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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01533038
First Posted: February 15, 2012
Last Update Posted: November 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
NeoTract, Inc.
  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
Benign Prostatic Hyperplasia Device: UroLift System Procedure: Transurethral Resection of the Prostate

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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 ]
    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.


Enrollment: 80
Study Start Date: February 2012
Study Completion Date: January 2016
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
The Royal Hallamshire Hospital
Sheffield, United Kingdom
City Hospitals Sunderland NHS Foundation Trust
Sunderland, United Kingdom
Frimley Park Hospital
Surrey, United Kingdom, GU16 7UJ
Musgrove Park Hospital
Taunton, United Kingdom, TA1 5DA
Sponsors and Collaborators
NeoTract, Inc.
Investigators
Principal Investigator: Francesco Montorsi, MD University Vita Salute San Raffaele
  More Information

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 Submitted: February 10, 2012
First Posted: February 15, 2012
Results First Submitted: October 22, 2015
Results First Posted: November 26, 2015
Last Update Posted: November 20, 2017
Last Verified: October 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