N/A
N=206
The Safety and Effectiveness of UroLift: LIFT Pivotal Study
Benign Prostatic Hyperplasia
Bottom Line
View on ClinicalTrials.gov: NCT01294150 ↗Enrolled (actual)
206
Serious AEs
34.5%
Results posted
Aug 2015
Primary outcome: Primary: Collection of Post-treatment Catheterization for Safety — 2 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- UroLift System (Device); Cystoscopy (Other); Crossover (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- Male
- Sponsor
- NeoTract, Inc.
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Collection of Post-treatment Catheterization for Safety |
2 | — |
| PRIMARY Comparison of IPSS for Efficacy |
11.1; 5.9 | 0.003 sig |
| PRIMARY Mean UroLift Improvement in IPSS at 12 Months |
45.5 | — |
| SECONDARY Sexual Function |
0.0 | — |
Summary
The purpose of the study is to evaluate the safety and effectiveness of the UroLift(R) System when used in subjects with symptomatic benign hyperplasia (BPH). Primary effectiveness will be achieved by looking at the improvement of International Prostate Symptom Score (IPSS) and safety will be reviewed based on pertinent adverse events.
Eligibility Criteria
Inclusion Criteria
- Males age of 50 years or older diagnosed with symptomatic benign prostatic hyperplasia (BPH)
Exclusion Criteria
- Size, volume,length of prostate
Data sourced from ClinicalTrials.gov (NCT01294150). 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.