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

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ClinicalTrials.gov Identifier: NCT01533038
Recruitment Status : Completed
First Posted : February 15, 2012
Results First Posted : November 26, 2015
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
NeoTract, Inc.

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.

Condition or disease Intervention/treatment
Benign Prostatic Hyperplasia Device: UroLift System Procedure: Transurethral Resection of the Prostate

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: BPH-6: A UroLift® System Post Market Multi-Center Randomized Study
Study Start Date : February 2012
Primary Completion Date : October 2015
Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: UroLift System
UroLift System procedure
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.
Active Comparator: Transurethral Resection of the Prostate
Transurethral Resection of the Prostate surgery
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.



Primary Outcome Measures :
  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 [ Time Frame: Month 12 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01533038


Locations
Denmark
Herlev Hospital
Herlev, Denmark
Germany
PAN Klinik
Cologne, Germany, 50667
University Hospital Freiburg
Freiburg, Germany, 79106
Ludwigs-Maximilians Universität / Klinikum Großhadern
Munich, Germany, 81377
University Hospital Tuebingen
Tuebingen, Germany
United Kingdom
Frimley Park Hospital
Frimley, United Kingdom, GU16 7UJ
The Royal Hallamshire Hospital
Sheffield, United Kingdom
City Hospitals Sunderland NHS Foundation Trust
Sunderland, United Kingdom
Musgrove Park Hospital
Taunton, United Kingdom, TA1 5DA
Sponsors and Collaborators
NeoTract, Inc.
Investigators
Principal Investigator: Francesco Montorsi, MD University Vita Salute San Raffaele

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: NeoTract, Inc.
ClinicalTrials.gov Identifier: NCT01533038     History of Changes
Other Study ID Numbers: CP12317
First Posted: February 15, 2012    Key Record Dates
Results First Posted: November 26, 2015
Last Update Posted: December 19, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male