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
• Sponsor: NeoTract, Inc.
• Information provided by (Responsible Party): NeoTract, Inc.

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Benign Prostatic Hyperplasia	Device: UroLift System; Procedure: Transurethral Resection of the Prostate	Not Applicable

Detailed Description:

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   1. LUTS: ≥ 30% reduction in IPSS compared to baseline
   2. Recovery Experience: Return to pre-operative activity levels by 1 month
   3. Erectile function: Less than 6-point reduction in SHIM compared to baseline.
   4. Ejaculatory function: Response on MSHQ-EjD that indicates emission of semen. This excludes the response "Could not ejaculate"
   5. Continence: ISI score of 4 points or less at all follow-up time points
   6. 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.

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Denmark

Herlev Hospital

Herlev, Denmark

Germany

PAN Klinik

Cologne, Germany, 50667

University Hospital Freiburg

Freiburg, Germany, 79106

Ludwigs-Maximilians Universität / Klinikum Großhadern

Munich, Germany, 81377

University Hospital Tuebingen

Tuebingen, Germany

United Kingdom

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

Sponsors and Collaborators

NeoTract, Inc.

Investigators

• Principal Investigator: Francesco Montorsi, MD; University Vita Salute San Raffaele

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sønksen J, Barber NJ, Speakman MJ, Berges R, Wetterauer U, Greene D, Sievert KD, Chapple CR, Montorsi F, Patterson JM, Fahrenkrug L, Schoenthaler M, Gratzke C. Prospective, randomized, multinational study of prostatic urethral lift versus transurethral resection of the prostate: 12-month results from the BPH6 study. Eur Urol. 2015 Oct;68(4):643-52. doi: 10.1016/j.eururo.2015.04.024. Epub 2015 Apr 30.

• Responsible Party: NeoTract, Inc.
• ClinicalTrials.gov Identifier: NCT01533038
• Other Study ID Numbers: CP12317
• First Posted: February 15, 2012
• Results First Posted: November 26, 2015
• Last Update Posted: December 19, 2017
• Last Verified: November 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Prostatic Hyperplasia; Hyperplasia; Pathologic Processes; Prostatic Diseases