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

Benign Prostatic Hyperplasia Clinical Trial

— BPH-6  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01533038
• Other study ID #: CP12317
• Status: Completed
• Phase: N/A
• First received: February 10, 2012
• Last updated: November 20, 2017
• Start date: February 2012
• Est. completion date: January 2016

Study information

• Verified date: November 2017
• Source: NeoTract, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

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.

Locations

Country	Name	City	State
Denmark	Herlev Hospital	Herlev
Germany	PAN Klinik	Cologne
Germany	University Hospital Freiburg	Freiburg
Germany	Ludwigs-Maximilians Universität / Klinikum Großhadern	Munich
Germany	University Hospital Tuebingen	Tuebingen
United Kingdom	Frimley Park Hospital	Frimley
United Kingdom	The Royal Hallamshire Hospital	Sheffield
United Kingdom	City Hospitals Sunderland NHS Foundation Trust	Sunderland
United Kingdom	Musgrove Park Hospital	Taunton

Sponsors (1)

Lead Sponsor	Collaborator
NeoTract, Inc.

Countries where clinical trial is conducted

Denmark,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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