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

Abstract

Background: The purpose of this prospective, investigator-initiated feasibility study is to evaluate the efficacy and safety of nonablative, cryogen-cooled, monopolar radiofrequency (CMRF) treatment for stress urinary incontinence (SUI). Materials and Methods: Subjects meeting all the inclusion and exclusion criteria were enrolled and divided into two groups. Subjects in Group 1 received a single SUI treatment, and subjects in Group 2 received two SUI treatments ∼6 weeks apart. Follow-up visits are planned for 1, 4, 6, and 12 months post-treatment. At each study visit, subjects are asked to perform a 1-hour pad-weight test (PWT) and to complete the Urogenital Distress Inventory-6 (UDI-6), Incontinence Impact Questionnaire-Short Form (IIQ-7), and International Consultation on Incontinence Modular Questionnaire-Urinary Incontinence-Short Form (ICIQ-UI-SF) questionnaires. In addition, subjects completed 7-day 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 PWT, with a >50% reduction in pad weight for 68.8% of the Group 1 subjects and 69.2% of the Group 2 subjects at 6 months. Initial review of the bladder voiding diaries suggests that subjects are having fewer urine leakage episodes per day. In addition to efficacy, the CMRF Viveve System was well tolerated and safe. Conclusions: The endpoints evaluated indicate an improvement in SUI symptoms and quality of life. The sustained benefit of the CMRF vaginal treatment at 6 months suggests potential use as a nonsurgical approach to treat SUI.

Trial registration: ClinicalTrials.gov NCT03066180.

Keywords: one-hour pad-weight test (1-hour PWT); radiofrequency (RF); stress urinary incontinence (SUI).

FIG. 1.

CONSORT diagram. Note, the final follow-up visit is at 12 months, but this article only discusses the trial through 6-month follow-up visit.

FIG. 2.

Mean composite scores for SUI-related patient-reported outcomes. The gray bar in each graph denotes a published MCID from the literature. ICIQ-UI-SF, International Consultation on Incontinence Modular Questionnaire-Urinary Incontinence-Short Form; IIQ-7, Incontinence Impact Questionnaire-Short Form; MCID, minimal clinical important difference; SUI, stress urinary incontinence; UDI-6, Urogenital Distress Inventory-6.