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

NCT01533038 | Completed Results

• 1 other identifier: CP12317
• Study Type: interventional
• Target: 80
• Locations: 3 countries
• Sites: 9

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.

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (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

  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.

  Month 12

Study Arms (2)

UroLift System

ACTIVE COMPARATOR

UroLift System procedure

Device: UroLift System

Transurethral Resection of the Prostate

ACTIVE COMPARATOR

Transurethral Resection of the Prostate surgery

Procedure: Transurethral Resection of the Prostate

Interventions

UroLift System DEVICE

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.

UroLift System

Transurethral Resection of the Prostate PROCEDURE

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.

Transurethral Resection of the Prostate

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men \>50 years old with moderate-severe BPH

You may not qualify if:

• Size, width of prostate
• Other medical condition or co-morbidity contraindicative for TURP or UroLift

Sponsors & Collaborators

• NeoTract, Inc.: lead

Study Sites (9)

Herlev Hospital

Herlev, Denmark

Location

PAN Klinik

Cologne, 50667, Germany

Location

University Hospital Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Ludwigs-Maximilians Universität / Klinikum Großhadern

Munich, 81377, Germany

Location

University Hospital Tuebingen

Tübingen, Germany

Location

Frimley Park Hospital

Frimley, GU16 7UJ, United Kingdom

Location

The Royal Hallamshire Hospital

Sheffield, United Kingdom

Location

City Hospitals Sunderland NHS Foundation Trust

Sunderland, United Kingdom

Location

Musgrove Park Hospital

Taunton, TA1 5DA, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 25937539 DERIVED

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Director of Clinical Affairs
• Organization: NeoTract

ehergenreter@neotract.com

925-401-0641

Study Officials

• Francesco Montorsi, MD

  University Vita Salute San Raffaele

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2012
• First Posted: February 15, 2012
• Study Start: February 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: January 1, 2016
• Last Updated: December 19, 2017
• Results First Posted: November 26, 2015

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4); DK (1); GB (4)