Retrospective Chart Review Study of Patients Treated With Votiva Device (NCT04437680) | Clinical Trial Compass
CompletedNot Applicable
Retrospective Chart Review Study of Patients Treated With Votiva Device
United States600 participantsStarted 2020-06-05
Plain-language summary
retrospective data collection is to gain insight into patients satisfaction post Votiva treatments for the complex of vulvovaginal symptoms.
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.