RF Rejuvenation for Pelvic Floor and Vagina

NCT ID: NCT03536819

Last Updated: 2020-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-17
• Study Completion Date: 2018-12-31

Brief 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.

Conditions

Symptoms Associated With Pelvic Floor Weakness

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Participants receive Votiva treatment

Group Type: EXPERIMENTAL

Votiva

Intervention Type: DEVICE

The applicator uses radio-frequency energy to treat the vaginal canal

Interventions

Votiva

The applicator uses radio-frequency energy to treat the vaginal canal

Intervention Type: DEVICE

Eligibility Criteria

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.
• History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin
• Severe concurrent conditions, such as cardiac disorders, sensory disturbances.
• Use of Isotretinoin (Accutane®) within 6 months prior to treatment.
• Diseases that may be stimulated by light, such as epilepsy, lupus and urticaria.
• Any other previous treatments in the vaginal or perineal area, such as CO2 laser or RF performed on the same area.
• Any surgical procedure in the vaginal area within the past 12 months.
• Recent tan from sun, sunbeds or chemicals or planned excessive sun exposure.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

InMode MD Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

George Kouris, MD

Role: PRINCIPAL_INVESTIGATOR

Midwest Plastic Surgery, 5201 S. Willow Springs Road, Suite 440 LaGrange, IL, 60525

Locations

Midwest Plastic Surgery

LaGrange, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

DO607404A

Identifier Type: -

Identifier Source: org_study_id