N/A
Completed N=45
Study of Median Lobe Prostatic UroLift Procedure
Benign Prostatic Hyperplasia (BPH)
Source: ClinicalTrials.gov NCT02625545 ↗
Enrolled (actual)
45
Serious AEs
11.1%
Results posted
Feb 2019
Primary outcomePrimary: At 6 Months, the 95% Lower Confidence Limit of the Mean Percent Improvement in IPSS Over Baseline for the UroLift System Must be ≥ 25%. — 57.7 percent change
Summary
The purpose of this study is to evaluate the safety and effectiveness of using UroLift in subjects with a prostatic median lobe enlargement due to benign prostatic hyperplasia (BPH).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY At 6 Months, the 95% Lower Confidence Limit of the Mean Percent Improvement in IPSS Over Baseline for the UroLift System Must be ≥ 25%. |
57.7 | — |
| SECONDARY Intent to Treat Population International Prostate Symptom Scores at Baseline and 12 Month Follow-up |
24.1; 10.6 | — |
| SECONDARY Intent to Treat Population International Prostate Symptom Score Percent Change From Baseline to 12 Month Follow-up |
-55.1 | — |
| SECONDARY Intent to Treat Population Quality of Life Scores at Baseline and 12 Month Follow-up |
4.9; 1.9 | — |
| SECONDARY Intent to Treat Population Quality of Life Score Perfect Change From Baseline to 12 Month Follow-up |
-61.1 | — |
| SECONDARY Intent to Treat Population BPHII Scores at Baseline and 12 Month Follow-up |
7.7; 2.1 | — |
| SECONDARY Intent to Treat Population BPHII Score Percent Change From Baseline to 12 Month Follow-up |
-70.4 | — |
| SECONDARY Intent to Treat Population Peak Flow Rate Scores at Baseline and 12 Month Follow-up |
7.1; 13.5 | — |
| SECONDARY Intent to Treat Population Peak Flow Rate Percent Change From Baseline to 12 Month Follow-up |
108.4 | — |
| SECONDARY Intent to Treat Population Post Void Residual Measurement at Baseline and 12 Month Follow-up |
108.5; 69.9 | — |
| SECONDARY Intent to Treat Population Post Void Residual Change From Baseline to 12 Month Follow-up |
-4.8 | — |
Eligibility Criteria
Inclusion Criteria
- Enlarged median lobe (ML) contributing to obstruction of the prostate
- BPH
Exclusion Criteria
-
Data sourced from ClinicalTrials.gov (NCT02625545). 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. Informational only — not medical advice.