Retrospective Chart Review Study of Patients Treated With Votiva Device

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

Study Overview

• Status: Completed
• Conditions: Vulvovaginal Signs and Symptoms
• Intervention / Treatment: Device: Votiva device

• Study Type: Observational
• Enrollment (Actual): 600

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Hilton Head Island, South Carolina, United States, 29926
      • Advanced Women's Care of the Lowcountry
  • Texas
    • Lubbock, Texas, United States, 79424
      • Owen Health Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

A retrospective chart review of the medical records of 2 practices will be performed by investigators listed in the approved IRB protocol. Patients are seen at 1 site from August 2018 - May 2020, at 2nd site from September 2018 - February 2020 will be included. Patents who have received RF treatment with Votiva will be identified and selected.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant satisfaction 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]	4 weeks post treatment

Collaborators and Investigators

• Sponsor: InMode MD Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2020
• Primary Completion (Actual): December 30, 2020
• Study Completion (Actual): December 30, 2020

Study Registration Dates

• First Submitted: June 16, 2020
• First Submitted That Met QC Criteria: June 16, 2020
• First Posted (Actual): June 18, 2020

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 10, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: DO609635A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes