Effect of Single-Treatment, Surface-Cooled Radiofrequency Therapy on Vaginal Laxity and Female Sexual Function: The VIVEVE I Randomized Controlled Trial

Abstract

Introduction Vaginal laxity is a highly prevalent and undertreated medical condition. Aim To evaluate the efficacy and safety of surface-cooled, monopolar radiofrequency (RFc) therapy for the treatment of vaginal laxity in the VIVEVE I trial. Methods The VIVEVE I trial was a prospective, randomized, single-blinded, and sham-controlled study. Nine study centers in Canada, Italy, Spain, and Japan participated. Women presenting with vaginal laxity were screened and informed consent was obtained. Major study inclusion criteria were premenopausal status, age at least 18 years, at least one full-term vaginal delivery, and normal genito-pelvic examination results. Enrolled subjects were randomized (2:1) to receive RFc therapy (Active [90 J/cm2] vs Sham [1 J/cm2], respectively) delivered to the vaginal tissue. Main Outcome Measures The primary efficacy outcome was the proportion of randomized subjects reporting “no vaginal laxity” (Active vs Sham) at 6 months postintervention, which was assessed using the Vaginal Laxity Questionnaire. Treatment-emergent adverse events were evaluated in all treated subjects. Secondary efficacy end points included change on the Female Sexual Function Index (FSFI) and the revised Female Sexual Distress Scale (FSDS-R). Results No vaginal laxity was achieved by 43.5% and 19.6% (P = .002) in the Active and Sham groups, respectively. Differences in FSFI and FSDS-R total scores (Active vs Sham) were 1.8 (P = .031) and −2.42 (P = .056), respectively, in favor of Active treatment. Treatment-emergent adverse events were reported by 11.1% and 12.3% of subjects in the Active and Sham arms, respectively. Conclusion The VIVEVE I trial is the first randomized, controlled, blinded, clinical study of RFc for the treatment of vaginal laxity. A single treatment of RFc therapy was found to be safe and associated with both improved vaginal laxity and improved sexual function. The results from this trial support the use of a novel non-surgical therapy for vaginal laxity, a prevalent and undertreated condition.

Correlates of vaginal laxity symptoms in women attending a urogynecology clinic in Saudi Arabia

“…This nonspecific definition underscores the heterogeneity of presentations among women complaining of this condition, as well as the unestablished correlation with other symptomatology. Indeed, most of the literature addressing the symptom of VL has focused on treatment modalities, nonsurgical and surgical, rather than on the clinical characteristics and coexisting conditions . The prevalence of VL has not been consistent across studies, ranging from 2% to 48% .…”

The clinical role of LASER for vulvar and vaginal treatments in gynecology and female urology: An ICS/ISSVD best practice consensus document

“…The term VLS and therefore its therapy, vaginal rejuvenation, is not endorsed or formally defined by the leading gynecological societies . However, management of the symptoms have evolved from techniques involving sutures and the adaptation of traditional urogynecological procedures to the use of LASER and radiofrequency procedures …”

“…11 However, management of the symptoms have evolved from techniques involving sutures and the adaptation of traditional urogynecological procedures to the use of LASER 61,90 and radiofrequency procedures. [91][92][93][94][95][96][97][98][99] In 2011, there was an attempt to restore the rugae of the vagina in postmenopausal women ("vaginal rugation rejuvenation"), by vaporization of the vaginal wall in order to create parallel grooves. The procedure was performed in women with a sensation of a loose or smooth vagina.…”

Lasers and energy‐based devices marketed for vaginal rejuvenation: A cross‐sectional analysis of the MAUDE database

“…Another study showed similar results lasting up to a year . One recently completed, randomized, sham‐controlled trial (NCT02261974) evaluated the safety and efficacy of Geneveve™ to treat vaginal laxity and sexual function in women following childbirth In 186 participants who were treated with this device, vaginal laxity improved in 43.5% participants in the treatment arm and in 19.6% of the sham group . Although there were no serious adverse events reported, the study was not powered to detect serious adverse events .…”