Trial Outcomes & Findings for The Safety and Effectiveness of UroLift: LIFT Pivotal Study (NCT NCT01294150)

Last Updated: 2018-09-05

Results Overview

The primary safety endpoint is an assessment of the rate of extended post-operative urinary catheterization in the subjects randomized to the UroLift group of the study in the ITT group. The extended post-operative urinary catheterization rate is defined as including those subjects who required catheterization within the first 3 days as part of post-operative management for inability to void, and required the catheter for more than 7 days. 2/140 met this endpoint.

Recruitment status

COMPLETED

Study phase

Target enrollment

206 participants

Primary outcome timeframe

Cath within first 3 days post-procedure which extended beyond 7 days, up to 12 days

Results posted on

2018-09-05

Participant Flow

The first subject was enrolled into the L.I.F.T. clinical study on February 8, 2011. Study enrollment was completed on December 14, 2011 and the final subject reached the 12-month study endpoint on December 5, 2012.

Washout of for 3 months (5ARI) and 2 week (alpha blocker) required before baseline questionnaires.

Participant milestones

Participant milestones
Measure	UroLift System The treatment group subjects underwent the UroLift (UL)system procedure. The subject was blinded as to whether he was in the control or treatment group. Unblinding occurred at 3 months post procedure after the assessments were completed. Between 3 and 12 month follow-up assessments, a subject was allowed to be retreated with the UroLift system if he met the retreatment inclusion and exclusion criteria. Subjects that went on to UL retreatment within the first 12 months were considered treatment failures, but started their follow-up schedule over. All subjects will be followed at a minimum of 5 years per the assessment schedule.	Cystoscopy (Control/Sham) The control group subjects underwent a cystoscopy procedure. The subject was blinded as to whether he was randomized to the control or treatment group. Unblinding occurred at 3 months post procedure after follow-up assessments were completed. Between 3 and 12 month follow-up assessments, a subject was allowed to crossover and undergo procedure with the UroLift system, provided he met the inclusion and exclusion criteria. Subjects crossing over are then to be followed for 5 years post-treatment. If subject did not crossover, his participation was not required beyond the 12 month visit.
Overall Study STARTED	140	66
Overall Study COMPLETED	138	64
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	UroLift System The treatment group subjects underwent the UroLift (UL)system procedure. The subject was blinded as to whether he was in the control or treatment group. Unblinding occurred at 3 months post procedure after the assessments were completed. Between 3 and 12 month follow-up assessments, a subject was allowed to be retreated with the UroLift system if he met the retreatment inclusion and exclusion criteria. Subjects that went on to UL retreatment within the first 12 months were considered treatment failures, but started their follow-up schedule over. All subjects will be followed at a minimum of 5 years per the assessment schedule.	Cystoscopy (Control/Sham) The control group subjects underwent a cystoscopy procedure. The subject was blinded as to whether he was randomized to the control or treatment group. Unblinding occurred at 3 months post procedure after follow-up assessments were completed. Between 3 and 12 month follow-up assessments, a subject was allowed to crossover and undergo procedure with the UroLift system, provided he met the inclusion and exclusion criteria. Subjects crossing over are then to be followed for 5 years post-treatment. If subject did not crossover, his participation was not required beyond the 12 month visit.
Overall Study Physician Decision	2	2

Baseline Characteristics

The Safety and Effectiveness of UroLift: LIFT Pivotal Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	UroLift System n=140 Participants Average of 4.9 implants per prostate implanted. The prostatic urethral lift is performed by placing permanent transprostatic implants to lift apart the prostate lobes and reduce urethral obstruction.	Cystoscopy n=66 Participants Sham treatment entailed rigid cystoscopy, a blinding screen and sounds that mimicked those of the prostatic urethral lift procedure.	Total n=206 Participants Total of all reporting groups
Age, Continuous	67 years STANDARD_DEVIATION 8.6 • n=99 Participants	65 years STANDARD_DEVIATION 8.0 • n=107 Participants	66 years STANDARD_DEVIATION 8.6 • n=206 Participants
Sex: Female, Male Female	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Sex: Female, Male Male	140 Participants n=99 Participants	66 Participants n=107 Participants	206 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=99 Participants	3 Participants n=107 Participants	5 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	136 Participants n=99 Participants	63 Participants n=107 Participants	199 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	5 Participants n=99 Participants	0 Participants n=107 Participants	5 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Black or African American	2 Participants n=99 Participants	3 Participants n=107 Participants	5 Participants n=206 Participants
Race (NIH/OMB) White	131 Participants n=99 Participants	62 Participants n=107 Participants	193 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
Region of Enrollment United States	94 participants n=99 Participants	45 participants n=107 Participants	139 participants n=206 Participants
Region of Enrollment Canada	20 participants n=99 Participants	10 participants n=107 Participants	30 participants n=206 Participants
Region of Enrollment Australia	26 participants n=99 Participants	11 participants n=107 Participants	37 participants n=206 Participants

PRIMARY outcome

Timeframe: Cath within first 3 days post-procedure which extended beyond 7 days, up to 12 days

Outcome measures

Outcome measures
Measure	UroLift System n=140 Participants The treatment group subjects underwent UroLift system procedure. The subject was blinded to the randomization of control or treatment group. Unblinding occurred at 3 months post procedure after the assessments were completed. No matter which retreatment therapy, all subjects will be followed at a minimum of 5 years per the assessment schedule.	Cystoscopy The control group subjects underwent a cystoscopy procedure only. The subject was blinded as to whether he was in the control or treatment group. Unblinding occurred at 3 months after follow-up assessments were completed. Between 3 and 12 month follow-up assessments, a subject was allowed to crossover and undergo the UroLift system procedure if he met inclusion and exclusion criteria. Subjects who crossed over will then be followed for 5 years post-treatment. The subjects that did not crossover were not required to participate beyond 12 months.
Collection of Post-treatment Catheterization for Safety	2 participants	—

PRIMARY outcome

Timeframe: 3 month

The UroLift system will be considered superior to the Control if the mean International Prostate Symptom Score (IPSS) change (improvement) from baseline at 3 months demonstrates a minimum statistical margin of 25% compared to mean improvement from baseline for cystoscopy alone. The IPSS is an 8 question (7 symptom questions + 1 quality of life question) written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). SCORING: 0-7 Mildly symptomatic 8-19 Moderately symptomatic 20-35 Severely symptomatic

Outcome measures

Outcome measures
Measure	UroLift System n=140 Participants The treatment group subjects underwent UroLift system procedure. The subject was blinded to the randomization of control or treatment group. Unblinding occurred at 3 months post procedure after the assessments were completed. No matter which retreatment therapy, all subjects will be followed at a minimum of 5 years per the assessment schedule.	Cystoscopy n=66 Participants The control group subjects underwent a cystoscopy procedure only. The subject was blinded as to whether he was in the control or treatment group. Unblinding occurred at 3 months after follow-up assessments were completed. Between 3 and 12 month follow-up assessments, a subject was allowed to crossover and undergo the UroLift system procedure if he met inclusion and exclusion criteria. Subjects who crossed over will then be followed for 5 years post-treatment. The subjects that did not crossover were not required to participate beyond 12 months.
Comparison of IPSS for Efficacy	11.1 IPSS total score Standard Deviation 7.67	5.9 IPSS total score Standard Deviation 7.66

PRIMARY outcome

Timeframe: 12 months

The International Prostate Symptom Score (IPSS) is a standardized 8 question (7 symptom questions + 1 quality of life question) written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). Those patients scoring 7 or below are generally considered mildly symptomatic, whereas 20 or above is considered severely symptomatic. To meet co-primary effectiveness endpoint, the lower bound of a one-sided 97.5% confidence interval of IPSS mean percent change from baseline at Month 12 in the UroLift group must be greater than or equal to 30%.

Outcome measures

Outcome measures
Measure	UroLift System n=140 Participants The treatment group subjects underwent UroLift system procedure. The subject was blinded to the randomization of control or treatment group. Unblinding occurred at 3 months post procedure after the assessments were completed. No matter which retreatment therapy, all subjects will be followed at a minimum of 5 years per the assessment schedule.	Cystoscopy The control group subjects underwent a cystoscopy procedure only. The subject was blinded as to whether he was in the control or treatment group. Unblinding occurred at 3 months after follow-up assessments were completed. Between 3 and 12 month follow-up assessments, a subject was allowed to crossover and undergo the UroLift system procedure if he met inclusion and exclusion criteria. Subjects who crossed over will then be followed for 5 years post-treatment. The subjects that did not crossover were not required to participate beyond 12 months.
Mean UroLift Improvement in IPSS at 12 Months	45.5 % IPSS Score Improvement Interval 38.3 to This was a one-sided confidence interval	—

SECONDARY outcome

Timeframe: 12 Months

Over the 12 month follow-up period, the proportion of UroLift patients who experience de novo sustained erectile dysfunction and retrograde ejaculation will be reported. Control subjects are not included in this analysis since controls could crossover option opened at 3 months.

Outcome measures

Outcome measures
Measure	UroLift System n=140 Participants The treatment group subjects underwent UroLift system procedure. The subject was blinded to the randomization of control or treatment group. Unblinding occurred at 3 months post procedure after the assessments were completed. No matter which retreatment therapy, all subjects will be followed at a minimum of 5 years per the assessment schedule.	Cystoscopy The control group subjects underwent a cystoscopy procedure only. The subject was blinded as to whether he was in the control or treatment group. Unblinding occurred at 3 months after follow-up assessments were completed. Between 3 and 12 month follow-up assessments, a subject was allowed to crossover and undergo the UroLift system procedure if he met inclusion and exclusion criteria. Subjects who crossed over will then be followed for 5 years post-treatment. The subjects that did not crossover were not required to participate beyond 12 months.
Sexual Function	0.0 % of Subjects	—

Adverse Events

UroLift System

Serious events: 52 serious events

Other events: 133 other events

Deaths: 9 deaths

Crossover

Serious events: 19 serious events

Other events: 49 other events

Deaths: 4 deaths

Cystoscopy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	UroLift System n=140 participants at risk The treatment group subjects underwent UroLift system procedure. The subject was blinded to the randomization of control or treatment group. Unblinding occurred at 3 months post procedure after the assessments were completed. All subjects will be followed at a minimum of 5 years per the assessment schedule.	Crossover n=53 participants at risk Between 3 and 12 month follow-up assessments, a subject was allowed to crossover and undergo the UroLift system procedure if he met inclusion and exclusion criteria. Subjects who crossed over will then be followed for 5 years post-treatment. The subjects that did not crossover were not required to participate beyond 12 months.	Cystoscopy n=13 participants at risk The control group subjects underwent a cystoscopy procedure only. The subject was blinded as to whether he was in the control or treatment group. Unblinding occurred at 3 months after follow-up assessments were completed. Between 3 and 12 month follow-up assessments, a subject was allowed to crossover and undergo the UroLift system procedure if he met inclusion and exclusion criteria. Subjects who crossed over will then be followed for 5 years post-treatment. The subjects that did not crossover were not required to participate beyond 12 months.
Renal and urinary disorders Dysuria	38.6% 54/140 • Number of events 57 • Comparison safety data between two cohorts (we are listing 3 arms UroLift system, Cystoscopy and Crossover) at Index procedure through 5 Year Visit. All reported AEs are presented, including unrelated to device/procedure. The majority of the non-serious adverse events were deemed mild or moderate. No UADEs were reported through 5 Year Visit.	39.6% 21/53 • Number of events 21 • Comparison safety data between two cohorts (we are listing 3 arms UroLift system, Cystoscopy and Crossover) at Index procedure through 5 Year Visit. All reported AEs are presented, including unrelated to device/procedure. The majority of the non-serious adverse events were deemed mild or moderate. No UADEs were reported through 5 Year Visit.	0.00% 0/13 • Comparison safety data between two cohorts (we are listing 3 arms UroLift system, Cystoscopy and Crossover) at Index procedure through 5 Year Visit. All reported AEs are presented, including unrelated to device/procedure. The majority of the non-serious adverse events were deemed mild or moderate. No UADEs were reported through 5 Year Visit.
Renal and urinary disorders Haematuria	33.6% 47/140 • Number of events 52 • Comparison safety data between two cohorts (we are listing 3 arms UroLift system, Cystoscopy and Crossover) at Index procedure through 5 Year Visit. All reported AEs are presented, including unrelated to device/procedure. The majority of the non-serious adverse events were deemed mild or moderate. No UADEs were reported through 5 Year Visit.	28.3% 15/53 • Number of events 15 • Comparison safety data between two cohorts (we are listing 3 arms UroLift system, Cystoscopy and Crossover) at Index procedure through 5 Year Visit. All reported AEs are presented, including unrelated to device/procedure. The majority of the non-serious adverse events were deemed mild or moderate. No UADEs were reported through 5 Year Visit.	0.00% 0/13 • Comparison safety data between two cohorts (we are listing 3 arms UroLift system, Cystoscopy and Crossover) at Index procedure through 5 Year Visit. All reported AEs are presented, including unrelated to device/procedure. The majority of the non-serious adverse events were deemed mild or moderate. No UADEs were reported through 5 Year Visit.
Renal and urinary disorders Micturation Urgency	14.3% 20/140 • Number of events 20 • Comparison safety data between two cohorts (we are listing 3 arms UroLift system, Cystoscopy and Crossover) at Index procedure through 5 Year Visit. All reported AEs are presented, including unrelated to device/procedure. The majority of the non-serious adverse events were deemed mild or moderate. No UADEs were reported through 5 Year Visit.	18.9% 10/53 • Number of events 11 • Comparison safety data between two cohorts (we are listing 3 arms UroLift system, Cystoscopy and Crossover) at Index procedure through 5 Year Visit. All reported AEs are presented, including unrelated to device/procedure. The majority of the non-serious adverse events were deemed mild or moderate. No UADEs were reported through 5 Year Visit.	0.00% 0/13 • Comparison safety data between two cohorts (we are listing 3 arms UroLift system, Cystoscopy and Crossover) at Index procedure through 5 Year Visit. All reported AEs are presented, including unrelated to device/procedure. The majority of the non-serious adverse events were deemed mild or moderate. No UADEs were reported through 5 Year Visit.
Renal and urinary disorders Pelvic Pain	20.0% 28/140 • Number of events 32 • Comparison safety data between two cohorts (we are listing 3 arms UroLift system, Cystoscopy and Crossover) at Index procedure through 5 Year Visit. All reported AEs are presented, including unrelated to device/procedure. The majority of the non-serious adverse events were deemed mild or moderate. No UADEs were reported through 5 Year Visit.	20.8% 11/53 • Number of events 12 • Comparison safety data between two cohorts (we are listing 3 arms UroLift system, Cystoscopy and Crossover) at Index procedure through 5 Year Visit. All reported AEs are presented, including unrelated to device/procedure. The majority of the non-serious adverse events were deemed mild or moderate. No UADEs were reported through 5 Year Visit.	0.00% 0/13 • Comparison safety data between two cohorts (we are listing 3 arms UroLift system, Cystoscopy and Crossover) at Index procedure through 5 Year Visit. All reported AEs are presented, including unrelated to device/procedure. The majority of the non-serious adverse events were deemed mild or moderate. No UADEs were reported through 5 Year Visit.
Renal and urinary disorders Urinary Incontinence	15.0% 21/140 • Number of events 21 • Comparison safety data between two cohorts (we are listing 3 arms UroLift system, Cystoscopy and Crossover) at Index procedure through 5 Year Visit. All reported AEs are presented, including unrelated to device/procedure. The majority of the non-serious adverse events were deemed mild or moderate. No UADEs were reported through 5 Year Visit.	7.5% 4/53 • Number of events 4 • Comparison safety data between two cohorts (we are listing 3 arms UroLift system, Cystoscopy and Crossover) at Index procedure through 5 Year Visit. All reported AEs are presented, including unrelated to device/procedure. The majority of the non-serious adverse events were deemed mild or moderate. No UADEs were reported through 5 Year Visit.	0.00% 0/13 • Comparison safety data between two cohorts (we are listing 3 arms UroLift system, Cystoscopy and Crossover) at Index procedure through 5 Year Visit. All reported AEs are presented, including unrelated to device/procedure. The majority of the non-serious adverse events were deemed mild or moderate. No UADEs were reported through 5 Year Visit.
Renal and urinary disorders Urinary Retention	7.1% 10/140 • Number of events 10 • Comparison safety data between two cohorts (we are listing 3 arms UroLift system, Cystoscopy and Crossover) at Index procedure through 5 Year Visit. All reported AEs are presented, including unrelated to device/procedure. The majority of the non-serious adverse events were deemed mild or moderate. No UADEs were reported through 5 Year Visit.	7.5% 4/53 • Number of events 4 • Comparison safety data between two cohorts (we are listing 3 arms UroLift system, Cystoscopy and Crossover) at Index procedure through 5 Year Visit. All reported AEs are presented, including unrelated to device/procedure. The majority of the non-serious adverse events were deemed mild or moderate. No UADEs were reported through 5 Year Visit.	0.00% 0/13 • Comparison safety data between two cohorts (we are listing 3 arms UroLift system, Cystoscopy and Crossover) at Index procedure through 5 Year Visit. All reported AEs are presented, including unrelated to device/procedure. The majority of the non-serious adverse events were deemed mild or moderate. No UADEs were reported through 5 Year Visit.
Renal and urinary disorders Calculus urinary	13.6% 19/140 • Number of events 19 • Comparison safety data between two cohorts (we are listing 3 arms UroLift system, Cystoscopy and Crossover) at Index procedure through 5 Year Visit. All reported AEs are presented, including unrelated to device/procedure. The majority of the non-serious adverse events were deemed mild or moderate. No UADEs were reported through 5 Year Visit.	20.8% 11/53 • Number of events 11 • Comparison safety data between two cohorts (we are listing 3 arms UroLift system, Cystoscopy and Crossover) at Index procedure through 5 Year Visit. All reported AEs are presented, including unrelated to device/procedure. The majority of the non-serious adverse events were deemed mild or moderate. No UADEs were reported through 5 Year Visit.	0.00% 0/13 • Comparison safety data between two cohorts (we are listing 3 arms UroLift system, Cystoscopy and Crossover) at Index procedure through 5 Year Visit. All reported AEs are presented, including unrelated to device/procedure. The majority of the non-serious adverse events were deemed mild or moderate. No UADEs were reported through 5 Year Visit.
Gastrointestinal disorders Constipation	0.71% 1/140 • Number of events 1 • Comparison safety data between two cohorts (we are listing 3 arms UroLift system, Cystoscopy and Crossover) at Index procedure through 5 Year Visit. All reported AEs are presented, including unrelated to device/procedure. The majority of the non-serious adverse events were deemed mild or moderate. No UADEs were reported through 5 Year Visit.	5.7% 3/53 • Number of events 3 • Comparison safety data between two cohorts (we are listing 3 arms UroLift system, Cystoscopy and Crossover) at Index procedure through 5 Year Visit. All reported AEs are presented, including unrelated to device/procedure. The majority of the non-serious adverse events were deemed mild or moderate. No UADEs were reported through 5 Year Visit.	0.00% 0/13 • Comparison safety data between two cohorts (we are listing 3 arms UroLift system, Cystoscopy and Crossover) at Index procedure through 5 Year Visit. All reported AEs are presented, including unrelated to device/procedure. The majority of the non-serious adverse events were deemed mild or moderate. No UADEs were reported through 5 Year Visit.
Renal and urinary disorders Nocturia	7.1% 10/140 • Number of events 10 • Comparison safety data between two cohorts (we are listing 3 arms UroLift system, Cystoscopy and Crossover) at Index procedure through 5 Year Visit. All reported AEs are presented, including unrelated to device/procedure. The majority of the non-serious adverse events were deemed mild or moderate. No UADEs were reported through 5 Year Visit.	3.8% 2/53 • Number of events 2 • Comparison safety data between two cohorts (we are listing 3 arms UroLift system, Cystoscopy and Crossover) at Index procedure through 5 Year Visit. All reported AEs are presented, including unrelated to device/procedure. The majority of the non-serious adverse events were deemed mild or moderate. No UADEs were reported through 5 Year Visit.	0.00% 0/13 • Comparison safety data between two cohorts (we are listing 3 arms UroLift system, Cystoscopy and Crossover) at Index procedure through 5 Year Visit. All reported AEs are presented, including unrelated to device/procedure. The majority of the non-serious adverse events were deemed mild or moderate. No UADEs were reported through 5 Year Visit.
Renal and urinary disorders Pollakiuria	7.1% 10/140 • Number of events 10 • Comparison safety data between two cohorts (we are listing 3 arms UroLift system, Cystoscopy and Crossover) at Index procedure through 5 Year Visit. All reported AEs are presented, including unrelated to device/procedure. The majority of the non-serious adverse events were deemed mild or moderate. No UADEs were reported through 5 Year Visit.	9.4% 5/53 • Number of events 5 • Comparison safety data between two cohorts (we are listing 3 arms UroLift system, Cystoscopy and Crossover) at Index procedure through 5 Year Visit. All reported AEs are presented, including unrelated to device/procedure. The majority of the non-serious adverse events were deemed mild or moderate. No UADEs were reported through 5 Year Visit.	0.00% 0/13 • Comparison safety data between two cohorts (we are listing 3 arms UroLift system, Cystoscopy and Crossover) at Index procedure through 5 Year Visit. All reported AEs are presented, including unrelated to device/procedure. The majority of the non-serious adverse events were deemed mild or moderate. No UADEs were reported through 5 Year Visit.
Investigations Prostatic specific antigen increased	7.1% 10/140 • Number of events 10 • Comparison safety data between two cohorts (we are listing 3 arms UroLift system, Cystoscopy and Crossover) at Index procedure through 5 Year Visit. All reported AEs are presented, including unrelated to device/procedure. The majority of the non-serious adverse events were deemed mild or moderate. No UADEs were reported through 5 Year Visit.	9.4% 5/53 • Number of events 6 • Comparison safety data between two cohorts (we are listing 3 arms UroLift system, Cystoscopy and Crossover) at Index procedure through 5 Year Visit. All reported AEs are presented, including unrelated to device/procedure. The majority of the non-serious adverse events were deemed mild or moderate. No UADEs were reported through 5 Year Visit.	0.00% 0/13 • Comparison safety data between two cohorts (we are listing 3 arms UroLift system, Cystoscopy and Crossover) at Index procedure through 5 Year Visit. All reported AEs are presented, including unrelated to device/procedure. The majority of the non-serious adverse events were deemed mild or moderate. No UADEs were reported through 5 Year Visit.
Renal and urinary disorders Residual urine	5.0% 7/140 • Number of events 7 • Comparison safety data between two cohorts (we are listing 3 arms UroLift system, Cystoscopy and Crossover) at Index procedure through 5 Year Visit. All reported AEs are presented, including unrelated to device/procedure. The majority of the non-serious adverse events were deemed mild or moderate. No UADEs were reported through 5 Year Visit.	1.9% 1/53 • Number of events 1 • Comparison safety data between two cohorts (we are listing 3 arms UroLift system, Cystoscopy and Crossover) at Index procedure through 5 Year Visit. All reported AEs are presented, including unrelated to device/procedure. The majority of the non-serious adverse events were deemed mild or moderate. No UADEs were reported through 5 Year Visit.	0.00% 0/13 • Comparison safety data between two cohorts (we are listing 3 arms UroLift system, Cystoscopy and Crossover) at Index procedure through 5 Year Visit. All reported AEs are presented, including unrelated to device/procedure. The majority of the non-serious adverse events were deemed mild or moderate. No UADEs were reported through 5 Year Visit.
Infections and infestations Urinary tract infection	9.3% 13/140 • Number of events 15 • Comparison safety data between two cohorts (we are listing 3 arms UroLift system, Cystoscopy and Crossover) at Index procedure through 5 Year Visit. All reported AEs are presented, including unrelated to device/procedure. The majority of the non-serious adverse events were deemed mild or moderate. No UADEs were reported through 5 Year Visit.	15.1% 8/53 • Number of events 11 • Comparison safety data between two cohorts (we are listing 3 arms UroLift system, Cystoscopy and Crossover) at Index procedure through 5 Year Visit. All reported AEs are presented, including unrelated to device/procedure. The majority of the non-serious adverse events were deemed mild or moderate. No UADEs were reported through 5 Year Visit.	0.00% 0/13 • Comparison safety data between two cohorts (we are listing 3 arms UroLift system, Cystoscopy and Crossover) at Index procedure through 5 Year Visit. All reported AEs are presented, including unrelated to device/procedure. The majority of the non-serious adverse events were deemed mild or moderate. No UADEs were reported through 5 Year Visit.

Additional Information

Emily Hergenreter Director of Clinical Affairs

NeoTract

Phone: 650-739-5570

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Investigator agreements restricted data disclosure until written agreement by or publication by Sponsor. The first publication appeared in the Journal of Urology, June 2013. "The Prostatic Urethral Lift for the Treatment of Lower Urinary Tract Symptoms Associated with Prostate Enlargement Due to Benign Prostatic Hyperplasia: The L.I.F.T. Study " Claus G. Roehrborn, Steven N. Gange, Neal D. Shore, Jonathan L. Giddens, et al. The Vol. 190, Issue 6, Pages 2161-2167.
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