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

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

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.

Study Overview

• Status: Completed
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Device: UroLift System; Procedure: Transurethral Resection of the Prostate

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Herlev, Denmark
    • Herlev Hospital
• Germany
  • Cologne, Germany, 50667
    • PAN Klinik
  • Freiburg, Germany, 79106
    • University Hospital Freiburg
  • Munich, Germany, 81377
    • Ludwigs-Maximilians Universität / Klinikum Großhadern
  • Tuebingen, Germany
    • University Hospital Tuebingen
• United Kingdom
  • Frimley, United Kingdom, GU16 7UJ
    • Frimley Park Hospital
  • Sheffield, United Kingdom
    • The Royal Hallamshire Hospital
  • Sunderland, United Kingdom
    • City Hospitals Sunderland NHS Foundation Trust
  • Taunton, United Kingdom, TA1 5DA
    • Musgrove Park Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: NeoTract, Inc.
• Investigators: Principal Investigator: Francesco Montorsi, MD, University Vita Salute San Raffaele

Publications and helpful links

General Publications

• Sonksen 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: February 10, 2012
• First Submitted That Met QC Criteria: February 14, 2012
• First Posted (Estimate): February 15, 2012

Study Record Updates

• Last Update Posted (Actual): December 19, 2017
• Last Update Submitted That Met QC Criteria: November 20, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: CP12317

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No