Prostatic Urethral Lift in Subject With Acute Urinary Retention
Phase: NA
Conditions: Acute Urinary Retention, Benign Prostatic Hyperplasia
Sponsor: NeoTract, Inc.

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Number/Date:  CP00004; Rev D/ 14-Dec-2018 
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Prostatic Urethral Lift in Subjects with Acute Urinary 
Retention Study (PULSAR) 
Study Protocol 
 
 
Clinical Protocol Number : CP00004  Revision D  
14-December-2018 
 
 
 
Sponsored by: 
NeoTract®, Inc. 
4473 Willow Road, Suite 100 
Pleasanton, CA 94588 
 
 
 
 
 
UroLift® System Registration # 252.1059 (NSAI) 
UroLift® System CE Mark Approved: 3 June 2010 
IRAS ID: 228068  
 
 
 
 
 

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TABLE OF CONTENTS 
INVESTIGATOR SIGNATURE PAGE ........................................................................................................ 6 
1 
Protocol Summary ......................................................................................................................... 7 
2 
Study Contacts ............................................................................................................................... 8 
3 
Abbreviations and Definitions ....................................................................................................... 9 
4 
Introduction ................................................................................................................................. 11 
5 
Previous UroLift ® System Clinical Studies ................................................................................... 14 
5.1 
Pivotal Randomised Study (“L.I.F.T.”) .......................................................................... 14 
 
Effectiveness Endpoints ...................................................................................... 14 
 
Safety Assessment .............................................................................................. 17 
5.2 
BPH-6: A UroLift System Post Market Multi-Centre Randomised Study ..................... 18 
5.3 
UroLift System ............................................................................................................. 18 
 
Indication for Use ................................................................................................ 21 
 
Instructions for Use ............................................................................................. 21 
6 
Rationale ...................................................................................................................................... 22 
6.1 
Objectives .................................................................................................................... 24 
6.2 
Primary Study Assessment .......................................................................................... 25 
6.3 
Primary Safety Assessment ......................................................................................... 25 
6.4 
Other Assessments ...................................................................................................... 25 
7 
Study Design ................................................................................................................................ 26 
8 
Enrolment Criteria ....................................................................................................................... 26 
8.1 
Inclusion Criteria .......................................................................................................... 26 
8.2 
Exclusion Criteria ......................................................................................................... 26 
9 
Withdrawal Criteria ..................................................................................................................... 27 
10 
Subject Procedures:  Prospective Cohort ................................................................................ 28 
10.1 
Subject Identification and Recruitment ....................................................................... 28 
10.2 
Screening Procedures .................................................................................................. 28 
 
Informed Consent Process .................................................................................. 28 
 
Determining Eligibility ......................................................................................... 29 
 
Other Baseline Procedures ................................................................................. 31 
10.3 
Enrolment .................................................................................................................... 33 
 
UroLift System Procedure Instructions ............................................................... 33 
 
UroLift System Equipment .................................................................................. 34 
 
Training in Prostatic Urethral Lift Procedure ...................................................... 34 

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Post Procedure Instructions ................................................................................ 34 
10.4 
Post-Procedure Trial Without Catheter (TWOC) ......................................................... 35 
10.5 
6 Week Follow-up Procedures ..................................................................................... 35 
10.6 
3 Month Follow-up Procedures ................................................................................... 36 
10.7 
6 Month Follow-up Procedures ................................................................................... 37 
10.8 
12 Month Follow-up Procedures ................................................................................. 37 
10.9 
Interim Visits ................................................................................................................ 38 
10.10 
Surgical Intervention ................................................................................................... 38 
 
Alternative Surgical Intervention ........................................................................ 38 
 
Secondary PUL .................................................................................................... 39 
10.11 
Treatment Failure ........................................................................................................ 39 
10.12 
Subject Follow-up Rate ................................................................................................ 39 
10.13 
Protocol deviations ...................................................................................................... 39 
10.14 
Performance of Study Procedures ............................................................................... 41 
 
Lab tests .............................................................................................................. 41 
 
Transrectal or Transabdominal Ultrasound ........................................................ 41 
 
Cystoscopy .......................................................................................................... 41 
 
Urodynamic testing ............................................................................................. 42 
 
Freestanding Uroflowmetry ................................................................................ 42 
 
Post Void Residual Urine Volume ....................................................................... 42 
11 
Electronic Case Report Form (eCRF) Entry .............................................................................. 43 
12 
Data Collection and Confidentiality ........................................................................................ 43 
13 
Risks and Benefits of PUL and the Clinical Investigation ......................................................... 44 
13.1 
Anticipated clinical benefits ........................................................................................ 44 
13.2 
Anticipated Adverse Events ......................................................................................... 44 
13.3 
Anticipated Procedural Adverse Events ...................................................................... 45 
13.4 
Protocol Required Testing with Anticipated Adverse Events ...................................... 45 
13.5 
UroLift System Adverse Events .................................................................................... 45 
13.6 
Possible Interactions with Concomitant Medical Treatments .................................... 47 
13.7 
Possible Risks of Participation in a Clinical Trial .......................................................... 47 
13.8 
Risk Mitigation ............................................................................................................. 47 
13.9 
Risk-to-Benefit Rationale ............................................................................................. 47 
14 
Adverse Events ........................................................................................................................ 48 
14.1 
Serious Adverse Events ................................................................................................ 48 

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14.2 
Unexpected Adverse Event.......................................................................................... 48 
14.3 
Not an Adverse Event .................................................................................................. 48 
14.4 
Adverse Event Assessment .......................................................................................... 49 
14.5 
Adverse Event Reporting ............................................................................................. 50 
14.6 
Adverse Event Independent Reviewer ........................................................................ 51 
14.7 
Device Malfunctions, Failures, or Near Incidents ........................................................ 53 
15 
Study Procedures – Retrospective Cohort .............................................................................. 53 
15.1 
Qualifications for Case Abstractors ............................................................................. 53 
15.2 
Subject Identification ................................................................................................... 54 
15.3 
Modified Enrolment Criteria for Retrospective Arm ................................................... 54 
 
Retrospective Inclusion Criteria .......................................................................... 54 
 
Retrospective Exclusion Criteria ......................................................................... 54 
15.4 
Enrolment Procedures- Retrospective arm ................................................................. 55 
15.5 
Patient Informed Consent – Retrospective arm .......................................................... 55 
15.6 
Subject Withdrawal Procedure – Retrospective arm .................................................. 55 
15.7 
Mitigating potential sources of error .......................................................................... 55 
15.8 
Case Abstraction:  Data Collection .............................................................................. 57 
 
Screening ............................................................................................................. 57 
 
Procedure ............................................................................................................ 58 
 
Post-procedure ................................................................................................... 58 
16 
Study Data Analysis ................................................................................................................. 59 
16.1 
Interim Safety and Conduct Assessment ..................................................................... 59 
16.2 
Per Protocol Population ............................................................................................... 59 
16.3 
Safety Population......................................................................................................... 59 
16.4 
Missing Data ................................................................................................................ 59 
16.5 
Analysis of Success Measures ...................................................................................... 60 
16.6 
Additional Assessments ............................................................................................... 60 
16.7 
Evaluation of Study Success......................................................................................... 61 
17 
Roles and Responsibilities: Sponsor and Investigator ............................................................. 61 
17.1 
Sponsor Responsibilities .............................................................................................. 61 
17.2 
Investigator and Site Personnel Training ..................................................................... 61 
17.3 
Monitoring Responsibilities ......................................................................................... 62 
17.4 
Patient Informed Consent Form (PICF) Template Approval ........................................ 62 
17.5 
Investigator Responsibilities ........................................................................................ 63 

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17.6 
Approval to Recruit -Ethics Committee Review and Compliance................................ 64 
18 
Device Use and Ancillary Equipment ....................................................................................... 65 
19 
Potential Device Changes ........................................................................................................ 65 
20 
Termination of Study ............................................................................................................... 65 
21 
Early Study Centre Termination .............................................................................................. 65 
22 
Study Protocol Amendments .................................................................................................. 66 
23 
Publication Policy .................................................................................................................... 67 

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INVESTIGATOR SIGNATURE PAGE 
Trial Title 
Prostatic Urethral Lift in Subjects with Acute Urinary Retention Study 
(PULSAR) 
Device 
NeoTract® UroLift® System With commercial license 
Protocol Number Version 
CP00004, Revision D 
Original Issue Date 
30 May 2017 
Version Issue Date 
14 December 2018 
Trial Sponsor 
NeoTract, Inc. 
Investigator Acknowledgement Signature: 
 
I,_______________________________________, and  I, __________________________________at  
 
(name of principal investigator) 
 
 
(name of co-principal investigator) 
the_____________________________________, 
 
 (name of hospital)  
The undersigned, attest that we have read and understood this Protocol specified above and agree on 
its content and to abide by the above mentioned version and any subsequent amendments during my 
participation in the evaluation. We agree to perform and conduct the study as described in the protocol 
and in accordance with the relevant parts of the ICH Guidelines for GCP, the ISO 14155, the Declaration 
of Helsinki, and the pertinent individual country laws/regulations. 
 
_____________________________________ 
___________________________________ 
Principal Investigator Signature 
 
 
 
 
 Date 
_____________________________________ 
___________________________________ 
Co-Principal Investigator Signature 
 
 
 
 
  Date 
Review by Head of Medical Affairs: 
 
I have reviewed the contents of this PULSAR protocol CP00004 Revision D, and the Informed Consent 
Forms for the prospective and retrospective study arms in conjunction with Risk Management 
document RSK00003 Rev N. The expected potential benefits of participation in the PULSAR study 
outweigh the expected potential risks.   
_____________________________________  
___________________________________ 
Jacqueline Welch M.D, Ph.D. 
 
 
 
 
                                     Date 
Medical Affairs 
 
 
Approval by Head of Clinical Affairs: 
 
_____________________________________  
___________________________________ 
Monica Ransom 
 
 
 
 
 
                                     Date 
Director, Clinical Affairs 
 
 
 
 

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1 
Protocol Summary 
Study Title 
Prostatic Urethral Lift in Subjects with Acute Urinary Retention 
Study (PULSAR) 
Study Objectives 
Assess feasibility and safety of the Prostatic Urethra Lift (PUL) 
procedure in patients with acute urinary retention secondary to 
BPH.  Research methodology will also be evaluated for larger, 
randomised study.   
Study Design 
Multi-centre, prospective evaluation of PUL and retrospective 
review of invasive surgery as potential comparator. 
Sample Size 
Up to 55 subjects treated with PUL. 
Retrospective chart review will include BPH patients that 
presented with AR and went on to de novo invasive surgery from 
June 1, 2015 to December 31, 2015. 
Subject Population 
Males over the age of 50 diagnosed with symptomatic benign 
prostatic hyperplasia (BPH) and ongoing acute urinary retention 
after failed TWOC. 
Number of Centres 
(Sites) 
Up to six centres in the United Kingdom.  
Clinical Indication 
The UroLift System is indicated for the treatment of symptoms 
due to urinary outflow obstruction secondary to benign prostatic 
hyperplasia (BPH) in men 50 years of age or older. 
 Primary Study 
Assessment 
Successful post-procedure voiding trial without catheter (2-4 
days).       
Safety Assessment 
Rate of serious adverse events (SAEs) related to BPH 
intervention through 3 months.  
Additional 
Assessments 
1. Need for further clean intermittent self-catheterisation (CISC) 
2. Urinary symptoms, post void residual (PVR) and peak flow rate 
over follow-up 
3. Subjects free from urinary retention through 1 month, 6 
weeks, 3, 6 and 12 months  
4. Subjects free from alternative surgical procedure for BPH 
through 12 months 
5. Duration of catheter prior to treatment and in follow-up 
between prospective (PUL) and retrospective (TURP/HoLEP) 
6. Rate of AEs in prospective PUL and retrospective TURP/HoLEP  
7. Assess enrolment rate, willingness of patients to enrol, 
inclusion criteria, and appropriateness of endpoint 
Follow-up Evaluations 
Post-procedure, 6 weeks, 3 months, 6 months (remote), 12 
months 
Anticipated Study Duration 
First patient in (FPI) 
15-April-2018  
Last patient in (LPI) 
31-December-2018 
Endpoint analysis 
28-February-2019  
Study close 
01-April-2020    

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2 
Study Contacts 
Chief Principal Investigator 
Mr. Oliver Kayes 
Consultant Urologist & Honorary Senior Lecturer 
St James’s University Hospital 
Leeds Teaching Hospital NHS Trust 
Sponsor 
NeoTract, Inc. 
4473 Willow Rd., Suite 100 
Pleasanton, CA 94588 
Emily Hergenreter, Sr. Director, Clinical Affairs 
Key Protocol Contributors 
Alphabetically 
 
Neil Barber, BSc, MB BS, FRCS (Urol) 
Consultant Urologist 
Frimley Park Hospital 
Frimley Health NHS Foundation Trust 
 
Oliver Kayes, MBBS MSc MD(Res) FRCS(Urol)  
Consultant Urologist & Honorary Senior Lecturer  
St James’s University Hospital 
Leeds Teaching Hospital NHS Trust 
 
Mark Rochester, MA MD FRCS(Urol) 
Consultant Surgeon, Urology Service Director 
Norfolk and Norwich University Hospital 
Norfolk and Norwich University Hospitals NHS 
Foundation Trust 
Adverse Event Independent 
Safety Reviewer 
Raj Shinghal, M.D. 
Urologist 
Fremont, CA 
Electronic Data Capture (EDC) 
iMedNet hosted by MedNet 
Minneapolis, MN 
 Urodynamics Central Reviewer 
Mr. Neil Harris* 
Consultant Urologist Surgeon 
St James’s University Hospital 
Leeds Teaching Hospital NHS Trust 
*Under the oversight of Mr. Oliver Kayes 
Biostatisticians 
Tami Crabtree 
Director of Biostatistics 
Advanced Research Associates 
 
John Breddy  
Owner  
Pharmastat Consulting Ltd. 
Medical Monitor 
Jacqueline Welch, M.D., Ph.D. 
Director, Medical Affairs 
NeoTract, Inc. 

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3 
 Abbreviations and Definitions 
Table 1 Abbreviations 
AE  
Adverse Event  
AIDS 
Acquired Immunodeficiency Syndrome 
AR 
Acute urinary retention 
AUR 
Acute urinary retention 
BPH  
Benign Prostate Hyperplasia  
BPH II 
Benign Prostatic Hyperplasia Impact Index  
CAPA 
Corrective and Preventative Action  
CEC 
Clinical Events Committee 
CI 
Confidence Interval 
CIP 
Clinical Investigation Plan – Study Protocol 
eCRF 
Electronic Case Report Form 
CT 
Capsular Tab 
DRE 
Digital Rectal Exam 
EC 
Ethics Committee 
EDC 
Electronic Data Capture (system) 
FDA 
Food and Drug Administration 
GDPR 
General Data Protection Regulation  
GCP 
Good Clinical Practices 
GU 
Genitourinary 
HoLEP 
Holmium Laser Enucleation of the prostate, alternative to TURP  
HRA 
Health Research Authority  
HREC 
Human Research Ethics Committee 
IB 
Investigator’s Brochure 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonisation 
IDE 
Investigational Device Exemption  
IFU 
Instructions for Use 
IIEF 
International Index of Erectile Function  
IPSS 
International Prostate Symptom Score  
IR 
Independent Reviewer  
ISI 
Incontinence Severity Index 
ITT 
Intention-to-Treat 
L.I.F.T. 
Luminal Improvement Following Prostatic Tissue Approximation for the 
Treatment of Lower Urinary Tract Symptoms 
LUTS 
Lower Urinary Tract Symptom 
MHRA 
Medicines and Healthcare Products Regulatory Agency 

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MI 
Multiple Imputation 
MIST 
Minimally Invasive Surgical Therapies 
OUS 
Outside U.S. 
PET 
Polyethylene Terephthalate 
PP 
Per Protocol 
PRN 
As needed 
PSA 
Prostate-Specific Antigen 
PUL 
Prostatic UroLift Procedure- procedure using the UroLift System 
PVP 
Photoselective vaporisation of the prostate by laser, alternative to TURP 
PVR 
Post Void Residual 
Qmax 
Peak Flow Rate 
QoL 
Quality of Life  
R&D 
Research & Development 
Rx 
Prescription Only 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SOC 
Standard of Care 
SHIM 
Sexual Health Inventory for Men 
TBD 
To Be Determined 
TRUS 
Transrectal Ultrasound 
TWOC 
Trial to void without catheter 
TURP 
Transurethral Resection of the Prostate  
UA 
Urinalysis 
U.S. 
United States 
US 
Ultrasound 
VAS 
Visual Analog Scale 
 
 
 

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Table 2 Definitions 
Adverse 
event (AE) 
An adverse event (AE) is defined as any undesirable medical occurrence in a 
clinical trial subject, whether it is considered to be related to the device or 
not, that includes a clinical sign, symptom, or condition. 
 
Once a subject is enroled, all AEs must be reported through follow-up 
period.  Only exacerbated conditions or new onset qualify as an AE.  
Principal Investigator will assess severity, relatedness, serious or 
unexpected.  
Alternative 
Surgical 
Intervention 
A post-index procedure surgery, other than PUL, to treat BPH.  
Acute 
Urinary 
Retention 
Painful inability to void and a residual volume < 1500 mL. 
Invasive BPH 
surgery 
 
Transurethral resection of the prostate (TURP) 
 
Transurethral Laser (PVP, HoLEP or Interstitial) 
 
Open Prostatectomy 
Index 
procedure 
The first procedure to which subjects are enroled.  
Precipitated 
AR 
Acute urinary retention that develops in response to a trigger such as UTI, 
anaesthesia, surgery, medications with sympathomimetic or anticholinergic 
effects. 
Serious 
Adverse Event 
(SAE) 
Serious Adverse Event (SAE) is defined as untoward occurrence that: (a) 
results in death; (b) is life-threatening; (c) requires hospitalisation or 
prolongation of existing hospitalisation (d) results in persistent or significant 
disability or incapacity; (e) consists of a congenital anomaly or birth defect; 
or (f) is otherwise considered medically significant by the investigator.  
 
(in-patient hospitalisation is at least 24 consecutive hours) 
Unexpected 
Adverse Event 
An unexpected adverse event is an event which by nature, incidence, 
severity or outcome has not been identified in the current version of the 
Sponsor risk management files. 
Spontaneous 
AR 
Associated with older age, BPH, elevated PSA, or presence of severe LUTS. 
PUL 
Procedure Time 
Time from first device insertion to last device removed. 
4 
Introduction 
Benign prostatic hyperplasia (BPH) impacts quality of life by causing lower urinary tract symptoms 
(LUTS).  The number of U.S. men with symptomatic BPH that seek treatment options is projected to 

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increase from 8.1 million in 2010 to 10.3 million in 2020.1  Current treatment options consist of 
watchful waiting, medical therapy and interventional procedures. Watchful waiting is generally 
reserved for those with mild symptoms.2,3  Over 4 million U.S. men are on medical therapy for BPH.4 
While symptom relief is modest with an American Urological Association Symptom Index (IPSS) 
improvement at 1 year of 3.5-7.5 vs. 0-5.7 for placebo, the incidence of side effects along with 
inadequate relief prompt over one-quarter of men on drug therapy to discontinue treatment early.2,4,5,6  
Most surgical approaches remove prostate tissue and, while highly effective, present with 
significant morbidity.  The gold standard remains transurethral resection of the prostate (TURP) that is 
associated with a 14.9 point improvement in IPSS at 1 year.2  This improvement, however, also comes 
with a 20% rate of perioperative morbidity and long-term complications that include urinary 
incontinence (3%), urethral stricture (7%), erectile dysfunction (10%) and ejaculatory dysfunction 
(65%).2,7  Because tissue is removed and underlying tissue injured, there is a healing response and 
tissue inflammation such that subjects experience routine catheterisation and irritative symptoms 
post-procedure.2  For these reasons, the number of TURP surgeries among the US Medicare population 
has been declining (from 72,163 in 1999 to 49,683 in 2005).8  Laser vaporisation is a newer approach to 
TURP that minimises blood loss compared to conventional TURP, but still typically requires general or 
spinal anaesthesia and overnight hospital stay.  There is routine catheterisation and post-operative 
dysuria, again as a result of tissue removal and injury.7  US Medicare data show that from 2005 to 2007, 
conventional TURP surgeries decreased by over 12,600 procedures while laser vaporisation procedures 
increased by over 12,100 procedures.9  Thus, laser vaporisation has been employed more as a 
                                                          
 
1  
Roehrborn, C.G., Current medical therapies for men with lower urinary tract symptoms and benign prostatic hyperplasia:  
achievements and limitations, Rev Urol 2008; 10:14. 
2  
Benign Prostatic Hyperplasia Guideline, Roehrborn, C.G., McConnell, J.D., Barry, M.J., Benaim, E., Bruskewitz, R.C., Blute, 
M.L., Holtgrewe, H.L., Kaplan, S.A., Lange, J.L., Lowe, F.C., Roberts, R.G., Stein, B.S.:  Guideline on the Management of 
Benign Prostatic Hyperplasia.  American Urological Association Education and Research, Inc., 2003. 
3         Kaplan, S.A., AUA guidelines and their impact on the management of BPH:  an update, Rev Urol 2004; 6 
 (Suppl 9): S46. 
4  
IMS Health Pharmaceutical Data. 
5  
Emberton, M., Fitzpatrick, J.M., Garcia-Losa, M., Qizilbash, N., Djavan, B., Progression of benign prostatic hyperplasia: 
systematic review of placebo arms of clinical trials, BJU International 2008; 102 (8): 981-6. 
6  
Verhamme, K.M.C., Dieleman, J.P., Bleumink, G.S., Bosch, J.L.H.R., Stricker, B.H. Ch., Sturkenboom, M.C. J.M., Treatment 
strategies, patterns of drug use and treatment discontinuation in men with LUTS suggestive of benign prostatic 
hyperplasia:  The Triumph Project, European Urology 2003; 44: 539. 
7  
Miano, R, De Nunzio, C., Asimakopoulos, A.D., Germani, S., Tubaro, A., Treatment options for benign prostatic 
hyperplasia in older men, Med Sci Monit 2008; 14: RA94. 
8  
Yu, X, Elliott, S.P., Wilt, T.J., McBean, A. M., Practice patterns in benign prostatic hyperplasia surgical therapy:  the 
dramatic increase in minimally invasive technologies, J Urol 2008; 180: 241. 
9  
Medicare data calculated from the Medicare Physician/Supplier Procedure Summary Master File, 2004-2007. 

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replacement for conventional TURP while the total number of TURP surgeries (inclusive of laser 
vaporisation) has been stable or is decreasing slightly. 
Thermotherapies such as transurethral microwave therapy (TUMT), transurethral steam injection 
(TSI) and transurethral needle ablation (TUNA) induce necrotic scarring of the prostate as a 
replacement for surgical resection.8 The effectiveness is greater than that of drugs but less than that of 
TURP (10.2 and 9.1 point improvement in IPSS at 1 year for TUMT and TUNA, respectively).2 There is a 
significant shortcoming of these thermotherapies that the subject experiences within the initial months 
after treatment.  By nature of inducing thermal injury to the prostate, there is a healing response, 
tissue inflammation and irritative voiding symptoms in virtually all subjects.2 Post-procedure, subjects 
face routine catheterisation, a 20-25% risk of acute urinary retention, and irritative voiding symptoms 
that last for 4-6 weeks.2,7 During the Prostalund Coretherm IDE study, the three TUMT patient groups 
experienced 14, 18, and 20 days mean post-treatment indwelling catheter time. 10   In addition, TUMT 
therapies have been associated with > 20% retrograde ejaculation rate.11,12  Thus, procedure volumes 
for thermotherapies among Medicare beneficiaries only increased gradually to modest levels of 37,637 
in 2005 and have been declining since.8,9   
With a high prevalence of subjects who discontinue medical therapy and a relatively low incidence 
of interventional treatment, there is a large subject population that remained inadequately addressed 
until the advent of the Prostatic Urethral Lift (PUL) procedure.  The UroLift® System was originally 
approved via De Novo (DEN130023) and Special 510(k) K133281. PUL is a tissue-sparing minimally 
invasive treatment for BPH, is based on the hypothesis that LUTS secondary to BPH could be treated by 
mechanically disassociating the obstructing prostatic lobes instead of removing or injuring prostate 
tissue, thereby offering the ability to relieve symptoms with low morbidity and a better subject 
experience.  At one year, subjects demonstrate an IPSS improvement similar to or better than 
thermotherapy (10.8 points), but the difference was the very low morbidity endured to reach that 
result.13  Catheterisation was only 32% for a mean duration less than a day.  IPSS significantly improved 
                                                          
 
10  
Summary of Safety and Effectiveness, Prostalund CoreTherm Microwave Therapy System, PreMarket Approval (PMA) 
Number P010055. 
11  
Norby, B, Nielsen, H.V., Frimodt-moller, P.C., Transurethral interstitial laser coagulation of the prostate and transurethral 
microwave thermotherapy vs transurethral resection or incision of the prostate: results of a randomized, controlled 
study in patients with symptomatic benign prostatic hyperplasia, BJU International 2002; 90: 853-62. 
12  
Ahmed, M., Bell, T., Lawrence, W.T., Ward, J.P., Watson, G.M., Transurethral microwave thermotherapy 
(Prostatron@version 2.5) compared with transurethral resection of the prostate for the treatment of benign prostatic 
hyperplasia: a randomized, controlled, parallel study, British Journal of Urology 1997; 79: 181-5. 
13    Roehrborn CG, Gange SN, Shore ND, Giddens JL, Bolton DM, Cowan BE, Brown BT, McVary KT, Te AE, Gholami SS, Rashid P, 
Moseley WG, Chin PT, Dowling WT, Freedman SJ, Incze PF, Coffield KS, Borges FD, Rukstalis DB. Multi-Centre randomized 
controlled blinded study of the prostatic urethral lift for the treatment of LUTS associated with prostate enlargement due 
to BPH: the L.I.F.T. study. J Urol 2013; 190: 2162-2167. 

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by 2 weeks.  There was, for the first time in a BPH device trial, no de novo sustained ejaculatory or 
erectile dysfunction.   
5 
  Previous UroLift ® System Clinical Studies 
5.1 
Pivotal Randomised Study (“L.I.F.T.”) 
The L.I.F.T. study design was prospective, multicentre, multinational, 2:1 randomised, single-
blinded controlled clinical trial of the UroLift System.  The study had two phases, a randomised single-
blind period followed by a non-randomised open-label period.  The blinded randomised trial portion of 
the study started at the time of the procedure and ended at the subject’s 3-month visit.  The 
effectiveness assessment was double blinded in terms of both the subject and the assessor.  
A total of 206 subjects were randomised in a 2:1 ratio, (UroLift: 140; Control: 66) at 19 
investigational sites.  Fourteen U.S. sites and 5 non-U.S. sites (three in Australia and two in Canada) 
participated in the investigation.  Subjects in the UroLift group underwent the UroLift System 
procedure.  Subjects in the Control group underwent a sham procedure, which included standard 
cystoscopy with perioperative sounds and verbal comments that mimicked the UroLift arm 
procedure.  All subjects were blinded to the randomised treatment, and maintenance of the blind was 
assessed four times from procedure discharge up to and including the 3-month visit. 
Once the 3-month follow-up was completed, the subjects were unblinded.  After unblinding, if 
their symptoms returned and treatment was required, subjects were allowed to receive 
treatment/retreatment (either de novo treatment if originally in the Control group or as a retreatment 
if originally treated by PUL) with the UroLift System or any other approved BPH treatment. 
 Effectiveness Endpoints 
At 3 months, the effectiveness of the UroLift System was demonstrated by comparison of the 
change from baseline of the International Prostate Symptom Score (IPSS) of the treated group to the 
Control group.  At 3 months, in the ITT population, treatment with the UroLift System resulted in a 
mean decrease of 11.1 (50.0%) in IPSS (IPSS 11.2±7.65 at 3 months vs. 22.2±5.48 at baseline).  Subjects 
in the Control group demonstrated a decrease of 5.9 (24.2%) in IPSS (IPSS 18.5±8.59 at 3 months vs. 
24.4±5.75 at baseline).  Thus, the mean improvement in the UroLift group was 188% of the mean 
improvement in the Control group.  Similar reductions in IPSS were observed in the PP population.  In 
both populations, the null hypothesis was rejected with a p-value of less than 0.025 (ITT p value = 
0.003; PP p value =0.014), demonstrating a statistically significant improvement in IPSS in the 
treatment group over the Control group.  The effectiveness results demonstrated a clinically 

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meaningful improvement in IPSS as compared to Control under blinded conditions in the first three 
months of the study. 
At 12 months, the long-term effectiveness for subjects in the UroLift group was demonstrated by 
comparison of the IPSS at 12 months and at baseline. In the ITT population, treatment with the UroLift 
System resulted in a 45.5% reduction in IPSS (IPSS 11.7±7.32 at 12 months vs. 22.0±5.49 at 
baseline).  Subjects in the PP population demonstrated a 47.6% reduction in IPSS (IPSS 11.3±7.04 at 12 
months vs. 21.8±5.37 at baseline).  In both the ITT and PP populations the null hypothesis was rejected, 
with the lower bound of the 97.5% confidence interval demonstrated to be greater than 30% (ITT 
lower bound 38.3%; PP lower bound 42.8%).     
Subjects were followed through five years.  LUTS severity (IPSS), quality of life, Qmax, sexual 
function, and adverse events were assessed throughout follow up. 
Procedural Results 
One hundred and forty (140) procedures were performed as part of the initial UroLift 
randomisation.  The procedure was considered successful if the post treatment cystoscopy (as 
determined by an independent reviewer of all available day-of-procedure cystoscopies) exhibits an 
increase in the urethral opening post-treatment and the subject is free of device/procedure-related 
serious adverse events (SAEs) immediately (defined as within the same calendar day) post 
treatment.  Procedural success for UroLift ITT subjects was 99.2% for the 120 subjects for which 
cystoscopy video was available, as shown in Table 3.  Although cystoscopy videos were either not 
obtained or were not readable to confirm procedural success for the remaining 20 UroLift System 
subjects, it is important to note that no other day-of-procedure SAEs were reported in this group.  
Table 3 L.I.F.T. Procedural Success 
Procedural Success Definition 
Procedural Success, 
% (n/N) 
95% C.I. 
An increase in urethral opening on cystoscopy post-
treatment 
-AND- 
Subject is free of device/procedure-related SAEs 
immediately (i.e., the same day) post treatment 
  
  
99.2 (119/120)1 
  
  
(95.4, 99.98) 
1 One subject had a device-related and procedure-related SAE of Haematuria on the day of procedure. 
 
Procedure information for the randomised subjects in both study groups, including prophylactic 
antibiotics, anaesthetic/sedation, procedure time, and catheter placed at discharge time, is 
summarised in Table 4.  The majority of subjects in the study received topical anaesthesia for their 
procedure, which was used in equal proportions in the UroLift System (90.7%) and Control (90.9%) 
groups.  Subjects may have had more than one type of anaesthesia and/or sedation.  It is an intended 

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design feature of the system to be able to perform the procedure with only local anaesthesia.  One 
hundred thirteen (113) subjects in the UroLift group (80.7%) and 53 subjects in the Control group 
(80.3%) had the procedure done with topical anaesthesia only.  Less than 20% of the UroLift and 
Control subjects had general anaesthesia.  When general anaesthesia was given, it was primarily 
because it was the sites’ standard procedure, not because it was determined to be medically indicated. 
The majority of subjects in the UroLift group, 60.7% (85/140), were not catheterised.  Catheters 
were placed in the UroLift System subjects at a higher rate than Control subjects, 39.3% (55/140) 
versus 10.6% (7/66), respectively, as would be expected in a sham-controlled study.  Some 
investigators chose to use catheters prophylactically or as part of routine or standard of care in 
subjects in the UroLift group (Table 4).    
Median procedure time, measured from subject preparation to time subject left procedure room, 
was somewhat longer in the UroLift group versus Control group, 63.0 versus 45.0 minutes, respectively, 
as would be expected.  
Mean time to return to pre-operative activity level was longer in the UroLift System group than in 
the Control group (8.6 ± 7.53 days vs. 3.1 ± 4.38 days).  This too would be expected given the greater 
degree of tissue manipulation required for device delivery in the UroLift group. 
Table 4  L.I.F.T. Procedure Information 
Procedure Component 
UroLift (N = 140) 
Control (N = 66) 
% (n/n responses) 
Anaesthesia  
Topical / Lidocaine jelly 
90.7 (127/140)  
90.9 (60/66)  
Prostate block 
1.4 (2/140)  
3.0 (2/66)  
Spinal 
0 (0/140)  
0 (0/66)  
General 
17.9 (25/140)  
16.7 (11/66)  
Prophylactic Antibiotics Used 
100 (140/140)  
100 (66/66)  
Sedation  
Oral 
67.9 (95/140)  
68.2 (45/66)  
Intramuscular 
0.7 (1/140)  
0 (0/66)  
Intravenous 
30.0 (42/140)  
33.3 (22/66)  
Catheter Placed Prior to Discharge 
39.3 (55/140)  
10.6 (7/66)  
 
Mean, Median, SD [min - max], (n) 
Cystoscopic Intervention Time1 (min) 
24.4, 21.0, 12.45           
[5 - 65], (140)  
9.6, 8.0, 5.54                
[2 - 25], (65)4  
UroLift Procedure Time2 (min) 
18.7, 15.0, 11.07           
[3 - 57], (140)  
 
Overall Procedure Time3 (min) 
66.2, 63.0, 23.84           
[24 - 162], (140)  
46.8, 45.0, 17.21            
[18 - 100], (65)4  
Time to Return to Pre-operative Activity Level (days) 
8.6, 7.0, 7.53              
[0 - 43], (140)  
3.1, 2.0, 4.38                
[0 - 28], (66)  

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Procedure Component 
UroLift (N = 140) 
Control (N = 66) 
% (n/n responses) 
1Defined as cystoscopic start time to procedure end time. 
2Defined as time from 1st device insertion to last device removal. 
3Defined as start of anaesthesia time to time subject leave procedure room. 
4Subject 218-001 did not have a procedure end time recorded, thus only 65 cystoscopic intervention times and 
overall procedure times are available. 
Source: de novo one year report  
 Safety Assessment 
There were no unanticipated adverse effects observed for any subject in the study through the 5-
year follow-up, nor any de novo sustained ejaculatory or erectile dysfunction events.   During the 
blinded phase of the study, the Control group did not experience any serious adverse events (SAEs) 
related to the procedure.    During the first three years post index in the primary UroLift group, 8 SAEs 
in 8 separate subjects were reported then adjudicated by Clinical Events Committee (CEC) as at least 
possibly related to either the device and/or procedure. One of the events occurred in the immediate 
post-operative period, one before the 12-month visit, and the remaining 6 occurred in long-term 
follow-up.    
The primary safety endpoint was an assessment of the rate of extended post-operative urinary 
catheterisation in the subjects randomised to the UroLift group of the study in the ITT group.  The 
extended post-operative urinary catheterisation rate was defined as only including those subjects who 
required catheterisation within the first 3 days as part of post-operative management for inability to 
void, and required the catheter for more than 7 days.   
To meet the primary safety endpoint, the upper bound of a one-sided 97.5% exact binomial 
confidence interval of the observed rate of extended post-operative urinary catheterisation >7 days 
was required to be less than or equal to 10%. Subjects who had a catheter inserted within 3 days but 
required additional non-pharmacological intervention prior to the end of the 7-day insertion period 
were counted as having an event for this endpoint. 
The study met the primary safety endpoint, with only 1.4% (2/140) of the UroLift System subjects 
having an extended post-operative urinary catheterisation greater than 7 days.   The upper bound of 
the 97.5% CI for this rate was 5.1%, thus meeting the primary safety endpoint.  While each of these 
subjects underwent extended post-operative catheterisation, it is noted that the effectiveness of the 
procedure was not negatively affected.  The first subject experienced a 55% IPSS reduction by 1 month 
that increased to a 64% reduction by 12 months, and the second subject experienced 1- and 12-month 
IPSS reductions of 65% and 71%, respectively.  

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5.2 
BPH-6: A UroLift System Post Market Multi-Centre Randomised Study 
Lower urinary tract symptoms secondary to benign prostatic hyperplasia affect the quality of life of 
many men.  A significant number of these men value preserving sexual function, continence and safety 
as much as mitigating their LUTS.  For these men an effective therapy might best be defined by 
meeting a composite endpoint, termed “BPH-6 endpoint”.  The BPH-6 therapy effectiveness is defined 
as the ability to achieve all of the subject’s most important goals: 1) adequate relief from LUTS, 2) rapid 
return to normal activity, 3) maintenance of erectile function, 4) maintenance of ejaculatory function, 
5) maintenance of continence, and 6) avoidance of high grade perioperative complications.  Comparing 
the UroLift System treatment to the standard of care, TURP, by means of the BPH-6 composite 
endpoint will assist urologists and healthcare systems in determining the proper position for the 
UroLift System treatment as a treatment for LUTS secondary to BPH. 
This study provided the first randomised comparison of PUL and TURP in men suffering from LUTS 
secondary to BPH. Both study procedures effectively mitigated LUTS.  Analysis of the composite BPH-6 
endpoint demonstrated that TURP was superior in reducing IPSS (p = 0.05), whereas PUL was superior 
for preservation of ejaculatory function and quality of recovery (p < 0.0001).  One objective of a less 
invasive procedure is to improve surgical recovery. The recovery period after TURP can last from weeks 
to months, and may be disruptive for subjects and their families14. This is likely the first study to 
quantify recovery experience after TURP on a visual analog scale, and it gives a powerful indication of 
subject experiences.  The number of participants who experienced the BPH-6 definition of high-quality 
recovery (VAS > 80% by one month) was greater for PUL than for TURP (64% vs 44%).   
No significant differences were observed for erectile dysfunction, incontinence, or grade II+ 
adverse events.    
5.3 
UroLift System 
The UroLift System is manufactured by NeoTract, Inc. and consists of a delivery system (Figure 1) 
and a UroLift Implant (Figure 2) comprised of a nitinol Capsular Tab (CT) that rests on the outer capsule 
of the prostate and a stainless steel Urethral End-Piece (UE) that rests on the urethral wall.  The CT and 
UE are connected by a length of Polyethylene Terephthalate (PET) monofilament suture.  During the 
Prostatic Urethral Lift procedure, customised transprostatic implants are placed to hold open the 
obstructing prostatic lobes and expand the urethral lumen (Figure 3). The UroLift System is inserted 
                                                          
 
14 Mogensen K, Jacobsen JD.  The load on family and primary healthcare in the first six weeks after transurethral resection of the prostate.  
Scand J Urol Nephrol. 2008;42(2): pp. 132-136. 

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transurethrally through a rigid sheath under cystoscopic visualisation.  When the targeted area of the 
encroaching lateral prostatic lobe is located, the lobe is displaced by applying an outward pressure 
away from the urethra such that the obstructive lobe is compressed and the prostatic fossa enlarged.  
By applying this force, the effect of lifting the lobe can be tested before delivering an implant.  A 19 
gauge needle is then deployed from the tip of the delivery device extending from the intraluminal 
urethral wall through the prostatic capsular surface.  The CT is then delivered through the hollow bore 
of the needle.  As the needle is retracted, the CT engages the capsular prostatic surface and settles into 
a stable position, tension is applied, and the UE is secured onto the monofilament apposed to the 
urethral wall.  Because the fibromuscular capsule is less compliant than the peri-urethral tissue, the CT 
holds firmly in place while the UE holds the lobe in its displaced position thus expanding the urethral 
lumen.  When implanted, the UE can invaginate into the urethral wall, which reduces the foreign 
material surface area exposed to the urine stream and can lead to complete epithelialisation over time.  
Migration can be prevented by the nature of anchoring the implant in place. 
Based on the US FDA IDE L.I.F.T. Study, the UroLift System has exhibited a clinically meaningful 
improvement in lower urinary tract symptoms (LUTS) as early as 2 weeks post procedure that can be 
sustained through at least one year with an adverse event rate (e.g., catheterisation post treatment) 
that is equal to or lower when compared to other minimally invasive surgical therapies. This study led 
to FDA clearance by demonstrating the safety and effectiveness of the UroLift System for the 
treatment of BPH. 
Figure 1  UroLift Delivery Device 
 

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Figure 2 Components of UroLift Implant 
 

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Figure 3 Steps of UroLift procedure; Obstruction of the prostatic urethra before and after 
images 
 
 
 
 
 
 
 
 Indication for Use 
The UroLift System is indicated for the treatment of symptoms due to urinary outflow 
obstruction secondary to benign prostatic hyperplasia (BPH) in men 50 years of age or older. 
 Instructions for Use 
A copy of the Instructions for Use (IFU) accompanies each device when shipped. 
 
 
 
 
 

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6 
Rationale 
Acute urinary retention (AR) represents end-stage, painful, absolute failure to void urine and is 
associated with a significant morbidity.  The majority of cases in men (5315-65%16) usually result from 
the progressive obstruction to the bladder outlet due to benign prostatic enlargement17 (BPE).  The 
published incidence of AR due to BPH varies widely from 0.4% to 25%18.  The variability is partially due 
to the heterogeneous definition of acute retention, spontaneous AR, and level of evidence available.  
Alternatively, precipitous triggers for AR may include: prostate cancer, prostatitis, lower urinary tract 
infection (UTI), constipation, urethral stricture, genitourinary trauma, neurological injury or 
compromise. Potential contributory factors may include age, prescription drugs (e.g. anticholinergics, 
centrally acting drugs, alpha agonists), alcohol, and anaesthetics. It is unusual for AR to affect men 
under the age of 50 years where risk was found to be 1.6%, whereas men aged 70-79 years are at 10% 
risk of AR19.   
The current treatment pathway for men suffering their first episode of AR is delineated in Figure 4. 
The immediate steps are evidence based supported consistently with catheterisation paired with alpha 
blocker use doubling the rate of spontaneous voiding without catheter against placebo, typically 60% 
success (60% vs. 37% placebo)20. In the 40% that fail the trial without catheter (TWOC), Fitzpatrick21 
reports among a 6000+ survey of AR management that 49% were recatheterised and had BPH surgery, 
while the majority (44%) of the others repeated a subsequent TWOC with a success rate of 29.5%.  The 
majority of patients with BPE that have an episode of AR will eventually elect a surgical resolution.  
                                                          
 
15 Choong, S. and Emberton, M. (2000), Acute urinary retention. BJU International, 85: 186–201. doi:10.1046/j.1464-
410x.2000.00409.x 
16 Elhilali M, Vallacien G, Emberton M, et al. Management of acute urinary retention (AUR) in patients with BPH: A 
worldwide comparison.  J Urol. 2004; 171:407. 
17   Roehrborn CG, Bruskewitz et al: Urinary retention in patients with BPH treated with finasteride or placebo over 4 
years. Characterisation of patients and ultimate outcomes. The PLESS Study Group. Eur Urol 2000; 37: 528. 
18 Hartung, R; Do Alpha-blockers prevent the occurrence of Acute Urinary Retention? Eur Urol. 2001; 39 (13-18). 
19 Jacobsen SJ, Jacobson DJ, German CJ et al. Natural history of prostatism: Risk factors for acute urinary retention. J Urol. 
1997; 158:481-7. 
20 McNeill SA, Daruwala PD, Mitchell ID, Shearer MG,Hargreave TB. Sustained-release alfuzosin and trial without catheter 
after acute urinary retention: a prospective, placebo-controlled. BJU International 1999;84 
(6):622–7. 
21  Fitzpatrick, John M et al. “Management of Acute Urinary Retention: A Worldwide Survey of 6074 Men with Benign 
Prostatic Hyperplasia.” Bju International 109.1 (2012): 88–95. PMC. 
 

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Figure 4  Current Treatment Pathway for Acute Urinary Retention 22,23,24,25 
Present with 
first AUR 
episode
Diagnose and 
treat 
precipitating 
factors
Address any 
reversible 
factors
Urethral or SPC 
catheterisation
Lower urinary tract 
symptoms in men: 
management (2010 
updated 2015) 
NICE guideline CG97
Offer alpha 
blocker before 
removal
TWOC on alpha 
blockers
74%*
Variable (including 
surgery)
24%*
Recurrence 
Average drugs 
only 4.1 
months**
Succeed
TWOC again
Surgery
Overall, 78% post-
AR  
62% Fail ***
40% Fail
Majority
Fail
60% Succeed
Fail
57% w/in 2 yrs***
TWOC timing: 
49% after 2 days*
15% after 3-6 days*
 
See citations for *  
 
                                                          
 
22 Manikandan, R., Srirangam, SJ et al. Management of acute urinary retention secondary to benign prostatic hyperplasia 
in the UK: a national survey.  BJUI. 2004, V 93 (1) 84-88. 
23 Fitzpatrick, John M et al. “Management of Acute Urinary Retention: A Worldwide Survey of 6074 Men with Benign 
Prostatic Hyperplasia.” Bju International 109.1 (2012): 88–95. PMC. 
24 Roehrborn CG, Bruskewitz et al: Urinary retention in patients with BPH treated with finasteride or placebo over 4 
years. Characterisationof patients and ultimate outcomes. The PLESS Study Group. Eur Urol 2000; 37: 528. 
 
25 McNeill S.A, The Role of Alpha-Blockers in the Management of Acute urinary Retention Caused by Benign Prostatic 
Obstruction. E Urol. 2004, 45, 325-332. 

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Men failing a single TWOC have limited options to restore voiding.  Long-term catheter 
management may be elected, either indwelling or intermittent clean catheterisation (CISC), which 
carries a burden of maintenance and frequent UTIs (over half will experience).  Catheter use carries 
with it risk of haematuria, and less common AEs such as urethral diverticula and ischemic necrosis of 
the penis26. Many patients will opt instead to undergo an invasive BPH surgery such as TURP, PVP or 
HoLEP. These surgical options are known to be effective in treating BPH, however, the safety and 
recovery profile are more severe than a minimally invasive procedure including possible permanent 
sequelae. The complication rates vary depending on procedure, but common to all include infection, 
bleeding, pain, stress incontinence, sexual dysfunction, incontinence, delayed recovery up to 3-6 
months and re-treatment. The other reality of invasive surgery in U.K. is the long waiting period to 
secure OR time that extends time on catheter significantly. The waiting period averages 30 weeks to 
procedure after counselling the patient. 
The early UroLift studies described in section 5 above excluded subjects in urinary retention in 
order to provide non-confounding data on subjects with possible advanced bladder disease.  The 
clinical studies also required BPH medication washout which is known to be effective in short term 
treatment of AR. This population is not contraindicated; however, no study yet exists to assess if its 
efficacy and safety are similar to the voiding subjects. The UroLift System is designed to immediately 
de-obstruct the prostatic lobes without tissue damage, thereby reducing the pressure required to 
initiate micturition. Because of this mechanism, it is hypothesised that urinary retention may resolve 
after PUL removes the mechanical cause of the AR. The PUL technology could offer patients a shorter 
wait time, and a safety profile that could be an attractive option for AR patients.  As discussed above, 
the PUL procedure is a minimally invasive technique for BPH patients with demonstrated effectiveness 
and majority of adverse events mild or moderate and transient.  Recovery to normal activity was 
reported at 8-9 days in the L.I.F.T. study. Additional benefits include short operative times, minimal 
bleeding, shorter hospital stay and maintenance of normal sexual function. Treatment under local 
anaesthesia is an emerging technique offering rapid treatment and recovery in the clinical setting. 
6.1 
Objectives 
This study aims to assess if patients with acute urinary retention, who have failed at least one prior 
TWOC will benefit from the UroLift System.  Additionally, this study will determine best practices, 
endpoint, and feasibility of performing a larger study. Finally, this study will compare the benefits and 
                                                          
 
26 J Family Med Prim Care. 2016 Jul-Sep;5(3):539-542. doi: 10.4103/2249-4863.19726 

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risks of the PUL procedure with a retrospective matched population that underwent an invasive 
surgery such as TURP/HoLEP for AR. 
6.2 
Primary Study Assessment  
The primary study assessment will be successful trial without catheter (TWOC). Success is defined 
as a spontaneous voided volume of ≥ 100 mL associated with a post void residual volume by ultrasound 
< 300 mL at 3 days (± 1 day)  post index procedure.  
6.3 
Primary Safety Assessment  
Rate of serious adverse events (SAEs) related to BPH intervention through 3 months. 
6.4 
Other Assessments  
 Several other outcomes will be analyzed during the 12 month follow-up to understand post-TWOC 
durability: 
 
Catheter free rate and days free from catheter at 1 month and throughout follow-up    
 
Number of subjects who failed initial attempt but are able to void in subsequent TWOC 
 
Need for further clean intermittent self-catheterisation (CISC) 
 
Urinary symptoms peak flow rate, post void residual (PVR) volume 
 
Subjects free from alternative surgical procedure for BPH  
 
Duration of pre-index procedure catheter and its impact on durability 
 
Rate of adverse events 
 
The prospective arm will be compared to the available data collected in the retrospective 
surgical arm 

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7 
Study Design 
The study is a multi-centre, consecutive, prospective feasibility study of the UroLift System in acute 
urinary retention (AR) patients. A retrospective dataset (patients treated from June 1, 2015 to December 
31, 2015) of patients meeting similar criteria that underwent an invasive procedure to treat AR will be 
analysed against UroLift data. A maximum of 55 subjects undergoing UroLift will be enroled in up to six 
study centres in Great Britain. This feasibility study is the first to assess patients undergoing PUL with AR 
and will determine if a larger, quantitative study should be conducted with optimal methodology.  By 
evaluating results pertaining to study design, primary study assessment, conduct of trial, site 
performance, subject compliance, and inclusion criteria specifically, a robust safety and effectiveness 
study can follow.  
Clinical improvements will be assessed at post-procedure, 6 weeks, and months 3, 6, and 12 post-
index procedure.   
8 
Enrolment Criteria 
8.1 
Inclusion Criteria 
Subjects enroled in this clinical study must meet all of the following criteria. 
1. Male gender 
2. Diagnosis of symptomatic BPH 
3. Age ≥ 50 years 
4. Prostate volume ≤ 100 cc per ultrasound (US)  
5. Acute urinary retention with at least one failed trial without catheter (TWOC) while on alpha 
blocker 
8.2 
Exclusion Criteria  
Subjects will be excluded from the study if any of the following conditions apply. 
1. An obstructive or protruding median lobe of the prostate 
2. Previous BPH surgical procedure  
3. Previous pelvic surgery (i.e. incontinence sling, trauma repair, penile implants, artificial sphincter) 
or irradiation 
4. Urethral conditions that prevents insertion and delivery of device system into bladder (i.e. urethral 
strictures, meatal stenosis, bladder neck contracture) 

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5. Chronic retention volume of >1500 mL 
6. Has not had prostate cancer excluded 
7. History of prostate or bladder cancer 
8. Biopsy of the prostate within the 6 weeks prior to Index Procedure 
9. History of neurogenic or atonic bladder 
10. Acute or chronic renal failure 
11. Known coagulopathies or subject on anticoagulants within 3 days of index procedure (excluding up 
to 100mg ASA)  
12. Known bladder stones within the prior 3 months or treatment within 12 months 
13. Prostatitis requiring treatment (antibiotics) within the last year  
14. Other co-morbidities that could impact the study results such as: 
o severe cardiac arrhythmias uncontrolled by medications or pacemaker  
o congestive heart failure NYHA III or IV 
o history of uncontrolled diabetes mellitus 
o significant respiratory disease in which hospitalisation may be required  
o known immunosuppression (i.e. AIDS, post-transplant, undergoing chemotherapy) 
15. Life expectancy estimated to be less than 5 years 
16. Desire to maintain fertility post procedure 
17. Unable or unwilling to complete all required questionnaires and follow up assessments (e.g. lives 
out of area) 
18. Unable or unwilling to sign informed consent form 
19. Currently enroled in any other clinical research trial that has not completed the primary endpoint 
Refer to Section 15.3 for the modified enrolment criteria for the retrospective arm. 
9 
Withdrawal Criteria  
Subjects who have signed an informed consent form may be withdrawn from this study if they 
become unwilling or unable to comply with follow-up requirements, if they withdraw their consent, or 
if the investigator determines the subject should no longer continue in the study.  Regardless of the 

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reason for withdrawal, data available for the subject at the time of withdrawal, including the reason for 
withdrawal, will be collected and entered in EDC.  All practical efforts will be made to obtain the final 
AR status, retreatment status, and IPSS information. 
10 Subject Procedures:  Prospective Cohort 
10.1 Subject Identification and Recruitment 
Potential candidates for study will be identified through several paths (See Figure 4) with close 
oversite of the PI.  The enrolment rate targeted is (2) subjects per month at each site which will be 
accomplished only if PI plays an active role in recruitment. PI contribution will vary per site, but could 
include training additional staff (such as research fellows), reviewing medical records with or in parallel 
to Research Coordinating Nurses (RC), and implementing awareness programs for local consultants and 
GPs.  A plan should be established for a focused and efficient review of NHS medical records, along 
with monitoring BPH surgery waiting lists. Weekly time should be budgeted to execute the review plan 
and to discuss progress within the research team. Direct advertising is not planned, but may be 
implemented if enrolment proves challenging. The study will be posted on clinicaltrials.gov in advance 
of first subject, and other similar websites may be added. Sponsor may host web based meetings for 
the Research Coordinators to share expertise and troubleshoot any recruitment obstacles.  Study 
accoutrements for recruitment will be provided by Sponsor such as posters, post-cards, and template 
letters to physicians, and language to post on research websites, provided they are first approved by 
the EC if intended for patients.  
10.2 Screening Procedures 
 Informed Consent Process 
The investigator or trained designee will discuss the study background along with the benefits and 
risks of the PUL procedure, participation, and other study procedures. Ample time and opportunity for 
candidate to inquire about details of the trial and to decide whether or not to participate in the trial 
should be given. All questions about the trial should be answered to the satisfaction of the subject, or 
the subject’s legally acceptable representative.  
For this study, the potential subject must sign the consent form that has been approved by the 
study site's Ethics Committee (EC).  Failure to provide informed consent renders the subject ineligible 
for the study. 
Subjects who appear to generally meet the study Inclusion/Exclusion criteria will be asked to sign 
the EC approved Informed Consent form before any study-specific tests or procedures are performed.  

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A copy of the signed and dated written consent form shall be given to the subject, an original shall be 
filed in the subject’s medical record, and a copy maintained with the site’s research documentation. 
Subjects should first sign the informed consent prior to undergoing any non-standard of care testing 
required by this study protocol.   
Throughout the study, should there be important updates to the protocol and/or additional risks 
identified, a new EC approved consent form will require the subject’s signature and date.   
 Determining Eligibility  
To minimise stress and discomfort to the subject, some of the procedures that were documented 
and performed prior to subject informed consent, but within the timeframes specified below (

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Table 5) may be used as a guideline for eligibility and baseline data.  To further minimise burden on the 
subject, some eligibility tests are allowed on day of index procedure, therefore, proper expectations 
and alternatives will be discussed and planned with the subject.  Table 5 below provides a guideline of 
each of the inclusion and exclusion criteria timeframe and instructions.  Subjects enroled without 
meeting all criteria will be considered a significant violation, and data may be excluded from analysis.    

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Table 5: Eligibility Procedures 
Screening 
activity 
Relevant Eligibility Criteria  
Time Frame 
Instructions 
Ultrasound  
 
Prostate volume ≤ 
100 cc per 
ultrasound rule out 
enlarged middle 
(median) lobe 
During screening or 
just prior to 
procedure unless 
on file within 6 
months of Index 
Procedure.  
 
Can be utilised if 
performed within 6 
months of UroLift 
procedure/ 
enrolment, provided 
there is source 
documentation. 
 
See section 10.13.2 
for instructions. 
Cystoscopy 
 
Urethral conditions 
that prevent 
insertion 
 
Rule out obstructive 
or protruding median 
lobe 
In screening or 
adjacent to (prior) 
on day of index 
procedure. 
 
Complete eCRF for 
cystoscopy 
performed. 
 
Save digital recording 
and submit to 
NeoTract.  
Medical 
History by PI 
assessment 
 
Life expectancy 
estimated to be less 
than 5 years 
 
Co-morbidities that 
could impact the 
study 
 
Diagnosis of 
symptomatic BPH 
 
Acute or chronic 
renal failure  
 
Chronic retention 
volume of >1500 mL  
 
In screening up to 
index procedure; PI 
assessment should 
be as close to index 
procedure as 
possible.  
 
Patients with 
terminal conditions 
will be excluded. 
 
Significant co-
morbidities that 
impact life 
expectancy or ability 
to return for follow-
up, or exposes 
patient to 
unreasonable risk 
should be excluded. 
 
AR precipitated for 
reasons other than 
BPH must be 
confirmed and 
excluded.    
 
Signs of renal failure 
should be ruled out 
per SOC.  

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Screening 
activity 
Relevant Eligibility Criteria  
Time Frame 
Instructions 
Medical 
History by 
medical 
database 
 
Prostatitis requiring 
treatment 
(antibiotics) within 
the last year  
 
Known bladder stone 
within the prior 
3 months or 
treatment within 12 
months 
 
Previous BPH or 
pelvic surgical 
procedure  
 
Prostate or bladder 
cancer history 
 
Prostate biopsy 
(allowed if negative 
and ≥6 wks)  
 
Neurogenic or atonic 
bladder 
 
If available, pre-
procedure IPSS, peak 
flow rate, and PVR 
within 6 months  
In screening up to 
index procedure; 
review of database 
should be 
completed as close 
to index procedure 
as possible.  
 
These criteria should 
be confirmed 
through patient 
interview and 
consistent with 
medical chart.  
Diagnostic testing 
not required unless 
symptomatic.   
 
A thorough medical 
history should be 
documented to assist 
with adverse event 
reporting after 
enrolment, as each 
AE will require 
assessing if pre-
existing or new.  
Medical 
History by 
patient 
interview 
 
Unable or unwilling 
to complete all 
required 
questionnaires and 
follow up 
assessments  
 
Desire to maintain 
fertility post 
procedure 
 
Currently enroled in 
any other clinical 
research study that 
has not completed 
primary endpoint 
Prior to procedure 
 
Erectile health will be 
a part of the 
questionnaires and 
participants should 
be willing to 
complete. 
 Other Baseline Procedures 
Any subject questionnaire should be completed by the subject in a private setting after receiving 
instruction from research personnel.  The Research Coordinator should review questionnaires for 
completeness prior to enrolment.  If a question is left unanswered or is uninterpretable, the 
coordinator should return the questionnaire to the subject, requesting that subject complete the 
missed or equivocal question(s).  

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Table 6 summarises the pre-procedure activities not intended to screen for eligibility, but pertain 
to patient risk, confounding factors, and obtaining baseline health status. 

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Table 6 Pre-Procedure Activities* 
*Includes data collection and procedures that don’t determine eligibility 
Activity 
Considerations and instructions 
Time Frame 
Sexual Function 
Questionnaire 
 A baseline SHIM should be completed if 
patients are sexually active within the 
previous 6 months. 
 Recall period of 6 months; complete 
in screening as applicable.  
Urodynamics 
 Determine the grade of bladder outlet 
obstruction (BOO) and to assess detrusor 
contractility function 
 During screening, after consent, 
within 30 days of index procedure. 
 Urodynamics testing may be 
performed at each study site if a 
testing facility is available and a 
qualified operator is on-site. 
Medications  
 BPH, LUTS; Sexual Function; GU; should be 
captured. 
 Collect through 10 years history of 
non-transient prescriptions with 
approximate duration and indication.  
Alpha 
Blocker  
 It is required that subject was on alpha 
blocker at a minimum, through previous 
failed TWOC.     
 Alpha blockers should be prescribed 
per site’s standard of care throughout 
the duration of the study. Initiation 
and cessation should be documented 
on the concomitant medication log.  
Aspirin 
 If patient on regular dose ≤ 100 mg no 
washout required. 
 If patient takes PRN, instruct patient to 
avoid.  
 3 days prior to index procedure 
Anticoagulants  
 Patient should be cleared to washout or, 
excluded.  
 3 days prior to procedure 
Catheter use 
 Record history, type, duration, indication, of 
catheter, reason out 
 Most recent  
 
10.3  Enrolment  
A subject is considered enroled if he has signed the approved informed consent form to participate 
in the study, has met all inclusion and exclusion criteria, and the first UroLift delivery device has been 
inserted.  Once subject is enroled, adverse events need to be documented and reported. 
 UroLift System Procedure Instructions 
The UroLift System procedure may be performed in the office setting, ambulatory surgical centre, 
or hospital utilising appropriate level of anaesthesia and sedation per institutional standards.  
Antibiotic therapy will be initiated on or prior to procedure day with the type of antibiotic and duration 
identified per institutional standards (e.g. a five day course of oral ciprofloxacin).  The use of these 
agents will be recorded on the case report forms.   

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A pre-procedure cystoscopic visualisation should also be performed if not previously captured and 
recorded.  Cystoscopy should include visualisation of full prostatic urethra and bladder neck and to 
plan implant placement. The cystoscopy and procedure recorded file should be de-identified and 
provided to NeoTract.  
 UroLift System Equipment   
Per the Instructions for Use (IFU), the following ancillary equipment will be used: 
1. 2.9 mm 0° telescope (i.e. NeoTract REF UL-SCOPE, Storz REF 10324AA, or equivalent) 
2. 20F sheath (NeoTract REF UL-SHEATH, Storz REF 27026C, or equivalent) 
3. Visual obturator (NeoTract REF UL-VO, Storz REF 27028CN, or equivalent) 
 
The following equipment (“Retrieval Kit”) should be used if desired or necessary to retrieve or 
remove part of the UroLift Implant during the procedure.  
1. 4 mm 30° telescope (UL-SCOPE4 or equivalent) 
2. Telescope bridge (UL-WBRIDGE or equivalent) 
3. Endoscopic rigid grasper or rigid scissors 
 
Facility equipment should include:  
1. Cystoscopy camera, light box/cable and monitor, with video recording capability 
2. Standard fluid irrigation system including new, sterile fluid tubing 
All of the ancillary equipment, including the telescope, sheath, visual obturator, bridge and 
graspers must be sterilised per the respective manufacturer’s instructions before and after use.  
NeoTract will loan needed ancillary equipment as needed to study facilities throughout the 
enrolment period.   
 Training in Prostatic Urethral Lift Procedure 
Selected Principal Investigators in the study will have performed a minimum of 30 UroLift 
procedures.  Each will have undergone the NeoTract Professional Education Program.   
 Post Procedure Instructions 
After creating an unobstructed anterior channel, continue with cystoscopy to verify implants are 
not present in the bladder, or extending into the bladder vesical. Interrogate the bladder neck for 
protruding implants.  If a protruding or exposed implant is present, it should be removed.   
A urinary catheter will be placed prophylactically after the Investigator completes the UroLift 
procedure, and subject provided instructions on its proper maintenance. The subject should remain on 

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alpha blockers per the site’s standard of care. Initiation and cessation should be documented on the 
concomitant medication log. A post-procedure follow-up visit to perform Trial without Catheter will be 
scheduled for 3 days (± 1 day) after index procedure.   
The Investigator or designee will record the following procedural data: 
o Device:  number of UroLift devices used, location of implantation, lot number, 
performance 
o Cystoscopy findings, including confirmation of inclusion criteria, stones, and other 
notable pathology 
o Time:  subject enters and leaves procedure room, first/last UroLift device, catheter 
placement 
o Anaesthesia/sedation:  duration, type, and delivery of procedural medications 
o Clinical staff required during the procedure 
o Complications/adverse events 
o Venue type (clinic, outpatient, inpatient, etc.) 
o Time to discharge or release from treatment facility 
o Urinary catheter placement, type and timing (length) 
o Medications used  
o Post-operative interventions (if any) 
 
10.4 Post-Procedure Trial Without Catheter (TWOC) 
 The subject will return to clinic 3 days (± 1 day) after Index procedure for the primary study 
assessment screening of bladder function without catheter.  TWOC will be considered successful if the 
spontaneous void is ≥100 mL with PVR < 300 mL. If subject fails the initial TWOC, at least one additional 
TWOC will be performed per standard of care.  All catheterisations will be recorded on the eCRF. 
The following evaluations will be performed in office 3 days (± 1 day) after index procedure in 
conjunction with the TWOC:  
 
Relevant Concomitant medications: BPH/LUTS; Sexual Function; GU; Prostate Cancer 
 
Freestanding uroflow and post void residual (PVR) 
 
Catheterisation review 
 
Adverse Event review; Intervention review 
10.5 6 Week Follow-up Procedures  
The following evaluations will be performed in office 6 Weeks (± 7 days) after index procedure:  
 
Questionnaires to be completed by the subject: 

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o Urinary Symptoms questionnaires including IPSS & QoL (International Prostate Symptoms 
Score with Quality of Life) and BPHII (Benign Prostatic Hyperplasia Impact Index) unless 
current indwelling catheter. 
o SHIM (Sexual Health Inventory for Men):   Recall period for this visit should cover only post-
enrolment activity. Completed if subject was sexually active at baseline.  
o Return to Normal  
o Patient Satisfaction 
o Symptom questionnaire upon occurrence (includes: Incontinence Severity Index (ISI), 
haematuria, dysuria, pelvic pain VAS)  
 
Relevant Concomitant medications: BPH/LUTS; Sexual Function; GU; Prostate Cancer 
 
Urinalysis (urine culture and sensitivity if abnormal, clinically significant and indicates a urinary 
infection). UA not required if current indwelling catheter. 
 
Freestanding uroflow and post void residual (PVR) 
 
Voiding Assessment 
 
Catheterisation Review 
 
Adverse Event Review; Intervention Review  
10.6 3 Month Follow-up Procedures 
The following evaluations will be performed in office at 3 months (± 14 days) post procedure:  
 
Questionnaires to be completed by the subject: 
o Urinary Symptoms questionnaires including IPSS & QoL (International Prostate Symptoms 
Score with Quality of Life) and BPHII (Benign Prostatic Hyperplasia Impact Index) unless 
current indwelling catheter. 
o SHIM (Sexual Health Inventory for Men):   Recall period since the last visit or 6 week follow-
up. Completed if subject was sexually active at baseline. 
o Return to normal if not already achieved 
o Patient Satisfaction   
o Symptom questionnaire upon occurrence (includes: Incontinence Severity Index (ISI), 
haematuria, dysuria, pelvic pain VAS) 
 
Relevant Concomitant medications: BPH/LUTS; Sexual Function; GU; Prostate Cancer 
 
Urinalysis (urine culture and sensitivity if abnormal, clinically significant and indicates a urinary 
infection). UA not required if current indwelling catheter. 
 
Freestanding uroflow and post void residual (PVR) 
 
Digital Rectal Exam (DRE) 
 
Voiding Assessment 
 
Catheterisation review 

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 
Adverse Event review; Intervention Review 
10.7 6 Month Follow-up Procedures 
The following evaluations will be performed by telephone, unless Investigator elects to perform in 
office, at 6 months (± 14 days) post index procedure: 
 
Telephone administration of subject questionnaires: 
o Urinary Symptoms questionnaires including IPSS & QoL (International Prostate Symptoms 
Score with Quality of Life) and BPHII (Benign Prostatic Hyperplasia Impact Index) unless 
current indwelling catheter. 
o Patient Satisfaction   
o Symptom questionnaires upon occurrence (includes: Incontinence Severity Index (ISI), 
haematuria, dysuria, pelvic pain VAS) 
 
Relevant Concomitant medications: BPH/LUTS; Sexual Function; GU; Prostate Cancer 
 
Voiding Assessment 
 
Catheterisation review 
 
Adverse Event review; Intervention review 
10.8 12 Month Follow-up Procedures 
The following evaluations will be performed at 12 months (± 30 days) post index procedure:  
 
If subject is scheduled for or has already undergone alternative surgical procedure, see also 
section 10.10.1. 
 
Questionnaires to be completed by the subject: 
o Urinary Symptoms questionnaires including IPSS & QoL (International Prostate Symptoms 
Score with Quality of Life) and BPHII (Benign Prostatic Hyperplasia Impact Index) unless 
current indwelling catheter.  
o SHIM (Sexual Health Inventory for Men):   Recall over the last 6 months. Completed if 
subject was sexually active at baseline. 
o Patient Satisfaction 
o Symptom questionnaires upon occurrence (includes: Incontinence Severity Index (ISI), 
haematuria, dysuria, pelvic pain VAS). 
 
Relevant Concomitant medications: BPH/LUTS; Sexual Function; GU; Prostate Cancer 
 
Freestanding uroflow and post void residual (PVR) unless current indwelling catheter or 
adverse event does not permit. 
 
Urinalysis (urine culture and sensitivity if abnormal, clinically significant and indicates a urinary 
infection). UA not required if current indwelling catheter.  
 
Digital Rectal Exam (DRE) 
 
Urodynamics testing, if applicable to site  

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 
Cystoscopy (flexible) 
 
Voiding Assessment 
 
Catheterisation Review 
 
Adverse Event Review; Intervention Review 
 
10.9 Interim Visits  
Testing or procedures performed for adverse events associated with BPH or LUTS should be 
recorded and entered into eCRFs throughout the duration of subject follow-up even if outside protocol 
visit windows.   
10.10 
Surgical Intervention 
The following information will be collected in association with secondary interventions:  
o Adverse Event leading to the intervention (Unless urinary retention- See Section 
14.3) 
o Date of procedure 
o Type(s) of procedure(s) performed 
o Pre-procedure diagnosis for undergoing procedure 
o Complications (as Adverse Events) 
o Count of UroLift implant removal(s) and placements, if applicable 
o Catherisation use 
 
Alternative Surgical Intervention 
A subject with recurring urinary retention requiring catheter or other LUTS may require alternative 
surgical intervention (HoLEP, TURP, PVP, etc).  The subject will remain in study through 12 months 
with the following abbreviated requirements: 
1) Upon the surgery scheduling, study visits will no longer be required with the exception of the 12 
month visit. 
a. If subject is on catheter during the final visit (12 month) the urinalysis and urinary 
symptoms will not be required. Ongoing adverse events and catheterizations will be 
required. Refer to Table 7, Schedule of Procedures.  
2) Between reintervention and 12 month visit, only urological serious adverse events (SAE) should 
be reported.  

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Secondary PUL  
A subject undergoing a procedure for UroLift implant removal (misplaced) or additional implant(s) 
placement will remain on their original follow-up visit schedule.    
10.11 
 Treatment Failure  
The early TWOC primary assessment is the standard data point to demonstrate urinary retention 
relief, however, does not consider long term durability.  An independent urologist will review the 
outcomes of each subject and adjudicate if considered a treatment failure.  The following outcomes will 
be reviewed to determine if a treatment failure:  
 (1) The number of successful and/ or failed TWOCs. 
(2) Duration of dependence on indwelling catheter. 
(3) Prescribed surgical intervention.     
10.12 
Subject Follow-up Rate 
Investigative centres and Sponsor will collaborate to implement robust methods to retain subjects 
through their 12 months study visit.  Appropriate management of the prospective clinical trial, proper 
screening of study subjects, and training of participating investigators, monitors, and study 
coordinators will mitigate the amount of missing data.   
10.13 
Protocol deviations 
Throughout the conduct of the study, data will be reviewed by Sponsor for the presence of 
deviations.  Study personnel will report any deviation from the study protocol or regulation upon 
occurrence.  The EDC will facilitate comprehensive deviation reporting through programmed edit 
checks which will trigger a protocol deviation eCRF.  Sponsor monitors will also review data and 
conduct for any deviations during on-site visits per the monitoring plan.  Reporting deviations in this 
study will be important not only for parsing the per protocol analysis, to assess quality of study 
conduct, but also to detect areas that should be modified for a larger study.    
The Sponsor will evaluate PD trends in relation to prevention: methods of mitigation or value of 
requirement to the goal and study scientific integrity.  Any individual site with high deviation rate will 
be investigated for root cause, and preventative measures will be implemented.  
 Any serious breaches of the Protocol, or the conditions and principles of GCP in connection to 
this trial, will be reported to the Ethics Committee. A serious breach is likely to effect to a significant 
degree – (a) the safety or physical or mental integrity of the subjects of the trial; or (b) the scientific 
value of the trial.  
 

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Table 7 Schedule of Procedures 
 
Tests and Assessments 
Screening 
Index 
Procedure 
Through 
Release 
Clinic Visit 
Post-procedure 
(3 days ± 1 day) 
Clinic Visit 
6 Weeks 
(± 7 days) 
 
Clinic Visit 
3 Months 
(± 14 days) 
Phone Visit1 
6 Month 
(± 14 days) 
 
Clinic Visit 
12 Months 
(± 30 days) 
Study Exit 
Informed Consent must be documented prior to any procedures outside 
standard of care 
Urinary Symptoms and UA are not required if subject is on current indwelling catheter. 
Subject Questionnaires 
 
Urinary Symptoms 
 
 
 
X 
X 
X 
X 
 
SHIM 
If sexually active 
within the last 6 
 
 
If sexually active 
at baseline 
If sexually active at 
baseline 
 
If sexually active at 
baseline 
 
Incontinence Severity Index 
 
 
 
If reported 
If reported 
If reported 
If reported 
 
Dysuria 
 
 
 
If reported 
If reported 
If reported 
If reported 
 
Haematuria 
 
 
 
If reported 
If reported 
If reported 
If reported 
 
Pelvic Pain VAS 
 
 
 
If reported 
If reported 
If reported 
If reported 
 
Return to Normal  
 
 
 
X  
X (if not previously 
achieved) 
 
 
 
Patient Satisfaction 
 
 
 
X 
X 
X 
X 
 
Subject Interview 
 
Medical History 
X 
 
 
 
 
 
 
 
Concomitant Medications2 
X 
X 
X 
X 
X 
X 
X 
 
Voiding Assessment 
 
 
 
X 
X 
X 
X 
 
 
Intervention Review 
X 
 
X 
X 
X 
X 
X 
 
Testing 
 
Freestanding uroflow; PVR3  
 
 
X 
X 
X 
 
X 
 
Urinalysis (UA)3 
X 
 
 
X 
X 
 
X 
 
Urine Culture and Sensitivity 
If indicated  
 
 
If indicated 
If indicated 
 
If indicated 
 
Investigator Completed 
 
 
 
 
 
 
 
 
DRE 
X 
 
 
 
X 
 
X 
 
Urodynamics3,6 
X4 
 
 
 
  
 
X 
 
US 
X4 
 
 
 
 
 
 
 
Cystoscopy (flexible)3 
X4 
 
 
 
 
 
X 
 
Procedure 
 
X 
 
 
 
 
 
 
Catheterisation Review 
X 
X 
X  
 X 
X 
X 
X 
 
Trial Without Catheter 
(TWOC) 
 
 
X5 
 
 
 
 
 
Adverse Event Review 
 
X 
X 
X 
X 
X 
X 
 
Subject Discontinuation 
 
 
 
 
 
 
 
X 
1 Office or phone visit acceptable. If subject returns to clinic due to an AE, any testing will be entered in EDC as interim (if outside visit window).  
2 Relevant medications and interventions only: BPH, LUTS; Sexual Function; GU; Prostate Cancer. 
3 Uroflow strip chart recordings, abnormal UA and urine culture results, urodynamics reports, and cystoscopy videos collected in the study will be retained as a part of the dataset and must be redacted.    
4 Can perform day of procedure prior to (index) UroLift procedure to reduce site and subject burden.  
5 TWOC should be repeated per standard of care if first attempt unsuccessful.   
6 Urodynamics testing may be performed at each study site if a testing facility is available and a qualified operator is on-site.  

 
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10.14 
Performance of Study Procedures 
 
Lab tests 
A urinalysis  will be collected and analysed from an accredited and certified laboratory.  
Redacted abnormal urinalysis results and urine culture results will be uploaded into the EDC 
system. Documents supporting laboratory credentials along with normal ranges should be 
kept in study files.  Urinalysis (UA) should be collected within 30 days prior to index 
procedure. As subjects in screening will be on a catheter due to urinary retention, UA results 
cannot be used exclusively to determine eligibility. Urinary tract infections and gross 
haematuria should be based on the medical opinion of the investigator and may supersede 
lab results. UA may be performed by dipstick or microscopic analysis. Urine cultures should 
be performed if UA abnormal, clinically significant and indicates a urinary infection.  Digital 
rectal exam (DRE) should also support the investigator decision to enrol and detect 
abnormalities in follow-up.   
 
Transrectal or Transabdominal Ultrasound   
Transrectal ultrasound (TRUS) or abdominal ultrasound shall be performed to assess 
eligibility for prostate volume (≤ 100cc) and rule out enlarged median lobe (or “middle 
lobe”).  In general, an intravesical prostatic protrusion (IPP) should be viewed under 
cystoscopy to rule out enlarged median lobe.  Additional measurements will be taken to 
characterise the prostate including length, transverse width, and anterior/posterior width. 
The ultrasound procedure can be performed in advance or on index procedure day. Results 
will be recorded on an eCRF. Exams that were performed prior to screening but within 6 
months of the index procedure, may be used instead of repeating for the study, provided 
there is source documentation. 
 
Cystoscopy 
A flexible cystourethroscopy (cystoscopy) shall be performed to determine eligibility for 
urethral tortuosity or strictures (i.e. ability to insert a 20F sheath), prostate and bladder neck 
morphology, calculus urinary, and presence of an enlarged median lobe contributing to 
obstruction.  A pre-procedure cystoscopic visualisation may be performed to qualify for the 
study provided the subject is aware of the potential for not meeting enrolment criteria.  The 
cystoscopy should be performed while digitally recording, and should adequately visualise 
the bladder, the full prostatic urethra, and bladder neck.  An additional cystoscopy after 

 
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implant placement shall be performed to rule out the presence of protruding or exposed 
implants.  
 
Urodynamic testing 
Urodynamics are now widely accepted as the reference standard to determine the 
grade of bladder outlet obstruction (BOO) and to assess detrusor contractility function. It is 
of particular interest to characterise the contribution and extent that each participate is in 
the AR disease state. Urodynamics testing may be performed at each study site if a testing 
facility is available and a qualified operator is on-site.  
To ensure consistency across visits, the equipment used for study procedures will have 
documented calibration per manufacturer standards that is copied to study files.  Detailed 
urodynamic procedure will be outlined in the manual of operations (MOP).  
 
Freestanding Uroflowmetry  
Subjects will be asked to refrain from voiding for two hours prior to uroflow testing. 
Uroflowmetry shall be obtained with the subject in a standing position prior to any 
instrumentation.  A bladder scan is recommended to be performed prior to voiding to 
assure that the subject has a bladder volume of at least 250 mL.  Site should ensure the 
subject has a full bladder to increase the validatity of the uroflow. Results will be recorded 
for each void in the eCRF and redacted waveform strip recordings uploaded in the electronic 
data capture system.   
There are several potential flows that would require over-read including spikes or rapid 
fluctuations in the uroflow curve.  These aberrations are commonly caused by mechanical 
disturbances of the flow sensor and abdominal straining either during or at the end of the 
void.  If the Investigator is of the opinion that the machine read peak flow rate is an artifact 
and that the peak flow rate should be over-read by applying the 2 second-rule, the 
Investigator may use standardised methodology.  
Detailed over-read procedure will be outlined in the manual of operations (MOP).  
 
Post Void Residual Urine Volume  
Following freestanding uroflow, residual urine volume in the bladder shall be assessed 
by bladder scanner or abdominal ultrasound.  Only post void residual urine volume 
visualised after the valid uroflow shall be used for analyses. 

 
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11 Electronic Case Report Form (eCRF) Entry 
The Sponsor will provide optional source worksheets in an organised, tabbed binder to 
facilitate capture of protocol required data.  Medical records from Institution and source 
worksheets will be entered into an online electronic data capture (EDC) system hosted by 
MedNet, Inc.  The EDC System and its eCRFs will be built by the Sponsor and undergo 
validation and testing prior to launch.  Each user will undergo documented training and 
must be a part of the delegation of authority log.  The EDC System requires a personal 
password that expires every 90 days, automatically logs out after 90 minutes, and since U.S. 
based, is 21 CFR part 11 compliant.  Modifications of data fields will be kept to a minimum, 
but if an unforeseen error or amendment to protocol demands a change, the system 
features ability to update in short time.   
Data entry should occur in a timely manner for accuracy, but additionally for complying 
with regulations if unanticipated or serious adverse event occurs. Further, the EDC System 
will be used by Sponsor to plan monitoring, issue payments, device resupply, and to control 
the study minimum and maximum enrolment thresholds.  See the entry time deadlines per 
data type below (Table 8).   
Table 8 eCRF Entry Timely Target 
eCRF Data 
Entry Time 
 Screening Forms and questionnaires 
 
Within 14 Days 
 Index Procedure  Forms 
Within 48 Hours 
 Device Performance Issues with clinical sequelae  
Within 24 Hours of knowledge of event 
 Serious Adverse Event Form (includes Unexpected 
Adverse Events) 
Within 24 hours of knowledge of event 
 Subject Death 
Within 24 hours of knowledge of event 
 Follow-up Forms & questionnaires 
Within 14 Days 
 Other Forms (Protocol Deviation, etc.) 
Within 14 Days 
 
12 Data Collection and Confidentiality 
Qualified trial staff at each site will perform primary data collection drawn from source 
document (hospital chart) review.  Sponsor designated monitors will perform clinical 
monitoring, including review of eCRFs with verification to the source documentation. 
All investigators and study site staff must comply with the requirements of the General 
Data Protection Regulation (GDPR) with regards to the collection, storage, processing and 

 
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disclosure of personal information and will uphold the regulation’s core principles. This will 
be completed as follows: 
 
Personal information will be collected and stored in secure locations at the site 
 
Participants will be given a site number followed by participant number to 
ensure data is coded and depersonalized 
 
Access to the EDC system will be limited 
 
Data will be transmitted via an EDC system 
 
Media will redact any personal information before being transferred to Sponsor 
13 Risks and Benefits of PUL and the Clinical Investigation 
13.1 Anticipated clinical benefits 
There are no guaranteed benefits from participation in this study.  Extensive clinical 
experience with the UroLift System, in absence of urinary retention, has established the 
safety of the procedure and effectiveness of the UroLift System. For those subjects who 
suffer from acute urinary retention and BPH, the UroLift System has the potential to address 
their condition without heating, burning, or cutting tissue.  The UroLift System has received 
CE Mark in Europe, allowing it to be marketed to the United Kingdom.  In published clinical 
studies, it has been shown to significantly reduce LUTS rapidly while preserving important 
functions, such as sexual function and continence.   
Because the PUL procedure takes a prostatic tissue sparing approach rather than tissue 
resection or ablation, there are potential benefits over conventional surgical treatments for 
BPH.  There is a potential that the PUL procedure requires less anaesthesia and causes less 
bleeding and sexual dysfunction than more invasive modalities such as transurethral 
resection of the prostate (TURP) or laser resection.  There is a potential that there may be a 
decrease in procedure time, catheter time, and/or post-operative recovery time when 
compared to other surgical therapies.  There is potential that the time waiting for a 
procedure while catheterised is reduced. Information gained from this study may be used to 
benefit future subjects and help guide their therapy. 
13.2 Anticipated Adverse Events 
Adverse events will be solicited from the subject and documented after enrolment (see 
section 14 Adverse Events) the UroLift System Treatment, and at each follow-up time point. 
The risks of the undergoing the PUL procedure as part of this study are the same as having 
the procedure without being in the study.   

 
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Possible anticipated adverse events may be, but are not limited to those symptoms or 
events related to the disease process, the procedure (Section 13.3), device use (Section 
13.5), reactions to medication inclusive of anaesthesia, and/or the study testing.   
Anticipated adverse events that are: (1) reflective of the disease process (such as 
exacerbation of LUTS) and/or (2) inherent to this and any prostatic invasive procedure and 
expected to occur in this subject population are still to be reported as AEs during this study.  
13.3 Anticipated Procedural Adverse Events 
Possible anticipated complications related to procedure, anaesthesia and medication 
include, but are not limited to: death, damage to non-urinary systems, surgical trauma, 
bleeding, catheter misplacement, allergic reaction, decrease in kidney function, pulmonary 
embolism and infection.  
13.4 Protocol Required Testing with Anticipated Adverse Events  
Possible anticipated adverse events related to urodynamic testing are discomfort 
passing urine, urgency, frequency, bladder spasms, lower urinary tract symptoms, 
haematuria, and urinary tract infection.  
13.5 UroLift System Adverse Events  
Possible adverse events related to UroLift PUL27 include but are not limited to: 
Adverse tissue reaction or allergic response 
Bleeding associated with the urinary tract, gastrointestinal tract, pelvic region or 
abdomen 
Change in urine control muscle function or narrowing of the urine path 
Changes in ejaculation such as semen going into the bladder rather than out the end 
of the penis (retrograde ejaculation), inability to ejaculate (anejaculation), reduced 
ejaculation volume, delayed ejaculation, change in ejaculate characteristics, blood in 
semen (hematospermia), and pain with ejaculation 
Cloudy urine, discharge, bleeding (haematuria), proteinuria, or blood clots in urine 
that may require a catheterisation with or without fluid irrigation of the to bladder 
and urethra (bladder irrigation or evacuation) 
Equipment malfunction or device failure such as broken needle or device associated 
with undesirable clinical sequelae  
Elevated PSA 
Foreign body in patient and associated problems including foreign body sensation, 
erosion, inflammation, or irritation 
                                                          
 
27 Complications listed in this section were identified through Sponsor risk management files and include 
both reported and theoretical risks; the majority of AEs reported through Sponsor’s clinical studies were mild or 
moderate and transient in nature (See Sections 5.1.2. and 5.2) 

 
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Embolization of foreign body or blood clot 
Gastrointestinal (GI) damage or changes including rectal damage, blockage or 
narrowing in rectum, fistula creation, hemorrhoid creation, hemorrhoidal pain, 
bleeding from the GI tract, constipation, diarrhea, vomiting, inability to control 
bowel movements (rectal incontinence), and additional procedure.  
Improperly placed implant, including those that are not removable 
Inability to urinate requiring a catheter be put in (urinary retention requiring a 
catheter) 
Increased, returned, or failure to improve lower urinary tract symptoms 
Having to urinate several times at night (nocturia) 
Hypotension or hypertension 
Weak urine stream 
Sudden urge to urinate (urgency) 
Frequency of having to urinate  
Urinating small amounts 
Straining to urinate  
Spraying of urine when going the bathroom, splitting of urinary stream 
Difficulty starting or continuing to urinate (urinary hesitancy/ intermittency) 
Sensation of not emptying bladder, feeling of incomplete emptying 
Incomplete emptying of bladder, increased residual urine 
Dribbling after urination 
Infection such as urinary tract infection (bacterial colonisation, leukocyturia, sepsis), 
epididymitis, orchitis, and prostatitis 
Stones (calculi) or encrustation on the implant or in the prostate, bladder or other 
parts of the urinary tract 
Pain or discomfort during urination (dysuria) 
Pain, tenderness, discomfort, spasms, or burning sensation in areas such as the 
lower abdomen, back, penis, prostate, scrotum, groin, perineum, urinary tract, 
bladder or pelvic region associated with undesirable clinical sequelae 
Urine leakage (incontinence) 
Urinary tract irritation, inflammation, edema, swelling, change in function and 
compromised function (including kidney, ureter, bladder, prostate, urethra, and 
penis)  
Prostate abnormalities and damage  
Puncture of, problems with, injury or damage to the urinary system, bladder, ureter, 
ureteral orifice, trigone, bladder neck, urethra, or nearby structures including but 
not limited to false passageway creation, blockage, trabeculation, stricture, 
adhesion, stenosis, contracture, reduced sensation, spasm and requirement of 
additional procedure or medication.  
Puncture, injury or damage to nerves or neurovascular bundles resulting in foreign 
body response, erectile dysfunction, pain, reduced sensation, or requirement of 
additional procedure or medication.  
Prostate, bladder, urinary tract or GI tract hyperplasia, dysplasia, neoplasia or polyp 
formation  
Pyrexia 
Reproductive system disturbances such as infertility, decreased potency, impotence, 
erectile dysfunction, pain with erection, penile damage, penile disorder, penile 
numbness, decrease or loss of sexual desire (libido), loss of orgasm 
Requirement for delayed, aborted, changed or additional procedure 
 

 
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13.6 Possible Interactions with Concomitant Medical Treatments 
There are no anticipated interactions with concomitant medical treatments. It is 
recommended that the subject is cleared to discontinue anticoagulant therapy for a period 
of at least three days prior to surgical intervention unless subject is on maintenance dose of 
aspirin (≤100mg).   
13.7 Possible Risks of Participation in a Clinical Trial 
There are standard risks of participating in a research study given potential of accidental 
disclosure of subject’s confidential information.  Every effort will be made to ensure that 
subject personal information remains confidential at all times including application of 
Subject ID and redacting personal information before submitting to Sponsor.  
13.8 Risk Mitigation 
Clinical risks will be minimised by careful assessment of the subject prior to, during, and 
after the procedure.  Careful follow-up will help minimise risks associated with changing 
conditions of the subject.  Proper subject selection will be achieved by following the subject 
inclusion and exclusion criteria.  Participating Investigators are highly experienced UroLift 
operators and experienced in clinical research.  The study centres have adequate resources 
and facilities to safely conduct study with compliance.  
The UroLift System itself has safety features.  The delivery device can’t be deployed 
without switching the safety trigger off and features a bypass suture cutting mechanism.  
Users are able to manually retract needle if necessary. All of these features are detailed in 
the instructions for use.   
13.9 Risk-to-Benefit Rationale 
The UroLift System is CE marked for use in the United Kingdom.  The potential clinical 
risks in subjects with acute urinary retention have been minimised through the selection 
criteria for appropriate subjects, experienced investigators (minimum of 30 PUL and 
seasoned researchers), and prior pre-clinical and clinical testing of the UroLift® System.  The 
analysis shows that the potential subject benefits outweigh the potential risks to the 
subject. This study will be conducted ethically and in adherence to regulations.   
The design of the feasibility study is qualitative, yet with the rigorous data point 
collection and reasonable sample size, it is expected to provide clinically meaningful 
information. The goals are twofold, the first to assess initial effectiveness and safety; the 

 
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second, to optimise the study design for a larger, significantly powered, randomised trial.  
The first goal will be supported by the primary endpoint, which is the most accepted 
surrogate for effective retention resolution. The follow-up schedule is also comprehensive, 
with five visits through 1 year to gauge the related safety profile, and, the maintenance of 
voiding without catheter.  The benefit of offering UroLift as an alternative option to invasive 
surgery may be recognised with the comparison to the matched dataset of invasive 
treatment. The potential for optimising future study design and conduct is increased by 
including multiple sites, each experienced in UroLift and clinical research, which service a 
large BPH population. 
14 Adverse Events 
The following definition is from the ISO 14155 standard. 
An adverse event (AE) is defined as any undesirable medical occurrence in a clinical trial 
subject, whether it is considered to be related to the device or not, that includes a clinical 
sign, symptom, or condition. 
14.1 Serious Adverse Events 
Serious Adverse Event (SAE) is defined as untoward occurrence that:  
(a) results in death;  
(b) is life-threatening;  
(c) requires hospitalisation or prolongation of existing hospitalisation  
(d) results in persistent or significant disability or incapacity;  
(e) consists of a congenital anomaly or birth defect; or  
(f) is otherwise considered medically significant by the investigator. 
(in-patient hospitalisation is at least 24 consecutive hours) 
14.2 Unexpected Adverse Event 
An unexpected adverse event is an event which by nature, incidence, severity or outcome 
has not been identified in the current version of the Sponsor risk management files. 
14.3 Not an Adverse Event  
Any reoccurrence of urinary retention will not be considered an adverse event, but clot 
retention that may lead to urinary retention will be considered an adverse event.  

 
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Any colonization of subjects requiring catheter deemed not clinically significant will not 
be considered an adverse event.  
The need for any alternative procedure is not considered an AE or SAE, however the 
diagnosis or symptoms that led to repeat procedure could be. If the alternative procedure 
involves either (a) hospitalisation greater or equal to 24 hours longer than the timeframe 
that is standard of care for that procedure at that site, or (b) an unexpected outcome then it 
will be recorded as an SAE. 
14.4 Adverse Event Assessment 
Any AE experienced after the first UroLift device is introduced (enrolment) will require 
reporting on the eCRF.  In general, a primary diagnosis for the event should be reported 
instead of each symptom, with the exception of LUTS.  Lower urinary tract symptoms should 
be reported individually per the elements of IPSS.  Only exacerbated conditions or new 
onset qualify as an AE, but if patient history is in question, report AE conservatively.   
 Adverse events will be summarised by overall adverse events (AEs), severe AEs (grade 3 
or higher on CTCAE scale (See Table 11), AEs related to device and/or procedure (See Table 
9), serious adverse events (SAEs) and SAEs related to device and/or procedure.  Adverse 
events will be coded using MedDRA and Common Terminology Criteria for Adverse Events 
(CTCAE)28 severity grades and will be presented by System Organ Class (SOC) and preferred 
term.   
Principal Investigators will be responsible for assessing severity via the CTCAE scale (Table 
11Table 10) and Relatedness (Table 9).  
Table 9 Device and Procedure Relatedness Definitions 
 
Highly probable -- The AE follows a reasonable temporal sequence 
from receipt (or attempted receipt) of the device treatment or 
procedure. 
 
Probable -- The AE follows a reasonable temporal sequence from 
receipt of the device treatment or procedure and the possibilities of 
factors other than the device treatment or procedure, such as 
underlying disease, concomitant drugs, or concurrent treatment can 
be excluded. 
                                                          
 
28  National Cancer Institute, Common Terminology Criteria for Adverse Events v4.0 NCI, NIH, DHHS. May 29, 
2009; NIH publication # 09-7473.  The reprint of the terminology will be part of manual of operations (MOP).  

 
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 
Possible -- The AE follows a reasonable temporal sequence from 
receipt of the device treatment or procedure and the possibility of 
device treatment or procedure involvement cannot be excluded.  
However, other factors such as underlying disease, concomitant 
medications, or concurrent treatment are presumable. 
 
Unlikely -- The AE has an improbably temporal sequence from receipt 
of the device treatment or procedure, or it can be reasonably 
explained by other factors, including underlying disease, concomitant 
medication, or concurrent treatment. 
 
Not related -- The AE has no temporal sequence from receipt of the 
device treatment or procedure, or it can be explained by other 
factors, including underlying disease, concomitant medication, or 
concurrent treatment 
 
14.5 Adverse Event Reporting 
Adverse events will be collected on all enroled subjects. Subjects will be asked about 
adverse events at each visit, and all AEs will be documented and reported regardless of 
relatedness.  
Adverse events will be documented on the AE electronic case report form (eCRF) within 
the study’s Electronic Data Capture System (EDC).   
When an SAE occurs, the Sponsor should be notified within 24 hours of site awareness 
via completion of the AE eCRF in the EDC System.  Sponsor will receive an alert upon any 
SAE entry and will be responsible for reporting to notified body, ethics committee and all 
other participating investigators as applicable.  Should Sponsor determine, either through 
investigator reports or in-house testing, that a unexpected SAE presents an unreasonable 
risk to all participating subjects, Sponsor will suspend the clinical investigation. 
It is the responsibility of the Chief Principal Investigator to report all related and 
unexpected Serious Adverse Events (SAEs) to the ethics committee. The Sponsor may report 
on behalf of the Chief Investigator. Device-related SAEs in this study, using a CE-marked 
device in a post-market surveillance study, are reportable to the MHRA Adverse Incident 
Centre as reported under the requirements of the Devices Vigilance requirement. 
Annual and final reports will be provided to the EC as applicable per EC requirements with 
Sponsor assistance.    

 
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14.6 Adverse Event Independent Reviewer  
An independent reviewer will be employed for safety review.  The  independent 
reviewer will provide comprehensive medical review and adjudicate the reported adverse 
events. The assessments of the independent reviewer will help to ensure that the adverse 
event data is accurate, free of bias, and consistently reported across the participating study 
centres.  This independent reviewer will be an independent urologist, with no ties to 
Sponsor or any of the participating ECs or third party providers. A Safety Plan that describes 
the adjudication conventions will be established.  The independent reviewer will review 
events, with the support of redacted source documents, to determine AE/SAE/UAE 
classification, event relatedness, degree of relatedness, event severity, and MedDRA coding.  
Adjudication will occur ongoing throughout the study and to be completed in advance of the 
study final report.  

 
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Adverse Events with onset within 90 days of Index Procedure will evaluated by 
independent reviewer per the Clavien-Dindo (CD) classification (Table 10). 
  The independent reviewer may also categorize by CTCAE classification (Table 11). 
Complications, outside the recovery course, will be assigned a CD grade.   
Table 10 Clavien Dindo Classification of Surgical Complications (Daniel Dindo, 2004)  
Complication Definition 
Unexpected events not intrinsic to the procedure (PI to 
assign grade), should be aligned with the AE relatedness 
assessment with probably or high probably related to 
procedure and/or device.  
Sequelae Definition 
Inherent events to the procedure (will not be assessed 
further). Example being mild haemaeturia that resolves 
without treatment.  
Grade Level for 
Complications 
Description 
I 
Any deviation from the normal postoperative course 
without the need for pharmacological treatment or surgical, 
endoscopic, and radiological interventions 
II  
Requiring pharmacological treatment with drugs other than 
such allowed for grade I complications (e.g. change in 
antibiotics), blood transfusions and total parenteral 
nutrition. 
III 
Requiring surgical, endoscopic or radiological intervention 
IIIa 
Intervention not under general anaesthesia 
IIIb 
Intervention under general anaesthesia 
IV 
Life –threatening complication (including CNS 
complications)* requiring IC/ICU management 
Iva 
Single organ dysfunction (including dialysis) 
IVb 
Multi-organ dysfunction 
V 
Death of a patient 
Suffix “d”** 
If the patient suffers from a complication at the time of 
discharge, the suffix d (for disability) is added to the 
respective grade of complication.  This label indicates the 
need for a follow-up to fully evaluate the complication.  
*Brain hemorrhage, ischemic stroke, subarrachnoidal bleeding, but excluding transient ischemic attacks. CNS, central 
nervous system; IC, intermediate care; ICU, intensive care unit. 
** For purposes of this study Suffix “d” will not be used. 
 
Table 11 Common Terminology Criteria for Adverse Events Definition 
Grade 
Guidance 
1 
Mild; asymptomatic or mild symptoms; clinical or diagnostic 
observations only; intervention not indicated. 
2 
Moderate; minimal, local or non-invasive intervention 
indicated; 

 
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Grade 
Guidance 
Limiting age-appropriate instrumental ADL*. 
3 
Severe or medically significant but not immediately life-
threatening; hospitalisation or prolongation of hospitalisation 
indicated; disabling; limiting self- care ADL*. 
4 
Life-threatening consequences; urgent intervention indicated. 
5 
Death related to AE 
*Activities of Daily Living (ADL) 
Instrumental ADL Refers to preparing meals, shopping for groceries or clothes, 
using the telephone, managing money, etc. 
Self-care ADL Refers to bathing, dressing and undressing, feeding self, using 
the toilet, taking medications, and not bedridden.  
 
14.7 Device Malfunctions, Failures, or Near Incidents 
All device failures or malfunctions will be documented on the appropriate case report 
form and reported to Sponsor within 24 hours of occurrence.  The malfunctioning device 
involved in the incident will be returned to Sponsor for evaluation, as available. Any 
unexpected Serious Adverse Event (SAE) occurring as a result of device deficiencies will be 
reported to the Competent Authorities in accordance with the European Medical Devices 
directives (93/42/EEC) and all applicable national regulations.  
Refer to the manual of operations (MOP) for device return to Sponsor instructions.   
15 Study Procedures – Retrospective Cohort 
The retrospective chart review will provide a dataset for comparison to specific 
outcomes in the UroLift cohort.  The target population for this arm is BPH patients that 
presented with AR and went on to de novo invasive surgery from June 1, 2015 to December 
31, 2015.   Baseline health status through 12 months post-procedure will be collected for 
those patients meeting criteria.           
15.1 Qualifications for Case Abstractors 
Case abstractors will be qualified by education or experience to abstract protocol- 
required information from the medical records; these qualifications will be documented. 
Case abstractors will be delegated by the Principal Investigator and trained prior to 
conducting study-specific activities. 

 
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15.2 Subject Identification  
Case abstractors will create a Master List of all invasive BPH surgeries (TURP, HoLEP, 
etc.) performed by the site from June 1, 2015 to December 31, 2015.  Each case will be 
reviewed against the study selection criteria (See Section 15.3) and case abstractors will 
document enrolment status for each subject and the reason(s) for that decision.  Patients 
meeting criteria will be contacted for consent.  
15.3 Modified Enrolment Criteria for Retrospective Arm 
 Retrospective Inclusion Criteria 
Patients enroled in this study must meet the following criteria: 
1. Male gender 
2. Diagnosis of symptomatic BPH 
3. Age ≥ 50 years 
4. Presented with acute urinary retention with at least one failed trial without catheter 
prior to invasive surgery (index procedure) 
5. Underwent invasive BPH surgery (TURP, HoLEP, etc.) while in retention and 
performed by site between June 01, 2015 and December 31, 2015. 
6. Prostate volume ≤ 100 cc as measured by ultrasound, specimen (tissue) weight, or 
other standard method for prostate evaluation 
 Retrospective Exclusion Criteria  
Patients will be excluded from the study if any of the following conditions apply. 
1. Underwent known BPH surgery prior to the AR and index procedure 
2. History of neurogenic or atonic bladder 
3. Acute renal failure  
4. History of prostate or bladder cancer prior to index procedure 
5. Known coagulopathies or subject on anticoagulants within 3 days of index 
procedure (excluding up to 100mg ASA) 
6. Known bladder stones within 3 months of index procedure 

 
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7. Known prostatitis requiring treatment (antibiotics) within year prior to index 
procedure  
8. Unable or unwilling to provide informed consent  
15.4 Enrolment Procedures- Retrospective arm 
A retrospective patient is considered enroled in the clinical study if his records meet 
inclusion and exclusion criteria and has provided proper consent.  Once subject is enroled, 
data will be extracted from the medical chart and entered into the study EDC.  
15.5 Patient Informed Consent – Retrospective arm 
A consent form specific to the retrospective arm will be utilised to inform patient of the 
study, the chart review process and that Sponsor representatives and government bodies 
may access personal information.  If consent is denied, or the patient is no longer reachable, 
the enrolment log will record reason, and no further data will be collected or retained.  At 
least three attempts, using multiple methods, should be used to contact potentially eligible 
patients, at the discretion of the PI.    
15.6 Subject Withdrawal Procedure – Retrospective arm 
Any subject who has provided consent may elect to withdraw their consent.   The 
reason for withdrawal will be recorded, and their data will be excluded.  
15.7 Mitigating potential sources of error   
There are many sources of bias in retrospective series; therefore, a checklist of potential 
biases along with proposed solutions was created to aid in the design of this study (Table 
12). The checklist is based on the work of Kaji et al,29 Gilbert et al30 and Walker and 
Nowacki.31 
                                                          
 
29  Kaji AH, Schriger D, Green S. Looking through the retrospectoscope: reducing bias in emergency medicine 
chart review studies. Ann Emerg Med. 2014 Sep;64(3):292-8. doi: 10.1016/j.annemergmed.2014.03.025. Epub 
2014 Apr 18. And http://lifeinthefastlane.com/ccc/retrospective-studies-chart-reviews/ 
30  Gilbert EH, Lowenstein SR, Koziol-McLain J, Barta DC, Steiner J. Chart reviews in emergency medicine 
research: Where are the methods? Ann Emerg Med. 1996 Mar;27(3):305-8. PubMed PMID:8599488. 
31  Walker E., Nowacki,AS. Understanding Equivalence and Noninferiority Testing J Gen Intern Med. 2010 
26(2):192–6.  

 
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Table 12 Retrospective Chart Review Design Quality Checklist 
Issue and Suggested Solution 
Study Design 
Chart Review Inappropriate for Study Question 
 
Establish whether necessary information is 
available in the chart. 
 
Define outcome variables to be collected a 
priori. 
 
Establish if there are sufficient charts to 
perform the analysis with adequate precision. 
 
Participating sites are research centres, two 
sites have presented their own UroLift 
datasets at medical conferences. 
 
The EDC system (host of the eCRFs) and 
source worksheets will guide the abstractor 
on exact data collection requirements. 
 
Participating PIs were qualified due to their 
high number of BPH patients they treat.  
Investigator Conflict of Interest or Bias 
 
Declare any conflict of interest.  
 
Provide evidence of Ethics Committee 
approval. 
 
Submit the data collection form, as well as the 
coding rules and definitions. 
 
Financial Disclosure and conflict of interest 
forms will be completed by all Principal 
Investigators. 
 
A regulatory binder will be maintained for 
HRA and EC correspondence including 
approval materials. 
 
Study will utilise EDC with eCRF completion 
instructions. MedDRA coding will be used and 
embedded in the EDC. 
Patient Sample is Non-Representative 
 
Case selection or exclusion using explicit 
protocols and well described the criteria. 
 
Ensure all available charts have an equal 
chance of selection. 
 
Study design requires that all surgeries during 
a set amount of time are evaluated for 
inclusion, and criteria are well matched to the 
prospective investigation.  
 
The NHS trust system is consistent across 
centres.  
Chart Abstraction is Not Systematic (Misclassification Bias) 
 
Use standardised abstraction forms to guide 
data collection 
 
Provide precise definitions of variables 
 
Pilot test the abstraction form 
 
EDC will be used with training, written 
guidelines. 
 
The EDC has been used extensively by 
Sponsor and can be modified with minimal 
time and sacrifice to study.  
Presence of Missing or Conflicting Data 
 
Ensure uniform handling of data that is 
conflicting, ambiguous, missing, or unknown 
 
Perform a sensitivity analysis if needed 
 
Handling of missing data for endpoint 
evaluation is described a priori in clinical 
protocol 
 
Abstractors Biased or Not Blinded 
 
Blind chart reviewers to the etiologic relation 
being studied or the hypotheses being tested. 
 
All data will be abstracted.  Blinding is not 
applicable. 
Abstractors Not Sufficiently Trained 
 
Train chart abstractors. 
 
Describe the qualifications and training of the 
chart abstracters. 
 
Abstractor training process will include 
collaborative review of mock medical chart 
and EDC entry to test environment.     

 
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Issue and Suggested Solution 
Study Design 
 
Ideally, train abstractors before the study 
starts, using a set of “practice” medical 
records. 
 
Ensure uniform training, especially in multi-
centre studies 
 
CV of individual(s) will be evaluated.  
Abstractors not sufficiently monitored 
 
Monitor the performance of the chart 
abstractors 
 
Hold periodic meetings with chart abstractors 
and study coordinators to resolve disputes and 
review coding rules. 
 
NeoTract will monitor and audit on a periodic 
basis 100% source verification  
 
A written monitoring plan will be established 
prior to study commencement and revision 
controlled throughout the study.  
 
Newsletters will be issued and RC meetings 
will be held  
Chart Abstraction Unreliable 
 
A second reviewer should re-abstract a sample 
of charts, blinded to the information obtained 
by the first correlation reviewer. 
 
Report a kappa-statistic, intra-class coefficient, 
or other measure of agreement to assess 
inter-rater reliability of the data 
 
Provide justification for the criteria for each 
variable 
 
Sites will audited according to an a priori audit 
plan prior to finalisation of data sets 
 
Analysis of inter-rater reliability of the data 
may be conducted 
 
Study variables are derived from clinical 
investigations and used for consistency 
between the study arms. 
Sources of Error from the Use of Electronic Medical Records 
 
The use of boilerplates, items copied and 
pasted, default tick boxes and delays in time 
stamps relative to actual care. 
 
Manual data entry will be required and EDC 
designed to prohibit serial data entry. 
 
A customised source documentation plan for 
each site utilising their medical record 
systems will be developed.  
15.8 Case Abstraction:  Data Collection    
 Screening 
The following medical history parameters will be collected from time when patient 
presented with AR.  
 Inclusion/Exclusion 
confirmation 
 Prostate volume 
(cc) by ultrasound or 
other methods  
 History of BPH: 
length of time, 
symptom scores, 
treatments 
sought 
 Catheterisation 
and TWOC history  
 Co-morbidities  
 
 Uroflowmetry/PVR 
within 6 months 
prior to intervention 
 IPSS within 6 
months prior to 
intervention 
 
Other GU 
treatments 

 
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 Procedure    
The following will be collected (if available): 
 Date, duration 
 Type of facility, 
type of surgery 
 Complications, 
adverse events 
(urological, sexual 
function, cancer 
and SAEs) 
 Duration of 
hospital stay 
 Catheterisation 
 Pathology 
(documentation 
only) 
 
 Post-procedure    
The following post-surgery data will be collected for period after discharge through 12 
months after their surgical intervention (if available): 
 Date of contacts 
 Type, reason of 
contact (phone, 
office visit) 
 Complications, 
adverse events 
(urological, sexual 
function, cancer and 
SAEs)  
 Interventions 
 BPH 
medications, 
indication 
  Symptom 
scores 
 Uroflowmetry/PVR  Catheterisations 
 

 
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16 Study Data Analysis 
All effectiveness analyses will be performed on the “intent-to-treat (ITT)” group.  All 
subjects who were enroled with at least one UroLift device introduced will be included in 
the intention to treat analysis. Effectiveness assessments for enroled subjects whom later 
undergo surgical retreatment with either PUL or with any other surgical procedure will be 
censored the day after the secondary intervention.  Censoring in adverse event analysis will 
be applied only to alternative surgical retreatments and not to secondary PUL.  
16.1 Interim Safety and Conduct Assessment 
This feasibility study is the first to study patients undergoing PUL with AR. As such, the 
study progress will be assessed formally after the enrolment of the first 15 subjects.   The 
TWOC success rate will be evaluated, as will the enrolment rate, screen failure reasons, 
related SAEs, and protocol compliance.  In the event changes to protocol are warranted, 
enrolment may be paused until a protocol amendment or informed consent form is 
approved by HRA.  If it is determined that the early success rate is unacceptable, the study 
may be terminated. 
16.2 Per Protocol Population   
The PP analysis population is a subset of the ITT population which excludes subjects who 
do not receive any implants or who have significant violations that impact the study data 
integrity.   
16.3 Safety Population 
The safety population will be used for all safety assessments.  The safety population 
includes all enroled subjects with at least one UroLift device introduced. Safety assessments 
for enroled subjects whom later undergo surgical retreatment with any other surgical 
procedure will be censored on the day of the secondary intervention.  Censoring in adverse 
event analysis will be applied only to alternative surgical retreatments and not to secondary 
PUL.  
16.4 Missing Data 
To protect the scientific integrity and validity of study, a robust data retention plan will 
be employed through 12 months and reasons for missing data or early exit will be collected.    
No imputation for missing data points is planned. 

 
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16.5 Analysis of Success Measures 
Primary Study Assessment: 
TWOC is a binary measure of success. The percent of subjects who have a successful 
TWOC at the 3 day post procedure visit will be presented.  Secondary assessments will 
include the catheter free rate at 1 month along with time without catheter. This primary 
study assessment will be calculated for both the ITT and the PP analysis populations. 
16.6 Additional Assessments 
Continuous measures will be summarised by visit. Summary statistics will include the 
available sample size, mean and standard deviation. Changes from baseline to each follow-
up visit will also be calculated and the summary statistics will include the number of patients 
with change score available, mean, median, standard deviation, and confidence intervals 
(CI).  These assessments will be calculated for both the ITT and PP analysis populations. 
The Kaplan-Meier method will be used to calculate freedom from alternative secondary 
surgery over time and freedom from medical treatment, from the time of the PUL 
procedure for the ITT and PP populations.  Subjects that do not have an alternative 
procedure will be censored at their last recorded follow-up visit.  The probability of freedom 
from urinary retention will be analysed in a similar manner for the safety population.  Time 
without catheter will be analysed using the Kaplan-Meier method in the ITT and PP 
populations.   
Adverse events will be summarised by overall adverse events (AEs), severe AEs (grade 3 
or higher on CTCAE scale), AEs related to device and/or procedure, serious adverse events 
(SAEs) and SAEs related to device and/or procedure.  Adverse events will be coded using 
MedDRA and CTCAE v4.0 severity grades and will be presented by System Organ Class (SOC) 
and preferred term.   Adverse events will be summarised for the safety population.  
Retrospective Arm 
The following baseline and procedural data points will be summarised for both the 
retrospective and the prospective arms.  Although the study is not powered to make 
comparisons between the retrospective surgical patients and the prospective Urolift 
subjects, comparisons in the observed data will be made statistically.  Continuous variables 
will be compared using a t-test or non-parametric alternative, binary data points will be 
compared using chi-square or Fisher’s exact test. 
1) Baseline demographics   

 
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2) Duration of catheterisation to procedure (days) 
3) Procedure time 
4) Hospitalisation time 
The following outcomes post procedure will be summarised for the retrospective 
surgical group and will compared to the results obtained in the prospective study.  The 
statistical significance of any observed differences will be assessed. 
1) Total numbers of related AE, SAE, and Clavien-Dindo ≥IIb individually 
2) Percent procedure/device related AE rates by month post index procedure and by 
severity 
3) Retreatment post index intervention by time to event and by month 
4) Medical treatment post index intervention by time to event and by month 
5) Urinary retention recurrence rates at 1 month, 6 weeks and at 3, 6 and 12 months 
6) Post-procedure TWOC success percent 
7) Catheterisation use 
16.7 Evaluation of Study Success 
There is no formal study success criteria for this feasibility study.  The results will be 
used to evaluate for a future controlled study of the device in the treatment of urinary 
retention.   
17  Roles and Responsibilities: Sponsor and Investigator 
17.1 Sponsor Responsibilities 
As the study Sponsor, NeoTract, Inc. has the overall responsibility for the conduct of the 
study, including assurance that the study meets the local regulatory requirements.  
17.2 Investigator and Site Personnel Training 
Investigators responsible for treating subjects with the UroLift System have expert 
experience with the device.  A proctoring of the first case will be performed by a NeoTract 
representative to ensure proper data collection.    
The training of appropriate clinical site personnel to the study will also be the 
responsibility of Sponsor. The Investigator is responsible for ensuring that his/her staff 
conduct the study according to the protocol and are qualified to perform their delegated 
study activities.  To ensure uniform data collection, adherence to Sponsor procedures and 

 
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protocol understanding Sponsor will present a formal training session to study site 
personnel before study recruitment commences.  During this training, navigation of EDC, 
source documents, protocol, mock retrospective entry, recruitment methods, and 
consenting documentation will be reviewed.   The training will be documented and kept in 
study files.     
17.3 Monitoring Responsibilities 
A responsibility of the Sponsor is to ensure proper monitoring of study. Qualified 
Sponsor clinical monitors will perform on site auditing of study records to ensure accuracy 
and compliance.  A monitoring plan will be established in advance and will include 
conventions of:  essential document compliance, ensuring EC approval is obtained prior to 
initiating the study, investigators understand and comply with the protocol, all subject 
consent forms are properly completed, electronic Case Report Forms (eCRFs) are accurate 
and supported by appropriate source documents (100% review), and all reports are filed in 
accordance with the study protocol and the appropriate regulations.  Additional site visits 
will be performed on a site-by-site basis, as warranted by the findings of previous 
monitoring visits.      
  The investigator and study staff are expected to cooperate and provide all relevant 
study documentation to the monitor upon request, including access to the study data, such 
as electronic or paper medical records. 
 If a monitor finds that an investigator is not complying with the executed study 
agreements, the study protocol, Government regulations, or the requirements of the 
reviewing EC, prompt action will be taken to secure compliance.   Clinical monitors may also 
be responsible for reviewing the adequacy of the facilities, training, and technical support. 
Monitoring visits will be conducted by representatives of Sponsor, qualified monitors, 
ICH Guidelines for GCP (E6). By signing this study protocol, the Investigator grants 
permission to Sponsor, and appropriate regulatory authorities to conduct on-site monitoring 
and/or auditing of all appropriate study documentation. 
17.4 Patient Informed Consent Form (PICF) Template Approval 
The Sponsor will provide the recommended and approved subject informed consent 
form template. This informed consent document complies with applicable regulatory 
guidelines (ISO 14155-2011 and the Declaration of Helsinki, Good Clinical Practices, GDPR). 
The overseeing ethics committee (EC) may alter or amend the text as appropriate, but the 

 
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Sponsor must approve the final text of the informed consent before subject enrolment can 
begin.  
17.5 Investigator Responsibilities 
The investigator is responsible for ensuring the study is conducted according to all 
signed agreements, the study protocol, country and local regulations and Good Clinical 
Practice requirements. Investigators will be trained on the appropriate records to maintain 
and reports to file.  Sponsor and investigators will maintain records relating to the clinical 
investigation for a period of two years after study termination or as required by local and 
national regulations.  No investigator may dispose of any of these records until receipt of 
written notification to do so from Sponsor. 
 
Investigators are required to maintain the following records:  
 
Subject reports including signed informed consent and case report forms. 
 
Sponsor notification of SAEs (sponsor to be notified within 24 hours of 
knowledge of event)  
 
Correspondence with HRA, NHS, EC, Sponsor, and any other study entity 
related to this study including with Co-Investigators.  
 
The protocol, protocol amendments and documentation (date and reason) for 
each deviation from the protocol. 
 
Investigator reports include: 
 
Unexpected serious adverse events – must be reported to Sponsor within 24 
hours of awareness. The Chief PI is responsible to report to the EC per EC 
requirements.  
 
Subject Death – must be reported to NeoTract, Inc. within 24 hours of site’s 
knowledge of event even if unrelated.  
 
Withdrawal of EC approval – must be reported to Sponsor within 5 working 
days. 
 
Annual Progress Reports– must be submitted to Sponsor, the monitor, and the 
EC at regular intervals, within 30 days of the anniversary date on which the 
favourable opinion was given, and annually until the study is declared ended. 
 
Deviations from the protocol – submit to Sponsor  as soon as possible, but no 
later than 5 working days, submit reports of serious breaches per guidelines to 
appropriate authorities. 
 
Final report – submit to Sponsor and the EC within 1 year after termination or 
completion of the study. 

 
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 
Records shall be maintained by the Investigators for (1) a period of 2 years 
after trial is terminated or completed, or (2) in accordance with applicable 
country regulations, whichever is longer.   
The investigators have been selected because of their medical qualifications, interest in 
participation, ability to conduct and document the results of the study, ability to accrue 
subjects, experience in treating subjects with BPH and acute urinary retention, and 
experience performing PUL procedures.   
All investigators will provide their curriculum vitae to Sponsor and sign an investigator 
agreement.  Investigator completion of financial disclosure forms will be required.    
It is the responsibility of the investigator to provide each subject with full and adequate 
verbal and written information before inclusion in the study using the EC approved informed 
consent document, including the objective and procedures of the study and the possible 
risks involved.  Informed consent will be obtained prior to performing any study-related 
procedures, including screening procedures and any washout of medications as applicable.   
In cases of withdrawal or lost to follow up, the study Investigator should document the 
contact attempts and reasons for subject withdrawal or loss to follow up with other 
supporting information as requested on the appropriate eCRFs.  
17.6 Approval to Recruit -Ethics Committee Review and Compliance 
The Investigator will submit the study protocol and Patient Informed Consent Form (PICF) 
to the local hospital trial administration and obtain the proper approval before being allowed 
to conduct and participate in this study.  
The Sponsor will submit the study protocol and Patient Informed Consent Form (PICF) and 
supporting materials to REC and HRA via the IRAS system. The PICF will be in compliance with 
requirements of the Declaration of Helsinki and Good Clinical Practice.  The investigator will 
be responsible for fulfilling any conditions of approval imposed by the human research ethics 
committee, such as regular reporting, study timing, etc.  The Investigator will provide the 
Sponsor with copies of such approvals and reports. 
     This study will be conducted in accordance with the ethical principles that have their 
origin in the Declaration of Helsinki and that are consistent with Good Clinical Practice and 
applicable regulatory requirements.   
Sponsor will submit any change to the study protocol to the HRA and EC for review and 
approval before implementation. 

 
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18 Device Use and Ancillary Equipment 
The Sponsor will provide UroLift System devices for enrolment free of charge.  These 
devices will be shipped from a European subsidiary throughout enrolment.  Any opened 
devices will be documented along with its lot number. After enrolment completes, unused 
devices will be returned.  The study device box will have a unique sticker to distinguish from 
the facility commercial supply.  Investigators will ensure the devices allocated for the study 
are stored securely and separately from commercial inventory.  Should the facility not have 
available the required ancillary equipment, Sponsor will loan UroLift compatible equipment 
sets for the duration of enrolment.   
19 Potential Device Changes 
No device changes are anticipated for this study. 
20 Termination of Study 
The study will be terminated after the following milestones have been met; a) all active 
subjects have completed their 12 month study visit and b) completion of the final study 
report and c) study centres are closed. Investigators will be notified by Sponsor of study 
termination for any other reason.    
21 Early Study Centre Termination 
Sponsor reserves the right to terminate participation in this study for any of the 
following reasons: 
 
Failure to secure Informed Consent from a subject or legal representative prior 
to enroling the subject into this study. 
 
Repeated protocol deviations which would affect primary study assessment 
evaluation or data integrity. 
 
Repeated failure to complete case report forms within the timeframe agreed to 
in this protocol. 
 
Repeated failure to collect and provide source documentation to support CRF 
entry. 
 
Failure to report serious adverse events on a timely basis.  
 
Inability to enrol a subject within 2 months of EC & R&D approval   

 
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22 Study Protocol Amendments   
Any amendment to the study protocol will be written by Sponsor. Amendments cannot 
be implemented without prior written EC approval except as necessary to eliminate 
immediate safety hazards to subjects.  A documented training of amendments will be 
conducted. An amendment intended to eliminate an apparent immediate hazard to subjects 
may be implemented immediately, provided the ECs are given expedited notification.    
Any amendments that impact the PICF will also require EC approval along with 
informing the subject and signature on the updated form.  
 
PROTOCOL REVISION HISTORY 
Protocol 
Revision 
Revision Date 
History 
A 
30 May 17 
Initial Release 
B 
31 Jan 18 
1. Replaced unanticipated with unexpected adverse 
event throughout. 
2. Clarified SAE reporting requirements  
3. Replaced CEC with an Independent Safety 
reviewer.   
4. Revised TWOC endpoint to 300 ml PVR.  
5. Updated to note urodynamics testing may be 
performed at each study site if a testing facility is 
available and a qualified operator is on-site  
6. Removed urodynamics and Active UTI from 
eligibility procedures 
7. Clarified language surrounding procedure 
antibiotics 
8. Clarified UA and urine culture requirements. 
9. Removed Active Urinary Tract Infection and 
active gross hematuria from exclusion criteria  
10. Removed reference to IPP size for inclusion for 
prospective arm  
11. Revised exclusion criteria language for 
prospective arm: #5, #10 and #11  
12. Revised inclusion criteria for retrospective arm: 
excl. #5 and #6  
13. Revised exclusion criteria for retrospective arm: 
#3, #5 and added #8.  
14. For retrospective arm, updated to include all site 
invasive BPH surgeries.  
15. Removed reference to protocol deviation waivers 
& over-read for enrolment. 
16. Removed refresher training  
C 
12 August 2018 
1. Removed symptom questionnaire requirements 
at screening. 

 
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Protocol 
Revision 
Revision Date 
History 
2. Removed questionnaire and UA requirements at 
post-procedure. 
3. SHIM only required at baseline and follow-up if 
subject is sexually active.  
4. Defined treatment failure, alternative procedure 
and secondary PUL criteria. 
5. Urine cultures only required if UA is abnormal, CS 
and indicates a urinary infection. Required 
uploads for abnormal UAs and urine cultures. 
6. Removed 125ml minimum voided volume for 
uroflows at follow-up.  
7. Removed requirement to discontinue alpha 
blockers on day of index procedure. 
8. Removed requirement for ultrasound uploads.  
9. Revised require case requirements for PIs from 
50 to 30.  
10. Expanded re-catheter rate assessment to 1 
month. Added re-catheter assessment to 
secondary assessments and removed from 
primary study assessment.  
11. Only AEs related to cancer, LUTs, SAEs and sexual 
function are required to be collected in the 
Retrospective arm.  
12. Revised 4 centres to 6 centres  
13. removed the word transrectal to include 
ultrasound as a method to evaluate prostate size. 
14. Defined symptoms not considered an adverse 
event.    
15. Minor risk revisions   
D 
14 Dec 2018 
1. Admin change on Protocol Signature Page: 
removed duplicate Sponsor signature 
2. Admin change on Table 7: removed Urine C&S “if 
indicated” at 6 months. This was a typo.  A UA is 
not required.  
3. Increased sample size to up to 55 subjects 
23 Publication Policy 
At the conclusion of the study, a manuscript may be prepared for publication in a scientific 
journal.  Publication of any study results, including any public presentation of data in abstract 
form, will be prepared using data retrieved from the study database and only with prior 
notification to Sponsor.