N/A N=45 Treatment

Study of Median Lobe Prostatic UroLift Procedure

Benign Prostatic Hyperplasia (BPH)

Bottom Line

View on ClinicalTrials.gov: NCT02625545 ↗

Enrolled (actual)

Serious AEs

11.1%

Results posted

Feb 2019

Primary outcome: 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 percent change

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: UroLift System procedure (Device)
Age: Adult, Older Adult · 50+ yrs
Sex: Male
Sponsor: NeoTract, Inc.
Primary completion: May 2017

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	—

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).

Eligibility Criteria

Inclusion Criteria

Enlarged median lobe (ML) contributing to obstruction of the prostate
BPH

Exclusion Criteria

View full record on ClinicalTrials.gov →

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.