The Viveve system employs a proprietary pulsed radiofrequency energy in combination with simultaneous cooling to protect the
upper cellular layer of tissue. This combined cooling and heating approach enables the safe delivery of energy to much deeper tissue
levels than other available technologies. The deep heating capability targets the connective tissue that plays a role in the structural
integrity of the vagina and urinary systems. The aim of this clinical study is to evaluate the efficacy and safety of non-ablative, cryogen-cooled, monopolar radiofrequency treatment for stress urinary incontinence (SUI).

Thirty-night women with SUI were included in the study and scheduled for pulsed radiofrequency energy in combination with simultaneous cooling to protect the upper cellular layer of tissue. All subjects had a baseline and 6 months post-treatment assessment that included perineal sonography, urodynamic study, and lower urinary tract symptoms. 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), International Consultation on Incontinence Modular Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF) questionnaires and  Female Sexual Function Index (FSFI) before and six months after treatment of Viveve
.

Significant improvements in incontinence with the evaluation of pad tests were found 6 months after Vive treatment when compared to the baseline results (p<0.001). The battery of questionnaires administered to patients, including the UDI-6, IIQ-7, OABSS and POPDI-6, all showed significant improvement post-treatment (P < 0.001). Two patients complained about bothersome vaginal dryness after treatment.  No permanent adverse events were found. The FSFI (Female Sexual Function Index) seemed no significant improvement after treatment.

Significant improvements in incontinence with the evaluation of pad tests were found 6 months after Vive treatment when compared to the baseline results (p<0.001). The battery of questionnaires administered to patients, including the UDI-6, IIQ-7, OABSS and POPDI-6, all showed significant improvement post-treatment (P < 0.001). Two patients complained about bothersome vaginal dryness after treatment.  No permanent adverse events were found.
The outcome measures indicate a significant improvement in SUI symptoms as evaluated by the 1-hour pad weight test, and associated life quality questionnaires. The Viveve treatment was well tolerated and no treatment-related adverse effects were reported. The sustained benefit of the CMRF treatment may offer a novel
approach to treat SUI, offering another option for women

The Viveve system seems to be a safe and efficacious treatment for women with  SUI at least six months. Long-term efficacy should be further evaluated.

Bruce B. Allan, Stacie Bell, PhD,  Kathryn Husarek: Early Feasibility Study to Evaluate the Viveve System for Female Stress Urinary Incontinence: Interim 6-Month Report.J Womens Health (Larchmt). March 2020