Retrospective Chart Review Study of Patients Treated With Votiva Device

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04437680

Enrollment

600

Registered

2020-06-18

Start date

2020-06-05

Completion date

2020-12-30

Last updated

2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vulvovaginal Signs and Symptoms

Brief summary

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

Interventions

DEVICEVotiva device

A retrospective chart review of the medical records

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Participant satisfaction post treatment	4 weeks post treatment	• Participant satisfaction post treatment. Number of patients who are satisfied with post treatment results \[ Time Frame: Baseline to 4 weeks post-treatment/s\]

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026