The Safety and Effectiveness of UroLift: LIFT Pivotal Study

Not Applicable

Completed

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Device: Crossover; Device: UroLift System; Other: Cystoscopy

• Registration Number: NCT01294150
• Lead Sponsor: NeoTract, Inc.

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-07
• Study First Submitted QC: 2011-02-10
• Study First Posted: 2011-02-11
• Primary Completion: 2013-02
• Results First Submitted: 2014-04-01
• Results First Submitted QC: 2015-07-15
• Results First Posted: 2015-08-13
• Study Completion: 2017-07-05
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-31
• Last Update Posted: 2018-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 206

Inclusion Criteria

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

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Exclusion Criteria

• Size, volume,length of prostate

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Crossover	Crossover	Between 3 and 12 month follow-up assessments, a subject was allowed to crossover and undergo a UL procedure if he met crossover inclusion and exclusion criteria. Subjects crossing over will then be followed for 5 years post-treatment. The subject can also be treated by other approved therapies, or receive no treatment at all, which would require participation through 12 months.
UroLift System	UroLift System	The treatment group subjects underwent the UroLift system procedure. The subject was blinded to his randomization into control or treatment group. Unblinding will occurred at 3 months post procedure after the assessments were completed. Between 3 and 12 month follow-up assessments, a subject was allowed to retreat 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 started their follow-up schedule over and were considered treatment failures. All UL subjects will be followed a minimum of 5 years.
Cystoscopy	Cystoscopy	The control group subjects underwent a cystoscopy procedure. The subject was blinded to his randomization into the control or treatment group. Unblinding will 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 a UL procedure if he met crossover inclusion and exclusion criteria. Subjects crossing over will then be followed for 5 years post-treatment. The subject can also be treated by other approved therapies, or receive no treatment at all, which would require participation through 12 months.

Primary Outcome Measures

Name	Time	Method
Collection of Post-treatment Catheterization for Safety	Cath within first 3 days post-procedure which extended beyond 7 days, up to 12 days	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.
Comparison of IPSS for Efficacy	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
Mean UroLift Improvement in IPSS at 12 Months	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%.

Secondary Outcome Measures

Name	Time	Method
Sexual Function	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.

Trial Locations

Locations (19)

Port Macquarie Urology Centre; 🇦🇺 Port Macquarie, Australia

Genesis Research LLC; 🇺🇸 San Diego, California, United States

Urology Associates of Denver; 🇺🇸 Englewood, Colorado, United States

Sheldon J. Freedman, M.D., Ltd.; 🇺🇸 Las Vegas, Nevada, United States

Jean Brown Research; 🇺🇸 Salt Lake City, Utah, United States

Cam Am HIFU; 🇨🇦 Toronto, Ontario, Canada

Shahram S. Gholami MD - A Professional Corp.; 🇺🇸 San Jose, California, United States

Advanced Urology Institute; 🇺🇸 Daytona Beach, Florida, United States

Pinellas Urology; 🇺🇸 Saint Petersburg, Florida, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Chesapeake Urology; 🇺🇸 Baltimore, Maryland, United States

Weill Cornell Medical College; 🇺🇸 New York, New York, United States

Geisinger Medical Center; 🇺🇸 Danville, Pennsylvania, United States

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Scott and White Healthcare; 🇺🇸 Temple, Texas, United States

Figtree Private Hospital; 🇦🇺 Figtree, New South Wales, Australia

Oakville Trafalgar Memorial Hospital; 🇨🇦 Oakville, Ontario, Canada

Carolina Urologic Research Center; 🇺🇸 Myrtle Beach, South Carolina, United States

Austin Hospital; 🇦🇺 Heidelberg, Victoria, Australia