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RF Rejuvenation for Pelvic Floor and Vagina

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03536819
Recruitment Status : Completed
First Posted : May 25, 2018
Last Update Posted : March 26, 2019
Information provided by (Responsible Party):
InMode MD Ltd.

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

Condition or disease Intervention/treatment Phase
Symptoms Associated With Pelvic Floor Weakness Device: Votiva Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Subjects will receive the treatment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radio-frequency Rejuvenation for Pelvic Floor and Vagina
Actual Study Start Date : November 17, 2017
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Arm Intervention/treatment
Experimental: Treatment
Participants receive Votiva treatment
Device: Votiva
The applicator uses radio-frequency energy to treat the vaginal canal

Primary Outcome Measures :
  1. Effect of RF on pelvic floor [ Time Frame: 4 months ]
    Evaluate the effects of radio frequency on pelvic floor strength as measured by intentional muscle contraction

  2. Recording of adverse events (safety) [ Time Frame: 4 months ]
    Observation, assessment and recording of reactions

Secondary Outcome Measures :
  1. Evaluate urinary symptoms associated with pelvic floor weakness [ Time Frame: 4 months ]
    Subjective evaluation using standard questionnaire

  2. Evaluate sexual dysfunction symptoms associated with pelvic floor weakness [ Time Frame: 4 months ]
    Subjective evaluation using standard questionnaire

  3. Evaluate quality of life symptoms associated with pelvic floor weakness [ Time Frame: 4 months ]
    Subjective evaluation using standard questionnaire

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03536819

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United States, Illinois
Midwest Plastic Surgery
LaGrange, Illinois, United States, 60525
Sponsors and Collaborators
InMode MD Ltd.
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Principal Investigator: George Kouris, MD Midwest Plastic Surgery, 5201 S. Willow Springs Road, Suite 440 LaGrange, IL, 60525
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Responsible Party: InMode MD Ltd. Identifier: NCT03536819    
Other Study ID Numbers: DO607404A
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No