N/A
N=51
UroLift System TOlerability and ReCovery When Administering Local Anesthesia
Benign Prostatic Hyperplasia
Bottom Line
View on ClinicalTrials.gov: NCT01876706 ↗Enrolled (actual)
51
Serious AEs
23.5%
Results posted
Nov 2015
Primary outcome: Primary: Quality of Recovery — 28; 16 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- UroLift® System (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- Male
- Sponsor
- NeoTract, Inc.
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quality of Recovery |
28; 16 | — |
| SECONDARY IPSS Scores at Baseline and 12 Month Follow-up |
20.78; 9.73 | — |
| SECONDARY IPSS 12 Month Change From Baseline |
11.05 | — |
| SECONDARY IPSS 12 Month Percent (%) Change From Baseline |
53.5 | — |
| SECONDARY BPH II Scores at Baseline and 12 Month Follow-up |
6.32; 1.71 | — |
| SECONDARY BPH II 12 Month Percent (%) Change From Baseline |
71.7 | — |
| SECONDARY BPH II 12 Month Change From Baseline |
4.61 | — |
| SECONDARY Qmax Scores at Baseline and 12 Month Follow-up |
8.33; 11.79 | — |
| SECONDARY QMAX 12 Month Change Minus Baseline |
3.45 | — |
| SECONDARY QMAX 12 Month Percent (%) Change in mL/Sec From Baseline |
57.4 | — |
| SECONDARY Pain Tolerability Throughout the UroLift System Procedure |
3.0; 4.8; 5.0; 3.4 | — |
| SECONDARY BPHII Baseline and 12 Month Median Score, 95% CI |
7.00; 1.00 | — |
| SECONDARY IPSS at Baseline and 12 Months, Median , 95% CI |
20.0; 8.00 | — |
| SECONDARY QMAX Median at Baseline and 12 Months With CI 95% |
9.00; 12.0 | — |
Summary
The purpose of the study is to evaluate procedure tolerability and surgical recovery following the UroLift® system procedure when conducted with local anesthesia in subjects with symptomatic benign hyperplasia (BPH). Primary effectiveness will be achieved by looking at the Quality of Recovery Visual Analog Scale (QoR VAS) by the one month follow-up visit.
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 (NCT01876706). 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.