A Post-Market Evaluation of the Altis® Single Incision Sling System Versus Transobturator or Retropubic Mesh Sling in the Treatment of Female Stress Urinary Incontinence
Conditions: Stress Urinary Incontinence
Sponsor: Coloplast A/S

Altis 522 Study 
Version 4.0 
November 01, 2018 
CONFIDENTIAL 
Page 1 of 47 
 
 
Clinical Study Plan 
Study ID SU020 
A Post-Market Evaluation of the Altis® Single Incision Sling System 
versus Transobturator or Retropubic Mesh Sling in the Treatment of 
Female Stress Urinary Incontinence (Altis 522 Study)  
 
Sponsor 
Coloplast Corp 
1601 W. River Rd. 
 
Minneapolis, MN 55411 
 
Version 4.0 
November 01, 2018 
 
 
 
 
This confidential document is the property of Coloplast Corp. No unpublished 
information contained herein may be disclosed without written approval of Coloplast 
Corp. 

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CONFIDENTIAL 
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Table of Contents 
Endpoints ....................................................................................................................................... 6 
Primary Safety Endpoint ........................................................................................................................................ 6 
Primary Effectiveness Endpoint ............................................................................................................................. 6 
Secondary Safety Endpoints .................................................................................................................................. 6 
Secondary Effectiveness Endpoints ....................................................................................................................... 7 
Inclusion Criteria for Subject Selection .................................................................................................................. 7 
Exclusion Criteria for Subject Selection ................................................................................................................. 7 
1 
List of personnel involved in the study ........................................................................... 13 
1.1 
Sponsor representatives ..................................................................................................... 13 
1.2 
Investigators ...................................................................................................................... 13 
1.3 
Other Representatives ........................................................................................................ 13 
2 
Study Justification ......................................................................................................... 14 
3 
Study Purpose and Design ............................................................................................. 15 
3.1 
Primary Objectives ............................................................................................................. 15 
3.2 
Secondary Objectives.......................................................................................................... 15 
3.2.1 
General ................................................................................................................................................ 16 
3.2.2 
Site and Investigator Selection ............................................................................................................ 16 
3.3 
Endpoints ........................................................................................................................... 18 
3.3.1 
Primary Safety Endpoints ..................................................................................................................... 18 
3.3.2 
Primary Effectiveness Endpoint ........................................................................................................... 18 
3.3.3 
Secondary Safety Endpoints ................................................................................................................ 18 
3.3.4 
Secondary Effectiveness Endpoint ....................................................................................................... 18 
3.3.5 
Risk Factors .......................................................................................................................................... 19 
3.4 
Subjects ............................................................................................................................. 19 
3.4.1 
Inclusion criteria for subject selection ................................................................................................. 19 
3.4.2 
Exclusion criteria for subject selection ................................................................................................ 19 
3.5 
Subject Recruitment and Enrollment ................................................................................... 20 
3.6 
Point of Enrollment ............................................................................................................ 20 
3.7 
Subject Withdrawal Criteria ................................................................................................ 20 
3.8 
Subject Retention ............................................................................................................... 20 
4 
Total Expected Duration of the Clinical Study ................................................................. 21 
5 
Procedures and Data Collection ..................................................................................... 21 
5.1 
Baseline Visit ...................................................................................................................... 22 
5.2 
Procedure Visit ................................................................................................................... 23 
5.3 
Follow-Up Visit Schedule .................................................................................................... 23 
5.3.1 
Follow-up Visits:  6, 12, 18, 24, and 36 Month .................................................................................... 23 

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5.3.2 
Unscheduled Follow-up Visits .............................................................................................................. 23 
5.4 
Device Revisions and Explants ............................................................................................. 24 
5.5 
Randomization Procedure ................................................................................................... 24 
5.6 
Blinding .............................................................................................................................. 24 
6 
Identification and Description of Devices ....................................................................... 24 
6.1 
Description of the Study Device .......................................................................................... 24 
6.2 
Description of Coloplast Control Devices ............................................................................. 25 
6.2.1 
Aris® Trans-Obturator Sling .................................................................................................................. 25 
6.2.2 
Supris® Retropubic Sling System .......................................................................................................... 25 
6.3 
Manufacturer ..................................................................................................................... 25 
6.4 
Identification, Traceability and Labeling of the Devices ........................................................ 25 
6.5 
Intended Population for the Device ..................................................................................... 26 
6.6 
Handling and Training ......................................................................................................... 26 
7 
Statistical Considerations .............................................................................................. 26 
7.1 
Analysis Populations ........................................................................................................... 26 
7.2 
General Analysis Principles ................................................................................................. 26 
7.3 
Missing Data....................................................................................................................... 26 
7.4 
Analysis of Primary Effectiveness Endpoint.......................................................................... 27 
7.5 
Analysis of Primary Safety Endpoint .................................................................................... 27 
7.6 
Analysis of Powered Secondary Safety Endpoints ................................................................ 28 
7.6.1 
Secondary Safety Endpoint .................................................................................................................. 28 
7.6.2 
Revision/Resurgery .............................................................................................................................. 28 
7.7 
Additional Secondary Endpoints.......................................................................................... 29 
7.7.1 
24-Hour Pad Weight ............................................................................................................................ 29 
7.7.2 
Quality of Life ....................................................................................................................................... 29 
7.7.3 
Adverse events .................................................................................................................................... 29 
7.8 
Propensity Analysis............................................................................................................. 29 
7.9 
Sample Size ........................................................................................................................ 30 
7.9.1 
Final Sample Size .................................................................................................................................. 30 
7.9.2 
Sample Size Estimation for Primary Effectiveness Endpoint ............................................................... 30 
7.9.3 
Sample Size Estimation for Primary Safety Endpoint .......................................................................... 30 
7.9.4 
Sample Size Estimation for Powered Secondary Safety Endpoints ..................................................... 30 
7.9.5 
Level of Significance and Power .......................................................................................................... 31 
7.9.6 
Drop-out .............................................................................................................................................. 31 
7.10 
Interim Analysis .............................................................................................................. 31 
8 
Data Quality Assurance ................................................................................................. 31 
8.1 
Electronic Data Capture ...................................................................................................... 31 

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8.2 
Monitoring Plan .................................................................................................................. 31 
8.3 
Audits ................................................................................................................................ 32 
9 
Ethical Considerations, Device and Clinical Study Risks and Benefits ............................... 32 
9.1 
Informed Consent Process .................................................................................................. 32 
9.2 
Sample Informed Consent Form .......................................................................................... 32 
9.3 
Institutional Review Board/Ethics Committee ..................................................................... 32 
9.4 
Data Protection .................................................................................................................. 33 
9.5 
Risks and Benefits ............................................................................................................... 33 
10 
Data Management ..................................................................................................... 33 
11 
Amendments to the Clinical Study Plan ....................................................................... 34 
12 
Clinical Study Deviations ............................................................................................ 34 
13 
Statement of Compliance ........................................................................................... 34 
14 
Adverse Events, Serious Adverse Events, and Device Deficiencies ................................ 35 
14.1 
Adverse Event/Complication Classification....................................................................... 35 
14.1.1 
Adverse Events (AE) ............................................................................................................................. 35 
14.1.2 
Serious Adverse Events ........................................................................................................................ 36 
14.1.3 
Unanticipated Adverse Device Effect (UADE) ...................................................................................... 36 
14.1.4 
Adverse Event Severity Classification and Device Causality ................................................................ 36 
14.2 
Device Deficiency and Technical Observations ................................................................. 37 
15 
Adverse Event Review ................................................................................................ 37 
15.1 
Clinical Events Committee ............................................................................................... 37 
16 
Reporting and Timelines ............................................................................................. 37 
16.1 
Investigator Reporting Responsibilities ............................................................................ 37 
16.2 
Records Retention ........................................................................................................... 41 
17 
Suspension or Premature Termination of the Clinical Study ......................................... 41 
18 
Suspension or Premature Termination of a Study Site ................................................. 42 
19 
Publication policy ....................................................................................................... 42 
20 
References ................................................................................................................. 43 
 
 
 

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List of Tables 
Table 1 Data Collection Schedule ........................................................................................ 21 
Table 2 Follow-up Schedule and Windows ........................................................................... 23 
Table 3 Investigator Reporting Requirements ...................................................................... 39 
Table 4 Coloplast Reporting Requirements .......................................................................... 41 
 
List of Figures 
Figure 1: Overall Study Design Flow-Chart .......................................................................... 17 
 
List of Attachments 
Attachment 1 Change Log ................................................................................................... 44 
 
 
 

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Synopsis of the Clinical Study  
The aim of this postmarket study is to compare the safety and effectiveness of the Altis Single 
Incision Sling (SIS) to an FDA cleared transobturator and/or retropubic mesh sling through 36 
months. The primary safety and effectiveness objectives are as follows: 
Primary Safety Objective 
To demonstrate that the rate of device and/or procedure related serious adverse events 
associated with use of Altis SIS is non-inferior compared to the rate associated with use of 
transobturator and/or retropubic slings at 36 months. 
Primary Effectiveness Objective  
To demonstrate that the rate of effectiveness associated with use of Altis SIS is non-inferior 
to the rate associated with use of transobturator or retropubic mesh slings for the treatment of 
stress urinary incontinence at 6 months. 
This study is a prospective, post-market, multi-center, cohort assessment comparing Altis SIS 
(n=178) and transobturator and/or retropubic slings (n=178) in the treatment of stress urinary 
incontinence, at up to 40 U.S. and International sites. Subjects will be followed for a total of 36 
months with scheduled visits at 6 months, 12 months, 18 months, 24 months, and 36 months.  
The study population will consist of adult female subjects with stress urinary incontinence who  
are clinically indicated for surgical intervention with a mesh sling. All study candidates who provide 
written informed consent and meet all of the inclusion criteria and none of the exclusion criteria 
will be included in the study.   
 
Endpoints 
Primary Safety Endpoint 
• 
Observed device and/or procedure-related serious adverse events through 36-months. 
 
Primary Effectiveness Endpoint 
• 
Observed effectiveness, defined as a reduction from baseline in 24 hour pad weight of at 
least 50% at 6 months. 
 
Secondary Safety Endpoints 
• 
Observed rates of device and/or procedure-related adverse events defined as organ 
perforation, bleeding, mesh exposure in the vagina, mesh erosion into the bladder, pelvic 
pain, infection, de novo dyspareunia, urinary retention, recurrent incontinence, other 
urinary problems and neuromuscular problems at 6 months, 12 months, 18 months, 24 
months, and 36 months post index procedure. 
 
• 
All observed adverse events at 6 months, 12 months, 18 months, 24 months, and 36 
months. 
 

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• 
Observed revision/re-surgery at 6 months, 12 months, 18 months, 24 months, and 36 
months. 
 
Secondary Effectiveness Endpoints 
• 
Observed effectiveness defined as a reduction from baseline in 24 hour pad weight of at 
least 50% at 12 months, 18 months, 24 months, and 36 months. 
 
• 
Observed effectiveness for subjects considered dry (pad weight ≤ 4.0 grams) at 6, 12, 18, 
24, and 36 months. 
 
• 
Quality of Life at 6 months, 12 months, 18 months, 24 months, and 36 months as 
measured through: 
o Patient Global Impression of Improvement (PGI-I) 
o Urogenital Distress Inventory (UDI-6) 
o Incontinence Impact Questionnaire-Short Form (IIQ-7) 
o Surgical Satisfaction Questionnaire (SSQ-8) 
o Visual Analog Scale for Pain (VAS Pain) 
 
Inclusion Criteria for Subject Selection 
To be included in the study, subjects must meet all of the following inclusion criteria: 
1. The subject is female and at least 18 years of age. 
2. The subject is able and willing to complete all procedures and follow-up visits indicated 
in this protocol. 
3. The subject has confirmed stress urinary incontinence (SUI) through cough stress test or 
urodynamics. 
4. The subject has failed two non-invasive incontinence therapies (such as Kegel exercise, 
behavior modification, pad use, biofeedback, etc.) for > 6 months. 
Exclusion Criteria for Subject Selection 
To be included in this clinical study subjects must not meet any of the following exclusion criteria: 
1. The subject has an active urogenital infection or active skin infection in region of surgery. 
2. The subject has confirmed Pelvic Organ Prolapse (POP) of Stage 2 or higher as 
determined by POP-Q prolapse grading. 
3. The subject is having a concomitant pelvic floor procedure. 
4. The subject has incontinence due to neurogenic causes (e.g. multiple sclerosis, spinal 
cord/brain injury, cerebrovascular accident, detrusor–external sphincter dyssynergia, 
Parkinson’s disease, or similar conditions). 
5. The subject had a prior surgical SUI treatment. 
6. The subject has undergone radiation or brachy therapy to treat pelvic cancer. 
7. The subject has urge predominant incontinence by MESA assessment. 
8. The subject has an atonic bladder or post void residual (PVR) above 100 cc on ≥ 2 
occasions.  

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9. The subject is pregnant and/or is planning to get pregnant in the future. 
10. The subject has a contraindication to the surgical procedure or the product IFU. 
11. The subject is enrolled in a concurrent clinical trial of any treatment (drug or device) that 
could affect continence function, without the sponsors’ approval. 
 
 

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LIST OF ABBREVIATIONS 
ABBREVIATION 
DEFINITION  
AE 
Adverse Event 
CEC 
Clinical Events Committe 
CRF/eCRF 
Case Report Form/Electronic Case Report Form 
CTM 
Clinical Trial Manager 
EC 
Ethics Committee 
EDC 
Electronic Data Capture 
FDA 
Food and Drug Administration 
IFU 
Instructions for Use 
IIQ-7 
Incontinence Impact Questionnaire (IIQ-7) 
IRB 
Institutional Review Board 
ISO 
International Organization for Standardization 
MESA 
Medical, Epidemiologic, and Social Aspects of Aging 
MUI 
Mixed Urinary Incontinence 
OAB 
Over Active Bladder 
PGI-I 
Patient Global Impression of Improvement (PGI-I) – Incontinence 
PI 
Principal Investigator 
PP 
Per Protocol 
QoL 
Quality of Life 
SAE 
Serious Adverse Event 
SIS 
Single Incision Sling 
SSQ 
Surgical Satisfaction Questionnaire 
SUI 
Stress Urinary Incontinence 
TO 
Transobturator 
TOT 
Transobturator Technique 
TVT-O 
Tension-free Vaginal Tape--Obturator 
UADE 
Unanticipated Adverse Device Effect 
UDI-6 
Urinary Distress Index (UDI-6) 
UTI 
Urinary Tract Infection 

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ABBREVIATION 
DEFINITION  
UUI 
Urge Urinary Incontinence 
VAS 
Visual Analog Scale 

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PRINCIPAL INVESTIGATOR SIGNATURE PAGE  
 
All parties hereby declare to follow the Clinical Study Plan in accordance with the Declaration of 
Helsinki, ICH E6 Good Clinical Practice, ISO 14155, the Medical Device Directive and appropriate 
FDA regulations, as applicable. 
 
 
 
[Principal Investigator Signature]                                                                                                              [ Date] 
 
 
NAME AND TITLE: 
 
 
ADDRESS: 
 
 
POSTAL CODE AND CITY: 
 
 
COUNTRY: 
 
 
PHONE NUMBER: 
 

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1 
List of personnel involved in the study 
1.1 
Sponsor representatives 
CLINICAL TRIAL MANAGER 
STATISTICIAN 
Kris Veltum 
Coloplast 
1601 West River Rd N 
Minneapolis, MN 
Phone:  (763) 248-5744 
Email:  uskve@coloplast.com 
Kaisa Kivilaid, M.S. 
RCRI 
5353 Wayzata Blvd, Suite 505 
Minneapolis, MN 
Phone:  (952) 746-8080 
Email:  kkivilaid@rcri-inc.com 
COUNTRY SPECIFIC 
REPRESENTATIVE(S) 
MEDICAL ADVISOR 
NA 
NA 
 
1.2 
Investigators 
A list of all investigators participating in the study will be maintained in the trial master file at 
Coloplast. 
 
1.3 
Other Representatives 
Study management activities including but not limited to database development may be 
outsourced to appropriate vendors. 
 
 

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2 
Study Justification  
Urinary incontinence (UI) is defined as the complaint of any involuntary loss of urine.1  It is a 
common and distressing medical disorder which is associated with significant decrements in 
function and quality of life. (QoL).  Age, BMI, race, medical comorbidity, current major depression, 
a history of hysterectomy, parity, and having only had cesarean deliveries are each independent 
factors significantly associated with the likelihood of having UI.2 
Types of urinary incontinence include stress, urge, and mixed incontinence.1,3 Stress 
Incontinence (SUI) is the complaint of involuntary leakage on effort or exertion, or on sneezing or 
coughing. Urge Incontinence is the complaint of involuntary leakage accompanied by or 
immediately preceded by urgency. Mixed Incontinence is the complaint of involuntary leakage 
associated with urgency and also with effort, exertion, sneezing and coughing.1 
Urinary incontinence affects up to 50% of all women and among these 50% to 80% are identified 
as having SUI.  An estimated 4% to 10% of women in the United States undergo surgery intended 
to restore continence, and this rate has increased steadily during the past 20 years4.  Additionally, 
it is commonly assumed by healthcare professionals that UI is an underreported condition, so the 
actual incidence rate may be much higher.5 
Surgical treatment of SUI is the most common and the most effective.  Surgical procedures 
performed for SUI increased from 18,820 to 32,480 from 1992 to 2001.6  By 2001, more than half 
of the surgical procedures (17,680) were being done with a pubovaginal sling.  The most common 
pubovaginal sling operations performed in the United States are the Tension-Free Vaginal Tape 
procedure (TVT)7,8 and the transobturator technique (TOT).8  In most respects, the TVT and TOT 
procedures are similar.  Both place a hammock like mesh that passes underneath the urethra to 
provide support and exit through incisions in the abdomen.  Tensioning is achieved by pulling the 
tape through the incisions and suturing the exit wounds.  Minimally invasive or single incision 
slings or “mini-slings” are a recent development to address complications with the traditional 
slings.  Mini-slings are placed through a single incision in the vaginal wall and anchored inside 
the body.  This anchoring inside the body eliminates the exit wounds required for traditional slings.  
Mini-slings potentially reduce the risk of blind needle passage through the groin or abdomen and 
may be implanted in an office setting with local anethesia.  All of these factors potentially reduce 
complications, recovery time, and pain compared to traditional slings. 
The Altis Single Incision Sling (SIS) System was developed by Coloplast as a minimally invasive 
“mini-sling.” The Altis SIS System comprises a length of the same material used for the Aris™ 
Trans-Obturator and Supris™ Retropubic Slings.  However, Altis is secured in the obturator 
foramen and has an integrated tensioning system that eliminates the need for additional skin 
exits. Effectiveness and safety outcomes of the Altis SIS Sling System were demonstrated in an 
Investigational Device Study conducted at 17 clinical sites in the United States and Canada.  The 
Altis Sling System received FDA clearance on November 5, 2012, based on Coloplast's 
submission of IDE study data on 113 study subjects implanted with the Altis SIS.   
Manufacturers of single-incision slings have been ordered to conduct post-market studies. These 
orders were issued on March 13, 2013 for the Altis SIS Sling System under Section 522 of the 
Federal Food, Drug, and Cosmetic Act. The reason for these orders is “that device failure would 
be reasonably likely to cause mesh erosion (i.e. organ perforation), severe pain, and fistula 
formation, which would meet the definition of "serious adverse health consequences" at 21 C.F.R. 
§ 822.3(j)” and because the device is intended to be implanted in the body for more than one 
year. 

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3 
Study Purpose and Design  
3.1 Primary Objectives  
The aim of this postmarket study is to compare the safety and effectiveness of Altis SIS to FDA 
cleared transobturator and/or retropubic slings in the treatment of stress urinary incontinence 
through 36 months. The primary safety and effectiveness objectives of this study are: 
• 
To demonstrate that the rate of device and/or procedure related serious adverse events 
associated with use of Altis SIS is non-inferior compared to the rate associated with use 
of transobturator and/or retropubic slings at 36 months. 
 
• 
To demonstrate that the rate of effectiveness associated with use of Altis SIS is non-
inferior to the rate associated with use of transobturator or retropubic mesh slings for the 
treatment of stress urinary incontinence at 6 months. 
 
3.2 Secondary Objectives 
The secondary objectives of this study are: 
• 
To demonstrate that the rate of device and/or procedure related adverse events defined  
as organ perforation, bleeding, mesh exposure in the vagina, mesh erosion into the 
bladder, pelvic pain, infection, de novo dyspareunia, urinary retention, recurrent 
incontinence, other urinary problems and neuromuscular problems associated with use of 
Altis SIS is non-inferior compared to the rate associated with use of transobturator and/or 
retropubic slings at 36 months. 
 
• 
To demonstrate that the rate of revision/resurgery associated with use of Altis SIS is non-
inferior compared to the rate associated with use of transobturator and/or retropubic slings 
at 36 months 
 
• 
To provide a descriptive comparison at all time points (6 months, 12 months, 18 months, 
24 months, and 36 months) between study groups of the rates associated with the 
following adverse events: organ perforation, bleeding, mesh exposure in the vagina, mesh 
erosion into the bladder, pelvic pain, infection, de novo dyspareunia, urinary retention, 
recurrent incontinence, other urinary problems and neuromuscular problems. 
 
• 
To assess the effectiveness observed in both study groups at 6 months, 12 months, 18 
months, 24 months, and 36 months. 
 
• 
To assess Quality of Life in both study groups at 6 months, 12 months, 18 months, 24 
months, and 36 months. 
 
• 
To assess the rates, severity, and relatedness of all observed adverse events (including 
mesh exposure and erosion) associated with both study groups at 6 months, 12 months, 
18 months, 24 months, and 36 months. 
 

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3.2.1 General 
This study is a prospective, post-market, multi-center, cohort assessment comparing Altis SIS 
(Study Subjects) and transobturator and/or retropubic slings (Control Subjects) in the treatment 
of stress urinary incontinence. Subjects will be followed for 36 months, with scheduled follow-up 
visits at 6 months, 12 months, 18 months, 24 months, and 36 months.  
The study will be analyzed under the intent-to-treat principle.  A propensity score analysis will be 
used to address potential sources of bias due to the cohort design. Additional mechanisms to 
control potential sources of bias include: rigorous well-defined inclusion/exclusion criteria, 
utilization of screening and enrollment log, and consecutive enrollment of eligible subjects. 
Treatment Group Subjects 
Altis Single Incision Sling 
Control Group Subjects 
Transobturator or Retropubic Slings 
N= 178 
N= 178 
 
Patient enrollment will continue until the required sample size is successfully reached. The study 
may include up to 40 U.S. and international sites. No site may attempt to implant more than 20% 
of subjects in each respective arm without prior approval from Coloplast Corp. 
 
3.2.2 Site and Investigator Selection 
Investigators experienced in the use of the study products for treatment of stress urinary 
incontinence will be recruited to participate in the study.  
 
 

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Figure 1: Overall Study Design Flow-Chart 
 
Altis Single 
Incision Sling
N=178
Transobturartor/
Retropubic sling
N=178
Subject 
Consented / 
Enrolled
No
Yes
Subject treated per 
indicated 
treatment arm 
All Inclusion / 
Exclusion Met
Subject treated per 
standard of care
Required follow-up
6 months
12 months
18 months
24 months
36 months
36 month visit 
complete. Subject 
partcipation complete
 
 
 
 

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3.3 
Endpoints 
3.3.1 Primary Safety Endpoints 
• 
Observed device and/or procedure-related serious adverse events through 36-months. 
 
3.3.2 Primary Effectiveness Endpoint 
• 
Observed effectiveness, defined as a reduction from baseline in 24 hour pad weight of at 
least 50% at 6 months. 
 
3.3.3 Secondary Safety Endpoints 
• 
Observed rates of device and/or procedure-related adverse events defined as organ 
perforation, bleeding, mesh exposure in the vagina, mesh erosion into the bladder, pelvic 
pain, infection, de novo dyspareunia, urinary retention, recurrent incontinence, other 
urinary problems and neuromuscular problems at 6 months, 12 months, 18 months, 24 
months, and 36 months post index procedure. 
 
• 
Observed adverse events within 6 months, 12 months, 18 months, 24 months, and 36 
months of the index procedure. 
 
• 
Observed revision/re-surgery at 6 months, 12 months, 18 months, 24 months, and 36 
months. 
 
3.3.4 Secondary Effectiveness Endpoint 
• 
Observed effectiveness, defined as a reduction from baseline in 24 hour pad weight of at 
least 50% at 12 months, 18 months, 24 months, and 36 months. 
 
• 
Observed effectiveness for subjects considered dry (pad weight ≤ 4.0 grams) at 6, 12, 18, 
24, and 36 months. 
 
• 
Quality of Life at 6 months, 12 months, 18 months, 24 months, and 36 months as 
measured through: 
o Patient Global Impression of Improvement (PGI-I) 
o Urogenital Distress Inventory (UDI-6) 
o Incontinence Impact Questionnaire-Short Form (IIQ-7) 
o Surgical Satisfaction Questionnaire (SSQ-8) 
o Visual Analog Scale for Pain (VAS Pain) 
 
 

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3.3.5 Risk Factors 
In addition to the primary and secondary endpoint analysis, a propensity analysis will be 
conducted to address potential risk factors of adverse events and procedural success. Risk 
factors that will be analyzed include but are not limited to: 
• 
Age  
• 
Parity 
• 
BMI 
• 
Smoking Status 
• 
Diabetes 
• 
Hysterectomy status 
• 
History of Multiple Urinary Tract Infections 
 
3.4 
Subjects  
The study population will consist of adult female subjects with SUI who are clinically indicated for 
surgical intervention with a mesh sling. All study candidates who meet all of the inclusion criteria 
and none of the exclusion criteria and provide written informed consent will be included in the study.   
3.4.1 Inclusion criteria for subject selection 
To be included in the study, subjects must meet all of the following inclusion criteria: 
1. The subject is female and at least 18 years of age. 
2. The subject is able and willing to complete all procedures and follow-up visits indicated in 
this protocol. 
3. The subject has confirmed stress urinary incontinence (SUI) through cough stress test or 
urodynamics. 
4. The subject has failed two non-invasive incontinence therapies (such as Kegel exercise, 
behavior modification, pad use, biofeedback, etc.) for > 6 months. 
 
3.4.2 Exclusion criteria for subject selection 
To be included in this clinical study subjects must not meet any of the following exclusion criteria: 
1. The subject has an active urogenital infection or active skin infection in region of surgery. 
2. The subject has confirmed Pelvic Organ Prolapse (POP) of Stage 2 or higher as 
determined by POP-Q prolapse grading. 
3. The subject is having a concomitant pelvic floor procedure. 
4. The subject has incontinence due to neurogenic causes (e.g. multiple sclerosis, spinal 
cord/brain injury, cerebrovascular accident, detrusor–external sphincter dyssynergia, 
Parkinson’s disease, or similar conditions). 
5. The subject had a prior surgical SUI treatment. 
6. The subject has undergone radiation or brachy therapy to treat pelvic cancer. 
7. The subject has urge predominant incontinence with MESA assessment. 

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8. The subject has an atonic bladder or post void residual (PVR) above 100 cc on ≥ 2 
occasions.  
9. The subject is pregnant and/or is planning to get pregnant in the future. 
10. The subject has a contraindication to the surgical procedure or the product IFU. 
11. The subject is enrolled in a concurrent clinical trial of any treatment (drug or device) that 
could affect continence function, without the sponsors’ approval. 
 
3.5 
Subject Recruitment and Enrollment 
Study subjects may be referred for surgical treatment of SUI by their primary care physician or 
specialist. Subjects must provide written informed consent prior to study-related procedures 
taking place. A screening and enrollment log will be maintained by study sites to document 
potential subjects who did not meet inclusion/exclusion criteria or who declined participation. 
3.6 
Point of Enrollment 
Once the subject signs the approved informed consent form the subject is considered enrolled 
and a subject number is assigned.  
3.7 
Subject Withdrawal Criteria 
The investigator may withdraw a subject from the study at any time if they judge withdrawal to be 
in the best interest of the subject for reasons including but not limited to the subject’s safety and/or 
well-being. 
Subjects are allowed to withdraw from the study at any time for whatever reason without any 
consequences to their future treatment outside the clinical study. If a participant expresses the 
desire to withdraw from the study, an end of study form must be completed. The reason for 
participant withdrawal must be documented.   
In the case that the participant cannot be reached to return for protocol required follow-up visits, 
the study site must make at least 3 attempts to contact the subject (e.g. telephone, email ). To be 
considered lost to follow-up, all attempts to contact the subject must be documented and a 
registered letter must be sent to the subject’s last known address. In the case that the participant 
is determined to be lost to follow-up, an  end of study form must also be completed.   
If a subject withdraws, is lost to follow-up, or dies they will not be replaced by enrolling additional 
subjects.  Participants will be considered to have completed the study after the 36-month follow-
up visit has been completed. 
3.8 
Subject Retention  
Subject follow-up visit compliance and long term retention of study subjects through 36-months 
is important. Every attempt should be made to complete the visit. If the follow-up visit cannot be 
completed within the established visit window, the visit should still be completed as soon as 
possible and a study deviation documented. 
Additional strategies to maximize subject retention may include:   

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• 
Use of an IRB approved tiered subject visit compensation rate that increases over the 
course of the study 
• 
Utilization of a follow-up window calculator tool to assist in targeting and scheduling future 
study follow-up visits  
• 
Utilization of study specific appointment reminder cards and direct telephone contact 
 
4 
Total Expected Duration of the Clinical Study 
Enrollment is expected to take approximately 2 years to complete and subjects will be followed 
for 36 months. The study will take approximately 5 years from first subject enrollment to final 
patient visit.  
5 
Procedures and Data Collection 
Prior to site activation, all study personnel must receive formal study training from qualified 
personnel from Coloplast or its designee. This training will include, but is not limited to device 
design, clinical study protocol, case report form completion, regulatory requirements and required 
study procedures. Before initiation of the clinical study, the investigator must obtain Institutional 
Review (IRB) approval and the sponsor must be provided with a signed investigator agreement 
and dated curriculum vitae for key personnel to verify and document qualifications. The 
investigator must ensure that all site personnel are trained for delegated activities, e.g. study 
procedures, eCRF completion, and adverse event reporting.  
 
Clinical data will be collected at baseline, procedure, 6 months, 12 months, 18 months, 24 months, 
and 36 months post index procedure. The Data Collection Schedule in Table 1 provides an outline 
of study data to be collected at each visit.   
Additional visits that occur for adverse event assessment or adverse event follow-up following 
the index procedure will be recorded on an Unscheduled Visit and Adverse Event eCRF.
Table 1 Data Collection Schedule 
Data Collection  
Baseline 
Procedure 
6 
Month 
12 
Month 
18 
Month 
24 
Month 
36 
Month 
Un-
scheduled4 
Informed Consent 
Obtained 
X 
 
 
 
 
 
 
 
Inclusion/Exclusion 
Criteria Verified 
X 
 
 
 
 
 
 
 
Pregnancy Test 
 X1 
 
 
 
 
 
 
 
Urinalysis 
 X2 
 
 
 
 
 
 
 
Medical History 
X 
 
 
 
 
 
 
 
Procedural Data 
 
X 
 
 
 
 
 
 
Cystoscopy 
 
X 
 
 
 
 
 
 
Post Void Residual 
Test 
 X3 
 
X 
X 
X 
X 
X 
 
Cough Stress Test 
 X3 
 
X 
X 
X 
X 
X 
 
24-Hour Pad Weight 
Test 
 X3 
 
X5 
X5 
X5 
X5 
X5 
 
Medication 
Documentation 
X 
X 
X 
X 
X 
X 
X 
 

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Data Collection  
Baseline 
Procedure 
6 
Month 
12 
Month 
18 
Month 
24 
Month 
36 
Month 
Un-
scheduled4 
Patient Global 
Impression of 
Improvement 
(PGI-I)  
 
 
X 
X 
X 
X 
X 
 
Surgical Satisfaction 
Questionnaire (SSQ-
8) 
 
 
X 
 
 
 
 
 
Visual Analog Scale 
for Pain (VAS Pain) 
X 
X6 
X 
 
 
 
 
 
Urinary Distress Index 
(UDI-6)  
X 
 
X 
X 
X 
X 
X 
 
Incontinence Impact 
Questionnaire  
(IIQ-7) 
X 
 
X 
X 
X 
X 
X 
 
Assessment of 
Adverse Events 
 
X 
X 
X 
X 
X 
X 
X 
1To be performed within 30 days prior to the index procedure for women of childbearing potential 
2 To be performed within 30 days prior to the index procedure 
3 To be performed within 6 weeks prior to index procedure 
4 Any procedures performed relevant to the continence state of the subject should be documented on the follow-up form (e.g. PVR, 
urinalysis, or CST testing). 
5 It is recommended that subjects complete pad weight testing within ± 1 month of the scheduled visit. 
6 The VAS Pain questionnaire will be completed by subjects at baseline, each day for the first 3 days following their index procedure, 
and at their 6 month follow-up visit. 
 
5.1 
Baseline Visit 
The following study procedures will be performed at or prior to (as described in Table 1) the 
baseline visit.  
• 
Informed Consent 
• 
Pregnancy Test 
• 
Urinalysis 
• 
Medical History 
• 
Post Void Residual Test 
• 
Cough Stress Test 
• 
24-hour Pad Weight Test 
• 
Medication Documentation 
• 
Urinary Distress Index (UDI-6) 
• 
Incontinence Impact Questionnaire (IIQ-7) 
• 
Visual Analog Scale for Pain (VAS Pain) 
 
 

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5.2 
Procedure Visit  
The first surgical implant procedure after the subject is enrolled in the study is considered the 
index procedure.  For newly implanted subjects a standard implant procedure is to be used as 
detailed in the Instructions for Use for Altis SIS or control product, as applicable.  Implant 
procedure information will be collected as well as medication use during and after the procedure.  
Any deviation from the procedure should be identified on the appropriate procedure form and 
detailed on a study deviation form.   
The subject will complete a VAS Pain questionnaire each day for the 3 days following their index 
procedure.  The subject will be supplied with a postage paid return envelope to send the 
questionnaires back to the study site upon completion. 
5.3 
Follow-Up Visit Schedule 
Data will be collected following the index procedure at 6 months, 12 months, 18 months, 24 
months, and 36 months following the index procedure. Every attempt should be made to complete 
follow-up visits, however, if the subject cannot be seen in person, required questionnaires and 
pad weight testing kits should be mailed to the participant with a postage paid return envelope.  If 
the follow-up visit cannot be completed within the visit window, the visit should still be completed 
as soon as possible and a study deviation form completed. All adverse events that are identified 
at any follow-up visit will be recorded on the appropriate adverse event form. 
5.3.1 Follow-up Visits:  6, 12, 18, 24, and 36 Month 
Subjects are required to return to the office for required follow-up visits. The following procedures 
will be performed at each follow-up visit: 
• 
Post Void Residual Test 
• 
Cough Stress Test 
• 
24-hour Pad Weight Test 
• 
Medication Documentation 
• 
Patient Global Impression of Improvement (PGI-I) 
• 
Urinary Distress Index (UDI-6) 
• 
 Incontinence Impact Questionnaire-Short Form (IIQ-7) 
• 
Surgical Satisfaction Questionnaire (SSQ-8) – 6 months only 
• 
Visual Analog Scale for Pain (VAS Pain) – 6 months only 
• 
Assessment of Adverse Events 
 
5.3.2 Unscheduled Follow-up Visits 
Unscheduled follow-up visits include adverse event assessment or adverse event follow-up visits.  
If an unscheduled visit occurs, the following items will be collected: 
• 
Assessment of Adverse Events (captured on an Unscheduled eCRF and Adverse Event 
eCRF, as applicable) 
• 
Assessment of any additional procedures (captured on Unscheduled eCRF) 
 
Table 2 Follow-up Schedule and Windows 

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Follow-Up 
Window Start 
Target Day 
Window End 
6 Months (+ 21 days) 
159 days 
180 days 
201 days 
12 months (+ 42 days) 
323 days 
365 days 
407 days 
18 months (+ 42 days) 
506 days 
548 days 
590 days 
24 months (+ 42 days) 
688 days 
730 days 
772 days 
36 months (+ 42 days) 
1053 days 
1095 days 
1137 days 
 
5.4 
Device Revisions and Explants 
All device revisions/resurgeries including explants will be recorded. 
Device Revision is defined as a surgical procedure to alleviate a problem associated with the 
implanted device after initial implant and/or removal and replacement with any mid-urethral sling.  
Device Explant is defined as the removal of the Altis Single Incision Sling or the 
transobturator/retropubic sling. 
If Altis SIS is removed for any reason, the device should be returned to Coloplast. The product 
should be handled as a bio-hazardous material and sent to: 
Coloplast Manufacturing 
Attn: Product Evaluation Dept 
1601 West River Road North 
Minneapolis MN 55411 
Ref: Altis 522 Study 
 
5.5 
Randomization Procedure  
There are no randomization procedures in this study.   
5.6 
Blinding 
Study subjects and investigational study personnel are not blinded to study group assignment. 
6 
Identification and Description of Devices 
6.1 
Description of the Study Device 
Altis SIS is a permanently implantable synthetic sling for the surgical treatment of SUI.  Altis SIS 
is made from a knitted, monofilament polypropylene with low elasticity. This structure gives Altis 
SIS resistance to traction, allows tissue in-growth and facilitates positioning during surgery.  Altis 
SIS is placed at the mid-urethra to treat SUI by providing a scaffold for tissue in-growth and 
support for stress events. 

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Altis SIS is sterile, single-use only synthetic sling with left and right introducer needles.  The 
specialized introducers allow the physician to position anchors in the obturator foramen through 
a single vaginal incision.  The introducers can only be used with Altis SIS and are indicated for 
single use. 
6.2 
Description of Coloplast Control Devices 
Coloplast currently markets slings that may be part of the Control group consisting of 
transobturator or retropubic slings.  Descriptions of these devices are provided. 
6.2.1 Aris® Trans-Obturator Sling 
Coloplast Aris Trans-Obturator sling is a permanent, synthetic sub-urethral sling. It is indicated 
for the surgical treatment of all types of stress urinary incontinence (SUI), for female stress urinary 
incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). Aris 
is made from knitted, monofilament polypropylene and has low elasticity. This structure gives Aris 
resistance to traction, allows tissue colonization and facilitates positioning during surgery. 
The Aris sling is provided sterile and is for single-use only. The Aris sling is sterilized by 
ethylene oxide. Introducer Needles are available and intended to facilitate the placement of the 
Aris Trans-Obturator Sling. 
 
6.2.2 Supris® Retropubic Sling System 
The Supris sling is a permanent, synthetic sub-urethral sling that is provided with disposable 
introducer needles in the Supris Retropubic Sling System. It is indicated for the surgical 
treatment of all types of stress urinary incontinence (SUI), for female stress urinary incontinence 
resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).  
 
Supris sling is made from knitted, monofilament polypropylene and has low elasticity. This 
structure gives the Supris sling resistance to traction, allows tissue colonization and facilitates 
positioning during surgery. The Supris sling is provided sterile and for single-use only. The 
Supris sling is sterilized by ethylene oxide. Sterile, single-use only, introducers are included in 
this system. The introducers are manufactured from polypropylene (handles) and medical grade 
stainless steel (Introducer Needles) and are sterilized by ethylene oxide. These introducers can 
only be used with Coloplast Supris sling. 
 
6.3 
Manufacturer 
Coloplast A/S manufactures Altis SIS, Aris Trans-Obturator Sling, and the Supris Retropubic 
Sling. 
6.4 
Identification, Traceability and Labeling of the Devices 
All devices are commercially available for use and will be labeled with a catalog and lot number. 
The catalog and lot number of each device used will be entered into the study database. 

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6.5 
Intended Population for the Device 
The study population will include adult female patients indicated for surgical treatment of stress 
urinary incontinence.  All study candidates must provide written informed consent and be available 
for follow-up visits at an approved study site.  
6.6 
Handling and Training 
Appropriate physician and site training will be required for study participation. Physicians new to 
using the slings and/or with less than 6 months of experience will be required to undergo surgical 
training for the study or Coloplast control device, which may include a cadaver lab, simulation 
training, or case proctoring by an experienced physician or by a Coloplast representative 
7 
Statistical Considerations 
7.1 
Analysis Populations  
The Intent-to-Treat (ITT) analysis population consists of all subjects who have undergone a sling 
implant attempt for stress urinary incontinence for this study using either Altis SIS or a FDA 
cleared transobturator or retropubic sling. The ITT analysis population is the primary population 
for the assessment of all safety and effectiveness endpoints. 
The per-protocol (PP) population includes all subjects in the ITT analysis population who meet all 
inclusion/exclusion criteria. The PP population will be used as a secondary (supplementary) 
analysis population to confirm and further substantiate the results of effectiveness endpoints 
based on the ITT analysis population.  
7.2 
General Analysis Principles 
All analyses will be performed by a contracted statistician. Continuous variables will be 
summarized with means and standard deviations or as medians and interquartile ranges. 
Categorical variables will be summarized with the number and proportion of subjects in each 
category. Binary outcomes will be presented as proportions with corresponding 95% asymptotic 
confidence limits.  
At a minimum, primary and secondary effectiveness endpoints will also be analyzed for subjects 
who had baseline urinary leakage of ≥4g as assessed by the 24-hour pad weight. Other subgroup 
analyses may be performed as appropriate for the question of interest. 
All statistical analyses will be conducted using SAS version 9.3 or later (SAS Institute Inc., Cary, 
NC) or R version 2.14 or later (R Development Core Team, 2012). 
7.3 
Missing Data 
The number and proportion of missing values at each observation period will be reported along 
with the reason for missing data, if known.  Specific missing data handling procedures for each of 
the powered primary and secondary endpoints are presented in the endpoint analysis sections 
below (7.4-7.6).  No missing data handling procedures for the other secondary endpoints are pre-
defined. 

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7.4 
Analysis of Primary Effectiveness Endpoint 
The number and proportion of patients meeting the primary endpoint will be tabulated for each 
treatment group at 6 months. Non-inferiority will be assessed using a normal approximation test 
(Z-test) for a difference in binomial proportion. Non-inferiority will be achieved if the upper limit of 
the 95% confidence interval for the difference in proportions (Control – Treatment) is less than 
0.15.  
The null and alternative hypothesis for this test will be as follows: 
Ho: πc – πT  ≥ 0.15 
Ha: πc – πT < 0.15 
where πc is the proportion of subjects in the control group meeting the primary effectiveness 
endpoint and πT is the proportion of subjects in the treatment group meeting the primary 
effectiveness endpoint and 0.15 is the non-inferiority margin. 
Handling of Missing Data 
The primary analysis of the primary effectiveness endpoint will include all available data and 
‘presumed failures’ from the ITT analysis population.  Presumed failures are defined as subjects 
with missing data where it is known that the cause of the data loss is either related to an adverse 
event (including death) or to a device failure.  Subjects with missing data for other reasons will be 
ignored in the primary analysis, but will be included in all sensitivity analyses. The sensitivity 
analyses for the primary effectiveness endpoint will include best case, worst case and tipping 
point analysis. 
7.5 
Analysis of Primary Safety Endpoint 
The number and proportion of subjects experiencing device- and/or procedure-related serious 
adverse events will be tabulated for each study group. Non-inferiority at 36 months will be 
calculated using a normal approximation test (Z-test) for a difference in binomial proportion with 
the following null and alternative hypotheses: 
 H0: πc – πT ≤ -0.10 
 HA: πc – πT > -0.10  
where πc is the proportion of patients who have the primary safety endpoint during follow-up in 
the control group and πT is the proportion of patients who have the primary safety endpoint during 
follow-up in the treatment group. 
Handling of Missing Data 
The primary analysis of this endpoint will include all available data from the ITT analysis 
population.  Subjects that have not experienced a device- and/or procedure-related serious 
adverse event and who have missing data at 36 months will be assumed to be free of such an 
adverse event.  However, the potential impact on the endpoint inference of all such subjects will 
be assessed via various sensitivity analyses that include best case, worst case and tipping point 

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analysis.  In addition, a Kaplan-Meier product limit analysis that right censors subjects lost to 
follow-up will be conducted to further understand the potential impact of subject loss. 
7.6 
Analysis of Powered Secondary Safety Endpoints 
7.6.1 Secondary Safety Endpoint 
The number and proportion of subjects experiencing any device- and/or procedure-related 
adverse event will be tabulated for each group. Non-inferiority at 36 months will be calculated 
using a normal approximation test (Z-test) for a difference in binomial proportion with the following 
null and alternative hypotheses: 
 H0: πc – πT ≤ -0.15 
 HA: πc – πT > -0.15  
where πc is the proportion of patients who have the secondary safety endpoint during follow-up 
in the control group and πT is the proportion of patients who have the secondary safety endpoint 
during follow-up in the treatment group. 
Handling of Missing Data 
The primary analysis of this endpoint will include all available data from the ITT analysis 
population.  Subjects that have not experienced a device- and/or procedure-related adverse event 
and who have missing data at 36 months will be assumed to be free of such an adverse event.  
However, the potential impact on the endpoint inference of all such subjects will be assessed via 
various sensitivity analyses that includes best case, worst case and tipping point analysis.  In 
addition, a Kaplan-Meier product limit analysis that right censors subjects lost to follow-up will be 
conducted to further understand the potential impact of subject loss. 
7.6.2 Revision/Resurgery 
The number and proportion of subjects experiencing revision and/or resurgery will be tabulated 
for each treatment group. Non-inferiority at 36 months will be calculated using a normal 
approximation test (Z-test) for a difference in binomial proportion with the following null and 
alternative hypotheses: 
H0: πc – πT ≤ -0.10 
HA: πc – πT > -0.10  
where πc is the proportion of patients who have the revision/resurgery endpoint during follow-up 
in the control group and πT is the proportion of patients who have the revision/resurgery endpoint 
during follow-up in the treatment group. 
Handling of Missing Data 
The primary analysis of this endpoint will include all available data from the ITT analysis 
population.  Subjects that have not experienced a revision/resurgery and who have missing data 
at 36 months will be assumed to be free of such an event.  However, the potential impact on the 

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endpoint inference of all such subjects will be assessed via various sensitivity analyses that 
includes best case, worst case and tipping point analysis.  In addition, a Kaplan-Meier product 
limit analysis that right censors subjects lost to follow-up will be conducted to further understand 
the potential impact of subject loss. 
7.7 
Additional Secondary Endpoints 
7.7.1 24-Hour Pad Weight 
Differences in 24-hour Pad Weight will be assessed at 6 months, 12 months, 18 months, 24 
months, and 36 months.   
7.7.2 Quality of Life 
Change in Quality of life (QoL) scores from baseline to follow-up will be summarized at each visit 
and for the treatment and control group for all QoL questionnaires. The treatment group will be 
compared to the control group using a linear model that is fit with generalized estimating equation 
methodology to control for correlation due to repeated measurements on each subject. 
Differences between the treatment group and the control group will be assessed at each visit and 
overall.  
For subjects with revision or resurgery within 36 months of the index surgery, QoL assessments 
following revision or resurgery will be evaluated. 
7.7.3 Adverse events  
All adverse events will be summarized at 6 months, 12 months, 18 months, 24 months, and 36 
months.  The proportions of subjects with events will be reported as well as Kaplan-Meier event 
rates at the time points of interest. 
For subjects with revision or resurgery within 36 months of the index surgery the rates of adverse 
events peri-procedural (within 30 days) following revision or resurgery will be assessed. 
7.8 
Propensity Analysis 
In addition to the primary and secondary analyses of the effectiveness and safety endpoints, a 
propensity analysis will be conducted to address the effect of potential confounding variables on 
our conclusion. Risk factors that will be analyzed are outlined in Section 3.3.5. 
For this analysis, a logistic regression model will be used to calculate the probability of 
treatment assignment given the covariates listed above (i.e., the propensity score). The 
covariates will not be grouped, resulting in one propensity score for each subject. The 
propensity score will be used in an adjusted regression model for each primary endpoint. A 
logistic regression model will be used for the primary effectiveness and safety endpoints.  

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7.9 
Sample Size  
7.9.1 Final Sample Size 
Sample size was calculated to assess non-inferiority of the primary effectiveness endpoint and 
primary safety endpoint at 80% power with a type-I error rate of 0.05 for each primary endpoint 
analysis. The sample size calculations were conducted in PASS 16. 
The final sample size was determined to be the maximum of these sample size calculations for 
the primary effectiveness and safety endpoints. This requires 328 total subjects.  
7.9.2 Sample Size Estimation for Primary Effectiveness Endpoint 
The sample size for the primary effectiveness endpoint was calculated to assess non-inferiority. 
We assume 20% loss to follow-up at the end of the study, 6 month event rates of 75% in Altis 
group and 75% in control group with a non-inferiority margin of 15%.  
Assuming an equal allocation, a minimum of 131 evaluable subjects per treatment arm are 
required to power this endpoint to the nominal 80% level. Accounting for 20% loss to follow-up, 
the minimum number of implanted subjects required is 164 in each arm for a total of 328 subjects. 
7.9.3 Sample Size Estimation for Primary Safety Endpoint 
The sample size for the primary safety endpoint was calculated to detect a non-inferiority limit of 
10% assuming an underlying rate of device and procedure related serious adverse event of 10% 
in each group with 80% power and assuming 20% loss to follow-up by 36 months. The rate of 
serious device and/or procedure related adverse events in the IDE study was 2.7% (3/113) 
through 12 months of follow-up. A conservative estimate of 10% was used for the purpose of 
sample size estimation to account for the additional follow-up time and to ensure adequate power. 
The sample size required to maintain 80% power is 178 subjects per study group accounting for 
20% attrition for a total of 356 subjects. 
7.9.4 Sample Size Estimation for Powered Secondary Safety Endpoints 
Device- and/or Procedure-Related Adverse Events 
The overall rate of device or procedure related adverse events in the IDE study was 14%. A 
conservative estimate of 20% is chosen to account for the additional follow-up time. Assuming an 
underlying rate of any device and/or procedure related adverse event of 20% in each group, a 
sample size of 112 subjects per study group, for a total of 224 subjects, is required to power for 
the assessment of the secondary safety endpoint. Accounting for up to 20% attrition, 140 subjects 
per study group would need to be implanted, for a total of 280 subjects. 
Revision/Resurgery 
Because the rates of revision/resurgery are expected to be less than the rates for the primary 
safety endpoint the study is adequately powered for this objective as this endpoint utilizes the 
same non-inferiority limit as the primary safety endpoint. 

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7.9.5 Level of Significance and Power 
All tests of significance will be performed at the two-sided 0.05 significance level (one-sided 
0.025). As both the primary effectiveness and safety objectives must be met for study success, 
no adjustment for multiplicity is required. Additionally, the secondary safety endpoints for 1) device 
and/or procedure related adverse events, and 2) revision or resurgery, will be tested hierarchically 
in the order presented in the event the primary safety objective is met. Therefore no adjustment 
for multiplicity is required. 
7.9.6 Drop-out 
Drop-out rates are expected to be uniform over time and not to exceed 20% of the original sample 
at the conclusion of the study. All sample size calculations were adjusted for the expected rate of 
drop-out and loss to follow-up. 
7.10 Interim Analysis  
No formal interim analyses are planned. Interim (or annual, as required) post-market surveillance 
reports will be submitted to FDA. These reports will include all the required elements, and 
summary and interpretation of study results. For the progress reports, endpoint results will be 
summarized as appropriate (e.g., via counts and percentages), however, no statistical testing will 
be performed and no p-values will be provided until data collection for this endpoint has been 
concluded. 
8 
Data Quality Assurance 
8.1 
Electronic Data Capture 
The study will use a secure 21 CFR Part 11 compliant Electronic Data Capture (EDC) system to 
collect and store data. The electronic case report forms (eCRFs) are designed to accommodate 
specific features of study design and will be used to capture data. All data will be entered in the 
EDC system. 
Paper QoL questionnaires will be provided to study subjects at each visit and will be entered in 
the EDC system after completion by study staff delegated and trained to perform eCRF 
completion. The principal investigator will review all eCRFs for completeness and accuracy and 
will electronically sign the forms to confirm approval. 
8.2 
Monitoring Plan  
It is the responsibility of Coloplast to ensure that proper monitoring of this study is conducted 
according to the Monitoring Plan. Appropriately trained personnel consisting of in-house and/or 
contracted monitors will perform site monitoring to ensure that the study is conducted in 
accordance with the signed Investigator Agreement and applicable regulations. The monitor must 
be allowed access to site and study subject files. The monitor will review subject records, consent 
forms, regulatory and study management documents to assess the accuracy of recorded data, 
study progress, and regulatory compliance. The principal investigator is ultimately responsible for 
compliance and will work with delegated research staff and the monitor to resolve all data queries 
and monitoring action items. Resolution of these items and completion of assigned tasks will be 
documented by the monitor or clinical designee. Failure to obtain compliance of monitoring 

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findings may result in suspension of enrollment until compliance is obtained.  The frequency of 
monitoring visits will be based on enrollment rates, duration of the study, site compliance, and 
data quality at each investigative site. 
8.3 
Audits 
Audits of the study may be conducted by the sponsor, regulatory agencies or a third party 
designated by the sponsor to evaluate compliance with the protocol, investigator agreement, and 
written procedures. These audits may cover all involved parties, systems, and facilities supporting 
the conduct of the study and are independent of, and separate from, routine monitoring functions. 
9 
Ethical Considerations, Device and Clinical Study Risks and Benefits 
The clinical study will be conducted in accordance with current law and applicable standards (see 
Section 13). The rights, safety and well-being of human subjects shall prevail over interest of 
science and society. 
9.1 
Informed Consent Process 
Written informed consent must be obtained from all subjects participating in the study following 
detailed written and verbal briefing and prior to completion of any study related activities according 
to IRB regulations. Each subject will be fully informed about the aim of the study, procedures, 
potential risks or inconveniences and/or expected benefits. Subjects will be provided sufficient 
time to ask questions before deciding on whether or not to participate in the study. Subjects will 
be informed that their participation is voluntary and that they may leave the study at any time, 
without influencing their further treatment. 
The informed consent signature form includes the signatures of the subject (or subject’s legal 
representative) and the date. A copy will be provided to the subject and the consent process 
should be documented in the subject’s medical record. 
If new information becomes available that can significantly affect a subject’s future health and 
medical care, the information will be provided to the subjects in written form. The Clinical Trial 
Manager is responsible for producing the written information and providing it to investigators who 
will provide it to the subjects. If applicable, all affected subjects will be asked to confirm their 
continued, informed consent in writing. 
9.2 
Sample Informed Consent Form 
A sample informed consent document suitable for use in this study, including the elements of 
informed consent in conformance with 21 CFR Part 50 will be provided by the sponsor. Changes 
to this document must include the essential elements of informed consent and should be approved 
by the sponsor prior to IRB/EC review. Subjects must be presented with the most current IRB/EC 
approved version of the consent form. 
9.3 
Institutional Review Board/Ethics Committee 
This protocol and/or other relevant study documents must be submitted to the appropriate local  
or central IRB/EC. Written approval must be obtained before commencement of the study. 

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Approval obtained from the IRB/EC should document the version of the protocol and consent that 
is being approved.  All amendments to the protocol will also be submitted to the same IRB/EC. 
9.4 
Data Protection 
All information collected during the course of this study will be kept strictly confidential. Any 
information that could identify a subject will remain with the investigator where it will be archived 
with study documents. Subjects will remain anonymous for the purposes of data analysis. Data 
collected for the purposes of this study should be made available for Coloplast or designated 
contracted monitors at all monitoring visits. A contracted statistician will conduct data analysis 
and provide data tables to the sponsor. 
9.5 
Risks and Benefits 
Subjects participating in the study will be exposed to the same operative and post-operative risks 
as patients undergoing surgical procedures for single-incision or traditional full length sling 
devices not associated with study participation. Risks can be minimized through the use of strict 
aseptic technique, compliance with this protocol and technical implant procedures, adherence to 
the guidelines for subject selection, close monitoring of the subject during implant and follow-up, 
and by promptly supplying the sponsor with all pertinent information in a timely manner. Risks to 
study subjects will be further minimized by providing appropriate training to study investigators 
new to using Coloplast products and by  study monitoring during the course of this clinical study. 
As with any surgical treatment for incontinence, there is always the risk that the treatment will not 
be successful or that incontinence will recur. There is a risk that, if the mesh causes problems, 
(e.g. extrusion - defined as mesh exposure in the vagina, pain, or infection), removal of the mesh 
may be necessary, and complete removal of the mesh may not be possible. Problems may 
persist, with or without complete mesh removal. These residual risks will be mitigated by pre-
implant patient education, informed consent, selection of experienced surgeons for participation 
in the study, appropriate patient selection, appropriate device-implant training for physicians new 
to using Coloplast slings, and use of good medical and surgical technique to avoid known and 
potential causes of mesh problems. 
Anticipated risks of use of the study device are listed in Section 14.  Potential risks of participation 
in the study include, but are not limited to: 
• 
Inadvertent sharing of study subject information that is intended to be private 
 
Potential benefits of the study device include, but are not limited to: 
• 
Cure or improvement of stress urinary incontinence 
• 
Improvement of quality of life 
 
10 Data Management 
Data will be captured in a database using eCRFs to accommodate specific features of the study 
design and will be used to capture study specific data.  Training will be provided for all study 
personnel entering data into the database prior to being given access to the database.  

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Edit checks will be created for quality control. Data will be subject to initial inspection for omitted 
data, data inconsistencies, and deviations. The resolution of any inconsistencies will be resolved 
through data queries. The site will be asked to review and respond to the data queries. 
Study staff delegated by the principal investigator may complete the eCRF; however, the principal 
investigator will review all eCRFs for completeness and will electronically sign the forms. 
11 
Amendments to the Clinical Study Plan 
Changes to the Clinical Study Plan are not permitted without Sponsor approval. Any significant 
changes to the study plan must be:  
 
Agreed to by the Principal Investigator 
 
Registered in the Change Log. 
 
Approved by the IRB/EC prior to implementation (if applicable). 
 
Approved by the appropriate regulatory authorities prior to implementation (if applicable). 
 
12 
Clinical Study Deviations 
A clinical study deviation is defined as an event where the clinical investigator or site personnel 
did not conduct the study in accordance to the Clinical Study Plan or the investigator agreement. 
No deviations are allowed from the study protocol unless under emergency circumstances and to 
protect the rights, safety and well-being of the subject(s). All deviations must be documented. 
Deviations must be reported to the sponsor and to the local IRB/EC per the specific reporting 
requirements.  In the case of continued or repeated deviations affecting subject rights, safety and 
well-being, the sponsor may terminate the PI from further participation in the study. 
13 
Statement of Compliance 
The clinical study is conducted, (as applicable to the geographic region of each individual clinical 
site) in accordance with:  
 
CFR Title 21: Part 11 – Electronic Records; Electronic Signatures 
 
CFR Title 21: Part 50 – Protection of Human Subjects 
 
CFR Title 21: Part 54 – Financial Disclosures by Clinical Investigators  
 
CFR Title 21: Part 56 – Institutional Review Boards 
 
ISO 14155:2011 (E) (as regionally applicable) 
 
Ethical principles that have their origin in the Declaration of Helsinki, 1964, Last amended 
at the 59th WMA General Assembly, Seoul, October 2008. 
 
ICH Guidelines for Good Clinical Practice (E6 or E6 R1, as regionally applicable) 
 
Guidance for Industry Investigator Responsibilities – Protecting the Rights, Safety, and 
Welfare of Study Subjects, October 2009 
 
Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs 
– Improving Human Subject Protection, January 2009 
 

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14 
Adverse Events, Serious Adverse Events, and Device Deficiencies 
14.1 Adverse Event/Complication Classification 
Collection of Adverse Events will begin at the time the first incision is made for the index surgical 
procedure and will continue until the subject’s study participation is complete. The investigator will 
be asked to assess the relationship of the event to the implanted study product, the implant study 
procedure, and the presence or performance of the mesh itself for each adverse event reported. 
Serious and non-serious adverse events will be collected and reported for this study. 
The principal investigator will ensure that adequate medical care is provided to all subjects 
experiencing an adverse event during or after participation in the clinical investigation. Any 
ongoing adverse events must be assessed on an ongoing basis to determine resolution.  
The current status of all ongoing adverse events is documented at the time of site close-out. The 
resolution date will be recorded on an adverse event eCRF. 
14.1.1 Adverse Events (AE) 
An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or 
untoward clinical sign (including abnormal laboratory findings) that may occur in subjects, users 
or other parties, whether or not it is related to the medical device(s), or the procedure’s involved. 
Potential adverse events include but are not limited to: 
 
• 
Erosion - Defined as movement of mesh into any other organ or body plane. 
• 
Exposure – Defined as a condition of displaying, revealing, exhibiting or making 
accessible (e.g. vaginal mesh visualized through separated vaginal epithelium) 
• 
Extrusion - Defined as passage gradually out of a body structure or tissue. 
• 
Sling Migration - Defined as movement from the original implanted mid-urethral site. 
• 
Transient or permanent urinary retention/obstruction. 
• 
Foreign body reaction - Defined as absence of tissue in-growth resulting in the 
presence of granulation tissue. 
• 
Reaction from anesthesia (respiratory failure, allergic reaction, thromboembolic event) 
• 
Vaginal discharge  
• 
Abscess 
• 
Pain 
• 
Delayed wound healing 
• 
De novo or worsening urgency/overactive bladder 
• 
De novo or worsening dyspareunia  
• 
Genital/pelvic pain 
• 
Hematoma and/or hemorrhage 
• 
Infection 
• 
Inflammation 
• 
Paresthesia (genital)  
• 
Scar tissue formation 
• 
Bladder perforation  
• 
Urethral perforation 
• 
Bowel perforation 
• 
Voiding dysfunction 
• 
Worsening incontinence 

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• 
Urethral obstruction 
• 
Vascular injury  
• 
Nerve injury  
• 
Urinary tract infection 
 
14.1.2 Serious Adverse Events  
A serious adverse event (SAE) is an adverse event that led to: 
 
Life Threatening: The participant was at imminent risk of dying at the time of the adverse 
event. 
 
Permanent Impairment: An adverse event that resulted in permanent impairment of a body 
function or permanent damage to a body structure. 
 
Necessitates Intervention: An adverse event that resulted in a condition that necessitates 
medical or surgical intervention to preclude permanent impairment of a body function or 
damage to a body structure. 
 
Hospitalization/Prolongs Hospitalization: Requires inpatient hospitalization or prolongs an 
existing hospitalization.  Planned hospitalization for a pre-existing condition is not 
considered a serious adverse event. 
 
NOTE: Emergency room visits that do not result in admission to the hospital should be 
evaluated for one of the other serious outcomes (e.g., life-threatening; required 
intervention to prevent permanent impairment or damage; other serious medically 
important event). 
 
Results in Death: An adverse event that results in the participant’s death. 
14.1.3 Unanticipated Adverse Device Effect (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 study 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. 
14.1.4 Adverse Event Severity Classification and Device Causality 
The investigator will classify adverse events by relatedness to the device or procedure, as follows: 
A device related adverse event is an event that results from the presence or performance of the 
device.  In this study, the device is the Altis Sling or control device (transobturator or retropubic 
sling).  Device related events can include, but are not limited to: erosion, extrusion, urinary 
retention, sling migration and foreign body reaction.  
 
A procedure related adverse event is an adverse event that occurs due to the implant procedure.  
 
The investigator will classify adverse events by severity, as follows:  
A Mild event is an adverse event that is reported without any action(s) taken. 
 
A Moderate event is an adverse event that is not severe, but requires action.  
 

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A Severe event is an adverse event that results in a subject’s hospitalization, or their 
hospitalization is unduly prolonged because of potential disability or danger to life, or an 
intervention has been necessitated, or the event is terminal. 
 
14.2 Device Deficiency and Technical Observations  
A device deficiency refers to the inadequacy of the medical device with respect to its identity, 
quality, durability, reliability, safety or performance. This includes malfunctions, misuse or user 
errors and inadequate labeling. 
A technical observation is a failure or malfunction of the device, or a device/system functioning 
not according to the design intent that does not result in subject symptoms. 
Examples of device deficiencies and/or technical observations include, but are not limited to: 
mechanical failure of the mesh, mesh does not withstand insertion or in use of forces when 
inserted, defect in mesh when removed from package.   
15 
Adverse Event Review 
15.1 Clinical Events Committee 
A clinical events committee (CEC) will be used to adjudicate device and procedure related serious 
adverse events. Additional adverse events may be specified for CEC adjudication throughout the 
study.  The CEC adjudication of adverse events will be used for data analysis. The CEC will be 
made up of a group of independent physicians specializing in the treatment of SUI. 
Responsibilities of the CEC may include, but are not limited to reviewing individual adverse events 
to determine severity and relationship to the study device and/or procedure.  
16 
Reporting and Timelines 
16.1 Investigator Reporting Responsibilities 
In addition to the requirements stated in the investigator agreement, the investigator is responsible 
for the preparation (review and signature) and retention of the records cited below. All of the 
records below, with the exception of case history records, should be kept in the Investigator Site 
File (i.e., study binder). The following records are subject to inspection and must be retained 
according to the agreed upon timeframe in the investigator agreement (or longer, if local law or 
hospital administration requires) after study closure. 
• 
All substantial correspondence that pertains to the conduct of the study. Any 
correspondence describing rationale for decisions made affecting subject safety and 
privacy or data collection and reporting is considered substantial correspondence 
• 
Subject’s case history records including: signed informed consent/applicable privacy 
protection authorization form; observations of adverse events/adverse device effects; 
medical history; implant and follow-up data; documentation of the dates and rationale for 
any deviation from the protocol 
• 
Signed Investigator Agreement and current curriculum vitae (CV) 
• 
Ethics committee documentation 
• 
Site personnel training records 
 

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The investigator is responsible for the preparation (review and signature) and submission to the 
sponsor of all eCRFs, adverse events (reported per the country-specific collection requirements), 
deaths, and any deviations from the study plan. These reports are also subject to inspection and 
to the retention requirements described above for investigator records. If any action is taken by 
an IRB/EC with respect to the clinical study, the information must be forwarded to the Sponsor. 
 

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Table 3 Investigator Reporting Requirements 
Report 
Submit To 
Description/ Constraints 
AE – Adverse Event 
Sponsor, IRB/EC (per 
local requirements) 
Any adverse event must be reported as soon as 
possible via the EDC system  
SADE - Serious Adverse Device Effect  
Sponsor, IRB/EC (per 
local requirements) 
Any adverse device effect must be no later than 
24 hours or the next business day after first 
learning of the event 
SAE-Serious Adverse Event 
Sponsor, IRB/EC (per 
local requirements) 
Any serious adverse event  must be reported no 
later than 24 hours or the next business day 
after first learning of the event  
UADE-Unanticipated Adverse Device Effect 
Sponsor, IRB/EC 
If an unforeseen complication is determined to 
be a Serious, device related, unanticipated AE 
then the investigator’s report must be submitted 
as soon as possible but no later than within 24 
hours or the next business day after the 
investigator first learns of the event 
Withdrawal of IRB/EC approval  
Sponsor 
Notification within 24 hours or next business day 
Progress Report  
(US only) 
Sponsor 
IRBs 
The investigator must submit this report 
annually, unless IRB requires more frequent 
submissions 
Deviation from study Plan 
Sponsor 
IRBs/ECs 
Any deviation from the study plan must be 
reported to the Sponsor via the EDC system and 
reviewing local IRB/EC per local reporting 
requirements 
Failure to obtain informed consent 
Sponsor 
IRBs/ECs 
 
In the US, the investigator must submit 
notification within 5 working days after device 
use.   
Final report (US only) 
Sponsor 
IRBs 
This report must be submitted within 3 months 
of study completion or termination.   
Device deficiency or technical observation 
Sponsor, IRB/ECs per 
local reporting 
requirements 
Notification within 24 hours or the next business 
day. 

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All adverse events listed above must be reported using the relevant adverse event/serious 
adverse event/device deficiency eCRF in the EDC system.  
 
Source documentation for adverse events, including medical history, operative data, follow-up 
visit notes, any hospitalization records may be requested by Coloplast. If requested, please 
submit redacted/de-identified source documentation with the subject ID to:  
 
Name:  Coloplast Clinical Department 
Address:  1601 West River Road N 
City, State:  Minneapolis, MN 55406 
Phone:  763-248-5744 
Fax:  612-337-7910 
Email:  uskve@coloplast.com 

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Table 4 Coloplast Reporting Requirements 
Report 
Submit To 
Description 
UADE-Unanticipated 
Adverse Device Effect 
Investigators IRBs/ECs  
as applicable,  FDA 
Notification within 10 working days 
after the sponsor first learns of the 
effect. 
Withdrawal of IRB/local 
ethics committee approval 
Investigators 
IRBs/ECs, as applicable 
FDA 
In the US, Notification within 5 
working days. 
Recall and device 
disposition 
Investigators 
IRBs ECs, as applicable 
FDA 
Notification within 30 working days 
and will include the reasons for any 
request that an investigator return, 
repair, or otherwise dispose of any 
devices. 
Progress Reports 
(If required by local law) 
Investigators 
IRBs/ECs, as applicable 
FDA 
Every 6 months for the first 2 
years, then annually after. 
Final report 
Investigators 
IRBs/ECs, as applicable 
FDA 
Coloplast will notify the 
investigators of the completion or 
termination of the study.  A final 
report will be submitted to the 
investigators and IRBs/MECs 
within three months after 
completion or termination of this 
study. In Europe, the investigator 
must confirm the receipt of the final 
report composed by Coloplast (and 
confirm agreement with the study 
results) 
 
16.2 Records Retention 
All study site files and the investigation database, must be archived for a minimum period of 2 
years following the date of study closure as determined by Coloplast .  
The monitor is responsible for informing the investigator and the trial manager if this period should 
be longer for their sites according to local regulations.  
17 Suspension or Premature Termination of the Clinical Study 
The sponsor may suspend or prematurely terminate  the  clinical study at any time for significant 
and documented reasons. Significant reasons include but are not limited to, safety concerns, 
failure to meet enrollment goals, or change in market conditions, such as, significant decrease in 
mesh-based transvaginal procedures for  stress urinary incontinence repair.  
If a suspicion relating to an unacceptable risk to subjects arises during the clinical study, the 
sponsor may suspend the study while the risk is assessed. The sponsor will terminate the study 
if an unacceptable risk is confirmed. The sponsor must ensure that the premature termination is 

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justified in writing and that the regulatory authorities and relevant IRB/EC(s) are informed 
promptly. 
In the event the clinical study is terminated, treated subjects (having undergone surgical 
intervention) should be followed per protocol through the completion of their 36 month follow-up 
visit. In addition, IRBs/ECs will be notified of the decision to terminate the study.  
After the follow-up requirements are met, subjects will be notified that their participation in the 
clinical study is complete. Following the completion of study participation, subjects should be seen 
per local standard of care.   
Adverse events that occur following study termination will be reported to Coloplast via the 
complaint management system and will be processed per Coloplast complaint handling 
procedures and reported to Regulatory Authorities per local reporting requirements. 
18 Suspension or Premature Termination of a Study Site 
If monitoring or auditing of a clinical study site identifies serious and/or repeated deviations, and 
compliance cannot be secured in a timely manner, the sponsor may suspend or terminate the 
study site. All reasonable efforts will be made by Coloplast in conjunction with the Principal 
Investigator to secure compliance and prevent future occurrences. The sponsor or investigator 
will inform the regulatory authorities as appropriate and notify the IRB/EC about the termination 
of the site. 
19 
Publication policy 
Coloplast will form a publication committee that includes at least two participating investigators. 
The committee will develop a collaborative publication strategy. 
 
 
 

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20 
References 
 
1.  Abrams P, Andersson KE, Birder L, et al. Fourth International Consultation on Incontinence - 
Recommendations of the International Scientific Committee: Evaluation and Treatment of 
Urinary Incontinence, Pelvic Organ Prolapse and Faecal Incontinence. Neurourol Urodyn. 
2010;29(1):213-40. 
2.  Melville JL, Katon W, Delaney K, et al. Urinary Incontinence in US Women – A Population-
Based Study. Arch Intern Med. 2005;165:537-542. 
3. Nitti V. The prevalence of urinary incontinence. Rev Urol. 2001; 3(Suppl 1): S2–S6 
4.   Kim JJ, Lee Y-S, Lee K-S. Randomized Comparative Study of the U- and H-Type 
Approaches of the TVT-Secur Procedure for the Treatment of Female Stress Urinary 
Incontinence: One-Year Follow-Up. Korean J Urol 2010;51:250-256 
5  Dionko AC, Brock BM, Brown MB, et al. Prevalence of urinary incontinence and other 
urological symptoms in the noninstitutionalized elderly. J Urol. 1986;136:1022. 
6  Anger, J. T., Weinberg, A. E., Albo, M. E. et al. Trends in surgical management of stress 
urinary incontinence among female Medicare beneficiaries. Urology, 74: 283, 2009. 
7  Ulmsten, U., Henriksson, L., Johnson, P. et al. An ambulatory surgical procedure under local 
anesthesia for treatment of female urinary incontinence. Int Urogynecol J Pelvic Floor 
Dysfunct, 7: 81, 1996.  
8  Abdel-Fattah M, Mostafa A, Familusi A, et al. Prospective Randomised Controlled Trial of 
Transobturator Tapes inManagement of Urodynamic Stress Incontinence in Women: 3-Year 
Outcomes from the Evaluation of Transobturator Tapes Study. European Urology 62 (2012) 
843-851. 
9 Staskin D, Kelleher C, Bosch R. Initial Assessment of Urinary Incontinence in Adult Male 
and Female Patients. Incontinence 5th Edition. Abrams P, Cardozo L, Khoury S. ICUD-EAU 
2013. Chapter 5A, Page 374, 2013. 
 
 
 
 
 

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Attachment 1 Change Log 
 
VERSION 
NUMBER 
ISSUED BY 
(INITIALS) 
COMMENTS (MAJOR CHANGES SINCE LAST REVISION) 
PAGE NUMBERS 
AFFECTED 
1.0  
USDKL 
Document established 
N/A 
2.0 
USLKR 
The registered trademark symbol, designated by ® was added 
after Altis. 
Page 1, Study Title. 
2.0 
USLKR 
The version of the protocol was updated to 2.0 and the date 
of April 22, 2014.  
Page 1, Cover page and 
footer for all pages.  
2.0 
USLKR 
Removed from study population, subjects who were enrolled 
in the Altis SIS FDA Investigation Device Exception (IDE) 
Study.  All research sites that participated in the IDE study 
will not take part in the 522 study. 
Page 6, Synopsis of 
Clinical Study. 
Page 16, Section 3.2.2 Site 
and Investigator Selection. 
Page 19 Section 3.4 
Subjects. 
Page 20 Section 3.5, 
Subject Recruitment and 
Enrollment.  
2.0 
USLKR 
Added to primary and secondary effectiveness endpoints “or 
are considered dry (pad weight ≤4.0 grams) at 6 months” 
using the 24 hour pad weight test per Reference Number 9 in 
Section 20. 
Page 6, Primary 
Effectiveness Endpoints. 
Page 7, Secondary 
Effectiveness Endpoint. 
Page 18, Section 3.3.2 
Primary Effectiveness 
Endpoints and Section 
3.3.4, Secondary 
Effectiveness Endpoint. 
2.0 
USLKR 
Added 2 questionnaires (Surgical Satisfaction Questionnaire 
and Visual Analog Scale for Pain) for quality of life 
assessment. 
Page 7, Secondary 
Effectiveness Endpoint. 
Page 18, Section 3.3.4 
Secondary Effectiveness 
Endpoint. 
2.0 
USLKR 
Stress or urge predominance will be determined using the 
MESA Incontinence questionnaire. 
Page 7, Exclusion Criteria 
for Subject Selection. 
Page 19, Section 3.4.2 
Exclusion criteria for 
subject selection. 
2.0 
USLKR 
Removed the word “consistently” and clarified the number of 
occasions a PVR of >100 would need to be obtained to meet 
the exclusion criterion.to reduce ambiguity. 
Page 7, Exclusion Criteria 
for Subject Selection, 
Number 8. 
Page 19 Section 3.4.2, 
Number 8. 
2.0 
USLKR 
Added MESA, SSQ, and VAS to the List of Abbreviations.  
Pages 9 and 10. List of 
Abbreviations. 
2.0 
USLKR 
Clarified maximum patient enrollment at each site to 
attempting to implant no more than 20% of subjects in each 
respective arm without prior approval from Coloplast. 
Page 16, Section 3.2.1 
General. 
2.0 
USLKR 
Updated Flow-Chart.  Inclusion exclusion criteria can be 
assessed through standard of care exams.  Therefore, 
informed consent process will occur after subject meets 
inclusion/exclusion criteria. 
Page 17. Figure 1: Overall 
Study Design Flow-Chart. 
2.0 
USLKR 
Updated the abbreviation for Urogenital Distress Inventory to 
“UDI-6.” 
Page 18, Section 3.3.4 
Secondary Effectiveness 
Endpoint. 
2.0 
USLKR 
Removed the specification of “70 +” after “Age” to describe 
the propensity analysis that will be conducted. 
Page 18, Section 3.3.5 
Risk Factors. 

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VERSION 
NUMBER 
ISSUED BY 
(INITIALS) 
COMMENTS (MAJOR CHANGES SINCE LAST REVISION) 
PAGE NUMBERS 
AFFECTED 
2.0 
USLKR 
Corrected typographical error; in the word “end.” 
Page 20 Section 3.7, 
Subject withdrawal criteria 
2.0 
USLKR 
Added “an Unscheduled Visit and Adverse Event eCRF” to 
describe where an adverse event assessment or adverse 
event follow-up will be recorded. 
Page 21 Section 5, 
Paragraph three. 
Page 22, Section 5.3.2. 
 
2.0 
USLKR 
Added column for Unscheduled Visit and collection of 
Medications, Surgical Satisfaction Questionnaires (SSQ-8), 
and Visual Analog Scale for Pain (VAS Pain).  Also added 
collection of cystoscopy at the procedure visit. 
Page 21 Table 1 Data 
Collection Schedule. 
Page 22, Section 5.1 and 
5.2. 
Page 23, Section 5.3.1. 
2.0 
USLKR 
Added Table Footnote 4, “Any procedures performed relevant 
to the continence state of the subject should be documented 
on the follow-up form (e.g. PVR, urinalysis, or CST testing).” 
Added Table footnote 5 “It is recommended that subjects 
complete pad weight testing within ± 1 month of the 
scheduled visit.” 
Added Table footnote 6 “The VAS Pain questionnaire will be 
completed by subjects at baseline and each day for the first 3 
days following their index procedure, and at their 6 month 
follow-up visit.” 
Page 21 and 22. Table 1 
Data Collection Schedule. 
 
Page 21, Section 5.1, 5.2, 
and 5.3.1. 
 
2.0 
USLKR 
Clarified CRFs to be used when an unscheduled visit occurs.  
Assessment of AEs will be captured on an Unscheduled 
eCRF and Adverse Event eCRF, as applicable.  The 
assessment of any additional procedures will be captured on 
an Unscheduled eCRF. 
Page 23, Section 5.3.2 
Unscheduled Follow-Up 
Visits 
2.0 
USLKR 
Clarified that the description of the control devices was for 
Coloplast products. 
Page 24, Section 6.2 
Description of Control 
Devices. 
2.0 
USLKR 
Replaced the trademark symbol ™ after Aris  and Supris with 
the registered trademark symbol, designated by ®. 
Page 24 Section 6.2.1 Aris 
Trans-Obturator Sling and 
Page 25, 6.2.2 Supris 
Retropubic Sling System. 
2.0 
USLKR 
Added that physicians new to using slings and/or with less 
than 6 months of experience will be required to complete the 
training listed.   
Page 25 Section 6.6 
Handling and Training. 
2.0 
USLKR 
Revised analysis population to subjects who have undergone 
a sling implant attempt for stress urinary incontinence and 
removed subjects who were part of the IDE study. 
Page 25 Section 7.1. 
Analysis Population. 
2.0 
USLKR 
Revised who will perform analyses to a contracted 
statistician. 
Page 26, Section 7.3 
General Analysis 
Principles. 
Page 31 Section 9.4 Data 
Protection. 
2.0 
USLKR 
Deleted references to the IDE study population since this 
population has been excluded from this study. 
Page 26 Section 7.4 
Missing Data. 
2.0 
USLKR 
Deleted description of imputation analysis for IDE cohort. 
Page 27 Section 7.8.1 24-
Hour Pad Weight Test. 
Page 27 Section 7.8.2 
Quality of Life. 
2.0 
USLKR 
Deleted Section 7.12 Deviation from the Statistical Plan as 
this applies to the Statistical Plan and not the protocol. 
Page 30 Section 7.12 
Deviation from the 
Statistical Plan. 
2.0 
USLKR 
Added that the study will be conducted according to the 
Monitoring Plan and that in-house and/or contracted monitors 
will be utilized.  Deleted the sentence on how data 
clarifications and monitoring action items will be documented.  
Pages 30, Section 8.2 
Monitoring Plan. 

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VERSION 
NUMBER 
ISSUED BY 
(INITIALS) 
COMMENTS (MAJOR CHANGES SINCE LAST REVISION) 
PAGE NUMBERS 
AFFECTED 
Added that a “clinical designee” may document resolution of 
data queries and monitoring action items.                                   
2.0 
USLKR 
Added “regulatory agencies” as body that may conduct study 
audits. 
Page 30, Section 8.3 
Audits. 
2.0 
USLKR 
Added that informed consent process must follow IRB 
regulations.  Deleted sentence in third paragraph regarding if 
new information becomes available, the sponsor will notify 
investigators as the next sentence provides more clarity as to 
what “new information” means. 
Page 31, Section 9.1 
Informed Consent Process. 
2.0 
USLKR 
Changed “and” in first sentence to “or.”  Removed “local” in 
front of IRB/EC. 
Page 31, Section 9.3 
Institutional Review 
Board/Ethics Committee. 
2.0 
USLKR 
Added “or designated contracted monitors” to people who 
would review data during monitoring visits.   
Page 31, Section 9.4 Data 
Protection. 
2.0 
USLKR 
Clarified that risks to study subjects will be minimized by 
providing training to investigators “new to using the Coloplast 
products.”   
Page 32, Section 9.5  
Paragraph one and two. 
 
2.0 
USLKR 
Modified the example of a risk to “(e.g. extrusion defined as 
mesh exposure in the vagina, pain, or infection.)” 
Page 32, Section 9.5 
Paragraph two. 
2.0 
USLKR 
Deleted the sentence, “There are no known direct benefits to 
study subjects, individuals, or communities through 
participation in this study.”   
Page 32, Section 9.5, 
Paragraph three. 
2.0 
USLKR 
Deleted part of a sentence describing study deviations “which 
may affect the rights, safety, and well-being of study subjects, 
the scientific soundness of the plan, validity of the data, or is 
non-compliant with applicable regulations. 
Page 33, Section 12 
Clinical Study Deviations. 
2.0 
USLKR 
Regarding serious and non-serious adverse events, the 
following was deleted, “that are deemed to be device or 
procedure related by the Principal Investigator. 
Page 33, Section 14.1 
Adverse 
Event/Complication 
Classification. 
2.0 
USLKR 
Deleted “Any ongoing adverse events must be assessed on 
an ongoing basis to determine resolution. 
Page 33, Section 14.1 
Adverse 
Event/Complication 
Classification 
2.0 
USLKR 
Added that “The CEC adjudication of adverse events will be 
used for data analysis.” 
Page 36, Section 15.1 
Clinical Events Committee 
2.0 
USLKR 
Changed the number of years that study records must be 
archived to “2 years following the date of study closure as 
determined by Coloplast” and deleted “after the final clinical 
study report has been signed. 
Page 39, Section 16.2 
Records Retention. 
2.0 
USLKR 
Deleted the word “prolapse” and inserted “stress urinary 
incontinence.”  
Page 39, Section 17 
Suspension or Premature 
Termination of the Clinical 
Study. 
2.1 
USLKR 
Updated the version and date of the protocol to 2.1 and 
September 10, 2014 
Cover page 
2.1 
USLKR 
Deleted “…or are considered dry (pad weight ≤ 4.0 grams)…” 
from the primary effectiveness endpoint 
Page 6 of the Synopsis and 
page 18 in Section 3.3.2 
Primary Effectiveness 
Endpoint 
2.1 
USLKR 
Deleted “…or are considered dry (pad weight ≤ 4.0 grams)…” 
from the secondary effectiveness endpoint so it now reads 
“Observed effectiveness defined as a reduction from baseline 
in 24 hour pad weight of at least 50% at 12 months, 18 
months, 24 months, and 36 months.” 
Page 7 of the Synopsis and 
page 18 in Section 3.3.4 
Secondary Effectiveness 
Endpoint 

Coloplast Corp 
Altis 522 Study 
Version 4.0 
November 01, 2018 
CONFIDENTIAL 
Page 47 of 47 
 
VERSION 
NUMBER 
ISSUED BY 
(INITIALS) 
COMMENTS (MAJOR CHANGES SINCE LAST REVISION) 
PAGE NUMBERS 
AFFECTED 
2.1 
USLKR 
Added a new secondary effectiveness endpoint, “Observed 
effectiveness for subjects considered dry (pad weight ≤ 4.0 
grams) at 6, 12, 18, 24, and 36 months.” 
Page 7 of the Synopsis 
3.0 
USLKR 
Changed version and date. 
Page 1 
3.0 
USLKR 
Updated biostatistician information 
Page 13 
3.0 
USLKR 
Modified enrollment to a 2:1 Altis:Comparator ratio. 
Page 16, Section 3.2.1 
3.0 
USLKR 
Adjusted statistical considerations to account for a 2:1 
Altis:Comparator ratio.  Also clarified how missing data would 
be handled and defined sensitivity analyses. 
Pages 26-32, Section 7 
4.0 
USKVE 
Changed version and date. 
Page 1 
4.0 
USKVE 
The number of required study subjects is returned to 178 per 
group (equal allocation) as in the previous FDA approved 
protocol version 2.1. 
   
Page 6 of the Synopsis and 
Page 16  
4.0 
USKVE 
Updated sponsor representative information. 
Pages 11, 13, 40 
4.0 
USKVE 
The number of study subjects is returned to 178 subjects per 
group (equal allocation) as in the previous FDA approved 
protocol version 2.1. 
 
Pages 30-31 in Section 7.9