BPH-6: Comparison of the UroLift System to TURP for Benign Prostatic Hyperplasia (BPH-6)
|ClinicalTrials.gov Identifier: NCT01533038|
Recruitment Status : Completed
First Posted : February 15, 2012
Results First Posted : November 26, 2015
Last Update Posted : December 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Benign Prostatic Hyperplasia||Device: UroLift System Procedure: Transurethral Resection of the Prostate||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||BPH-6: A UroLift® System Post Market Multi-Center Randomized Study|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||January 2016|
Active Comparator: UroLift System
UroLift System procedure
Device: UroLift System
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.
Active Comparator: Transurethral Resection of the Prostate
Transurethral Resection of the Prostate surgery
Procedure: Transurethral Resection of the Prostate
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.
- 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 [ Time Frame: Month 12 ]
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01533038
|Cologne, Germany, 50667|
|University Hospital Freiburg|
|Freiburg, Germany, 79106|
|Ludwigs-Maximilians Universität / Klinikum Großhadern|
|Munich, Germany, 81377|
|University Hospital Tuebingen|
|Frimley Park Hospital|
|Frimley, United Kingdom, GU16 7UJ|
|The Royal Hallamshire Hospital|
|Sheffield, United Kingdom|
|City Hospitals Sunderland NHS Foundation Trust|
|Sunderland, United Kingdom|
|Musgrove Park Hospital|
|Taunton, United Kingdom, TA1 5DA|
|Principal Investigator:||Francesco Montorsi, MD||University Vita Salute San Raffaele|