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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
NeoTract, Inc.
ClinicalTrials.gov Identifier:
NCT01533038
First received: February 10, 2012
Last updated: February 13, 2014
Last verified: February 2014
  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 System
Procedure: Transurethral Resection of the Prostate
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

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 ] [ 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: February 2015
Primary Completion Date: February 2014 (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

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
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, see Learn About Clinical Studies.

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

Locations
Denmark
Herlov Hospital
Herlov, 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

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: February 13, 2014
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 August 18, 2014