Retrospective Chart Review Study of Patients Treated With Votiva Device

InMode

Status: Completed

Conditions: Vulvovaginal Signs and Symptoms

Treatments: Device: Votiva device

Study type: Observational

Funder types: Industry

Identifiers

NCT04437680

DO609635A

Details and patient eligibility

About

retrospective data collection is to gain insight into patients satisfaction post Votiva treatments for the complex of vulvovaginal symptoms.

Enrollment: 600 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age ≥ 18years of age at the time of the procedure
• patients with symptoms of at least one of the following: vaginal relaxation syndrome, vaginal atrophy, vaginal dryness, dyspareunia, SUI, Vaginal laxity, recurrent UTI, recurrent vaginal infections, Linchen Sclerosis, perineal pain, itchiness.
• At least one Votiva procedure that included FormaV applicator treatment with or without combination with Fractora/Morpheus8 Applicators treatments

Exclusion criteria

• active infection, collagen disorders, immunocompromised state, medications that mitigate inflammatory response, and propensity for keloid/hypertrophic scarring.