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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: August 29, 2014
Last verified: August 2014

February 10, 2012
August 29, 2014
February 2012
December 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01533038 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
BPH-6: Comparison of the UroLift System to TURP for Benign Prostatic Hyperplasia
BPH-6: A UroLift® System Post Market Multi-Center Randomized Study

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Benign Prostatic Hyperplasia
  • 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.
  • 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.
  • Active Comparator: UroLift System
    UroLift System procedure
    Intervention: Device: UroLift System
  • Active Comparator: Transurethral Resection of the Prostate
    Transurethral Resection of the Prostate surgery
    Intervention: Procedure: Transurethral Resection of the Prostate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
December 2015
December 2014   (final data collection date for primary outcome measure)

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
Male
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Germany,   United Kingdom
 
NCT01533038
CP12317
No
NeoTract, Inc.
NeoTract, Inc.
Not Provided
Principal Investigator: Francesco Montorsi, MD University Vita Salute San Raffaele
NeoTract, Inc.
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP