The Safety and Effectiveness of UroLift: LIFT Pivotal Study

Benign Prostatic Hyperplasia Clinical Trial

— LIFT  

Official title:

Luminal Improvement Following Prostatic Tissue Approximation for the Treatment of Lower Urinary Tract Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01294150
• Other study ID #: 1012CP
• Status: Completed
• Phase: N/A
• Start date: February 2011
• Est. completion date: July 5, 2017

Study information

• Verified date: August 2018
• Source: NeoTract, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the safety and effectiveness of the UroLift(R) System when used in subjects with symptomatic benign hyperplasia (BPH). Primary effectiveness will be achieved by looking at the improvement of International Prostate Symptom Score (IPSS) and safety will be reviewed based on pertinent adverse events.

Description:

The randomized portion of the study is a prospective, multicenter, multinational, 2:1 randomized, single-blinded controlled clinical trial comparing the IPSS of the treatment group to the IPSS of the control group at the 3 month follow-up. Subjects in the active treatment group undergo UroLift system treatment. Subjects in the control group undergo a cystoscopy procedure.

All subjects will be followed through 12 months, and through 5 years for those that receive the investigational device.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: July 5, 2017
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Males age of 50 years or older diagnosed with symptomatic benign prostatic hyperplasia (BPH)

Exclusion Criteria:

• Size, volume,length of prostate

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Lower Urinary Tract Symptoms
• Prostatic Hyperplasia

Intervention

Device:
• UroLift System
The NeoTract UroLift System is a medical device approved for sale in the United States, European Union, and several other countries (see www.urolift.com). It was developed for the treatment of lower urinary tract symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH). During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra.

Other:
• Cystoscopy
The Control Group will undergo cystoscopy.

Device:
• Crossover
Subjects crossed over and received the UroLift System from the Control Group.

Locations

Country	Name	City	State
Australia	Figtree Private Hospital	Figtree	New South Wales
Australia	Austin Hospital	Heidelberg	Victoria
Australia	Port Macquarie Urology Centre	Port Macquarie
Canada	Oakville Trafalgar Memorial Hospital	Oakville	Ontario
Canada	Cam Am HIFU	Toronto	Ontario
United States	Chesapeake Urology	Baltimore	Maryland
United States	Northwestern University	Chicago	Illinois
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Advanced Urology Institute	Daytona Beach	Florida
United States	Urology Associates of Denver	Englewood	Colorado
United States	Sheldon J. Freedman, M.D., Ltd.	Las Vegas	Nevada
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Weill Cornell Medical College	New York	New York
United States	Pinellas Urology	Saint Petersburg	Florida
United States	Jean Brown Research	Salt Lake City	Utah
United States	Genesis Research LLC	San Diego	California
United States	Shahram S. Gholami MD - A Professional Corp.	San Jose	California
United States	Scott and White Healthcare	Temple	Texas

Sponsors (1)

Lead Sponsor	Collaborator
NeoTract, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collection of Post-treatment Catheterization for Safety	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.	Cath within first 3 days post-procedure which extended beyond 7 days, up to 12 days
Primary	Comparison of IPSS for Efficacy	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	3 month
Primary	Mean UroLift Improvement in IPSS at 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%.	12 months
Secondary	Sexual Function	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.	12 Months