A Clinical Feasibility Study for the Treatment of Female
Stress Urinary Incontinence

An Interim 6-Month Report

ABSTRACT

Introduction: The purpose of this clinical study is to evaluate the efficacy and safety of non-ablative, cryogen-cooled, monopolar radiofrequency (CMRF) treatment for stress urinary incontinence (SUI).

Methods:
This is a prospective, feasibility study designed to demonstrate the treatment under review meets primary efficacy and safety endpoints. Subjects meeting all the inclusion and exclusion criteria, were enrolled in the study. The study was divided into two groups; subjects in Group 1 received a single SUI treatment and subjects in Group 2 received two SUI treatments approximately six (6) weeks apart. Follow-up visits are planned for 1, 4, 6, and 12 months post-treatment. At the Screening Visit, and at each timepoint beginning at Month 1, subjects are asked to perform a 1-hour pad weight test and to complete the Urogenital Distress Inventory-6 (UDI-6), Incontinence Impact Questionnaire-7 (IIQ-7), and International Consultation on Incontinence Modular Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF) questionnaires. In addition, subjects completed a 7-day Daily Bladder Voiding Diary and safety assessments.

Results: Preliminary data indicate an improvement in SUI symptoms and quality of life for subjects, as determined by validated SUI-related patient reported outcomes and the objective 1-hour pad weight test, with a greater than 50% reduction in pad weight for 69% of the subjects at 6 months (data collected to date). The overall response rate thus far is between 75-85%, with all measures considered. Initial review of the bladder voiding diaries suggest that subjects are having fewer urine leakage episodes per day and are more active in their daily lives. In addition to efficacy, the CMRF Viveve System was well-tolerated and safe.

Conclusion:
The outcome measures evaluated indicate a significant improvement in SUI symptoms and quality of life as evaluated by the objective 1-hour pad weight test and several subjective patient-reported outcome measures. The sustained benefit of the CMRF vaginal treatment at 6 months suggests potential use as a non-surgical approach to treat SUI, offering another option for millions of women.

Clinical Trial Registration: clinicaltrials.gov Identifier: NCT03066180

*Data was submitted to support our FDA clearance for coagulation and hemostasis.

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