RF Rejuvenation for Pelvic Floor and Vagina

InMode

Status

Completed

Conditions

Symptoms Associated With Pelvic Floor Weakness

Treatments

Device: Votiva

Study type

Interventional

Funder types

Industry

Identifiers

NCT03536819

DO607404A

Details and patient eligibility

About

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

Full 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.

Enrollment

20 patients

Sex

Female

Ages

35 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.