urinary incontinence (SUI) is somewhat equivocal. 
While some studies (Castro, 2008; Sand, 1995) have shown a beneficial effect of ES that is 
comparable to other conservative interventions, there are other studies which have failed to 
show a clear benefit (Bo, 1999).  There has been a lack of homogeneity in the study designs and 
most especially in the equipment used. Most studies have used one or other of the commercially 
available trans-vaginal ES systems and little information has been provided as to the 
effectiveness of the particular system used in activating the target muscle group. A further 
difficulty with transvaginal ES is that some patients object to using the intra-vaginal probe 
electrodes.  A novel form of ES for pelvic floor stimulation has been developed which utilises 
an array of external electrodes and this is believed, based on observation using pelvic floor (PF) 
ultrasonography, to deliver much greater levels of PF muscle activation than the transvaginal 
approach. 
 
Thus in this study we will be using the Neurotech Vital Compact device to deliver 
neuromuscular electrical stimulation (NMES) to the pelvic floor muscles via an arrangement of 
external electrodes optimally positioned to successfully stimulate these muscles and held in 
place by a garment to facilitate good skin contact and repeatability of positioning. The 

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Neurotech Vital Compact device is the fourth generation of the device which has been 
developed using the same technology as the UCD RS device (first generation device) and Inko 
RS device (second generation device).  
 
Previous experience indicates that NMES muscle training effects are cumulative over a period 
of time and early indication using the device for five days with two rest days in a 7 day period 
for a stipulated period of weeks provides an optimum effect. A treatment regimen has therefore 
been selected where patients self-administer 30 minutes of treatment for 5 days each week for a 
12 week period. It is anticipated that most patients would respond in a quicker time with short 
term beneficial results within 8 weeks, however, a 12-week treatment period is more likely to 
result in cumulative muscle training effects. Patients will control the intensity of stimulation 
within predefined levels from the control unit which will also maintain an electronic record of 
usage times and intensity to check for compliance. 
 
2.4 
  Rationale for Using the itouch Sure Pelvic Floor Exerciser 
 
After consideration of the recommendations made by the Food and Drug Administration (FDA) 
at a meeting in October 2013, the itouch Sure Pelvic Floor Exerciser has been selected since it 
is a 510 (k) approved device in the USA. The comparator device is cleared by the FDA through 
the 510 (k) premarket notification process (K103698) and also CE Mark approved in Europe. 
 
The iTouch Sure Pelvic Floor Exerciser was specifically selected since its intended use is very 
similar to the Neurotech Vital Compact device. The iTouch device is intended to provide 
electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak 
pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women. 
In addition, the device is intended for home use by the patient with a pre-set programme for 
stress incontinence with a compliance monitor. In this study the itouch device will be used 
daily, as recommended by the manufacturer. 
 
There are no significant additional risks related to the treatment of the patients with the itouch 
Sure Pelvic Floor Exerciser.  Previous studies with vaginal electrodes have reported isolated 
incidents of vaginal irritation and infection. (Sand et al 1995) 
  
2.5 
    Rationale of a Single-Blind Study Design 
 
The study is considered single-blind as the subjects will be randomised to either the Neurotech 
Vital Compact device or the itouch Sure Pelvic Floor Exerciser. Since the two devices will be 
described in detail in the patient information sheet, the patients will know to which device they 
have been randomised, i.e. the Neurotech Vital Compact device delivers electrical stimulation 
through external electrodes and the itouch Sure Pelvic Floor Exerciser delivers electrical 
stimulation through an internal vaginal probe. This should not introduce any bias since patients 
would not have an expectation that the new device (Neurotech Vital Compact device) is better 
than the existing active control device (itouch Sure Pelvic Floor Exerciser). 
 
The site personnel who allocate the devices, perform the device training at baseline and monitor 
the device compliance at the follow-up visits will not be blinded, but the personnel who perform 
the follow-up assessments will be blinded.  
  
Verification to ensure that this blinding is maintained will be assessed at the monitoring visits.     
 

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2.6 
 Risk/Benefit of the Neurotech Vital Compact Device 
 
2.6.1 Residual Risks Identified in Risk Analysis Report 
 
As part of the risk analysis process conducted during development, all identified risks were 
subjected to review and were either eliminated or reduced to ‘as low as reasonably possible’ 
(ALARP) by changes in process, documentation and planned user training. 
 
Potential risks under these ALARP categories include manufacturing, labelling, storage and 
user error problems.   
 
2.6.2 Risks Associated with Participation in the Clinical Study 
 
There are no anticipated additional risks to involvement in this clinical study than would be 
expected for normal treatment of this condition with alternative NMES devices with the 
possible but unlikely exception of patient sensitivity to the constituent materials of the 
garment/device materials. However, there is no reason to suspect that any reaction would occur 
or that there would be any subsequent long term health problems. All of these materials have 
been extensively used and documented for their biocompatibility with human skin. The garment 
and devices will be used in accordance with the Instructions for Use. 
 
2.6.3 Possible Interactions with Concomitant Medical Treatments 
 
There is no reason to suspect that NMES treatment would cause any interaction with 
concomitant medications.  A full list of conditions contraindicated for use with NMES is 
documented in the Instructions for Use and subjects with these conditions are excluded via the 
inclusion/exclusion criteria for the study. 
 
2.6.4 Steps to be Taken to Control or Mitigate Risks 
 
Full Failure Modes Effects Analysis (FMEA) has been conducted, in line with ISO14971, for 
all stages of design, manufacturing, storage, shipping and clinical use of this device.  These 
have been continually updated at various stages during the introduction of this device aiming to 
identify and then address each potential risk in terms of severity of risk, potential frequency of 
occurrence (i.e. what could go wrong, what is the probability it could go wrong, what are the 
implications/severity if it does go wrong).  Each identified risk was then subject to discussions 
over whether any action could be taken internally or through ‘Instructions for Use’ to reduce 
these risk scores to the ALARP (as low as reasonably possible) level felt to be acceptable. 
 
2.7 
Risk/Benefit Rationale 
 
NMES is a safe treatment option for stress urinary incontinence.  Once patients have been 
trained in the use of the device and application of the electrodes and associated garments, self-
treatment is continued at home for up to 12 weeks without the need for prolonged interim 
hospital visits as part of routine care.  The Neurotech Vital Compact device can be used with 
external electrode placement which is more acceptable for patients than the use of internal 
(vaginal or anal) electrodes or other internal devices. 
 
Alternative non NMES treatment options such as Kegel pelvic floor exercises are not successful 
for many patients for a variety of reasons and may require regular motivational visits during the 

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training period.  Pharmaceutical options for stress urinary incontinence are very limited and are 
not suitable for all patients.  
 
Ultimately, surgical intervention provides relief for many patients but is obviously fraught with 
inherent surgical and anaesthetic risks not seen in less invasive therapies, in addition to hospital 
costs.  
 
Therefore, there is a safety and cost benefit for the use of an external NMES device over 
alternative treatment options including surgery. 
 
2.8 
Risk/Benefit of the itouch Sure Pelvic Floor Exerciser 
 
The itouch Sure Pelvic Floor Exerciser is manufactured by TensCare Ltd., 9 Blenheim Road, 
Longmead Business Park, Epsom, Surrey, KT19 9BE, UK.  
 
In accordance with its regulatory obligation for FDA clearance and European CE approval, 
Tenscare Ltd. are required to have completed a risk/benefit analysis and Full Failure Modes 
Effects Analysis (FMEA), in line with ISO14971, for all stages of design, manufacturing, 
storage, shipping and clinical use of this device  As evidenced by their continued certification to 
ISO13485, TensCare Ltd also maintain updated records in line with Medical Device Directive 
93/42/EC, as amended by 2007/47/EC, to ensure the continued device safety and performance 
profiles. 
 
The risk/benefit for the itouch Sure Pelvic Floor Exerciser is well established since the device is 
cleared by the FDA through the 510 (k) premarket notification process (K103698) in the USA 
and also CE Mark approved in Europe.  
 
The Manufacturer and User Facility Device Experience (MAUDE) database details medical 
device reports submitted to the FDA in the USA by mandatory reporters (manufacturers, 
importers and device user facilities) and voluntary reporters such as health care professionals, 
patients and consumers. To date, there are no recorded issues filed for the use of the itouch Sure 
Pelvic Floor Exerciser on the MAUDE database. 
 
The use of the device in this study poses no additional risks to the subjects since it is being used 
in accordance with the Instructions for Use (IFU for this device as used in this study are 
believed to be compliant with the US FDA 501(k) label). 
 
 
 
 

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3  Objectives 
 
3.1 
Primary Objective 
 
The primary objective of this clinical study is to evaluate and compare the safety and 
performance profile of the Neurotech Vital Compact device (delivering electrical stimulation 
through external electrodes) and the itouch Sure Pelvic Floor Exerciser (delivering electrical 
stimulation through an internal vaginal probe) for the treatment of stress urinary incontinence 
following a 12-week treatment program. 
 
3.2 
Secondary Objectives 
 
The secondary objectives of this clinical study are to further evaluate the safety and 
performance of the Neurotech Vital Compact device compared to the itouch Sure Pelvic Floor 
Exerciser. 
 
 
  
 

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4 Study Design 
 
This is a prospective, randomised, controlled, single-blind, multi-site clinical study to be 
conducted in the United States of America (USA) employing Neuromuscular Electrical 
Stimulation (NMES) to stimulate the pelvic floor muscles of women suffering from stress 
urinary incontinence. 
 
Approximately one-hundred and eighty (180) female patients diagnosed with stress urinary 
incontinence will be enrolled in this study. All patients who are considered eligible to 
participate in the clinical study and give consent will be randomised to complete either a 12-
week treatment programme with the Neurotech Vital Compact device or a 12-week treatment 
programme with the itouch Sure Pelvic Floor Exerciser. The 12-week treatment programme will 
be completed by the subjects at home with treatment with the device in accordance with the 
device Instructions for Use.  
 
Subjects included in the clinical study will be evaluated at screening, on enrolment into the 
study (baseline) and during the 12-week treatment programme at 4 and 12 weeks. A telephone 
call will be made at 1 week to check on the patient’s progress. In addition, subjects will be 
evaluated at 26 week following their commencement of the treatment.  
 
Telephone support will be available throughout the duration of the study. A clinical study 
Schedule of Events is presented in Appendix I. 
 
All information provided to the subjects will be provided in a language in which they are 
conversant for both reading and speaking which will include: Incontinence Quality of Life 
Questionnaire (I-QOL) (Appendix V); Instructions for Use for the allocated device (Appendices 
XI and XII); Medical, Epidemiologic and Social Aspects of Aging Urinary Incontinence 
Questionnaire (MESA) (Appendix VII) ; Pelvic Organ Prolapse/Urinary Incontinence Sexual 
Questionnaire (PISQ-IR) (Appendix VI); Patient Global Impression of Improvement (PGI-I) 
(Appendix IX); the voiding diary (Appendix VIII); patient information sheet and consent 
documents (Appendix X). 
 
 

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5 Trial Endpoints 
 
5.1 
Primary Endpoint 
 
The primary endpoint is defined as the proportion of subjects considered to have achieved 
‘significant improvement’ following a provocative pad weight test at 12 weeks compared to 
baseline.  
 
‘Significant improvement’ is defined as a greater than 50% reduction in pad weight from 
baseline. 
 
5.2 
Key Secondary Endpoints to Support Indication for Use 
 
The following key secondary endpoints will each be analysed, for superiority, at a 5% two-
sided significance level with a view to support labelling. In order to control the type I error rate 
the endpoints will be analysed in the following hierarchy (see Section 14.0 Statistical Plan for 
further details).  If any endpoint in the sequence fails to show a statistically significant 
difference then the inference is that there is insufficient evidence both for that endpoint and the 
subsequent endpoints in the hierarchy. 
 
 Between group comparison of mean change, with respect to baseline, in urine leakage in 
a provocative pad weight test at Week 12; 
 Within Neurotech Vital Compact group estimate of mean change, with respect to 
baseline, in urine leakage in a provocative pad weight test at Week 12; 
 Between group comparison of mean change, with respect to baseline, in urine leakage in 
the 24-hour pad weight test at Week 12; 
 Within Neurotech Vital Compact group estimate of mean change, with respect to 
baseline, in urine leakage in the 24-hour pad weight test at Week 12; 
 Between group comparison of mean change, with respect to baseline, in the number of 
incontinence episodes/day recorded using a 7-day voiding diary at Week 12;  
 Within Neurotech Vital Compact group estimate of mean change, with respect to 
baseline, in the number of incontinence episodes/day recorded using a 7-day voiding 
diary at Week 12;  
 Between group comparison of the mean improvement, with respect to baseline, in 
Incontinence Quality of Life Questionnaire (I-QOL) score at Week 12; 
 Within Neurotech Vital Compact group estimate of mean improvement, with respect to 
baseline, in Incontinence Quality of Life Questionnaire (I-QOL) score at Week 12; 
 Between group comparison of mean change, with respect to baseline, in the number of 
pads used/day recorded using a 7-day voiding diary at Week 12; 
 Within Neurotech Vital Compact group estimate of mean change, with respect to 
baseline, in the number of pads used/day recorded using a 7-day voiding diary at Week 
12; 
 Between group comparison of the proportion of subjects achieving dryness at Week 12 
(<1g on the provocative pad weight test). 
 
5.3 
Secondary Endpoints - Other 
 
Other secondary endpoints that will be evaluated at 4 weeks and 26 weeks are as follows: 
        

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 Proportion of subjects considered to have achieved significant improvement, defined as 
a greater than 50% reduction in pad weight, from baseline on the provocative pad weight 
test. 
 Urine leakage on the provocative pad weight test (following standardized bladder-filling 
protocol). 
 Urine leakage experienced by the subject at home in the 24-hour pad weight test; 
 Incontinence episodes/day recorded using a 7-day voiding diary; 
 Proportion of subjects achieving dryness (<1g on the provocative pad weight test)  
 Improvement in quality of life assessed using the Incontinence Quality of Life 
Questionnaire (I-QOL); 
 Number of pads/day recorded using a 7-day voiding diary; 
 Dryness, defined as a pad weight of less than 1.3g on the 24-hour pad weight test 
(including an evaluation at 12 weeks); 
 Proportion of subjects considered to have achieved significant improvement, defined as 
a greater than 50% reduction in pad weight, from baseline on the 24-hour pad weight 
test (including an evaluation at 12 weeks). 
 
Other data that will be evaluated are as follows: 
 
 Proportion of subjects achieving dryness at Week 12 in each group (<1g on the 
provocative pad weight test). 
 Within Neurotech Vital Compact group estimate of mean change, with respect to 
baseline, in sexual function as measured by the Pelvic Organ Prolapse/Urinary Incontinence 
Sexual Questionnaire (PISQ-IR) (Appendix VI) at Week 12; 
 Between group comparison of mean change, with respect to baseline, in sexual function 
as measured by the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-
IR) at Week 12; 
 Within Neurotech Vital Compact group estimate of patient response to the Patient 
Global Impression of Improvement (PGI-I) at Week 12. 
 Between group comparison of patient response to the Patient Global Impression of 
Improvement (PGI-I) at Week 12; 
 Safety in relation to adverse events and device deficiencies reported; 
 Evaluation of reduction in urine leakage on the provocative pad weight test in relation to 
the mean intensity of the stimulation delivered during the 12-week treatment 
programme; 
 Evaluation of the reduction in urine leakage on the provocative pad weight test at Week 
12 in relation to the BMI category (underweight/normal/overweight/obese) of the 
subjects; 
 Evaluation of the reduction in urine leakage on the provocative pad weight test at Week 
12 in relation to the baseline severity of stress urinary incontinence of the subjects; 
 Device compliance of the Neurotech Vital Compact device with the treatment protocol 
during the 12-week treatment programme; 
 Device compliance of the itouch Sure Pelvic Floor Exerciser with the treatment protocol 
during the 12-week treatment programme. 
 
 

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6 Trial Population 
 
6.1 
Number of Subjects 
 
Subjects who meet all of the inclusion and none of the exclusion criteria will be randomized 
into the study until approximately 180 healthy female subjects have completed the study.   
 
6.2 
Inclusion Criteria 
 
1. Subjects who are female and at least 18 years of age, and not more than 65 years of age. 
2. Subjects who have signed the informed consent form prior to any study related activity. 
3. Subjects who have previously tried and failed to improve their condition using Kegel 
exercises. 
4. Subjects who have been clinically diagnosed with stress urinary incontinence and 
demonstrate a greater than or equal to 3g urine leakage and a less than or equal to 90g 
urine leakage (>3g and < 90g) following a bladder-filling protocol and then a 
standardised stress test (provocative pad weight test) at the baseline assessment. 
5. Subjects who score 9 or less (<9) out of 18 for the Urge Incontinence Questions and are 
confirmed as having predominant stress urinary incontinence on the Medical, 
Epidemiologic and Social Aspects of Aging Urinary Incontinence (MESA) 
Questionnaire completed at the screening assessment. 
6. Subjects with a Body Mass Index of ≤ 35 kg/m2. 
7. Subjects of child-bearing potential who are using a highly effective contraceptive 
method (established use of oral, injected, implanted hormonal method of contraception 
or barrier method of contraception with spermicide). 
8. Subjects who are willing not to seek any other treatment for stress incontinence during 
the study period. 
9. Subjects who are able to give voluntary, written informed consent to participate in this 
study and from whom consent has been obtained. 
10. Subjects who are able to understand this study and are willing to complete all the study 
assessments. 
 
6.3 
Exclusion Criteria 
 
1. Subjects who have an existing medical condition that would compromise their 
participation in the study, e.g. reduced sensory perception in the contact area of the 
stimulation electrodes; scars or vaginal tissue wounds,  lesions or inflamed/infected 
areas in the contact area of the stimulation electrodes; vaginal bleeding between 
menstrual periods; uncontrolled diabetes.  
2. Subjects who have a physical condition that would make them unable to perform the 
study procedures, e.g. pelvic or hip surgery within the past 6 weeks. 
3. Subjects who have been diagnosed with Chronic Obstructive Pulmonary Disease 
(COPD).  
4. Subjects with a history of an underlying neurological condition, e.g.  Multiple Sclerosis, 
Parkinson’s disease, epilepsy. 
5. Subjects with any bladder abnormality that would affect the urinary flow through the 
lower urinary tract including signs or symptoms of an active urinary tract infection, 
abnormal bladder capacity (e.g., >300 cc), post void residual volume >200 cc, spastic 
bladder, vesico-ureteral reflux or bladder stones.  
6. Subjects with a blood clotting disorder or who are taking anti-coagulant medications. 

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7. Subjects who have previously had any uro-gynaecological related surgery that would 
affect the pelvic floor muscles or urinary flow through the urethra (excluding 
hysterectomy). 
8. Subjects who have previously had pelvic floor radiation. 
9. Subjects who have previously been treated for stress incontinence with injectable 
bulking agents and/or vaginal probes within the past 6 months. 
10. Subjects with a clinical diagnosis of prolapse greater than Stage 2. 
11. Subjects who are pregnant or could be pregnant. 
12. Subjects who are less than 6 months post-partum or who are lactating. 
13. Subjects who have any conductive intra-uterine devices or metal implants in the pelvic 
area, including hip and lumbar spine. 
14. Subjects with pelvic pain or fibromyalgia or paravaginal defect. 
15. Subjects with an active implanted medical device (i.e. pacemaker, insulin pump etc.) or 
conditions that may be adversely affected by electrical stimulation (e.g. cardiac 
arrhythmias). 
16. Subjects with a current or active history of pelvic cancer and/or subjects with a life 
expectancy of less than 12 months. 
17. Subjects who are currently involved in any injury litigation claims. 
18. Subjects who have participated in a clinical study in the last 3 months or any previous 
clinical study with Bio-Medical Research Ltd. 
19. Subjects who have been committed to an institution by virtue of an order issued either 
by the courts or by an authority. 
 
6.4 
Withdrawal Criteria 
 
During the course of this study, subjects may be withdrawn, or may elect to withdraw through 
any of the listed following reasons below. However all subjects will be assessed on an 
individual basis when clarifying their withdrawal and for this reason, measurable parameters 
cannot be specifically defined for the withdrawal criteria below: 
 
 
Subject’s rescission of consent.   
 
Any adverse event, related to the device or not, which may endanger the well-being of the 
subject if they were not withdrawn. 
 
Subject non-compliance or protocol violation. 
 
Subject unable to meet the protocol requirements. 
 
Development of a medical condition or illness which may compromise safety of the 
subjects or invalidate the results of the study. 
 
The Investigator will clearly document the date and reason(s) for withdrawal in the Case Report 
Form.  
 
All subjects discontinued from the study due to an adverse event will be followed up by the 
Investigator until resolution or condition has stabilised. 
 
Subjects who are withdrawn prior to the completion of the baseline assessments only will be 
replaced.  
 
6.5 
Monitoring for Subject Compliance 
 

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Subject compliance will be based on three assessments, namely, the level of completion of 
patient 7-day voiding diary, attendance at scheduled follow-up visits plus evaluation of the 
internal memory of the Neurotech Vital Compact device and the itouch Sure Pelvic Floor 
Exerciser or the Device Record (diary) to check daily use parameters and schedules. 

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7 Study Treatments  
 
One device will be issued to each randomized subject in a single-blinded manner.  The 
investigator and those administering the 1-hour provocative stress test, evaluating adverse 
events and reviewing diary data are to remain blinded regarding treatment assignment.  
 
7.1 
Description 
 
The Neurotech Vital Compact Device consists of a controller and a garment.  
 
7.1.1 Neurotech Vital Compact Controller 
 
The Neurotech Vital Compact Controller is a powered Neuromuscular Electrical Stimulation 
(NMES) device manufactured by Bio-Medical Research Ltd. 
 
The Neurotech Vital Compact Controller is manufactured as a sealed, handheld portable unit 
containing electronics and a rechargeable battery with an LCD screen and keypad for 
interaction with the user (see Figure 1).  The outer casing is manufactured from ABS resin and 
the device has been independently certified to comply with IEC60601-1-1 and IEC60601-2-10.  
 
The Neurotech Vital Compact Controller is CE Mark approved as a Class IIa Device in Europe, 
in line with Medical Device Directive 93/42/EC as last amended by 2007/47/EC, and will be 
used in accordance with the Instructions for Use. 
 
Figure 1. The Neurotech Vital™ Compact device Controller 
 
 
 
 
The stimulation current is delivered to the body through an array of conductive adhesive 
electrodes (in accordance with the pre-defined parameters) which are held in place by a garment 
which wraps around the buttocks and thigh area (see  Table 1). This ensures the current passes 
from the electrode set on one side of the body to the other and this approach has been found to 
be particularly effective in activating the pelvic floor muscles. 
 
 

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 Table 1.  Parameter Specifications on the Neurotech Vital Compact Controller 
 
The 
pulse 
is 
a 
conve
ntiona
l symmetric biphasic type with constant current control. The phase duration is 620μs and the 
maximum current amplitude is 120mA, leading to a maximum charge per pulse of 74 μC. The 
maximum rms current of this pattern is 30mA. The total power from the device at maximum 
output intensity setting with all electrodes active into a 500Ω load is 0.45 W. This maximum is 
comparable to the available power from several 8-electrode systems which are already cleared 
to market by the US Food and Drug Administration (FDA). For example Compex Sport 
(K011880) delivers up to 0.48W (100mA @ 120Hz, phase duration=400 μs). 
 
Subjects will be at liberty to alter the intensity of the stimulation to the highest tolerable level 
and provided with guidance on the intensity of the muscle contraction to be achieved.  
 
The Neurotech Vital Compact Controller will only permit stimulation if the garment is 
connected to the unit.   
 
For purposes of this study, the Neurotech Vital Compact is to be used per the Instructions for 
Use (IFU) provided in Appendix XI.  A Vital Compact Quick Start Guide is also included in 
Appendix XI. 
 
7.1.2 Neurotech Vital Garment 
 
The Neurotech Vital Compact Garment is intended for use with the Neurotech Vital Compact 
Controller to aid the placement of the electrodes and to help keep them securely in place (see 
Figure 2). The garment is made from an outer material which is 80% nylon, 20% elastane and 
a100% polyurethane inner.  Fasteners are manufactured in nylon.  All of these materials have 
been extensively used and documented for their biocompatibility with human skin. The garment 
will be used in accordance with the Instructions for Use. 
 
Duration 
of each 
session 
Frequency 
Pulse 
Width 
Ramp-Up 
time 
Contract 
Time 
Ramp 
Down Time 
Relax 
time 
30 minutes 
50Hz 
620s 
0.5 
seconds 
5 seconds 
0.5 seconds 
5 seconds 

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Figure 2. The Neurotech Vital Compact device connected to the garment 
 
 
 
7.1.3 Hydrogel Electrodes 
 
The hydrogel electrodes are comprised of a three-layer conductive medium to deliver the 
electrical current. The electrodes are manufactured by Axelgaard (Fallbrook, C.A USA), a 
leading supplier to the medical device sector, and have undergone rigorous safety and 
biocompatibility testing. The double adhesive electrodes in the Neurotech Vital Compact device 
measure 15.0 by 10.5 cm and disperse the current over a large area of skin resulting in a low 
current density. The maximum current density remains low at less than 0.05 mA/cm2 which is 
typical of TENS devices used in clinical practice. 
 
The hydrogel electrodes are CE Mark approved as a Class I Device in Europe, in line with 
Medical Device Directive 93/42/EC as last amended by 2007/47/EC. 
 
7.1.4 Pre-clinical Data 
 
The Neurotech Vital Compact Controller has been tested by an independent test house (SGS, 
UK) and certified to be in conformance with the requirements of the IEC60601 series of 
standards. The controller is CE-marked under the European Medical Device Directive, 
authorised by the notified body, VDE Germany. The garment and electrode materials are 
certified to be in conformance with bio-compatibility standard ISO 14993. 
 
There are no tissues of human or animal origin or any medicinal substances used in the 
garments, electrodes, or Neurotech Vital Compact device. 
 
7.2 
itouch Sure Pelvic Floor Exerciser 
 

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The itouch Sure Pelvic Floor Exerciser is manufactured by TensCare Ltd., 9 Blenheim   Road, 
Longmead Business Park, Epsom, Surrey, KT19 9BE, UK. 
 
This is an intravaginal device that will be used daily for 20 minutes.  Further details on the 
itouch Sure Pelvic Floor Exerciser are presented in the 510(k) Summary (see Appendix II) and 
Instructions for Use (Appendix XII). The device will be used in accordance with the 
Instructions for Use provided for this study for treatment of stress incontinence. 
 
7.2.1 Packaging and Labelling 
 
The Neurotech Vital Compact device will be provided packaged, along with its electrode lead 
and hydrogel electrodes, in a box with an identifying serial number, part number and subject 
number. The device will also bear the CE mark.   
 
The Neurotech Vital garments will be separately packaged and also will have their own 
identifiable lot numbers.  Expiry dates will also be found on the electrode packaging.   
 
The itouch Sure Pelvic Floor Exerciser will be provided packaged, along with vaginal 
lubricating gel, in a box with identifying serial number and subject number.  The device will 
bear the CE mark.  
 
Each device will be in packaging with a label with at least the following information: 
 
For Clinical Trial Use Only 
Study Number: 
BMR-13-1001 
Contents: One Neurotech Vital Compact or itouch Sure Pelvic Floor Exerciser 
Subject Number: 
XXXXX 
Treatment Duration: 12 weeks at 30 minutes 5 days a week (Neurotech Vital Compact) or 12 
weeks of 20 minutes 7 days a week (itouch Sure Pelvic Floor Exerciser) 
Lot number: XXXXXXXX 
Storage:  Store at ambient (room) temperature 
Study Sponsor and Manufacturer for Neurotech Vital Compact:  Bio-Medical Research Ltd., 
Parkmore Business Park West, Galway, Ireland.   
US Study Director Expedite Research, LLC, 15 Kerry LN, Phoenixville, PA 19460 
Caution:  The Neurotech Vital Compact is an investigational device limited by US Federal 
Law to be used by qualified Investigators only. 
 
7.3 
Device Storage and Accountability 
 
Formal accountability will be performed for all devices. The Investigator will be provided with 
a Device Accountability Log to track disposition of all devices including the itouch Sure Pelvic 
Floor Exerciser, Neurotech Vital Compact devices, hydrogel electrodes and Neurotech Vital 
garments (left and right).  
 

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All devices must be stored in a secure place at ambient temperature. It is the responsibility of 
the Investigator to ensure that devices are stored correctly at the site. The Investigator must also 
make the devices, eCRFs, clinic notes and Investigator File available for inspection by the 
monitor upon request.   
 
During this clinical study or upon its completion or termination, the Investigator will return all 
devices to Bio-Medical Research Ltd.  Bio-Medical Research Ltd will keep a record of the 
number of devices provided and returned. 
 
7.4 
Device Training/Experience 
 
At the initiation visit, the Principal Investigator and the research team will be provided with 
extensive training on the use of the Neurotech Vital Compact device and the itouch Sure Pelvic 
Floor Exerciser. The site will also be provided with training on how to train the subjects in the 
use of the devices in accordance with the Instructions for Use. All site and subject training will 
be documented. 
 
7.5 
Randomisation and Blinding  
 
Subjects will be randomised to the Neurotech Vital Compact device or the itouch Sure Pelvic 
Floor Exerciser (1:1 ratio).  They will know to which device they have been randomised since 
the two devices will be described in detail in the patient information sheet i.e., the Neurotech 
Vital Compact device delivers electrical stimulation through external electrodes and the itouch 
Sure Pelvic Floor Exerciser delivers electrical stimulation through an internal vaginal probe.  
 
The site personnel who perform the device training at baseline and monitor the device 
compliance at the follow-up visits will not be blinded, but the personnel who perform the 
follow-up assessments will be blinded regarding device assignment.  
 
Verification to ensure that this blinding is maintained will be assessed at the monitoring visits. 
 
7.6 
Concomitant Medication and/or Treatments 
 
Subjects may use any medication that affects urinary output function if the medication has been 
used for at least 4 weeks prior to study enrolment and the medication regimen is not changed 
during the 12-week device treatment program 
 
No device re-treatment will be allowed during the subject’s participation in the study. 
 
 
7.7 
Treatment Compliance 
 
Compliance will be assessed by reviewing the medical chart for information regarding the date 
and time of study visits.  At each visit, information will be obtained from the devices 
(depending on the device) including treatment time, highest intensity reached and average 
intensity.  In addition, subjects will be asked to complete a daily record of device use which will 
capture the duration of treatment and the maximum intensity reached during that session. 
 
7.8 
Unblinding/Breaking the Blind 
 

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The first course of treatment for any suspected device-related event or effect is to stop using the 
device.  If necessary, the investigator may be made aware of the allocated treatment via the 
unblinded personnel at the site. 
 
 
 
 

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8 Study Procedures 
 
8.1 
Ethical and Regulatory Considerations 
 
Prior to the study start relevant Institutional Research Board (IRB) approval will be obtained in 
writing and submitted to the Sponsor and no subjects will be recruited until a formal site 
initiation visit has been conducted. 
 
This study will be conducted in compliance with: 
 
 
Study Protocol 
 
Applicable local IRB requirements  
 
US and international standards of Good Clinical Practice (FDA abbreviated IDE 
requirements set forth in 21 CFR 812.2(b), 21 CFR Part 50 and FDA guidance E6. 
 
Declaration of Helsinki as adopted by the 18th World Medical Assembly in 1964 and as 
revised in Tokyo (1975), Venice (1983), Hong Kong (1989), South Africa (1996), 
Edinburgh (2000), Washington (2002 note of clarification added), Tokyo (2004 note of 
clarification added), Korea (2008) and Brazil (2013). 
 
Clinical study insurance and indemnity will be provided as required under local laws and 
practices. 
 
Confidentiality of subject data will be maintained at all times. Subject anonymity will be 
guaranteed and all documentation relating to a subject will be kept in a secure location. 
 
8.2 
Regulatory Considerations 
 
The Sponsor considers this study is a Nonsignificant Risk Study for the following reasons: 
 
 
In response to a written submission (Q 130879) filed by the company, giving details of the 
study design and the devices to be used, FDA has informed the sponsor in writing that this 
study may be considered a Nonsignificant Risk Study. 
 
The study does not meet the definitions for a Significant Risk Study. 
 
Non-implantable Electrical Incontinence Devices are classed by the FDA as an example of 
a nonsignificant risk device. 
 
The Neurotech Vital Compact included in this study is a Class II, CE marked medical 
device but has not been 510 (k) cleared by the FDA in the USA. 
 
The risks related to the use of the devices are minimal and the devices are being used under 
the supervision of the Investigator. 
 
The study will therefore be conducted in accordance with the abbreviated Investigational 
Device Exemption (IDE) requirements set forth in 21 CFR 812.2(b). 
 
The FDA also confirmed that the Neurotech Compact device can be classified as a 
Nonsignificant Risk device (19 September 13) since it met the definitions under 21 CFR 
812.3(m). 
 
8.3 
Informed Consent 
 

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The Investigator will introduce the subject to the study by explaining the study procedures and 
objectives to the subject. The Investigator will then provide an information sheet describing the 
study, potential discomforts, risks and benefits of participation.  The subject will have sufficient 
time to decide whether she wishes to participate in this study.  
 
Any queries that subjects may have regarding this study will be addressed appropriately by the 
Investigator. Subjects will be instructed that they are free to obtain further information from the 
Investigator at any time, that they are free to withdraw their consent and to discontinue their 
participation in the study at any time without prejudice. 
 
 
If the subject is willing to participate in the study, they must read, understand and sign the 
informed consent form.  The Investigator will also sign this on the same occasion.  The original 
copy of the signed consent form will be kept in the secure location at the study site, a copy 
provided to the subject and a copy filed in the medical records.    
 
Written informed consent from the subject must be obtained before any clinical study related 
procedures are performed. 
 
8.4 
Study Start and Training 
 
A summary of the schedule of events is provided in Appendix I.  The study will not commence 
at a site until all the necessary approvals are in place and a formal study initiation visit has taken 
place. At the initiation visit, the monitor will ensure that all study personnel are fully aware of 
all study requirements and assessments. Extensive training on the use of the Neurotech Vital 
Compact device and the itouch Sure Pelvic Floor Exerciser will be provided as will training on 
how to train the subjects to use the devices correctly. 
Study staff will document completion of protocol, device and study methodology training by 
signing the Study Training Log.   
8.5 
Study Recruitment  
Subjects who attend the clinic for treatment of urinary stress incontinence will be approached 
by the Investigator to take part in the clinical study. Additionally, an approved advertisement 
will be made available to sites if they wish to advertise to recruit subjects into this clinical 
study. 
8.6 
Study Duration 
 
Each subject will receive a 12-week period of treatment, which is preceded by a short period of 
time (2 to 4 weeks) for discussions of potential study involvement and provision of informed 
consent and formal evaluation of suitability for study inclusion.  
 
Each subject will remain in the study for 14-weeks following completion of the 12 week 
treatment programme, therefore each subject will be involved for approximately 30 weeks. 
 
8.7 
Subject Eligibility 
 
Once written informed consent has been obtained, the Case Report Form will be completed to 
document adherence to the inclusion and exclusion criteria.  

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Where a subject fails to fulfill any element of the inclusion and exclusion criteria, this will be 
documented and the signed consent form and completed inclusion/exclusion criteria retained by 
the Investigator. The subject will not be advanced further in the study.  
 
When a subject is considered eligible for entry into the study, the subject will be randomized to 
the next available subject number (subject ID number). This number will be the unique 
identifier of the subject and written on each page of the Case Report Form and all other study 
documentation relating to the subject.  
 
8.8 
Randomisation 
 
At the initiation visit, the designated personnel will be trained regarding how to conduct and 
document the randomisation of subjects enrolled into the study at that site.  
 
The site will be provided with randomisation envelopes which will be used to allocate the 
devices. Access to these randomisation envelopes will be limited to the designated un-blinded 
personnel working on the study at the site.  
 
When a subject has agreed to participate in the study, given informed consent, and is considered 
eligible with the inclusion/exclusion criteria, she will be entered into the study and only then 
will she be randomised to either device. The designated un-blinded personnel will train the 
subject according to which treatment has been allocated. 
 
In the event of an emergency whereby it becomes necessary to know to which treatment the 
subject has been allocated, the investigator may be made aware of the allocated treatment via 
the unblinded personnel at the site. A documented procedure will be provided to the site before 
the study commences.  
 
All baseline assessments must be completed prior to randomisation.  
 
8.9 
Screening Assessments – Visit 1 
 
Each subject considered eligible for entry into this clinical study, and from whom written 
consent has been obtained, will have a screening assessment with the following 
information/procedures recorded (within 14 days of baseline assessment): 
 
 Demographic data including height and weight. 
 Medical history including details of stress urinary incontinence, previous bladder/kidney 
infections and any current/previous urological treatments.  
 Physical examination including a detailed urological history to assess urinary symptoms and 
symptoms of bowel function, sexual function and pelvic organ prolapse.  
 Details of all medication (over-the-counter and prescription) and dietary/herbal supplements 
in the previous 6 months. 
 Urine pregnancy test to confirm subject is not pregnant (women of child-bearing potential 
only). 
 Complete the Medical, Epidemiologic and Social Aspects of Aging Urinary Incontinence 
(MESA) Questionnaire (patient quality of life questionnaire). 
 Complete a standardized stress test to evaluate amount of urine lost following a standardized 
bladder-filling protocol verified by ultrasound bladder scanning (provocative pad weight 

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test).  The data from this test will not be used for analysis purposes, it is only to allow 
patients to practice the stress test. Further details of the stress test protocol and instructions 
for the Investigator and subject are provided in Appendix III.   
 Record any cough or cold symptoms. 
 Record any adverse events. 
 
Prior to leaving the clinic, subjects will also be provided with the following: 
 A 7-day voiding diary to complete seven days prior to the Visit 2 (baseline) appointment.   
 Pre-weighed incontinence pads in a sealed bag to complete the 24-hour pad collection for 
three days prior to the Visit 2 (baseline) appointment.   
 
The subject will then be asked to return the 7-day voiding diary and incontinence pads in the 
same sealed bag to the clinic at Visit 2. Any subjects menstruating during the three days prior to 
Visit 2 will also be asked to record this on the voiding diary. Any subjects who have sexual 
intercourse during this three day period will be asked to expel any fluid post-intercourse and 
also record this on the voiding diary. 
 
8.10 Baseline Assessments – Visit 2 
 
On the subject’s return to the clinic to return the 7-day voiding diary and incontinence pads, the 
following information/procedures will be recorded: 
 
 
Complete the Incontinence Quality of Life Questionnaire (I-QOL) (patient quality of life 
questionnaire). 
 
Complete the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-
IR). 
 
Complete a standardized stress test to evaluate amount of urine lost following a 
standardized bladder-filling protocol verified by ultrasound bladder scanning (provocative 
pad weight test). This assessment will be used to determine the subject’s eligibility to 
participate. Further details of the stress test protocol and instructions for the Investigator 
and subject are provided in Appendix III. 
 
Number of incontinence episodes/day from 7-day voiding diary. 
 
Number of pads used/day from 7-day voiding diary. 
 
Mean weight of urine leaked during three consecutive 24-hour periods at home (difference 
in post- and pre-weight incontinence pads) (24-hour pad weight test). Severity score will be 
assessed as dry (less than 2g), mild (greater or equal to 2g and less than 10g), moderate 
(greater or equal to 10g and less than 50g) and severe (greater than 50g) (O’Sullivan, 
2004). 
 
Record any medication use or changes in medication since the last visit. 
 
Record any cough or cold symptoms since the last visit. 
 
Record any adverse events since the last visit. 
 
These assessments will be performed by the designated blinded site personnel only. 
 
8.10.1 Device Training 
 
Subjects will be briefed by the designated non-blinded site personnel on the set-up of the 
Neurotech Vital Compact device or the itouch Sure Pelvic Floor Exerciser (in accordance with 
the allocated treatment as per the randomisation schedule). Subjects will then be asked to follow 

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the set-up instructions and complete a 30 minute session with the Neurotech Vital Compact 
device or a 20 minute sessions with the itouch Sure Pelvic Floor Exerciser in accordance with 
the appropriate Instructions for Use. Subjects will be at liberty to alter the intensity of the 
stimulation to the highest tolerable level and will be advised on the importance of achieving a 
strong pelvic floor contraction. Guidance will be given on the typical minimum intensity setting 
to achieve this effect. Subjects will be advised that it not necessary to achieve this level in their 
first session but that they should gradually increase the setting in their first week of use. 
 
All of the subject’s training will be documented. Subjects unable to demonstrate competent use 
of the Neurotech Vital Compact device or the itouch Sure Pelvic Floor Exerciser will be 
withdrawn from the clinical study.  
 
The subject will be provided with the Neurotech Vital Compact device or the itouch Sure Pelvic 
Floor Exerciser to take home with them. Details of all devices provided, including the serial/lot 
numbers, will be recorded.  
 
8.10.2  Treatment Programme Schedule – Neurotech Vital Compact device 
 
Subjects will be advised that they should empty their bladder prior to commencing the 30 
minute session of the Neurotech Vital Compact device at home. 
 
The subjects will be instructed to use the device at home once per day, in a therapeutic position, 
for five days each week with two rest days taken within a 7 day week period, for the 12-week 
period. Each treatment cycle is fixed at 30 minutes and the device will alert the subject when 
the cycle is completed.   
 
Subjects will be advised that during the 12-week treatment programme not to do any new pelvic 
floor exercises. 
 
8.10.3 Treatment Programme Schedule – itouch Sure Pelvic Floor Exerciser 
 
Subjects will be advised that they should empty their bladder prior to commencing the 20 
minute session of the itouch Sure Pelvic Floor Exerciser at home. 
 
In accordance with the instructions for use for the device, the subjects will be instructed to use 
the device at home once per day for the 12-week period. Each treatment cycle is fixed at 20 
minutes and the device will alert the subject when the cycle is completed.   
 
Subjects will be advised that during the 12-week treatment programme not to do any new pelvic 
floor exercises. 
 
8.10.4 Prior to Leaving Clinic 
 
Prior to leaving the clinic, subjects will also be provided with the following: 
 
 A 7-day voiding diary to complete seven days prior to Visit 3 appointment.  
 A device record form to record device use each day. 
 Pre-weighed incontinence pads in a sealed bag to complete the 24-hour pad collection 
for three days prior to the Visit 3 appointment.   
 

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The subject will then be asked to return the 7-day voiding diary, device record and incontinence 
pads in the same sealed bag to the clinic at Visit 3. Any subjects menstruating during the three 
days prior to Visit 3 will also be asked to record this on the voiding diary. Any subjects who 
have sexual intercourse during this three day period will be asked to expel any fluid post-
intercourse and also record this on the voiding diary 
 
Subjects will be advised they can telephone the clinic at any time to discuss any concerns.
 
 
 
8.11 Assessments During 12-Week Treatment Programme – Visit 3 and Visit 4 
 
8.11.1 Early Termination 
 
If a subject starts treatment discontinues before completing all study visits, she is to be asked to 
return to the clinic to complete a Visit 4 visit as an early termination visit  (if prior to that visit) 
or a Visit 5 visit (if after Visit 4 has taken place).   
 
8.11.2 Telephone Contact 
 
The subjects will be contacted via telephone at one week (Week 1) following Visit 2 to assess if 
there are any issues with the treatment, if they are using the device as per the Instructions for 
Use and to assess if there are any adverse events and/or changes to medication. 
 
8.11.3 Timing of Visit Assessments (+/- 7 days) 
 
Patients included in the clinical study will return for follow-up visits at 4 weeks (Visit 3) and 12 
weeks (Visit 4) during the 12-week treatment programme.  
 
8.11.4 One Week Prior to Visit 
 
Approximately 7 days before each of the planned assessments, subjects will be contacted by 
telephone to remind them that their follow-up appointment is due and that they should start 
completing the 7-day voiding diary they have been provided which collects information on 
number of leaks and number of pads used per day.  They will also be reminded that they should 
also start using their pre-packaged pads to complete the 24-hour pad collection 3 days prior to 
their appointment and remind them to bring the diary, pads and device back to the clinic.   
 
8.11.5 Assessments 
 
At each visit the following information/procedures will be recorded by the designated blinded 
site personnel: 
 
 
Urine pregnancy test to confirm subject is not pregnant (women of child-bearing 
potential only) (Week 4 only). 
 
Complete the Incontinence Quality of Life Questionnaire (I-QOL) (patient quality of 
life questionnaire). 
 
Complete the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire 
(PISQ-IR) (Week 12 only). 
 
Complete the Patient Global Impression of Improvement (PGI-I) (Week 12 only). 
 
Complete a standardized stress test to evaluate amount of urine lost following a 

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standardized bladder-filling protocol verified by ultrasound bladder scanning 
(provocative pad weight test). Further details of the stress test protocol and 
instructions for the Investigator and subject are provided in Appendix III. 
 
Number of incontinence episodes/day from 7-day voiding diary. 
 
Number of pads used/day from 7-day voiding diary. 
 
Mean weight of urine lost during a three day 24-hour period at home (difference in 
post- and pre-weight incontinence pads) (24-hour pad weight test).  
 
Record any medication use or changes in medication since the last visit. 
 
Record any cough or cold symptoms since the last visit. 
 
Record any adverse events since the last visit. 
 
At this visit the following information/procedures will be recorded by the designated unblinded 
site personnel only: 
 
 Hydrogel electrodes will be checked and replaced with new electrodes if required 
(Neurotech Vital Compact device only). 
 Data from the device will be recorded to determine stimulation parameters and 
duration of treatments that were completed according to the planned treatment 
programme. If usage information has been inadvertently erased, the device record 
provided by the patient may be used to provide compliance data. 
 
At Visit 3 and Visit 4 subjects will be provided with a 7-day consecutive voiding diary and pre-
weighed incontinence pads in a sealed bag to complete prior to the next visit. Subjects will be 
reminded to return the 7-day voiding diary and incontinence pads in the same sealed bag to the 
clinic at the next visit. Any subjects menstruating during the three days prior to the next visit 
will also be asked to record this on the voiding diary. Any subjects who have sexual intercourse 
during this time will be asked to expel any fluid post-intercourse and will be asked to record this 
on the voiding diary. 
 
8.12 Pelvic Floor Exercises – Visit 4 Only 
 
At Visit 4, the subjects will be provided with a set of instructions for pelvic floor exercises 
(Kegel exercises as outlined in Appendix IV). Subjects will be advised to perform Kegel 
exercises daily from 12 weeks to the 26 weeks follow-up.  The device and all study-related 
equipment must be returned to the clinic at this visit. 
    
8.13 Assessments Following Treatment Programme – Visit 5 
 
The same assessments as detailed in Section 9.9.3 and 9.9.4, apart from any assessments related 
to the devices will be performed at  6 months (+/- 14 days) (Visit 5).  
                  
8.14 Adverse Event Reporting – All Visits 
 
All subjects will be evaluated throughout the study for adverse events. All adverse events, 
including the following, will be assessed by the Investigator, and recorded in the subject Case 
Record Form including: 
 
 
Observed or volunteered problems 
 
Complaints 

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 
Physical signs and symptoms 
 
Medical condition which occurs during the study, having been absent at baseline 
 
The need to capture adverse events is not dependent upon whether or not the clinical event is 
associated with the use of the device. The Investigator will take all appropriate and necessary 
therapeutic measures required for resolution of the adverse event. 
 
The Investigator should institute appropriate therapeutic and follow-up measures in accordance 
with good medical practice but should notify the monitor of such actions and record them in the 
subject’s Case Report Form.   
 
Further details on adverse events including definitions are provided in Section 10.0. 
 
Each adverse event must be described in detail including the date of onset, date of resolution, 
severity, anticipated/unanticipated, frequency of the event (single episode, intermittent, 
continuous), action taken (none, medical and/or surgical), outcome, relationship to 
device/procedure, device details (type no./lot no./device status) and if defined as serious must 
be recorded.  Each adverse event must be recorded separately. 
 
Severity will be assessed using the following definitions: 
 
 
Mild  
Aware of sign or symptom, but easily tolerated 
Moderate  
Discomfort enough to cause interference with usual activity 
Severe 
Incapacitating with inability to work or do usual activity 
 
The relationship to the device will be assessed by the Investigator using the following 
definitions: 
 
 Not   
Related 
Evidence exists that the adverse event definitely has a cause other 
than the study device (e.g. pre-existing condition or underlying 
disease, current illness, or concomitant medication) and does not 
meet any other criteria listed.  
  
 Possibly  
Related 
A temporal relationship exists between the event onset and 
administration of device.  Although the adverse event may appear 
unlikely to be related to the study device, it cannot be ruled out 
with certainty; and or the event cannot be readily explained by the 
subject’s clinical state or concomitant therapies. 
 
Probably 
Related 
A temporal relationship exists between the event onset and 
administration of device, and appears with some degree of 
certainty to be related based on known mechanism of action of the 
device.  It cannot be readily explained by the subject’s clinical 
state or concomitant therapies. 
 
Definitely 
Related 
Strong evidence exists that the device caused the adverse event.  
There is a temporal relationship between the event onset and 
administration of the device.  There is strong mechanistic evidence 
that the event was caused by the device.    The subject’s clinical 
state and concomitant therapies have been ruled out as a cause.  

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9 Adverse Events and Device Deficiencies 
 
9.1 
Adverse Events Definitions 
 
Adverse Events: 
Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs 
(including laboratory findings) in subjects, users or other persons, whether or not related to the 
medical device.  
 
Adverse Device Effects: 
An adverse event related to the use of a medical device. 
 
Device Deficiency: 
An inadequacy of a medical device with respect to its identity, quality, durability, reliability, 
safety or performance. Device deficiencies include malfunctions, user errors and inadequate 
labelling. 
 
Collection of Adverse Events: 
Adverse events will be collected for randomized subjects only. 
 
Serious Adverse Events (SAE): 
An adverse event that: 
 Led to death, 
 Led to a serious deterioration in the health of a subject, that resulted in 1) a life 
threatening illness or injury, or 2) a permanent impairment of a body structure or a body 
function, or 3) in patient or prolonged hospitalisation or 4) medical or surgical 
intervention to prevent life threatening illness or injury or permanent impairment to a 
body structure or a body function 
 Led to foetal distress, foetal death or a congenital abnormality or birth defect 
 
Unanticipated Adverse Device Effects (UADE): 
Any serious adverse effect on health or safety or any life-threatening problem or death caused 
by, or associated with, a device, if that effect, problem or death was not previously identified in 
nature, severity, or degree of incidence in the investigational plan or application (including a 
supplementary plan or application), or any other unanticipated serious problem associated with 
a device that relates to the rights, safety, or welfare of subjects. 
 
9.2 
Anticipated Adverse Events 
 
There are a number of known potential adverse events that have been documented, or are 
theoretically potential adverse events with Neuromuscular Electrical Stimulation (NMES).   
 
Potential anticipated adverse events inherent to the use of Neuromuscular Electrical Stimulation 
(NMES) including:  
 
 Temporary skin reaction (irritation, redness and/or inflammation) at or near the 
stimulation site during and following periods of stimulation;  
 Discomfort and pain (including throbbing pain) at or near the stimulation site;  
 Stomach ache; 

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 Change in bowel habits; 
 Twitching, numbness, muscular contraction, tightening, aching; 
 Use of excessive intensity or usage time can cause muscle injury; 
 On very rare occasions, some patients have reported feeling light-headed or faint, so it is 
recommended that patients have somewhere to sit nearby should this happen. 
 
Potential anticipated adverse events specifically related to the use of the Neurotech Vital 
Compact device:  
 Develop a sensitivity to the hydrogel electrodes 
 
Potential anticipated adverse events specifically related to the use of the itouch Sure Pelvic 
Floor Exerciser: 
 Abdominal cramps 
 Vaginal irritation or infection. 
 
9.3 
Reporting to Bio-Medical Research Ltd 
 
ALL SERIOUS ADVERSE EVENTS, SERIOUS ADVERSE DEVICE EFFECTS, 
UNANTICIPATED 
ADVERSE 
DEVICE 
EFFECTS 
AND/OR 
ANY 
DEVICE 
DEFICIENCIES MUST BE REPORTED TO BIO-MEDICAL RESEARCH LTD OR ITS 
AGENT WITHIN 24 HOURS OF BECOMING AWARE OF THE EVENT TO ENSURE 
THE NECESSARY VIGILANCE PROCEDURES/REPORTING REQUIREMENTS AT 
BIO-MEDICAL RESEARCH LTD CAN BE MET. 
 
Expedite Research, LLC must be contacted on the following numbers: 
 
Contact Name:  
Barbara Powers 
Telephone Number: 
1-484-686-0545 
Fax Number: 
1-610-933-1284 
Email: 
Barbara.Powers@ExpediteResearch.com 
 
The Vigilance Department at Bio-Medical Research Ltd must also be contacted on the 
following numbers: 
 
Contact Name:  
Brendan McCormack, Quality Manager  
 
Telephone Number: 
011-35391-774300 
  
 
Fax Number: 
011-35391-774301 
 
 
Email: 
quality@bmr.ie 
 
 
 
9.4 
Institutional Review Board (IRB) Reporting 
 
All serious adverse events, unanticipated adverse device effects and/or device deficiencies will 
be reported to the Institutional Review Board in accordance with the local site requirements and 
to Bio-Medical Research Ltd in accordance with the Study Specific Procedure for the study.  
 

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9.5 
Food and Drug Administration (FDA) Reporting 
 
This study is considered a Nonsignificant Risk Device Study and is being conducted in 
accordance with the abbreviated Investigational Device Exemption (IDE) requirements set forth 
in 21 CFR 812.2(b). 
 
All necessary reporting to the FDA as outlined in FDA guidance (Records under 812.140(b) 4 
and 5 and Reports under 812.150(b) 1-3 and 5-10) will be followed.  
 

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10 Statistical Analysis  
 
This section describes the statistical methods to be used for the analysis and reporting of data 
collected under BMR-13-1001.  Additional details will be provided in the statistical analysis 
plan (SAP). 
 
10.1 Analysis Populations 
 
The primary analysis population will be the intent to treat (ITT) population.  This will include 
all randomized subjects.  Patients will be summarized according to their randomized 
assignment.   
 
A per-protocol (PP) population will also be evaluated for the primary endpoint.  The PP 
population will consist of the following subjects and may be further defined in the Statistical 
Analysis Plan (SAP): 
 
 Signed informed consent 
 Meet inclusion/exclusion criteria 
 Treated per randomized assignment 
 12 week outcome data available  
 
The Safety population will include all randomized subjects who used the device at least once.  
Patients will be summarized according to the actual device used, rather than the randomized 
assignment. 
 
10.2 Sample Size 
 
Sample size calculations were performed using the NQuery Advisor® version 5.0, under a two 
group test of proportions.   
 
Research suggests that the response rates for Neurotech Vital and itouch Sure at 12 weeks will 
be 71% and 46%, respectively (itouch success rate based on Sand, 1995). 
 
The sample size calculation is based on the assumption that the itouch Sure Pelvic Floor 
Exerciser success rate is 52% and the Neurotech Vital Control success rate is 71%. A sample 
size of 87 subjects per group will provide 90% power using a one-sided Type I error rate of 
0.025, and a non-inferiority margin of 5%. A randomization allocation of 1:1 was also assumed. 
For practical reasons, the sample size has been increased to a recruitment of 180 patients (90 
patients per treatment group). 
 
10.3 Statistical Methods 
 
10.3.1 General Statistical Considerations 
 
Data will be summarized using descriptive statistics.  For continuous measures this will include 
mean, standard deviation, median, and range.  For categorical measures, counts and percentages 
will be provided.   Data will be summarized separately for each randomized arm under the 
principles of intent to treat, unless otherwise noted. 
 

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10.3.2 Primary Endpoint 
 
The primary endpoint is defined as the proportion of subjects considered to have achieved 
‘significant improvement’ following a provocative pad weight test at 12 weeks compared to 
baseline.  
 
 
‘Significant improvement’ is defined as a greater than 50% reduction in pad weight from 
baseline. 
 
10.3.3 Hypothesis test 
 
The primary hypothesis that will be tested is that the proportion of patients who respond (i.e. 
have achieved ‘significant improvement’) using Neurotech Vital Compact is not less than 5% 
worse than the itouch Sure Pelvic Floor Exerciser (i.e. the lower bound of the confidence 
interval about the difference between device groups should be greater than - 5%).   
Using a one-sided 2.5% level significance test: 
H0:  pNeurotech Vital Compact  - pCONTROL ≤ - 5% 
H1:  pNeurotech Vital Compact - pCONTROL > - 5% 
Where pNeurotech Vital is the proportion of patients who respond on receiving Neurotech Vital 
Compact and similarly pCONTROL for the itouch Sure Pelvic Floor Exerciser.   
 
If the primary non-inferiority endpoint is met, a hierarchically nested test of superiority will be 
performed.   The hypothesis test for the assessment of superiority is as follows, using a one-
sided 2.5% level significance test: 
 
H0:  pNeurotech Vital Compact  - pCONTROL ≤ 0% 
            H1:  pNeurotech Vital Compact - pCONTROL > 0% 
Where pNeurotech Vital is the proportion of patients who respond on receiving Neurotech Vital 
Compact and similarly pCONTROL for the itouch Sure Pelvic Floor Exerciser. 
 
 
10.3.4 Analysis Methods 
 
For the primary analysis variable (proportion of patients who respond at Week 12) the 
difference in the proportions of responders and a 95% CI of the difference in proportion of 
responders will be calculated using the normal approximation to the binomial distribution. The 
ITT population will serve as the primary analysis population, with PP population analyses 
serving as supportive.  For the ITT analysis, if a subject does not complete the 12 week 
assessment, their outcome will be imputed using multiple imputations.  Non-inferiority will be 
claimed if the lower limit of the 95% CI is greater than -5%. 
 
The total number of successes in each study arm will be summarized, along with the 
corresponding proportions and 95% CIs.  The difference between proportions will also be 
summarized with its corresponding 95% CI. 
Sensitivity analyses will be performed to assess the impact of missing data on the primary 
endpoint results.  These analyses will be based on the ITT population.  A last observation 

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carried forward (LOCF) method will be used to account for all missing data.  A tipping point 
analysis will also be performed (Campbell et al., 2011 and Yan X. et al., 2009).  
10.3.5 Key Secondary Endpoints 
 
The key secondary endpoints listed below will be tested only if the primary efficacy endpoint is 
met.  These endpoints will each be tested at a 5% two-sided significance level. In order to 
control the type I error rate the endpoints will be analysed in the following hierarchy.  If an 
endpoint in the sequence fails to show a statistically significance then no further testing of the 
subsequent endpoints in the hierarchy will be performed. 
 
1. Between group comparison of mean change, with respect to baseline, in urine leakage in a 
provocative pad weight test at Week 12; 
2. Within Neurotech Vital Compact group estimate of mean change, with respect to baseline, 
in urine leakage in a provocative pad weight test at Week 12; 
3. Between group comparison of mean change, with respect to baseline, in urine leakage in the 
24-hour pad weight test at Week 12; 
4. Within Neurotech Vital Compact group estimate of mean change, with respect to baseline, 
in urine leakage in the 24-hour pad weight test at Week 12; 
5. Between group comparison of mean change, with respect to baseline, in the number of 
incontinence episodes/day recorded using a 7-day voiding diary at Week 12;  
6. Within Neurotech Vital Compact group estimate of mean change, with respect to baseline, 
in the number of incontinence episodes/day recorded using a 7-day voiding diary at Week 
12;  
7. Between group comparison of the mean improvement, with respect to baseline, in 
Incontinence Quality of Life Questionnaire (I-QOL) score at Week 12; 
8. Within Neurotech Vital Compact group estimate of mean improvement, with respect to 
baseline, in Incontinence Quality of Life Questionnaire (I-QOL) score at Week 12; 
9. Between group comparison of mean change, with respect to baseline, in the number of pads 
used/day recorded using a 7-day voiding diary at Week 12; 
10. Within Neurotech Vital Compact group estimate of mean change, with respect to baseline, 
in the number of pads used/day recorded using a 7-day voiding diary at Week 12; 
11. Between group comparison of the proportion of subjects achieving dryness at Week 12 (<1g 
on the provocative pad weight test). 
 
 
10.3.6 Hypothesis tests 
 
The key-secondary hypothesis for the between group tests (1, 3, 5, 7 and 9 in the hierarchy 
listed above) is that the key-secondary endpoints of Neurotech Vital Compact is not equal to the 
itouch Sure Pelvic Floor Exerciser.   
Using a two-sided 5% level significance test: 
 
H0: µNeurotech Vital Compact  = µCONTROL  
 
Ha: µNeurotech Vital Compact    ≠ µCONTROL   
Where µNeurotech Vital Compact  and µCONTROL are the mean responses for the key-
secondary variable for Neurotech Vital Compact and the itouch Sure Pelvic Floor Exerciser, 
respectively. 

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The hypothesis for key-secondary endpoint 11 is as follows, using a one-sided 2.5% level 
significance test: 
H0:  pNeurotech Vital Compact  - pCONTROL ≤ 0% 
            H1:  pNeurotech Vital Compact - pCONTROL > 0% 
Where pNeurotech Vital is the proportion of patients who become dry on receiving Neurotech Vital 
Compact and similarly pCONTROL for the itouch Sure Pelvic Floor Exerciser. 
 
The key-secondary hypothesis for the within-group tests (2, 4, 6, 8 and 10 in the hierarchy listed 
above) is that the key-secondary endpoints of Neurotech Vital Compact are not equal to 0.   
Using a two-sided 5% level significance test: 
H0: µNeurotech Vital Compact  = 0  
Ha: µNeurotech Vital Compact    ≠ 0   
Where µNeurotech Vital Compact is the mean responses for the key-secondary variable for Neurotech 
Vital Compact. 
10.3.7 Analysis Methods 
 
Analysis of secondary endpoints will be based on the ITT population.  All available data will be 
used, and no imputation is planned for missing data.  The Week 12 summaries for each device 
group will include the number of observations, mean, median, standard deviation, minimum, 
maximum, and 95% confidence interval.  The difference between device groups will be 
summarized using mean change, standard deviation, and 95% confidence interval of the 
difference.  P-values will be obtained from two-sample t-tests for key-secondary endpoints 1, 3, 
5, 7, and 9.  For key-secondary endpoint 11, the proportion and counts of subjects achieving 
dryness at Week 12 will be summarized by group, along with 95% confidence interval.  The 
difference between device groups will be summarized with the 95% confidence interval for the 
difference.  The p-value from the comparison will be based on a chi-square test.  One-sample t-
tests will be used for key-secondary endpoints 2, 4, 6, 8, and 10.  In the event that data are 
highly non-normal, non-parametric methods may be employed (i.e. signed-rank test, rank-sum 
test). 
 
10.3.8 Other Secondary Endpoints 
 
Additional secondary endpoints will be summarized using descriptive statistics.  There are no 
formal statistical tests associated with these endpoints, and no claims for labelling will be made.     
 
The secondary endpoints that will be evaluated at 4 weeks and 26 weeks are as follows: 
 
 Proportion of subjects considered to have achieved significant improvement, defined as 
a greater than 50% reduction in pad weight, from baseline on the provocative pad weight 
test; 
 Urine leakage on the provocative pad weight test (following standardized bladder-filling 
protocol); 
 Urine leakage experienced by the subject at home in the 24-hour pad weight test; 
 Incontinence episodes/day recorded using a 7-day voiding diary; 
 Proportion of subjects achieving dryness (<1g on the provocative pad weight test);  

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 Improvement in quality of life assessed using the Incontinence Quality of Life 
Questionnaire (I-QOL); 
 Number of pads/day recorded using a 7-day voiding diary; and 
 Dryness, defined as a pad weight of less than 1.3g on the 24-hour pad weight test 
(including an evaluation at 12 weeks). 
 Proportion of subjects considered to have achieved significant improvement, defined as 
a greater than 50% reduction in pad weight, from baseline on the 24-hour pad weight 
test (including an evaluation at 12 weeks). 
 
Other secondary measures to be evaluated are as follows: 
 
 Proportion of subjects achieving dryness at Week 12 in each group (<1g on the 
provocative pad weight test). 
 Within Neurotech Vital Compact group estimate of mean change, with respect to 
baseline, in sexual function as measured by the Pelvic Organ Prolapse/Urinary 
Incontinence Sexual Questionnaire (PISQ-IR) at Week 12; 
 Between group comparison of mean change, with respect to baseline, in sexual function 
as measured by the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire 
(PISQ-IR) at Week 12; 
 Within Neurotech Vital Compact group estimate of patient response to the Patient 
Global Impression of Improvement (PGI-I) at Week 12. 
 Between group comparison of patient response to the Patient Global Impression of 
Improvement (PGI-I) at Week 12; 
 Safety in relation to adverse events and device deficiencies reported; 
 Evaluation of reduction in urine leakage on the provocative pad weight test in relation to 
the mean intensity of the stimulation delivered during the 12-week treatment 
programme; 
 Evaluation of the reduction in urine leakage on the provocative pad weight test at Week 
12 in relation to the BMI category (underweight/normal/overweight/obese) of the 
subjects; 
 Evaluation of the reduction in urine leakage on the provocative pad weight test at Week 
12 in relation to the baseline severity of stress urinary incontinence of the subjects; 
 Device compliance of the Neurotech Vital Compact device with the treatment protocol 
during the 12-week treatment programme; 
 Device compliance of the itouch Sure Pelvic Floor Exerciser with the treatment protocol 
during the 12-week treatment programme; 
 
10.3.9 Safety 
 
Safety analyses will be performed on the Safety population. 
 
Adverse events will be summarized overall, by severity, seriousness and by relationship to 
investigational device.  Adverse device effects and early withdrawals due to adverse events will 
be listed and summarised separately.  Adverse events will be collected for randomized subjects 
only. 
 
Ninety-five percent confidence intervals may also be provided for the comparison of serious 
adverse event rates between randomized arms. 
 

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10.3.10  Interim Analysis for Futility 
 
An interim analysis for futility will be conducted when 90 patients have Visit 4 (12 week) data 
available. The analysis will be conducted by an independent statistician. A conditional power 
will be calculated based on projecting the observed trend of the difference between the two 
groups in the primary efficacy parameter for patients completing the study. If the analysis 
indicates that the conditional power for a positive outcome of non-inferiority is less than 30%, 
the independent statistician will communicate to a designated sponsor’s representative that the 
study is unlikely to meet its primary objective. The sponsor may evaluate additional information 
and make a final decision regarding continuation of the study. The interim analysis will not be 
used to stop the study early for a positive outcome; therefore, no adjustment to the Type-1 error 
is indicated (Lachin, 2005).  Details of the interim analysis for futility will be specified in the 
Statistical Analysis Plan. 
 
 
10.3.11  Poolability Analysis 
 
A poolability analysis will be performed on the primary endpoint to test for a differential 
treatment effect across study centres.  The primary endpoint will be summarized by study 
centre.  Poolability will be assessed using a logistic regression model.  The logistic regression 
model will include a covariate for the treatment arm, study centre, and interaction effect of 
treatment by centre.  The p-value for the interaction effect will be provided. 
Analyses will be performed for both the ITT and PP population. 
 
10.3.12  Subgroup Analyses 
 
Subgroup analyses will be performed on the primary endpoint to test for differential treatment 
effects across baseline subgroups.  At a minimum, subgroups will be derived for the following 
parameters: race, BMI, and baseline pad weight.  Descriptive statistics will be provided for the 
primary endpoint success rate for each subgroup.   
 
Logistic regression models will be used to statistically evaluate the effect of the subgroups on 
the primary endpoint.  Specifically, the logistic regression model will include a covariate for the 
treatment arm, subgroup, and interaction effect of treatment by subgroup.  The p-value for the 
interaction effect will be provided. 
 
Analyses will be performed for both the ITT and PP population. 
 
10.3.13  Software 
 
All analyses will be performed using SAS, version 9.3 or later.  In the event an analysis is 
required that is better suited for a statistical package other than SAS, this other package (e.g. R) 
will be used. 
 
 
 
 

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11 Investigator Responsibilities 
 
11.1 Investigator Responsibilities 
 
11.1.1 Informed Consent 
The investigator is responsible for obtaining informed consent under 21 CFR Part 50. 
 
11.1.2 Records 
Clinical investigators must maintain the records of each subject’s case history and exposure to 
the device under §812.140(a)(3)(i). Case histories include case report forms and supporting 
data, including signed and dated consent forms and medical records, including progress notes of 
the physician, the individual’s clinical records(s), and the nurses’ notes (where applicable to 
healthy volunteers). Records must include documents demonstrating informed consent and, for 
any use of a device by the investigator without informed consent, any written concurrence of a 
licensed physician and a brief description of the circumstances justifying the failure to obtain 
informed consent. The case history of each individual must document that informed consent 
was obtained prior to participation in the study. 
 
11.1.3 Reports 
Clinical investigators must make the following required reports when applicable: 
 Unanticipated Adverse Device Effects [§812.150(a)(1)]  
 Withdrawal of IRB Approval [§812.150(a)(2)]  
 Informed consent [§812.150(a)(5)]  
 Other reports requested by a reviewing IRB or FDA [§812.150(a)(7)]  
 
11.1.4 Financial Disclosure 
Because the data in this study is planned to be submitted in a marketing application, then 21 
CFR 54, Financial Disclosure, applies. The Investigator must disclose to the Sponsor sufficient 
accurate financial information to allow the IDE applicant (or sponsor) to submit certification or 
disclosure of financial interests. The investigator must update the information if any relevant 
changes occur during the course of the study and for one year following completion of the study 
(§ 812.110). 
 
11.1.5 Investigator Qualifications and Training 
 
The Investigators have been selected to participate in this study due to their extensive 
experience and publications in the field of Women’s Health/Urology/Urogynecology/ and study 
of investigational medical devices.  
 
11.1.6 Financial Considerations and Support 
 
Details of financial support provided by Bio-Medical Research Ltd for the conduct of the study 
will be addressed in the Investigator Agreement. 
 

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11.2 Data Collection 
 
11.2.1 Completion of Case Report Forms 
 
An electronic case report form (eCRF) will be utilised for this study.  Prior to the start of the 
clinical study, the eCRF provider will provide the site with appropriate log-in credentials for the 
Investigator, study personnel (blinded and unblinded).  The Investigator will be responsible for 
the accuracy and completeness of the eCRF for each individual subject and be responsible for 
completing the eCRF in a timely manner. The personal data recorded on all documents will be 
regarded as confidential.   
 
The Investigator must record the subject’s participation in this clinical study in the subject’s 
clinic notes.  In addition, the Investigator must keep a separate Subject Identification Log of all 
subjects entered into the clinical study showing each subject’s name, date of birth and assigned 
subject number for identification purposes.  
 
11.3 Review and Return of Completed Documentation 
 
The Investigator will make the original source documentation available to the Sponsor’s 
designated monitor at each visit.  At the conclusion of the clinical study, completed eCRFs will 
be electronically signed by the Investigator.  A copy of the eCRF will be provided to the site at 
the conclusion of the study. 
 
11.4 Retention of Documentation 
 
The Investigator will retain all copies of the records for a period of 15 years from the 
discontinuation of the clinical study.  In all cases, the Investigator must contact the Sponsor 
prior to disposing of any records related to the clinical study.  Included in records to be 
maintained are signed Study Protocol, copies of the Case Report Forms, signed consent forms, 
ethics committee approval letters, device accountability records, correspondence concerning the 
clinical study and any other documents to identify the subjects.  
 
In addition, if the Investigator leaves the position, etc., he/she should provide Bio-Medical 
Research Ltd with the name and address of the person who will be responsible for the clinical 
study related records. 
 
11.5 Maintenance of Randomisation and Blinding 
 
A randomisation schedule will be provided. The randomisation schedule is in a permuted block-
format randomisation, stratified by study site, to ensure that the subject allocation at the sites 
remains balanced. 
 
The Subject ID number, randomisation date and patient initials will be recorded along with the 
allocated treatment.  
 
It is not anticipated that there will be any need to unblind (break the randomisation code) of any 
subject participating in the study because of an adverse event/adverse device effect, however, 
the information will be available at the site via the unblinded personnel. 
 

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One member of the investigational site team will be responsible for patient training and will 
consequently be unblinded to required treatment instructions for training.  A different member 
of the team will be responsible for all other patient assessments and CRF completion. 
 
11.6 Data Management 
 
All required data will be entered into the electronic Case Record Forms (eCRF) by designated 
site personnel.  The data will be maintained securely within the database by means of password 
protection and other security measures with restricted access as detailed by the data 
management company.   
 
Database validation will have been carried out prior to inclusion of study data and once verified 
an appropriate documentation trail will be maintained to include details of initial entry, data 
validation checks, query resolution and database amendment. 
 
The database will be subject to quality control checks and the resulting output will be used to 
raise any data queries, after reference to the eCRF throughout the study.  All data queries will 
be resolved with the assistance of monitoring staff and according to the Data Management Plan. 
 
On resolution of all data queries, the database will be closed and data listings, summary tables, 
graphical output and descriptive statistics produced.   
 
 
 

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12 Sponsor Responsibilities 
 
The Sponsor agrees to adhere to the ICH Note for Guidance on Good Clinical Practice 
(CPMP/ICH/135/95, Jan.97) and US FDA Regulations.  It is the Sponsor's responsibility to 
obtain appropriate regulatory approval to perform the trial (if applicable).  The Sponsor should 
notify promptly all concerned investigator(s), IRB(s)/IEC(s) and the Regulatory Authority of 
findings that could adversely affect the health of the patients/ subjects, impact on the conduct of 
the trial or alter the Regulatory Authority’s authorization to continue the trial.  If it is necessary 
to change, or deviate from the protocol to eliminate an immediate hazard to the subjects the 
Sponsor will notify the relevant regulatory authority and relevant IRB/IEC of the new events, 
the measures taken and the plan for further action as soon as possible.  This will be by telephone 
in the first instance followed by a written report.   
On completion of the trial, the Sponsor will inform the regulatory authority that the trial has 
ended.  If the study is terminated for any reason the Sponsor will provide a written statement to 
the relevant regulatory authority and the IRB/IEC with the reasons for termination of the trial.  
This will be conducted within 15 days of the decision to terminate the trial.  The Sponsor will 
report in an expeditious manner all suspected unexpected serious adverse reactions (SUSARs) 
to the relevant regulatory authority and IRBs/IECs, as required.   
12.1  Indemnity 
The Sponsor will provide “no-fault” compensation insurance against any risk incurred by a 
subject as a result of participation in this trial.  The Sponsor will indemnify the Investigator as 
detailed in a separate document. 
12.2 Study Monitoring 
 
The Investigator will permit a designated representative of Bio-Medical Research Ltd to inspect 
all Case Report Forms and corresponding subject’s clinic records at regular intervals throughout 
the clinical study.  These monitoring visits are for the purpose of verifying adherence to the 
Study Protocol and the completeness and accuracy of the data being entered on the Case Report 
Forms and will be conducted in accordance with an approved monitoring plan.  
 
The monitor will be responsible for securing the compliance of the Investigator to the signed 
agreement, the Study Protocol and requirements of FDA abbreviated IDE requirements set forth 
in 21 CFR 812.2(b) and international standards of Good Clinical Practice (FDA guidance E6). 
Assessments will also be made regarding the subjects’ protection and safety, as well as the 
quality, completeness, and integrity of the data.   
 
Subject diaries, device records and questionnaires completed by the subject will be classified as 
source data. All other study data should have alternative identifiable source documents agreed 
by the Investigator and Bio-Medical Research Ltd prior to the start of the study, in the subject 
notes. 
 
The planned extent of source data verification will be documented in a monitoring plan which is 
agreed and signed off by the Study Manager prior to the commencement of the first monitoring 
visit. 
 

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12.3 Final Report 
 
Statistical analyses for the final report will be carried out when all subjects have completed the 
study or withdrawn from the study and the database has been locked.   
 
12.4 Publications 
 
The results of this clinical study may be submitted for publication. Details of publications will 
be addressed in the Investigator Agreement. 
 
 
12.5 Quality Control and Quality Assurance 
 
Investigators are reminded that in agreeing to participate in this clinical study and by signed 
agreement of the Study Agreement documentation, they will seek to ensure that all subjects 
included in the study are compliant with the requirements of the study at the point of entry and 
remain so during their participation in the study. 
 
Repeated and serious failures in subject compliance will be addressed as they have the potential 
to affect both patient safety and study outcome and where necessary corrective and preventative 
actions will be taken. 
 
12.6 Termination Procedure 
 
The clinical study will be stopped when the risk benefit profile of the study becomes negative 
caused by the occurrence of unexpected serious adverse device effects or lack of performance.  
 
If such action is taken, the Sponsor/Coordinating Investigator will discuss the reasons with the 
Investigator.   
 
If the study is terminated or suspended due to safety reasons, the Sponsor/Coordinating 
Investigator will inform research ethics committee promptly and provide the reason(s) for the 
suspension or termination. 
 

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13 References 
 
1. Ashton-Miller J, Howard D, DeLancey JO. The functional anatomy of the female pelvic 
floor and stress incontinence control system.  Scan J Urol Nephrol Suppl 2001, 
Supplement 207:  1-7. 
2. Bo, K. Pelvic Floor muscle training is effective in treatment of female stress urinary 
incontinence, but how does it work? Int Urogynecol J Pelvic Floor Dysfunct 2004, 
15(2): 76-84. 
3. Campbell G, Pennello G, Yue L Missing data in the regulation of medical devices J. 
Biopharm. Stat. 2011:   21; 180-195 
4. Castro RA, Arruda RM, Zanetti MRD, Rotta AL, Santos PFD, Sartori MGF, Girão 
MJBC. Single blind, randomized, controlled trial of pelvic floor muscle training, 
electrical stimulation, vaginal cones and no active treatment in women with stress 
urinary incontinence. Clinics 2008; 63(4):465-72. 
5. Lachin JM.  A review of methods for futility stopping based on conditional power. Stat 
Med. 2005 Sep 30;24(18):2747-64. 
6. Maher R.M, Crowe L.  The impact of surface neuro muscular electrical stimulation 
(NMES) on stress urinary incontinence patient outcomes. University College Dublin, 
2008. 
7. Maher R. M Crowe L, Caulfield B.  A novel externally applied neuromuscular 
stimulator for the treatment of stress urinary incontinence – A Pilot Study. Neurourology 
and Urodynamics, 2009,  28 (2): 70 – 71. 
8. R.O’Sullivan, et al “Definition of Mild, Moderate and Severe Incontinence on the 24-
hour pad test”. BJOG, International Journal of Obstetrics and Gynecology. August 2004. 
Volume III, pgs. 859-862. 
9. Soeder A, Tunn R.  (2013) Neuromuscular-Electrical Stimulation (NMES) of the Pelvic 
Floor Muscles using a Non-invasive Surface Device in the Treatment of Stress Urinary 
Incontinence (SUI); A Pilot Study.  Presentation IUGA Conference, Dublin, Ireland. 
10. Yalcin I, Bump R. Validation of two global impression questionnaires for incontinence. 
Am J Obstet Gynecol 2003;189:98-101 
11. Yan X, Lee S, Li N Missing data handling methods in medical device clinical trials J. 
Biopharm. Stat. 2009: 19; 1085-1098 
  
 
 

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14 Appendices  
 
 

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14.1 Appendix I.  Schedule of Events 
 
 
 
12-week treatment programme with Neurotech 
Vital Compact device or itouch Sure Pelvic 
Floor Exerciser 
 
Kegel  
Exercises 
Week 12 to 
26 
 
V1 
V2 
Telephone 
V3 
V4 
V5 
Assessments 
Screening      Baseline 
Week 1 
Week 4 
Week 12 
Week 26 
(6 months) 
Patient Consent 
X 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
Medical 
History/Physical 
Examination 
X 
 
 
 
 
 
Medication Use (or 
change of medication) 
X 
X 
X 
X 
X 
X 
Record cough/cold 
symptoms 
X 
X 
 
X 
X 
X 
Adverse Events 
X 
X 
X 
X 
X 
X 
Pregnancy Test (pre-
menopausal subjects 
only) 
X 
 
 
X 
 
 
Subject device 
training 
 
X 
 
 
 
 
Stress test following 
standardised bladder 
filling (provocative 
pad test) 
X 
Practice 
test 
X 
To 
determine 
eligibility 
 
X 
X 
X 
24-h pad weight test  
(3 days prior to visit) 
 
X 
 
X 
X 
X 
7-day voiding diary 
(prior to visit) 
 
X 
 
X 
X 
X 
Incontinence Quality 
of Life Questionnaire 
(IQOL)  
 
X 
 
X 
X 
X 
Pelvic Organ 
Prolapse/Urinary 
Incontinence Sexual 
Questionnaire (PISQ-
IR) 
 
X 
 
 
X 
 
Patient Global 
Impression of 
Improvement (PGI-I) 
 
 
 
 
X 
 
MESA questionnaire 
 
X 
 
 
 
 
 
Telephone Contact 
 
 
 
X 
 
 
 
Download compliance 
data; review device 
record 
 
 
 
X 
X 
 
Kegel exercise 
instructions 
 
 
 
 
X 
 
 
 
 
 
 
 

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14.2 Appendix II. itouch Sure Pelvic Floor Exerciser 510k Summary  
 
See Itouch Sure Pelvic Floor Exerciser 510K letter from the FDA dated June 21 2011. 
 
 
 
 

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14.3 Appendix III.  Stress Test Protocol 
 
Where possible the assessment will be performed by the same examiner each time for the 
duration of the study, for a given subject, as follows: 
 
Balance Calibration 
 All pad weights will be weighed using a balance supplied by the Sponsor. 
 On each day of the assessments and prior to the weighing of the pads, the balance will be 
calibrated using calibration weight supplied by the Sponsor and the details recorded to 
verify the balance is operational. 
 All zip-lock freezer bags will be weighed in a container to minimise any weight 
fluctuations. 
 
Bladder Filling Protocol  
 Prior to the stress1h pad test, a pad (moderate POISE) is placed in a zip-lock bag (Weight 
A). 
 Subjects are advised to attend the clinic with a comfortably full bladder. 
 Following the pregnancy test, the subject voids the bladder and then drinks 500 mL of 
water. 
 The subject is instructed not to go to the toilet and waits for 1 hour. 
 After approximately 1 hour, the Investigator will check that natural diuresis has resulted in a 
bladder volume of more than 250mL as confirmed by ultrasound or other appropriate 
method. 
 If the bladder volume is not 250mL or more, the subject will be instructed to wait for 
approximately 30 minutes when it will be re-checked. The exact bladder volume will be 
recorded. 
 On confirmation the bladder volume is 250mL or more, the pad is handed to the subject in 
the bag and the subject is instructed to attach the pad in their underwear and put the 
packaging and pad liner back in the zip-lock freezer bag.  
 
 Stress Test Protocol is a modified version of the provocative test determined by Bo, 1999. 
 The metronome is set to 132bpm. 
 The subject is instructed not to contract their pelvic floor muscles but to ‘leak’ as usual. 
 The subject is then instructed to run on the spot (with their knees bent) for 30 seconds 
followed immediately by 30 seconds of jumping jacks (with their arms straight and legs as 
wide as they can). 
 The subject will be encouraged to keep pace with the metronome during the test. If the 
subject cannot, it will be documented how much of the protocol was completed to establish 
their baseline. This exact test must then be used in subsequent follow up visits. 
 The subject will be asked to sit and stand 10 times from a chair, (the same chair to be used 
in repeated tests) 
 The subject will cough forcefully 10 times 
 The subject will pick an object, e.g a pencil, off the floor 5 times. 
 The subject then places the pad in the ziplock freezer bag which is weighed (Weight B) 
 The weight of urine loss during the stress test is then calculated (Weight B – Weight A) 
 All timings will be conducted using a stop-watch or smart phone. 
 
 
 
 

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14.4 Appendix IV.  Pelvic Floor Exercises   
 
How to do Kegel exercises 
It takes diligence to identify your pelvic floor muscles and learn how to contract and relax them. 
Here are some pointers: 
 
Find the right muscles 
To make sure you know how to contract your pelvic floor muscles, try to stop the flow of urine 
while you're urinating.  If you succeed, you've got the basic move. Or try another technique: 
Insert a finger inside your vagina and try to squeeze the surrounding muscles. You should be 
able to feel your vagina tighten and your pelvic floor move upward. Then relax your muscles 
and feel your pelvic floor move down to the starting position. As your muscles become stronger 
— and you become more experienced with the exercises — this movement will be more 
pronounced. 
 
But don't make a habit of starting and stopping your urine stream. Doing Kegel exercises 
with a full bladder or while emptying your bladder can actually weaken the muscles. It 
can also lead to incomplete emptying of the bladder, which increases your risk of a 
urinary tract infection. 
 
Perfect your technique 
Once you've identified your pelvic floor muscles, empty your bladder and lie down. Then: 
 
 Contract your pelvic floor muscles. 
 Hold the contraction for three seconds then relax for three seconds. 
 Repeat 15 times. 
 Once you've perfected three-second muscle contractions, try contracting it for four 
seconds at a time, alternating muscle contractions with a four-second rest period. 
 Work up to keeping the muscles contracted for 10 seconds at a time, relaxing for 10 
seconds between contractions. 
 
To get the maximum benefit, focus on tightening only your pelvic floor muscles or isolating 
your pelvic floor muscles. Be careful not to flex the muscles in your abdomen, thighs or 
buttocks. Also, try not to hold your breath. Just relax, breathe freely and focus on tightening the 
muscles around your vagina and rectum. 
 
Repeat twice a day 
Perform 3 sets of 15 Kegel exercises twice a day. The exercises will get easier the more often 
you do them. You might make a practice of fitting in a set every time you do a routine task, 
such as checking e-mail or commuting to work. 
 
 

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14.5 Appendix V.  Incontinence Quality of Life (I-QOL) Questionnaire 
 

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14.6 Appendix VI.  PISQ-IR questionnaire 
 
 

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14.7 Appendix VII.  Medical, Epidemiologic and Social Aspects of Aging Urinary 
Incontinence (MESA) Questionnaire  
 
 
 
 

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14.8 Appendix VIII. 7-Day Voiding Diary and Device Record 
 
 
 
 

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14.9 Appendix IX.  Patient Global Impresssion of Improvement – Incontinence (PGI-I) 
 
The PGI-I is a transition scale that is a single question asking the patient to rate their urinary 
tract condition now, as compared with how it was prior to before beginning treatment on a scale 
from 1.  Very much better to 7.  Very much worse (Yalcin & Bump, 2003). 
 
 
 

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14.10 Appendix X.  Sample Informed Consent 
 
Sample Consent to Participate in Research Study BMR-13-1001 
(May be revised with Sponsor consent if required by local IRB) 
  
A single-blind, multi-centre, randomised controlled, non-inferiority clinical study to assess the 
safety and performance of the Neurotech Vital Compact device compared to the itouch Sure 
Pelvic Floor Exerciser for the treatment of stress urinary incontinence in female subjects. 
 
Study to be conducted at: [Insert Site Name] 
 
Sponsor Name: Bio-Medical Research Ltd, Parkmore Business Park West, Galway, Ireland 
 
Principal Investigator: [Insert Principal Investigator Name and Address, Telephone] 
 
Further information and contact details: 
For more information concerning this study and research-related risks or injuries, or to give 
comments or express concerns or complaints, you may contact the principal investigator, xxxx, 
MD.  You may also contact a representative of the Institutional Review Board XXXXXX  for 
information regarding your rights as a participant involved in a research study or to give 
comments or express concerns, complaints or offer input.  You may obtain the name and 
number of this person by calling xxxxx. 
 
Introduction: 
You are being asked to participate in a research study. However, before you choose to be a 
research participant, it is important that you read the following information and ask as many 
questions as necessary to be sure that you understand what taking part in this research study will 
involve. Your signature on this consent form will acknowledge that you received all of the 
following information and explanations verbally and have been given an opportunity to discuss 
your questions and concerns with the Investigator.  
 
What is the purpose of the study? 
The purpose of this study is to determine whether the safety and performance profile of the 
Neurotech Vital Compact (delivering electrical stimulation through external electrodes) is 
equivalent to the itouch Sure Pelvic Floor Exerciser (delivering electrical stimulation through an 
internal vaginal probe) over a 12-week treatment period with a 14-week follow-up period.   
 
What are the devices that are being used in the study? 
Neurotech Vital™ Compact: The Neurotech Vital Compact device is considered by the US 
FDA to be an investigational product currently under development by the Sponsor of this 
clinical research study, Neurotech Group, a division of Bio-Medical Research (BMR) Ltd (Bio-
Medical Research Ltd, Parkmore Business Park West Galway, Ireland). The Neurotech Vital 
Compact device uses neuromuscular electrical stimulation (NMES) to activate the pelvic floor 
muscles. A small electrical current is delivered to the muscles via electrodes contained within a 
pair of wrap-around garments that will be positioned in specific areas on the outside of your 
body around your pelvic area. The product is intended to strengthen the pelvic floor muscles of 
women who have stress urinary incontinence (SUI). The Neurotech Vital Compact device is on 
the market in Europe but it is not approved in the US.  
 

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itouch Sure Pelvic Floor Exerciser®:  The itouch Sure Pelvic Floor Exerciser is manufactured 
by TensCare Ltd., 9 Blenheim Road, Longmead Business Park, Epsom, Surrey, UK. The itouch 
Sure Pelvic Floor Exerciser sends an electrical stimulation to the pelvic floor muscles through a 
probe inserted into the vagina. The product is intended to strengthen the pelvic floor muscles of 
women who have stress urinary incontinence (SUI). The itouch Sure Pelvic Floor Exerciser is 
marketed in Europe and approved in the USA. This product is being used as a comparator in 
this study. 
 
Which device will I be given? 
If you choose to participate in this study and meet the eligibility requirements, you will be given 
either the Neurotech Vital Compact device or the itouch Sure Pelvic Floor Exerciser and 
instructed on its use. Which device you will be given will be randomly determined (like a flip of 
a coin) at the start of the study. You have an equal chance of receiving either device (ratio 1:1).  
 
You and the study staff member who shows you how to use the assigned device will know 
which device you have been given. If you have any questions or concerns about the device or 
using it, you can discuss your questions with this staff member openly at any time. 
 
The study staff who will care for you (including the doctor) throughout the study will not know 
which device you have been given so it is important you do not discuss the device you are using 
with them at any time. 
 
The study will compare the results of the two devices and see if there are any differences in the 
treatment of stress urinary incontinence if the electrical stimulation is delivered through 
electrodes placed on the outside of the body (Neurotech Vital Compact device) or electrical 
stimulation delivered through an internal vaginal probe (the itouch Sure Pelvic Floor Exerciser). 
 
Why have I been invited to participate? 
You have been invited to take part in this study because you are female, you are over eighteen 
and less than 66 years of age and you have been diagnosed with stress urinary incontinence. If 
you suffer from a different form of incontinence (for example as a result of damaged nerves ), if 
you are pregnant or lactating, if you had a heart attack or stroke, if you have implants like a 
pacemaker or suffer from a serious illness like cancer, you may not participate in the study. 
Your study team will personally discuss the requirements for study participation with you. 
 
Do I have to take part? 
No. It is up to you to decide. The study procedures and devices will be described to you, and 
you and a member of the study team will review this consent sheet together.  You will have the 
chance to meet with the doctor and ask any questions you have about the study, the devices, and 
your stress urinary incontinence condition.  If you agree to take part in this study and fully 
understand all the information, we will ask you to sign this consent form to show you have 
agreed to take part. You are free to withdraw your consent at any time, without giving a reason. 
You will receive a copy of this signed form. Your study records cannot be reviewed or released 
for research purposes unless you agree. If you do not agree to this use, you will not be able to 
participate in this study.  
 
What are my responsibilities? 
If you participate, you must follow the instructions of the Investigator, agree to participate in the 
below-mentioned examinations, come to the clinic for the required visits and use the device as 
directed for 12 weeks. Additionally, you have to report to your Investigator/study team any new 

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problems or health issues that might arise with the device or your health, even if you do not 
think they are related to the device or the study procedures.  
  
What is involved and how long will I be in the study? 
The study is being carried out in clinics in the USA. You will be required to attend the clinic for 
this screening visit then five study visits which will take about two hours each time, and be 
available for contact by telephone on one occasion which will take up approximately 5 minutes 
of your time. Participation will be required for the full 26 weeks (6 months).  
 
During the study you will be asked to complete a 12-week treatment programme with your 
allocated device. You will be asked to use the device according to the manufacturer’s 
instructions for use. 
  
The Neurotech Vital Compact device is used once-a-day for five (5) days each week with each 
daily session lasting 30 minutes for the 12-week period. The itouch Sure Pelvic Floor Exerciser 
is used once-a-day for seven (7) days each week with each daily session lasting 20 minutes 
during the 12-week period.  
 
It is important that during the 12-week treatment program you do not begin any new pelvic 
floor exercises.   
 
Following completion of the 12-week treatment programme, you will be asked to continue in 
the study by performing Kegel exercises to maintain your pelvic floor tone for another 14 
weeks. 
 
What will happen to me if I take part? 
If you agree to take part, we will check whether you meet the study requirements. If you meet 
these criteria, you will be need to give written consent to participate in the study.  If you are of 
childbearing potential you will take a urine pregnancy test to ensure your maximum safety to 
enter the study.  
 
A summary of what will happen at each visit follows: 
 
Screening Assessment – Visit 1 (up to 2 weeks before enrolling) 
At this visit we will review the study with you to see if you are eligible and review and 
sign this informed consent.  We will then ask you a series of questions about your medical 
history, what medications you are taking, measure your weight and height and perform a 
urine pregnancy test if you are of childbearing potential. You will complete a questionnaire 
called the Medical, Epidemiologic and Social Aspects of Aging Urinary Incontinence 
Questionnaire (MESA). This questionnaire takes about 5 minutes to complete and asks you 
questions about your incontinence.  
 
You will then complete a 1-hour Pad Weight Test.  For this test, you will drink 500mL 
(about 16 ounces) of water, and wait one hour without going to the toilet. An ultrasound 
examination of your bladder will check if your bladder is full. If not, you will have to wait 
for your bladder to fill. 
 
When your bladder is full, you will complete a 1-minute exercise routine. This will be 30 
seconds of running on the spot, 30 seconds doing jumping jacks, coughing, standing up 
from a chair 10 times and picking up a small object off the floor while wearing a pre-

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weighed pad so that we see how much urine you leak while performing those tests. During 
this test it is important that you do not contract your pelvic floor muscles to try to withhold 
passing any urine, but while you carry out the routine you ‘leak’ as usual. 
 
If you leak a sufficient amount, at the end of the visit, you will be given a diary to 
complete at home for 7 days before your next visit. In the diary you will write down the 
number of drinks you have, how many times you go to the toilet (urinate), and if you 
accidentally leaked urine from your bladder. You will be given pre-weighed pads, and we 
will ask you wear these pads and collect them for 3 days before the next visit so we can 
measure the urine leaked. If you have sexual intercourse during the three day period while 
wearing the pads, it is important that you expel any fluid following intercourse and write 
this on your diary. In addition, if you are menstruating during this pad test it is important 
you record this on the diary. We will try to schedule pad collections when you are not 
expected to be menstruating. 
 
Visit 2 (Baseline, within 2 weeks of your initial visit) 
At this visit, we will collect the voiding diary and the pads you have used as instructed. We will 
also ask you how you are feeling, what medications you are taking and perform a urine 
pregnancy test if you are of childbearing potential.  
 
You will complete a questionnaire called the Incontinence Quality of Life Questionnaire (I-
QOL). This 10-minute, written questionnaire rates the effect of your condition on your 
quality of life. You will also be asked to complete a Pelvic Organ Prolapse/Urinary 
Incontinence Sexual Questionnaire (PISQ-IR), which asks questions about whether your stress 
urinary incontinence has affected your ability to have a satisfying sex life. 
 
We will ask you to repeat the 1-hour Pad Weight Test during which you will drink 500mL 
of water, wait one hour without going to the toilet, have the bladder ultrasound performed 
to show that your bladder is full and then complete the  1-minute exercise, stand up from a 
chair and cough routine.  
 
We will then re-check you meet all the criteria for entry into the study. If you meet all the study 
criteria, you will then be randomly allocated to one of the devices and trained how to use it. 
 
What will happen if I get the Neurotech Vital Compact Device? 
You will be given instructions about how to put on and take off the device. All training and 
instructions will be given in a private treatment room at the clinic. Application of the garments 
will require you to take off your clothes below the waist to expose your buttocks and inner 
thighs. The garment will be attached to your thighs, hips and bottom with special gel electrodes. 
The garment will be connected to a control unit (called the Neurotech Vital Compact controller) 
that has buttons which control the intensity of stimulation. The unit will be turned on and the 
intensity of the electrical current will be gradually increased until you begin to feel the sensation 
(many users say they feel a tingling sensation).  If you are comfortable, you may increase the 
intensity.  Stimulation will continue for 30 minutes. You will dictate the level of intensity (how 
strong the stimulation is) and at no stage will you be required to attain a level of stimulation that 
feels too strong to you. During this training period you may be asked questions of a sensitive 
nature, for example where you can feel the stimulation on your thighs, hips and bottom and be 
in your underwear covered by a sheet for the duration of the treatment session. 
 

                   Study No: BMR-13-1001 
 
 
Study Ref: Neurotech Vital Compact RCT 
 
 
Version: 2.0 FINAL 27 March 2015 
 
CONFIDENTIAL                                                     Page 85 of 132 
 
If you are comfortable with using the device and putting on the garment, you will be given the 
Neurotech Vital Compact device to take home to begin a 12-week treatment programme using 
the device for 30 minutes a day at home, 5 days a week, for 12 weeks. Remember to empty your 
bladder before starting each session. You will also be given sealable baggies with pre-weighed 
pads to wear during the 3 days prior to your next clinic visit, and a 7-day diary to be completed 
during the 7 days prior to your next clinic visit. Please bring your device, garment, diary pages 
and all pads to your next clinic visit. 
   
What will happen if I get the itouch Sure Pelvic Floor Exerciser? 
You will be given training and instructions about how to use the device in a private treatment 
room at the clinic. Application of the device will require you to take off your clothes below the 
waist, lie down on an examination table and be covered with a sheet. A special gel is provided 
to lubricate the vaginal probe.  You will insert the lubricated probe into your vagina. The 
vaginal probe will be connected to a control unit (the itouch Sure) that has buttons which 
control the intensity of stimulation. Increasing stimulation will be applied through the vaginal 
probe until you begin to feel the effect and then continued for 20 minutes. You will dictate the 
level of intensity (how strong the stimulation) is and at no stage will you be required to attain a 
level of stimulation that feels too strong to you. During this training period you may be asked 
questions of a sensitive nature, for example where you can feel the stimulation and be without 
clothes below the waist covered by a sheet for the duration of the treatment session. 
 
If you are comfortable with using the device and inserting it into your vagina, you will be given 
the itouch Sure Pelvic Floor Exerciser to take home to begin the 12-week programme using the 
device for 20-minutes a day at home, each day, for the 12 weeks. Remember to empty your 
bladder before starting each session. You will also be given sealable baggies with pre-weighed 
pads to wear during the 3 days prior to your next clinic visit, and the 7-day diary to be 
completed during the 7 days prior to your next clinic visit. Please bring your device, diary pages 
and all pads to your next clinic visit. 
 
How much time do I need? 
It is really important that you have the time and are willing to perform the entire 12-week 
programme with the assigned device, otherwise we will not be able to analyse the results of the 
study. It is also important you bring the device to each visit so we can check how you are 
positioning the device at home. Both devices track how many sessions have been completed as 
well as the intensity level of the device. 
 
Telephone Call (1 Week after Baseline Visit 2) 
Arrangements will be made to contact you for a follow-up telephone call about one week 
following your baseline visit to see if you have questions or concerns with the treatment and 
how you are feeling.  
 
Visit 3 (4 Weeks after Visit 2) + Visit 4 (12 Weeks after Visit 2) 
The same procedures as were performed at the Baseline visit will be performed during this visit. 
Before the visit, drink normally so when you arrive at the clinic you have a comfortably 
full bladder. 
 
At Visit 3 and 4 we will collect the voiding diary and the pads you have used as instructed. We 
will also ask you how you are feeling and what medications you are taking. At Visit 3 a urine 
pregnancy test will be performed if you are of childbearing potential.  
 

                   Study No: BMR-13-1001 
 
 
Study Ref: Neurotech Vital Compact RCT 
 
 
Version: 2.0 FINAL 27 March 2015 
 
CONFIDENTIAL                                                     Page 86 of 132 
 
At Visit 4, we will ask you to complete the Pelvic Organ Prolapse/Urinary Incontinence 
Sexual Questionnaire (PISQ-IR) and the Patient Global Impression of Improvement (PGI-
I). 
 
At the end of visits 2, 3 and 4, you will be provided with a voiding diary to complete at 
home for 7 days before your next visit and pre-weighed pads. We will ask you to collect 
the pads you wear for 3 days before the next visit so we can measure the urine lost. 
 
You will be asked to return the device to the clinic at the end of Visit 4.   
 
Also at Visit 4 you will be instructed regarding how to perform Kegel exercises to perform 
daily at home for the next 14 weeks. These are exercises that will teach you how to contract and 
relax your pelvic floor muscles and detailed instructions will be available for you to take home. 
  
Visit 5 (26 Weeks after Visit 2) 
At this visit we will collect the voiding diary and the Kegel exercise diary and the pads you 
have used as instructed. We will also ask you how you are feeling and what medications you are 
taking.  
 
You will also be asked to complete the 1-hour Pad Weight Test in which you will drink 
500mL of water, wait one hour without going to the toilet, have the bladder ultrasound 
performed to confirm your bladder is full and then complete the 1-minute exercise, stand 
up from a chair and cough routine. You will complete the I-QOL questionnaire.  At this 
point you will have completed all the visits for the study.  
 
What are the possible risks associated with participation in the study? 
Both devices in this study have been determined by FDA to be “nonsignificant risk” devices.  
The risks associated with participation in the study are minimal. There are no anticipated 
additional risks to involvement in this clinical study than would be expected for normal 
treatment of this condition with alternative NMES devices with the possible, but unlikely, 
exception of patient sensitivity to the fabric/materials of the garment or its electrodes.  
However, there is no reason to suspect that any reaction would occur or that there would be any 
subsequent long term health problems. All of these materials have been extensively used and 
documented for their biocompatibility with human skin. The garment and devices will be used 
in accordance with the Instructions for Use. 
 
The Neurotech Vital Compact device is a CE-marked device which means it is approved for use 
in Europe and has been available to use in Europe for several years, but is not approved for use 
in the US. The itouch Sure Pelvic Floor Exerciser is CE-marked and is cleared for use in the 
USA. 
 
People with implanted electronic devices (like pacemakers or defibrillators), other heart 
problems (like arrhythmia or heart disorder) or insulin pumps are excluded from this study and 
should not get stimulation because the electronic signals might lead to health problems like 
ventricular fibrillation or other cardiac arrhythmias.   
 
It is also unknown whether electrical stimulation has any effect on an unborn child. To ensure 
maximum safety, if you could be pregnant then you are not allowed to take part in the study and 
we will check if you are pregnant by conducting a pregnancy test at each visit. Women of 
childbearing potential must use safe contraception (oral contraception, hormonal contraceptive) 

                   Study No: BMR-13-1001 
 
 
Study Ref: Neurotech Vital Compact RCT 
 
 
Version: 2.0 FINAL 27 March 2015 
 
CONFIDENTIAL                                                     Page 87 of 132 
 
and you must provide details of this method to the study team at the start of the study. If you 
become pregnant during the study you must inform the study team immediately. 
 
Adverse effects that have occurred with use of Neuromuscular Electrical Stimulation (NMES) 
(both devices) include:  
 
 Temporary skin/surface reaction (irritation, redness and/or inflammation) at or near the 
stimulation site during and following periods of stimulation;  
 Discomfort and pain (including throbbing pain) at or near the stimulation site;  
 Stomach ache; 
 Change in bowel habits; 
 Twitching, numbness, muscular contraction, tightening, aching; 
 Muscle injury caused by use of excessive intensity or usage time. 
 
Potential anticipated adverse events specifically related to the use of the Neurotech Vital 
Compact device:  
 On very rare occasions, some patients have reported feeling light-headed or faint, so it is 
recommended that patients have somewhere to sit nearby should this happen; 
 Develop sensitivity to the hydrogel electrodes. 
 
Potential anticipated adverse events specifically related to the use of the itouch Sure Pelvic 
Floor Exerciser: 
 Abdominal cramps; 
 Vaginal irritation or infection. 
 
In summary, if you experience any adverse reactions while using the device, or after using the 
device, you should stop using the device immediately and notify the study team. 
 
What should I expect while using the device? 
Neurotech Vital Compact Device: During the study you will be applying electrical muscle 
stimulation to your body which is similar to regular exercise. Electrical stimulation works by 
activating the muscles, and slight muscle pain/discomfort is a known after-effect, especially 
when first starting to use the device.  Increase stimulation levels gradually over the period of a 
week or so to avoid this effect.  When you first turn on the unit, you will increase the intensity 
until you feel a mild tingling in the buttocks area.  As you increase the intensity level, the 
feeling gradually moves to the area between the legs and you will experience a strong 
contraction of your pelvic muscles.  The treatment goal is to get to a level of 75 units within a 
few weeks after starting treatment, and to maintain this level for the remainder of the 12 weeks. 
If you must pause the treatment during a 30-minute session, turn the intensity back to zero. The 
treatment is conducted in a standing position, and you may move around a little bit during the 
treatment as long as you do not dislodge the electrodes.  You may also lie on your back with 
knees bent if more comfortable for you. 
 
The electrodes are designed to be sticky to ensure good skin contact, and mild skin irritation and 
pain/discomfort have been reported following their use, however, this reaction is usually 
temporary and quickly subsides. It is also possible that you may become sensitive to the 
electrodes during the study – this will be monitored at every visit and any such reaction will be 
discussed with the Investigator and appropriate action will be taken and documented. It is 
important not to attach the electrodes to other body parts. Avoid any usage of ointments or skin 

                   Study No: BMR-13-1001 
 
 
Study Ref: Neurotech Vital Compact RCT 
 
 
Version: 2.0 FINAL 27 March 2015 
 
CONFIDENTIAL                                                     Page 88 of 132 
 
creams on the buttocks or upper thighs during the study, as the electrical conductivity of the 
skin will be decreased.    
 
On very rare occasions, some participants have reported feeling light-headed or faint during the 
treatment, so have somewhere to sit nearby should this happen during your treatment.  
 
itouch Sure Pelvic Floor Exerciser:  
The muscle contractions caused by electrical stimulation can lead to training aches which 
usually disappear within a week. After treatment tingling sensations may continue or your skin 
may feel numb which is normal.  Use of excessive intensity or usage time can cause muscle 
injury. Always increase intensity gradually. If stimulation causes pain reduce intensity or stop 
treatment. 
 
You will increase the intensity until you feel the sensation but it is not overly painful. It is 
important to be conservative upon initial use. As long as you can feel the contraction, itouch 
sure is working. You can build up the strength slowly over a number of days. The intensity 
increases in steps of 0.5 and the range is 0 to 99.5. If you experience discomfort reset the 
intensity down one step. During use you may feel cramping. If this happens, stop using the 
itouch sure until the cramping goes away, then start again using a lower intensity. 
 If you must pause the treatment during a 30-minute session, turn the intensity back to zero. The 
treatment is conducted while you are lying down.  Your head may be propped on a pillow, but 
you may not move around during the treatment.  If you have a urinary infection or any surface 
irritations in the vagina, you are not recommended to use the device. 
 
What are the possible benefits of taking part in this research study? 
It is hoped you will get some benefit from participation in this study with an improvement in 
your stress urinary incontinence symptoms such as not leaking as much or being able to stop 
using pads. We cannot promise this study will help you, but the information we get from this 
study will help improve the treatment of people like you who suffer from stress urinary 
incontinence. 
 
Are there any alternative treatments? 
One alternative treatment available for women who suffer from stress urinary incontinence is 
oral medications, which affect the nervous system of the bladder.  Another alternative is 
surgical intervention (implanting medical products or surgery). Another is to work with a 
physical therapist to strengthen your pelvic floor muscles.  You can discuss all advantages and 
disadvantages of alternative treatments with your Investigator if you wish.  
 
What happens when the research study stops? 
After completing your 12-week treatment programme, you will be trained, then asked to 
perform standard Kegel exercises each day for 14-weeks then visit the clinic for a final 
assessment. The study team will discuss with you at this final contact how you are feeling and 
what other treatments may be available to you, if needed.  
 
What happens if the study ends early?  
If you or the study team observe unanticipated adverse device effects, if your health condition 
worsens or if you do not follow the instructions of the study team, your study participation may 
be ended early. You can also decide to withdraw your consent early. If this situation should 
arise, the next visit should still preferably be conducted, as some safety examinations will be 

                   Study No: BMR-13-1001 
 
 
Study Ref: Neurotech Vital Compact RCT 
 
 
Version: 2.0 FINAL 27 March 2015 
 
CONFIDENTIAL                                                     Page 89 of 132 
 
done during the visit. But if you do not agree, the routine standard treatment for people with 
your condition will be offered to you.   
 
Authorization to use and disclose (release) medical information:  
As part of this research study, your study doctor and the research team will keep records of your 
participation in this study.  These study records may be kept on a computer and will include all 
information collected during the research study, and any health information in your medical 
records that is related to the research study.  Your study doctor and research team will use and 
disclose (release) your information in an anonymous manner as they conduct this study.  To 
evaluate the results of the study and for compliance with federal and state law, your health 
information may be examined and copied by the Food and Drug Administration (FDA), other 
governmental regulatory agencies, the Institutional Review Board of the study or Hospital 
System, the study sponsor and the sponsor’s authorized representative(s). This study may result 
in scientific presentations and publications, but steps will be taken to make sure you are not 
identified.   
 
Under federal privacy laws, your study records cannot be used or released for research purposes 
unless you agree.  If you sign this consent form, you are agreeing to the use and release of your 
health information.  If you do not agree to this use, you will not be able to participate in this 
study.  
 
The right to use your health information for research purposes does not expire unless you 
withdraw your agreement.  You have the right to withdraw your agreement at any time.  You 
can do this by giving written notice to your study doctor.  If you withdraw your agreement, you 
will not be allowed to continue participation in this research study.  However, the information 
that has already been collected will still be used and released as described above.  You have the 
right to review your health information that is created during your participation in this study.  
After the study is completed, you may request this information. Once your health information 
has been released, federal privacy laws may no longer protect it from further release and use. 
 
If you have any questions about the privacy of your health information, please ask your study 
doctor.  All data from the study will be handled confidentially. Data collected for analysis will 
not carry your name or your address or other information that can identify you. This 
information will also be sent to the sponsor’s agent for data analysis. At the beginning of the 
study you will be assigned a participant number which will be noted on all documentation. It 
will not be possible to identify you outside the department. The collected data may be 
transferred to any of the Sponsor offices including, but not limited to, the Sponsor head-office 
(Parkmore Business Park West, Galway, Ireland). The information may be recorded by the 
sponsoring company in paper form or in a computer database. However, they will obtain only 
your participant number.  Your name and your address will be removed from all data being 
transferred outside the department to ensure that you cannot be identified.   
 
Compensation for Injury as a Result of Study Participation: 
We will provide you with the care needed to treat any injury or illness that directly results from 
taking part in this research study.  Your insurance company or other third parties may be 
responsible for the care you get for an injury.  You may also be responsible for these costs.  For 
example, if the care is billed to your insurer, you will be responsible for the payment of any 
deductibles and co-payments required by your insurer or even possibly the entire cost of the 
service.  
 

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Study Ref: Neurotech Vital Compact RCT 
 
 
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Injuries sometimes happen in research even when no one is at fault. The study sponsor, the 
clinic or hospital or the investigators as part of this study have no plans to pay you or give you 
other compensation for an injury, should one occur. However, you are not giving up any of your 
legal rights by signing this form. If you think you have been injured or have experienced a 
medical problem as a result of taking part in this research study, tell the person in charge of this 
study as soon as possible.  
 
What if new information becomes available? 
Sometimes we get new information about the treatment being studied. If this happens, your 
Investigator will tell you and discuss whether this affects your personal situation and whether 
you should continue in the study.  A new written informed consent may become available 
which you would have to sign to participate further in the study. If you decide not to carry on, 
the Investigator will make arrangements for your care to continue.   
 
If the study is stopped for any other reason, we will tell you and arrange your continuing care.  
 
Who has reviewed the study? 
The clinical study presented here has been looked at and approved by a duly-constituted 
Institutional Review Board (IRB) in compliance with the law.  
 
What will happen to the results of the study? 
The results will be analysed and a report will be written and may be submitted for 
publication in a scientific journal.  This report will not contain any information that could 
be used to identify you in any way.  
 
Who is organising and funding the research? 
Bio-Medical Research Ltd. is the Sponsor and will pay the investigator (doctor) and study team 
for including you in this study. 
 
Expenses and payments: 
There is no cost to you to participate in this study.  Study funds will pay for the study device, 
incontinence pads and all study-related examinations that are provided to you.  If you have any 
questions about costs to you that may result from taking part in the research, please speak with 
the study doctors and study staff.   
 
Payment for participation:  
You will be paid to participate in this study.  You will be paid up to a total of $TBD depending 
on how many study visits you complete. You will be eligible to receive your payments after the 
completion of all functional tests and questionnaires required at each data collection 
appointment.  If you do not complete the required tests and questionnaires at your 
appointments, you will not receive the payment for that visit. 
 
 
 
 
 
 
 
 
 
 

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Study Ref: Neurotech Vital Compact RCT 
 
 
Version: 2.0 FINAL 27 March 2015 
 
CONFIDENTIAL                                                     Page 91 of 132 
 
 
 
CONSENT TO PARTICIPATE 
My study doctor, ____________________________________________, has explained the 
nature and purpose of this study to me.  I have been given the time and place to read and review 
this consent form and I choose to participate in this study.  I have been given the opportunity to 
ask questions about this study and my questions have been answered to my satisfaction.  I agree 
that my health information may be used and disclosed (released) as described in this consent 
form.  After I sign this consent form, I understand I will receive a copy of it for my own 
records.  I do not give up any of my legal rights by signing this consent form. 
 
Printed Name of Participant   
______________________________ 
 
Signature of Participant 
 
 ______________________________  
 
Date ____________Time ________ 
 
Signature of Witness  
 
_______________________________ 
 
Date 
____________Time________ 
 
INVESTIGATOR STATEMENT 
I have carefully explained to the participant the nature and purpose of this study.  The 
participant signing this consent form has (1) been given the time and place to read and review 
this consent form; (2) been given an opportunity to ask questions regarding the nature, risks and 
benefits of participation in this research study; and (3) appears to understand the nature and 
purpose of the study and the demands required of participation.  The participant has signed this 
consent form prior to having any study-related procedures performed. 
 
Investigator Print Name:  ________________________ 
 
Investigator Signature: ___________________________  
 
Date ________Time______ 
 
 
 
 
 
 
 
 
 
 
 

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CONFIDENTIAL                                                     Page 92 of 132 
 
14.11 Appendix XI. Neurotech Vital™ Compact Instructions for Use and Quick Start 
Guide 
 
 

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14.12  Appendix XII.  itouch Sure Pelvic Floor Exerciser Instructions for Use 
 
 
 

                   Study No: BMR-13-1001 
 
 
Study Ref: Neurotech Vital Compact RCT 
 
 
Version: 2.0 FINAL 27 March 2015 
 
CONFIDENTIAL                                                     Page 118 of 132 
 
 
 
 
IMPORTANT: Read this manual carefully before starting to use your itouch sure Pelvic Floor Exerciser. 
INAPPROPRIATE OR INCORRECT USE COULD BE UNSAFE. 
 
This user manual is provided to you as part your participation in a clinical study. Please only use the iTouch 
sure as directed by your study doctor 
 
Caution: U.S. Federal Law restricts this device to sale by or on the order of a licensed healthcare practitioner. 
 
Support 
Please call your study doctor if you have any questions. 
 
 
 
TABLE OF CONTENTS 
CONTENTS OF PACKAGE 
 
 
 
 
 
 
3 
Before you use itouch sure for the first time 
 
 
 
 
3 
CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS  
 
 
4 
ITOUCH SURE INDICATIONS FOR USE 
 
 
 
 
 
5 
TREATING URINARY INCONTINENCE 
 
 
 
 
 
6 
HOW TO SET UP AND USE itouch sure 
 
 
 
 
 
7 
iTOUCH SURE "SMART FEATURES" 
 
 
 
 
 
9 
ITOUCH SURECONTROLS 
 
 
 
 
 
 
11 
SCREEN DISPLAYS 
 
 
 
 
 
 
 
14 
Treatment 
 
 
 
 
 
 
 
 
16 
BATTERY USE 
 
 
 
 
 
 
 
 
17 
ITouch SURE CLEANING AND STORAGE  
 
 
 
 
18 
TROUBLESHOOTING 
 
 
 
 
 
 
 
19 
PRODUCT SPECIFICATIONS 
 
 
 
 
 
 
19 
PROGRAM SETTINGS 
 
 
 
 
 
 
 
20 

                   Study No: BMR-13-1001 
 
 
Study Ref: Neurotech Vital Compact RCT 
 
 
Version: 2.0 FINAL 27 March 2015 
 
CONFIDENTIAL                                                     Page 119 of 132 
 
 
CONTENTS OF PACKAGE 
Itouch Sure Control Unit 
itouch sure Electrode 
Connecting lead wire 
Four AA batteries 
Instruction booklet 
Storage pouch 
 
Before you use itouch sure for the first time 
An examination of the vaginal tissue should be completed prior to initial treatment to rule out any 
contraindications, establish the baseline tissue condition and assess the physiology discussed below.  Pelvic 
floor stimulation may not be successful if the urethra has excessive scarring or if there is significant 
denervation of the pelvic floor. The neuromuscular structures involved in urine storage must also be at least 
partially preserved. Patients with intact sacral reflex arcs and some innervation of the pelvic floor may benefit 
from pelvic floor stimulation. 
 
The itouch sure unit must only be used in accordance with the advice of your treating physician. 
Be sure to read the instructions included in this booklet   to supplement the information provided 
to you by your physician. 

                   Study No: BMR-13-1001 
 
 
Study Ref: Neurotech Vital Compact RCT 
 
 
Version: 2.0 FINAL 27 March 2015 
 
CONFIDENTIAL                                                     Page 120 of 132 
 
 
 
CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS 
Contraindications 
 
Should not be used if you have any of the following conditions: 
If you have a heart pacemaker or a rhythm problem 
If you are pregnant or trying to become pregnant 
If you have been diagnosed or treated for cervical, or any pelvic, cancer 
If you have, or have had epilepsy 
While driving, or during any activity in which involuntary muscle contractions may put the user at undue risk of 
injury 
If you have: 
An active urinary tract infection 
Recent history of vaginal bleeding between menstrual periods 
Infections or lesions in the area of electrode placement 
Diminished sensory perception 
Inability to understand the directions of use or operate the device correctly 
History of urinary retention or post-void residual volume greater than 200 cc If any discomfort occurs when 
inserting the electrode consult your study doctor. 
 
Warnings 
 
The patient should discontinue use and immediately consult the clinician if irritation, pain or unusual bleeding 
occurs. 
Keep out of reach of children. 
Do not use in water (for example, while bathing) or device may shock user. 
This equipment is not rated for use while immersed or under dripping water. 
Do not use simultaneously with high frequency hospital diagnostic/therapeutic equipment. Doing so may result 
in burns at the site of the electrodes and possible damage to the device. 
Do not use simultaneously with patient monitoring equipment such as EKG monitors without investigating the 
possibility of output from the device causing erroneous monitor readings. 
Do not carry batteries in a pocket, purse or other place where the terminals could become short circuited, (e.g. 
by way of a coin or paperclip). Intense heat could be generated and injury may result. 

                   Study No: BMR-13-1001 
 
 
Study Ref: Neurotech Vital Compact RCT 
 
 
Version: 2.0 FINAL 27 March 2015 
 
CONFIDENTIAL                                                     Page 121 of 132 
 
 
 
 
The long term effects of chronic electrical stimulation are unknown. 
Do not use with products other than those recommended by your treating clinician. 
 
Precautions 
Review the following precautions before using: 
It is not recommended to use the device while under the influence of alcohol or other substances, such as 
sleeping pills or tranquilizers, which could affect the patient's ability to operate the system correctly. 
Removing or inserting the electrode while the system is on could result in discomfort. 
Use while operating hazardous equipment, machinery or motorized vehicles could cause abrupt changes in 
stimulation which can startle the patient and create a hazard. 
Do not use in close proximity (e.g. <3ft.) to transmitting cellular (wireless) telephones or two-way radios. This 
equipment may produce instability in the stimulatory output. Sudden unexpected changes in output could 
startle the patient and create a hazard. 
Use while sleeping is not recommended. 
The patient should discontinue use and consult a clinician if a significant change in the stimulation sensation 
occurs without changing the intensity settings. It is normal to feel a difference in sensation when changing 
positions during stimulation. 
Caution should be used following recent surgical procedures when muscle contraction may disrupt the healing 
process. 
 
 
ITOUCH SURE INDICATIONS FOR USE 
 
Your physician has prescribed the use of the itouch sure Pelvic Floor Exerciser for the treatment of your 
urinary incontinence symptoms. itouch sure is indicated for the rehabilitation and strengthening of weak pelvic 
floor muscles in the treatment of stress, urge, and mixed urinary incontinence. 

Study No: BMR-13-1001 
 
 
Study Ref: Neurotech Vital Compact RCT 
 
 
Version: 1.2 DRAFT 27 March 2015 
 
CONFIDENTIAL                                                     Page 122 of 132 
 
 
 
TREATING URINARY INCONTINENCE 
 
You have been selected for this study because you suffer from Stress Urinary Incontinence and 
the iTouch sure is indicated for the treatment of this condition. The device may also be used for 
other forms of incontinence however in this study you will only be using the Stress treatment. 
 
Please always ensure that the letters “STRES” are displayed at the top of the screen during 
treatment. If the words URGE, MIXD or TONE are displayed then you are using the wrong 
program. Press button P until STES appears on the screen and continue treatment 
 
 
Please follow the instructions for use given to you by your study physician. The initial electrode 
fitting and the treatment session should be done under medical supervision by study staff. 
 
You should experience the sensation of a muscular contraction in the vagina when using itouch 
sure. 
 
 

Study No: BMR-13-1001 
 
 
Study Ref: Neurotech Vital Compact RCT 
 
 
Version: 1.2 DRAFT 27 March 2015 
 
CONFIDENTIAL                                                     Page 123 of 132 
 
 
 
HOW TO SET UP AND USE itouch sure 
 
Setting up and using the itouch sure Pelvic Floor Exerciser is very simple. 
 
 
 
 
 
Step 1: Before you use itouch sure for the first time, clean the Probe gently with soap and water 
(do not immerse). 
 
Step 2: Insert two AA batteries into the Control Unit (see "Inserting the Batteries"). To test that the 
batteries have been inserted correctly and that the unit is working, press and hold the "ON" button 
for three seconds. The screen will light up and you will hear a beep. 
 
Step 3: Insert the two prongs of the lead wire into the matching receptacle end of the itouch sure 
Probe wire. 
 
Step 4: Plug the USB port end of the lead wire directly into the bottom of the itouch sure Control 
Unit as shown. 
 
 
 

Study No: BMR-13-1001 
 
 
Study Ref: Neurotech Vital Compact RCT 
 
 
Version: 1.2 DRAFT 27 March 2015 
 
CONFIDENTIAL                                                     Page 124 of 132 
 
 
Step 5: Before you insert the itouch sure Electrode, empty your bladder (urinate), and make sure 
the itouch sure Control Unit is switched OFF. 
 
 
 
 
 
 
Step 6: Lubricate the itouch sure Probe with the conductive gel provided.  
 
Step 7: After the wires are securely connected, insert the Probe into the vagina, in the same way 
you would a tampon, until only the flange at the end is visible. 
The Probe will naturally position itself with the widest part of the flange vertically (see diagram). 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: The flange should not be inserted into the vagina and should remain outside of the vagina at all times. 
 
It is important to relax and choose a comfortable position - such as a semi-reclined pose - or to lie 
down on a bed or couch when performing this step. 
Step 8: Turn the itouch sure ON by pressing the ON button 
 for three seconds. When the unit 
is switched ON an audible "beep" will be heard. 
 
Step 9: You will be using the STRES program in this study. The P Button is used to change the 
program. Please do not change the Program. If you accidentally change it you can get the STRES 
program back again by pressing the P button a few times. 
 
 
 
 
 
 
Step 10: After insertion, adjust the strength by pressing the strength 
 button. The selected 
intensity will appear on the display. Begin to increase the strength to a level where you feel the 
sensation but is not overly painful. You may not feel any sensation until the strength reaches a 
certain level. This level may vary based on individual use and any pre-existing physical conditions, 
but stimulation occurs as soon as the strength is registered above 0. 
 
 
 
 
 
 
 
Note: It is important to be conservative upon initial use. As long as you can feel the contraction, itouch sure is working. 
You can build up the strength slowly over a number of days. 
 

Study No: BMR-13-1001 
 
 
Study Ref: Neurotech Vital Compact RCT 
 
 
Version: 1.2 DRAFT 27 March 2015 
 
CONFIDENTIAL                                                     Page 125 of 132 
 
During use you may feel cramping. If this happens, stop using the itouch sure until the cramping 
goes away, then start again using a lower strength.   
 
Step 11: To decrease intensity, press the strength down 
button.  
NOTE: itouch sure cycles between active stimulation and periods of rest to allow your muscles to 
recover between contractions. It is normal to feel the stimulation ramp down, stop briefly, and then 
ramp back up again during treatment. (During the "rest" period, the strength display flashes "0.0".) 
 
 
 
Step 12: The length of each session has been set at 20 minutes. Please do not change the preset 
time. 
 
 
Step 13: When the timer reaches zero, your session is complete. Press and release the OFF button 
once to turn off the power or it will automatically turn off. 
 
 
Step 14: Remove the itouch sure Probe from your vagina by grasping the probe flange and gently 
pulling outward. It is important that you do not pull from the wires, as it may become disconnected 
at the two-prong connection. 
 
 
Step 15: Wash and thoroughly dry the itouch sure Probe before placing it and the itouch sure 
Control Unit into the storage pouch. 
 
Note: As with any new exercise regimen, with the first few sessions your muscles may be a bit sore the next day. 
 
 
Note: The next time you turn on the unit, it will default to the mode last used but at half strength. 
Thus, it may be beneficial for you to adjust the intensity to the desired setting for your next 
treatment session prior to turning off the itouch sure Pelvic Floor Exerciser. 
 
 
iTOUCH SURE "SMART FEATURES" 
itouch sure Pelvic Floor Exerciser is designed with state-of-the art electronic features including: 
 
Controllable Stimulation 
The strength of the stimulation is under your control. You can gradually increase or decrease the 
intensity whenever you want to make sure the stimulation always feels comfortable. 
 
 
Easy Start - One Touch Memory 
The itouch sure has intelligent memory that enables the unit to remember the last settings you 
used, and return to similar settings at your next use. 
 
 
•Automatic Safety Shutoff 
This feature automatically turns the device off after 20 minutes of use to protect the pelvic floor 
muscles from being overworked. If your physician recommends sessions that are longer than 20 
minutes, you can adjust the device to override the safety shutoff and allow a longer session. 
 

Study No: BMR-13-1001 
 
 
Study Ref: Neurotech Vital Compact RCT 
 
 
Version: 1.2 DRAFT 27 March 2015 
 
CONFIDENTIAL                                                     Page 126 of 132 
 
 
 
 
To turn itouch sure ON: Press and hold the ON button for three seconds.  
When the unit turns on, you will hear a beep.  
 
Memory Start 
If you turned the unit off before completing the session, it will automatically start in the program you 
used last, at about 50% of the strength level you were using. This way you can adjust the strength 
comfortably for each new session. 
Strength UP  
Button 
To increase strength: Press and hold the Strength UP 
button until your desired strength is displayed on the screen.  
You may not feel any initial sensation, as it is a gentle increase of intensity. 
To increase the strength, press and release the button until you reach  
your required level. The strength will increase in 0.5 increments 
up to a maximum of 99.5. 
 
 
Strength DOWN 
Button 
To decrease strength: Press and hold the Strength DOWN button until 
 the desired strength is achieved. To decrease the strength, press and 
release the button until you reach your desired level. 
 
 
 
 
Program ( P) Button 
itouch sure has four preset programs which appear as STRES,  
URGE, MIXD and TONE on the screen.  You will be only using 
 the STRES program in this study. The P Button is used to change 
 the program. Please do not change the Program. If you accidentally 
 change it you can get the STRES program back again by pressing  
the P button a few times. 
 
ITOUCH SURECONTROLS 

Study No: BMR-13-1001 
 
 
Study Ref: Neurotech Vital Compact RCT 
 
 
Version: 1.2 DRAFT 27 March 2015 
 
CONFIDENTIAL                                                     Page 127 of 132 
 
 
 
Lock Button 
The Lock button can be used to lock all the controls except for the 
 strength down and OFF buttons. This way you won't accidentally 
 change the settings while you use the unit, but you still have the 
 ability to decrease the strength at any time. To lock the unit, press 
and hold down the Lock button for three seconds until LOCK is 
 displayed on the screen. To unlock the unit, simply repeat. 
 
                        Time Selector Button 
The itouch sure Pelvic Floor Exerciser counts down the minutes of 
 your session. This countdown is displayed on the screen. When 
the count reaches zero, the unit will automatically turn off. 
 
 
Each time you switch on the itouch sure, the time selector will be set at 20 minutes which is the 
treatment time for this study. Please do not change the timer setting. 
 
 
To PAUSE the session - in case you need to suspend the treatment session and resume later - 
hold down the Time Selector button for three seconds. The display will read "PAUSE". 
 
To return to the main screen, press any other key and you will return to the settings where you left 
off. 
 
OFF  
 Button 
To turn itouch sure OFF: Press the OFF button. You will hear a 
 double beep. 
 
 
 
NOTE: Always make sure the unit is OFF before removing the itouch sure Probe from your vagina. 
 
 
SCREEN DISPLAYS 
The screen lights up whenever a button is pressed. 
 
 
 

Study No: BMR-13-1001 
 
 
Study Ref: Neurotech Vital Compact RCT 
 
 
Version: 1.2 DRAFT 27 March 2015 
 
CONFIDENTIAL                                                     Page 128 of 132 
 
LEADS ALARM 
 
itouch sure monitors the contact between you, the Probe,  
and the itouch sure Control Unit. If either of these go outside 
of a standard range, while the strength is above 20.0, the uni 
t will flash "LEADS", beep three times, and return strength to zero. 
 
 
The most common causes are: 
Poor contact with your vaginal walls. 
•A broken lead wire. 
•A faulty connection at the USB port or at the dual probe connectors. 
 
 
If the LEADS alarm sounds, make sure the wires are connected properly. If that doesn't solve the 
problem: 
 
Change the position of the probe in the vagina; or 
Change your body position; or 
Add lubrication to the itouch sure Probe so that it can make a better contact with the 
vaginal 
tissue. 
 
 
If you have taken the above steps above and the alarm still shows, please refer to Troubleshooting 
section for further information. 
 
Treatment 
Please follow the instructions for use given to you by your study physician. The initial electrode 
fitting and the treatment session should be done under medical supervision by study staff. 
 
Set the strength level to that prescribed by your study doctor. If you experience discomfort reset 
the intensity down one step. Don't "overdo" it early on. As long as you can feel the contractions, 
itouch sure is working properly. You can build up slowly over a number of sessions. 
 
Your muscles may be sore the next day- the same reaction you would get with any new exercise - 
and you may need to stop using your itouch sure for a day or two until the soreness goes away, 
and then start again using a lower strength and shorter treatment time. As the pelvic floor muscles 
get stronger, you will be able to increase your strength level and time. 
 
 
 
NOTE: itouch sure cycles between active stimulation and periods of rest. It is normal to feel the 
stimulation ramp down, stop briefly and then ramp back up again during treatment. 
 
BATTERY USE 
 
Inserting the Batteries 
 
 
 
Open the battery cover: 
 
Press down in centre of battery cover and 
slide the cover downwards in the direction 
of the raised arrows. 
 
 
 
Insert the batteries in the direction shown inside the case. Make sure that the ribbon goes behind 
the batteries, which makes them easier to remove later. When the batteries are running low, a low 
battery indicator will show on the screen (battery symbol) and the display will begin to fade. The 
intensity of your workout, however, will stay the same until the battery runs out and the unit shuts 
off. 

Study No: BMR-13-1001 
 
 
Study Ref: Neurotech Vital Compact RCT 
 
 
Version: 1.2 DRAFT 27 March 2015 
 
CONFIDENTIAL                                                     Page 129 of 132 
 
 
 
Battery removal and replacement: 
 
When the batteries need to be changed the low battery sign, " BATT", will be displayed on the 
screen. To remove batteries, pull gently on the ribbon behind them. Remove batteries from your 
itouch sure unit if the unit is unlikely to be used for a long period. 
 
Battery type: 
ONLY use either AA alkaline batteries. . DO NOT mix batteries of different types. Do not try to 
recharge alkaline batteries. Properly dispose of used batteries, as batteries should not be 
disposed of with household waste. 
 
Warning: 
Keep batteries out of the reach of small children 
If battery leakage occurs and comes in contact with the skin or eyes, wash thoroughly with lots of 
water. 
Do not attempt to revive alkaline batteries by heating, charging or other means 
Never put batteries in a fire nor try to disassemble them 
 
ITouch SURE CLEANING AND STORAGE 
 
Cleaning the Probe 
 
It is important to clean the itouch sure Probe after each use to prevent bacterial growth that could 
possibly lead to an increased risk for infection. Wash the probe with warm soapy water and then 
wipe the probe with an alcohol wipe, and dry thoroughly. 
DO NOT immerse the probe under water, or in boiling water, as this will damage it. 
 
The Probe that is supplied with the itouch sure Pelvic Floor Exerciser is intended strictly for one 
person's use. Do not let anyone else use your itouch sure. 
 
Cleaning the itouch sure Control Unit 
Clean the itouch sure Control Unit weekly with a cloth or paper towel dampened with soapy water, 
but DO NOT immerse it under water. Dry it with a clean cloth and make sure it is fully dry before 
storing the unit in its pouch. 
 
Storing Your itouch sure Pelvic Floor Exerciser 
Store itouch sure in its pouch. 
Do not store at high temperatures or in damp conditions. 
Do not store or use near a microwave oven. 
Remove batteries if storing for more than 30 days 
 
 
TROUBLESHOOTING 
If you have problems with the operation of your itouch sure Pelvic Floor Exerciser, follow these 
directions: 
 
 
Fading display or no display - 
The display will begin to fade as the batteries run low, and there will be nothing on the display 
when there is no power left in the batteries. Make sure the batteries are charged and inserted 
correctly. If necessary, replace them. (For more information, see " Battery Use" on page 19) 
 
Controls won't work - 
The unit may be on LOCK, in which case the display will read "LOCK". Hold down the Lock button 
on the side for three seconds. If "LOCK" is not showing on the display, remove and replace the 
batteries. 
 
No sensation / No leads alarm - 
If you feel no sensation when you use itouch sure, first try increasing the strength level according 
to instructions. If that does not work, dampen your hand with water and a little table salt. Holding 

Study No: BMR-13-1001 
 
 
Study Ref: Neurotech Vital Compact RCT 
 
 
Version: 1.2 DRAFT 27 March 2015 
 
CONFIDENTIAL                                                     Page 130 of 132 
 
the Probe in your hand, increase the strength gradually. If you don't feel anything, the unit may 
need to be replaced. 
 
NOTE: If you are able to feel the sensation in your hand but not in your vagina, you may have nerve damage. Stop using 
itouch sure and call your physician 
 
 
PRODUCT SPECIFICATIONS 
Maximum Intensity 
 
 
50V zero to peak.  
Setting  
 
 
 
0·100 in steps of 0.5  
OC cutout  
 
 
 
below 160 Ohm.  
Constant current  
 
 
160-470 Ohm 470-2000 Ohm constant voltage. 
 
Channels 
 
 
 
Single 
 
Waveform 
 
 
 
Asymmetrical rectangular 
 
Max Pulse energy 
 
 
*Total output limited to 25uC per pulse 
 
Power 
 
 
 
 
2 xAA Alkaline 
 
Battery life 
 
 
 
At least 15 hours at 5omA 3oouS 50Hz 
 
Adjustable Timer  
 
 
10, 20, 30 45, 60, 90 min defaults to 20 min 
 
Pause button 
 
 
 
"Clock" key when running 
 
Output plug 
 
 
 
Fully shielded: touch-proof mini USB 
 
Weight  
 
 
 
90 gms without batteries 
 
Dimensions 
 
 
 
102 x 53 x 30 mm 
 
Safety Classification 
 
 
Internal power source. 
Type BF  
 
 
 
Designed for continuous use. No special moisture 
 protection. 
Environmental Operating:  
 
Humidity: 20% - 65% RH 
 
Storage Humidity:  
 
 
10 to 90% RH Temperature range: 0°C to 55°C 
 
Temperature range 
 
 
0°C to 35°C 
 
The electrical specifications are nominal and subject to variation from the listed values due to normal 
production tolerances. 
 
 
PROGRAM SETTINGS 
 
 
 

Study No: BMR-13-1001 
 
 
Study Ref: Neurotech Vital Compact RCT 
 
 
Version: 1.2 DRAFT 27 March 2015 
 
CONFIDENTIAL                                                     Page 131 of 132 
 
Device Output Parameters and Waveform 
The waveform below illustrates a typical output waveform from the itouch sure device: 
 
 
 
 
Max Pulse Energy: 23 µC 
 
 
Use special precautions regarding EMC according to the information provided below. 
 
Other portable and mobile RF communications equipment can affect performance. 
Do not use when adjacent to or stacked with other electrical equipment. 
 
 
Assistance 
If you have any problems with your device please contact your study doctor whose contact 
details are on the Informed Consent form you received at the beginning of the study. For 
further assistance you may contact 
 
Expedite Research, LLC 15 Kerry Lane 
Phoenixville, PA 19460-2771 
Office 610 933 1529 
 
 
These instructions for use were created specifically for study BMR 13 1001 by: 
 
Bio-Medical Research Ltd. Parkmore Business Park West Galway, Ireland