N/A Completed N=99 Randomized Quadruple-blind Treatment

LIBERATE International

Stress Urinary Incontinence

Source: ClinicalTrials.gov NCT03619174 ↗

Enrolled (actual)

Serious AEs

3.0%

Results posted

Aug 2022

Primary outcomePrimary: CFB in 1-hour Pad Weight Test — -8.1; -8.1 grams

Summary

This is a prospective, randomized, double-blind, sham-controlled clinical study. The study is designed to demonstrate that active is superior to sham for the efficacy endpoints and is deemed to have appropriate safety as compared to sham.

Outcome Measures

Outcome	Result	p-value
PRIMARY CFB in 1-hour Pad Weight Test	-8.1; -8.1	—
SECONDARY Safety and Adverse Event Reporting	24; 14	—

Eligibility Criteria

Key Inclusion Criteria

Signed and dated ICF
Pre-menopausal females
Documented diagnosis of SUI

Exclusion Criteria

Pregnant or planning to become pregnant within the year
Undergone other SUI treatments (excluding Kegels)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03619174). 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.