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:
NeoTract, Inc.
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
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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 ]
- 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.
| 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.
|
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 May 21, 2013