A novel negative pressure treatment for the genitourinary syndrome of menopause: a feasibility pilot study with the VITA AV clinical system

OBJECTIVE: To determine the feasibility of using a novel negative pressure device for effectiveness and safety in treating genitourinary syndrome of menopause (GSM). METHODS: An unblinded feasibility study was performed in 12 women with GSM using the VITA AV Clinical System: a system with a disposable intravaginal tip with circumferential orifices, connected to a vacuum pump. Negative pressure draws the vaginal epithelium into the orifices, inducing microtrauma and a regenerative physiological response. Women underwent familiarization sessions with increasing negative pressure to the vaginal epithelium for 3 minutes, followed by three monthly sessions at 3, 4, and 5 minutes, respectively. Efficacy was assessed on the change in the most bothersome symptom (MBS) and vaginal health maturation index scores at 1 and 12 months after treatment. Tolerability was determined by pain scores during treatment. Safety data were collected throughout. RESULTS: All women completed the study and tolerated maximum negative pressure while reporting negligible to no pain during treatment. Seven of the 12 reported improvement, and 3 reported complete resolution in MBS at 1 month. Nine remained improved at 12 months. Vaginal maturation index improved in 92% at 1 month and 66% at 12 months. All women rated their satisfaction with the device as good to very good. No adverse or device-related events occurred. CONCLUSION: Negative pressure treatment was tolerated by women affected by GSM with no safety issues, and with observed favorable changes in reported symptoms and objective assessments. Controlled studies are warranted with larger sample sizes and increased frequency of follow-up to assess the time course of improvements.