Study of Median Lobe Prostatic UroLift Procedure
Phase: NA
Conditions: Benign Prostatic Hyperplasia (BPH)
Sponsor: NeoTract, Inc.

NeoTract Confidential  
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Page 1 of 8 
 
NeoTract® UroLift® System 
 
 
Executive Summary of the  
MedLift Study 
 
 
 
 
 
Study Title: Median Lobe Prostatic 
UroLift Procedure  
 
Protocol Number:  CP00001 Rev C 
 
24 Sep 2018 
NCT Number: NCT02625545 
 
Sponsored by: 
NeoTract®, Inc. 
4473 Willow Rd., Suite 100 
Pleasanton, CA 94588 
 
Telephone: 
925-401-0700 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
This document is a confidential communication of NeoTract, Inc.  Acceptance of this document 
constitutes the agreement by the recipient that no unpublished information contained herein will 
be published or disclosed without prior written approval from NeoTract, Inc. 
 
 
 
 
 
 
 
 
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               NeoTract 
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PROTOCOL SUMMARY 
 
Study Title: 
Median Lobe Prostatic UroLift Procedure 
Study Objectives: 
Evaluate the safety and effectiveness of the UroLift® System when used in 
symptomatic benign prostatic hyperplasia (BPH) subjects with an enlarged 
median lobe. 
Study Design: 
Prospective, multicenter, non-blinded, single arm (non-randomized) study. 
Sample Size: 
A total of no more than 48 subjects (minimum of 40) will be enrolled.    
Subject Population: 
Males age of 50 years or older diagnosed with symptomatic benign prostatic 
hyperplasia (BPH). 
Number of Centers: 
A maximum of 10 investigational sites located in the US 
 
Clinical Indication: 
The UroLift System is indicated for the procedure of symptoms due to urinary 
outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over 
the age of 50. 
Effectiveness 
Endpoint: 
At 6 months, the 95% lower confidence limit of the mean percent improvement 
in IPSS over baseline for the UroLift system must be ≥25%. The Lower 95% 
confidence Limit, determined using bootstrap method is 50.8%. 
Safety Endpoint: 
The composite observed rate of post-procedure device related serious complications 
less than or equal to 15% at 3 months. Composite device related serious complications 
for this endpoint are 1) De Novo (new) severe urinary retention lasting more than 21 
consecutive days post procedure, 2) Device related formation of fistula between the 
rectum and urethra, and 3) perforation of the rectum or GI tract, 4) damage to ureter or 
ureteral orifices 5) damage to the trigone requiring surgical repair or 6) de novo, 
sustained erectile dysfunction.   
Additional 
Assessments: 
Over the 12 month follow-up period, lower urinary tract symptoms (LUTS), quality of 
life (QOL), recovery, uroflowmetry, PVR, proportion of subjects who experience de 
novo sustained erectile dysfunction and anejaculation through 12 months, number of 
subjects with encrusted implants, patient satisfaction and adverse events severity and 
relatedness will be assessed.  
 
 
ENROLLMENT CRITERIA 
 
Inclusion Criteria 
Subjects enrolled in this clinical study must meet all of the following criteria. 
1. Male gender 
2. Diagnosis of symptomatic BPH 
3. Age ≥ 50 years 
4. International Prostate Symptom Score (IPSS) ≥ 13 
5. Peak urine flow rate ≤ 12 ml/sec on a voided volume ≥ 125 ml 
6. Prostate volume ≥ 30 cc to ≤ 80 cc per ultrasound 
7. Prostate Length measurement of ≥30 and ≤80 mm 
8. Enlarged median lobe contributing to obstruction of the prostate   
 
 
 
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               NeoTract 
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Exclusion Criteria 
Subjects will be excluded from the study if any of the following conditions apply. 
1. 
Current urinary retention 
2. 
Post void residual (PVR) urine > 250 mL  
3. 
Active urinary tract infection at time of procedure 
4. 
Previous BPH surgical procedure  
5. 
Urethral conditions that may prevent insertion and delivery of device system into bladder (i.e. 
urethral strictures, meatal stenosis, bladder neck contracture) 
6. 
Previous pelvic surgery (i.e. incontinence sling, trauma repair, penile implants, artificial 
sphincter) or irradiation 
7. 
History of neurogenic or atonic bladder 
8. 
Stress urinary incontinence  
9. 
Biopsy of the prostate within the past 6 weeks 
10. Life expectancy estimated to be less than 5 years 
11. History of prostate or bladder cancer 
12. Prostate-Specific Antigen (PSA) level above the age specific reference ranges, unless prostate 
cancer has been excluded to the satisfaction of the investigator. 
13. Current gross hematuria  
14. Known coagulopathies or subject on anticoagulants or antiplatelets other than aspirin ≤ 100 mg 
(unless antiplatelets are withheld minimum 3 days prior to procedure) 
15. Use of the following medications pre-screening (uroflow, questionnaires) 
 
Within 4 months of baseline assessment: estrogen, any drug producing androgen 
suppression, or anabolic steroids (excluding topical testosterone) 
 
 Within 3 months of baseline assessment: 5-alpha-reductase inhibitors 
 
Within 2 weeks of baseline assessment:  
 
alpha-blockers, androgens (topical are acceptable), gonadotropin-releasing 
hormonal analogs, anticholinergics or cholinergic medication  
 
phenylephrine, pseudoephedrine, or imipramine medications 
 
Within 1 week of baseline assessment, unless documented on stable dose for ≥ 6 months: 
beta blockers, antidepressants, anticonvulsants, and antispasmodics  
16. Calculus urinary within the prior 3 months 
17. Prostatitis requiring treatment (antibiotics) within the last year  
18. Other co-morbidities that could impact the study results such as: 
 
severe cardiac arrhythmias uncontrolled by medications or pacemaker  
 
congestive heart failure NYHA III or IV 
 
history of uncontrolled diabetes mellitus 
 
significant respiratory disease in which hospitalization may be required  
 
known immunosuppression (i.e. AIDS, post-transplant, undergoing chemotherapy) 
19. Desire to maintain fertility post procedure 
20. Unable or unwilling to complete all required questionnaires and follow up assessments (e.g. 
lives out of area) 
21. Unable or unwilling to sign informed consent form 
22. Currently enrolled in any other investigational clinical research trial that has not completed the 
primary endpoint. 
 
 
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SCREENING ACTIVITY TIME PERIODS 
 
 
Activity 
Time Frame 
Special Considerations 
Flexible Cystoscopy 
Within 6 months 
Cystoscopy performed outside of study, within 6 months of 
index procedure, can be used to qualify for enrollment, provided 
eligibility morphology was determined, (enlarged median lobe.).  
If not all data collected with recording prior, there will also be a 
pre-procedure cystoscopy. This procedure, with video recording, 
will capture additional anatomical details and assist in implant 
planning.       
TRUS or Pelvic 
Ultrasound 
Within 6 months 
Ultrasound performed outside of the study, within 6 months of 
screening, can be used to qualify enrollment, provided eligibility 
morphology (e.g. enlarged median lobe, Intravesical Prostatic 
Protrusion, etc.) and image are documented.   
In all cases, the image and data must be entered into EDC prior 
to index procedure.   
Medical History 
Within 30 days 
 
Uroflowmetry  
Within 30 days 
Either before cystoscopy or > 1wk after cystoscopy. 
Must be obtained after med washout 
PVR 
Within 30 days 
Must be obtained after med washout 
PSA 
Within 6 months 
 
Urinalysis, Urine Culture 
& Sensitivity  
Within 30 days 
 
Questionnaires 
Within 30 days 
Either before cystoscopy or > 1wk after cystoscopy.  
Must be obtained after med washout 
Medications 
Medication 
washout timeframe 
Caveats 
1) Estrogen, any drug 
producing androgen 
suppression, or anabolic 
steroids  
1) 4 months prior to 
uroflow studies & 
questionnaires 
 
2) 5-alpha-reductase 
inhibitors  
2) 3 months prior to 
uroflow studies & 
questionnaires 
2) Subjects should remain off 5ARIs for the duration of the 
study, unless clinically required.  
3) Alpha-blockers 
3) 2 weeks prior to 
uroflow studies & 
questionnaires 
3) Subjects should remain off alpha blockers for the duration of 
the study, unless clinically required. 
4) Phenylephrine, 
pseudoephedrine, 
imipramine,  
anticholinergic or 
cholinergic medication 
4) 2 weeks prior to 
uroflow studies & 
questionnaires 
 
5) Beta blockers, 
antidepressants, 
anticonvulsants, and 
antispasmodics 
5) 1 week prior to 
questionnaires 
5) Unless documented on stable dose for ≥ 6 months, in which 
case the drug should not be altered or discontinued for entrance 
into or throughout the course of the study; unless otherwise 
deemed necessary for patient care. 
6) Anticoagulants or 
antiplatelets other than 
aspirin ≤ 100 mg  
6) 3 days prior to 
procedure 
 
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NeoTract Confidential 
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SUMMARY OF PROCEDURES 
 
Tests and Assessments 
Screening Procedure Through 
Hospital Release 
1 Month 
(± 7 days) 
3 Months 
(± 14 days) 
6 Months 
(± 30 days) 
12 Months 
(± 30 days) 
Questionnaires 
 
Urinary Symptoms  
X 
 
X 
X 
X 
X 
Sexual Function that 
includes MSHQ-EjD 
Sexual function, 
Anejaculation Function, 
IIEF  
X 
 
X 
X 
X 
X 
Incontinence Severity 
Index 
X 
 
X 
X 
X 
X 
Dysuria 
X 
 
X 
X 
X 
X 
Hematuria 
X 
 
X 
X 
X 
X 
Quality of Recovery  VAS 
 
 
X 
 
 
 
Pain VAS 
X 
 
X 
X 
X 
X 
Patient Satisfaction 
 
 
X 
X 
X 
X 
Medical History 
X 
 
X 
X 
X 
X 
Sexual Function Assessment 
X 
 
X 
X 
X 
X 
Uroflowmetry1 
X 
 
X 
X 
X 
X 
PVR 
X 
 
X 
X 
X 
X 
PSA 
X 
 
 
 
 
 
UA 
X 
 
X 
X 
X 
 
Urine Culture and Sensitivity 
X 
 
X 
X 
X 
 
TRUS or Pelvic Ultrasound1 
X 
 
 
 
 
 
Flexible Cystoscopy1 
X2 
 X2 
 
 
X 
 
DRE 
 
X3 
 
 
 
 
Catheterization 
 
X 
X 
X 
 
 
Concomitant Medications 
X 
X 
X4 
X4 
X4 
X4 
Adverse Events 
 
X 
X 
X 
X 
X 
Intervention Review 
 
X 
X 
X 
X 
X 
1All subject Uroflow strip chart recordings, Ultrasound images and cystoscopy videos collected in the study 
will be forwarded to NeoTract  
2 Any cysto performed w/in 6 months can be used for screening if median lobe is identified. Index UroLift 
procedure to involve pre-procedure and post-procedure flexible cysto. Pre-procedure to record and confirm 
anatomy, plan implants; post-procedure to record outcome, ensure proper placement 
3 Performed to rule out rectum implantation 
4 Relevant medications only: BPH/LUTS; Sexual Function; GU; Prostate Cancer 
 
 
 
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STATISTICAL ANALYSIS 
 
 
Primary Hypotheses 
For the trial to be successful, the statistical evaluation of primary effectiveness endpoint must result 
in a rejection of the null hypothesis (H0) in favor of the alternative hypothesis (H1). 
Primary Effectiveness Endpoint: UroLift system compared to an Objective Performance Goal 
(OPG) at 6 months post treatment: 
Let p equal the expected percent change in IPSS scores from baseline at 6 months. The null and 
alternative hypotheses are as follows: 
 
H0: p ≤ 25% 
H1: p > 25% 
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Sample Size Estimate 
From a practical perspective, the sample size estimate can be based on the number of expected subjects 
that could have been included in the UroLift pivotal trial (L.I.F.T.) had subjects with median lobe been 
allowed to enroll. To statistically corroborate the sample size estimate, an evaluation of the IPSS response 
in the L.I.F.T. treatment arm at 6 months was evaluated.  Taking this value and applying a lower confidence 
bound, the estimated mean IPSS response for this study was determined. 
For a one-sided 95% confidence interval, based on a t-test, the sample size estimate was calculated.   
 
Intention to Treat Group 
The main analyses, including endpoints, will be performed on the “intent-to-treat (ITT)” group.  All 
subjects who are enrolled will be included in the intention to treat analysis. With the ITT analysis, primary 
outcome data from subjects retreated with either the UroLift System or with any other surgical procedure 
will be censored the day after the alternative procedure. Additionally, subjects that start on alpha blockers 
or 5ARI medications specifically for the treatment of BPH, and use then consistently will have their results 
censored the day after starting this medication.  Consistent usage is defined any medication use for more 
than 60 days. 
The IIT population is used for efficacy analyses. 
 
Safety Group 
Any safety analysis, outside of safety endpoint, will be performed on the “Safety Group”.  All data will be 
included through exit, unless a non-UroLift BPH surgical procedure (e.g. TURP, Laser, HOLEP) is 
performed.  In these cases, follow-up safety data will be censored on the day of the alternative procedure. 
 
Evaluation of Primary Effectiveness Hypothesis 
If the lower limit of the one-sided 95% confidence interval for mean IPSS percentage change for the UroLift 
system at 6 months is greater than or equal to 25%, then the null hypothesis will be rejected in favor of the 
alternative hypothesis. (The lower 95% confidence limit, determined using bootstrap method is 50.8%.) 
Subjects who have missing IPSS data due to lost to follow-up will have the percent change from baseline 
at 6 months value imputed using the MCMC (Markov Chain Monte Carlo) multiple imputation method. 
Partially completed IPSS questionnaires will also be considered missing. The lower bound of the one-sided 
95% confidence interval will be constructed using the mean and standard error from the MCMC method. 
 
Evaluation of Safety Endpoint 
The composite observed rate of post-procedure device related serious complications less than or equal to 
15% at 3 months. Composite device related serious complications for this endpoint are 1) de Novo (new) 
severe urinary retention lasting more than 21 consecutive days post procedure, 2) formation of fistula 
between the rectum and urethra, and 3) perforation of the rectum or GI tract, 4) damage to ureter or ureteral 
orifices 5) damage to the trigone requiring surgical repair or 6) de novo, sustained erectile dysfunction. 
The CEC will determine if any adverse events reported through 3 months post-index procedure qualify to 
meet the 6 elements of the composite safety endpoint. The observed rate of the six serious complications 
must be less than or equal to 15% for the trial to be successful. 
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Analysis of Success Measures 
For subjects treated with the UroLift System, the procedure will be considered successful if the post-
procedure cystoscopy exhibits an increase in the urethral opening post-procedure and the subject is free of 
device/procedure related serious adverse events immediately post-procedure. Independent of whether or 
not the procedure was successful, all subjects will be included in the ITT analysis of the primary endpoints. 
 
 
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