N/A
N=80
BPH-6: Comparison of the UroLift System to TURP for Benign Prostatic Hyperplasia
Benign Prostatic Hyperplasia
Bottom Line
View on ClinicalTrials.gov: NCT01533038 ↗Enrolled (actual)
80
Serious AEs
7.5%
Results posted
Nov 2015
Primary outcome: Primary: 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 — 52; 20 % Responders of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- UroLift System (Device); Transurethral Resection of the Prostate (Procedure)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- Male
- Sponsor
- NeoTract, Inc.
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
52; 20 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01533038). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.