Retrospective Chart Review Study of Patients Treated With Votiva Device
Completed
- Conditions
- Vulvovaginal Signs and Symptoms
- Registration Number
- NCT04437680
- Lead Sponsor
- InMode MD Ltd.
- Brief Summary
retrospective data collection is to gain insight into patients satisfaction post Votiva treatments for the complex of vulvovaginal symptoms.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 600
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Participant satisfaction post treatment 4 weeks post treatment • Participant satisfaction post treatment. Number of patients who are satisfied with post treatment results \[ Time Frame: Baseline to 4 weeks post-treatment/s\]
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Advanced Women's Care of the Lowcountry
🇺🇸Hilton Head Island, South Carolina, United States
Owen Health Group
🇺🇸Lubbock, Texas, United States