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

This study is currently recruiting participants.

Verified May 2013 by NeoTract, Inc.

Sponsor:

Information provided by (Responsible Party):

NeoTract, Inc.

ClinicalTrials.gov Identifier:

NCT01533038

First received: February 10, 2012

Last updated: May 6, 2013

Last verified: May 2013

History of Changes

Purpose

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	Intervention	Phase
Benign Prostatic Hyperplasia	Device: UroLift(R) System Procedure: TURP	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	BPH-6: A UroLift® System Post Market Multi-Center Randomized Study

Further study details as provided by NeoTract, Inc.:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]
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.

Estimated Enrollment:	100
Study Start Date:	February 2012
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: UroLift System treatment	Device: UroLift(R) 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	Procedure: TURP 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.

Arms

Assigned Interventions

Active Comparator: UroLift System treatment

Device: UroLift(R) 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

Procedure: TURP

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.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01533038

Locations

Canada, British Columbia
The Prostate Centre - Diamond Health Care Centre	Recruiting
Vancouver, British Columbia, Canada
Contact: Maureen Palmer Maureen.Palmer@vch.ca
Principal Investigator: Alan So, MD
Denmark
Herlov Hospital	Recruiting
Herlov, Denmark
Contact: Jane Grauengaard jane.grauengaard@regionh.dk
Principal Investigator: Jens Sønksen, MD
Germany
PAN Klinik	Recruiting
Cologne, Germany, 50667
Contact: Richard Berges, MD r.berges@pan-klinik.org
Principal Investigator: Richard Berges, MD
University Hospital Freiburg	Recruiting
Freiburg, Germany, 79106
Contact: Ursula Kimpel ursula.kimpel@uniklinik-freiburg.de
Principal Investigator: Ulrich Wetterauer, MD, PhD
Ludwigs-Maximilians Universität / Klinikum Großhadern	Recruiting
Munich, Germany, 81377
Contact: Christian Gratzke, MD +49897095-0 Christian.gratzke@med.uni-muenchen.de
Principal Investigator: Christian Gratzke, MD
University Hospital Tuebingen	Recruiting
Tuebingen, Germany
Contact: Susan Feyerabend, MD susan.feyerabend@med.uni-tuebingen.de
Principal Investigator: KD Sievert, MD
Italy
Ospedale San Raffaele S.r.l.	Recruiting
Milan, Italy
Contact: Luigi Barbieri, MD barbieri.luigi@hsr.it
Principal Investigator: Francesco Montorsi, MD
United Kingdom
The Royal Hallamshire Hospital	Recruiting
Sheffield, United Kingdom
Contact: Susannah Hulton, RN Susannah.Hulton@sth.nhs.uk
Principal Investigator: Christopher Chapple, MD
City Hospitals Sunderland NHS Foundation Trust	Recruiting
Sunderland, United Kingdom
Contact: Damien Greene, MD Damien.Greene@chsft.nhs.uk
Contact: Sue Asterling Susan.Asterling@chsft.nhs.uk
Principal Investigator: Damien Greene, MD
Frimley Park Hospital	Recruiting
Surrey, United Kingdom, GU16 7UJ
Contact: Neil Barber, MD neil.barber@urologypartners.co.uk
Principal Investigator: Neil Barber, MD
Musgrove Park Hospital	Recruiting
Taunton, United Kingdom, TA1 5DA
Contact: Mark Speakman, MD Mark.Speakman@tst.nhs.uk
Principal Investigator: Mark Speakman, MD

Sponsors and Collaborators

NeoTract, Inc.

Investigators

Principal Investigator:

Francesco Montorsi, MD

University Vita Salute San Raffaele

More Information

No publications provided

Responsible Party:	NeoTract, Inc.
ClinicalTrials.gov Identifier:	NCT01533038 History of Changes
Other Study ID Numbers:	CP12317
Study First Received:	February 10, 2012
Last Updated:	May 6, 2013
Health Authority:	Germany: Ethics Commission

Additional relevant MeSH terms:

Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013

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