N/A Completed N=206 Randomized Single-blind Treatment

The Safety and Effectiveness of UroLift: LIFT Pivotal Study

Benign Prostatic Hyperplasia

Source: ClinicalTrials.gov NCT01294150 ↗

Enrolled (actual)

206

Serious AEs

34.5%

Results posted

Aug 2015

Primary outcomePrimary: Collection of Post-treatment Catheterization for Safety — 2 participants

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.

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.