RF Rejuvenation for Pelvic Floor and Vagina

Radio-frequency Rejuvenation for Pelvic Floor and Vagina

NCT03536819•InMode MD Ltd.

View on ClinicalTrials.gov

Summary

Evaluation of efficacy and safety of the Votiva RF system with the Forma V handpiece for vaginal treatments.

Detailed Description

This study will evaluate the effects of radiofrequency on pelvic floor strength and the change in associated symptoms through direct measurement and patient reporting. The patients will undergo two separate evaluation appointments then receive two treatments. One group will receive a sham treatment and the other will receive the treatment. The sham group will be offered treatment at the end of the study.

Eligibility

Age

35 - 75 years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•Adult females between the ages of 35-75, seeking treatments for pelvic floor relaxation syndrome or atrophic vaginitis, which include but are not limited to: pelvic floor laxity, decreased muscle contraction in the pelvic floor, urinary incontinence, sexual dysfunction.
•Participants must have an evaluation by the Pelvic Floor Physical Therapists. All participants must have a minimum of 30% below average reading on initial assessment of internal or external pelvic floor contraction in order to be included in the study.
•Negative PAP smear and pelvic exam done within last 1 year.
•The patients should understand the information provided about the investigative nature of the treatment, possible benefits and side effects, and sign the Informed Consent Form, (including the permission to use photography).
•The patients should be willing to comply with the study procedure and schedule, including the follow up visit, and will refrain from using any other treatment methods in the treatment areas such surgeries,CO2 treatment, other radiofrequency treatments and fillers injections for the last 12 months and during the entire study period.

Exclusion Criteria

•Internal defibrillator, pacemaker, bladder stimulator or any other implanted electrical device anywhere in the body
•Permanent metal implant in the treatment area
•History of pelvic floor radiation
•Any surgery in the treatment area in the last 3 months
•Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles
•Pregnancy and nursing
•Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications
•Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regimen.
•Poorly controlled endocrine disorders, such as diabetes, thyroid dysfunction, polycystic ovary and hormonal virilization
•Any active condition in the treatment area, such as but not limited to open sores, psoriasis, eczema,vitiligo,herpes and rash.
+7 more criteria

Locations (1)

Midwest Plastic Surgery

LaGrange, Illinois, United States

Key Dates

Start Date

November 17, 2017

Primary Completion Date

December 31, 2018

Completion Date

December 31, 2018

Last Updated

November 18, 2020

Enrollment

ACTUAL participants

Conditions

Symptoms Associated With Pelvic Floor Weakness

Interventions

Votiva

DEVICE