BPH-6: Comparison of the UroLift System to TURP for Benign Prostatic Hyperplasia

Study Overview
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Brief Summary
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The purpose of this study is to compare the UroLift System Treatment to Transurethral Resection of the Prostate (TURP) in improving a patient's overall quality of life, while evaluating healthcare expenditures associated with each therapy.

Detailed Description
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The study is a prospective, consecutive, multi-center, 1:1 randomized study (UroLift System:TURP). The study is intended to be conducted at up to 20 different centers in Europe and Canada to enroll up to 100 subjects. Subject follow-up visits are at 2 weeks, 1, 3, 6, 12 and 24 months for all subjects.

Official Title
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BPH-6: A UroLift® System Post Market Multi-Center Randomized Study

Conditions
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Benign Prostatic Hyperplasia

Intervention / Treatment
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* Device: UroLift System
* Procedure: Transurethral Resection of the Prostate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Men >50 years old with moderate-severe BPH Exclusion Criteria: Size, width of prostate Other medical condition or co-morbidity contraindicative for TURP or UroLift

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: UroLift System<br>UroLift System procedure | Device: UroLift System<br>* The NeoTract UroLift System is a medical device approved for sale in the European Union, Australia, New Zealand, Canada, Serbia, and Turkey. It was developed for the intended use of soft tissue approximation and 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.<br>|
| Active Comparator: Transurethral Resection of the Prostate<br>Transurethral Resection of the Prostate surgery | Procedure: Transurethral Resection of the Prostate<br>* Transurethral Resection of the Prostate (TURP) is a surgical procedure which removes prostatic tissue by electrocautery dissection. During the procedure the tissue at the bladder neck and the adjacent adenoma are resected in quadrants. Resection continues into the midportion of the gland and concludes at the apex. Any remaining residual tissue is cleared, leaving a void from verumontanum to bladder neck.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder Analysis: A Subject is a Responder at the 12 Month Follow-up Time Point if All 6 Thresholds of the BPH-6 Endpoint Are Met | LUTS: ≥ 30% reduction in IPSS compared to baseline Recovery Experience: Return to pre-operative activity levels by 1 month Erectile function: Less than 6-point reduction in SHIM compared to baseline. Ejaculatory function: Response on MSHQ-EjD that indicates emission of semen. This excludes the response Could not ejaculate Continence: ISI score of 4 points or less at all follow-up time points Safety: No procedure-related adverse event greater than Grade I on the Clavien-Dindo classification system modified for TURP at any time during procedure or follow up. | Month 12 |