Early Feasibility Study to Evaluate the Viveve System for Female Stress Urinary Incontinence: Interim 6-Month Report

Area of Science:

• Urology
• Gynecology
• Medical Devices

Background:

• Stress urinary incontinence (SUI) affects many women, impacting quality of life.
• Current SUI treatments have limitations, necessitating novel approaches.
• Nonablative radiofrequency technology offers a potential new avenue for SUI management.

Purpose of the Study:

• To evaluate the efficacy and safety of cryogen-cooled, monopolar radiofrequency (CMRF) treatment for SUI.
• To assess patient-reported outcomes and objective measures following CMRF treatment.
• To determine the feasibility of CMRF as a non-surgical SUI therapy.

Main Methods:

• Prospective feasibility study involving two treatment groups (single vs. two CMRF sessions).
• Utilized 1-hour pad-weight tests (PWT) and validated questionnaires (UDI-6, IIQ-7, ICIQ-UI-SF).
• Included bladder voiding diaries and safety assessments over a 12-month follow-up period.

Main Results:

• Over 50% reduction in pad weight observed in 68.8% (Group 1) and 69.2% (Group 2) of subjects at 6 months.
• Significant improvements in SUI symptoms and quality of life reported.
• Fewer daily urine leakage episodes noted in bladder voiding diaries.

Conclusions:

• CMRF vaginal treatment demonstrates sustained efficacy and safety for SUI at 6 months.
• The Viveve System shows promise as a well-tolerated, non-surgical option for SUI.
• Further research is warranted to confirm long-term benefits and optimal treatment protocols.