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

NACompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

February 29, 2012

Primary Completion Date

October 31, 2015

Study Completion Date

January 31, 2016

Conditions
Benign Prostatic Hyperplasia
Interventions
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.

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.

Trial Locations (9)

50667

PAN Klinik, Cologne

79106

University Hospital Freiburg, Freiburg im Breisgau

81377

Ludwigs-Maximilians Universität / Klinikum Großhadern, Munich

Unknown

Herlev Hospital, Herlev

University Hospital Tuebingen, Tübingen

The Royal Hallamshire Hospital, Sheffield

City Hospitals Sunderland NHS Foundation Trust, Sunderland

GU16 7UJ

Frimley Park Hospital, Frimley

TA1 5DA

Musgrove Park Hospital, Taunton

All Listed Sponsors
lead

NeoTract, Inc.

INDUSTRY

NCT01533038 - BPH-6: Comparison of the UroLift System to TURP for Benign Prostatic Hyperplasia | Biotech Hunter | Biotech Hunter