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Evaluation of Efficacy and Safety of Votiva for Vaginal Rejuvenation

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.
 
ClinicalTrials.gov Identifier: NCT03520426
Recruitment Status : Unknown
Verified April 2018 by Jennifer Walden, Walden, Jennifer L., M.D.,P.L.L.C..
Recruitment status was:  Recruiting
First Posted : May 9, 2018
Last Update Posted : May 9, 2018
Sponsor:
Collaborators:
Aviva Preminger, MD., P.L.L.C.
InMode MD Ltd.
Information provided by (Responsible Party):
Jennifer Walden, Walden, Jennifer L., M.D.,P.L.L.C.

Brief Summary:
This is a multi-site, randomized, prospective study designed to evaluate the safety and efficacy of the Votiva device headpieces through radiofrequency for vaginal rejuvenation. An anticipated 50 subjects will undergo 3 treatments of the vulvovaginal area using radiofrequency unit or radiofrequency placebo. Study duration for each subject is approximately six months (including screening, 3 treatment sessions 3-4 weeks apart and 2 follow-up visit at 3 and 6 months post initiation of treatment (4 and 12 weeks after completion of last treatment). Efficacy will be measured and evaluated by validated questionnaires to include: The Vulvovaginal Symptoms Questionnaire, Vaginal Laxity Questionnaire (VLQ), Urogenital Distress Short Form (UDI-6) and Incontinence Impact Questionnaire Short Form (IIQ-7), Female Sexual Function Index (FSFI) and the Female Sexual Distress Scale-Revised (FSDS-R).

Condition or disease Intervention/treatment Phase
Vaginal Atrophy Vaginal Relaxation Stress Urinary Incontinence Device: Votiva RF Not Applicable

Detailed Description:

Vaginal rejuvenation is a catch-all term of aesthetic and functional procedures which claim to provide relief of many issues affecting women's health, ranging from postmenopausal vulvovaginal symptoms (i.e. dryness, burning, itching), stress urinary incontinence, sexual dysfunction or discomfort, vaginal laxity, and external labial appearance, amongst others.1,2 Several companies have emerged with non-invasive or minimally-invasive technologies to alleviate these conditions which operate by radiofrequency (RF) delivery, Hybrid Fractional Laser, fractional CO2 laser3, or Er:YAG4. Votiva by InMode is unique in its usage as both an internal and external rejuvenating device.

The RF technologies work theoretically by heating the connective tissue of the vaginal wall to 40 to 42°C thereby remodeling extracellular matrix configuration. Once optimal temperatures are reached, collagen contraction, neocollagenesis, vascularization, and growth factor infiltration could lead to durable vaginal wall changes with improvement in elasticity and moisture of the vaginal wall. Although numerous studies have demonstrated the therapeutic efficacy of energy-based devices in rejuvenation of the face, neck, and décolleté, their application in the vaginal canal is a fairly new concept that is currently being studied.11

Given the paucity of data, this study aims to assess the utility and safety of the RF device Votiva in a two arm prospective case control trial for improvement in external labial appearance, vaginal laxity, sexual function and urinary incontinence.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial for the Evaluation of Efficacy and Safety of Votiva for Vaginal Rejuvenation
Actual Study Start Date : March 12, 2018
Estimated Primary Completion Date : January 30, 2020
Estimated Study Completion Date : January 30, 2020

Arm Intervention/treatment
Experimental: Votiva RF
Patients will undergo radiofrequency treatment using the Votiva FormaV and FractoraV hand pieces, using the device's standard protocol. Patients will have 3 treatments spaced 3-4 weeks apart and two follow-up visits. Duration of each treatment visit is approximately 1-1.5 hours. Prior to treatment and follow-up visit, each patient will be assessed using standardized photos, perineometry, and validated questionnaires.
Device: Votiva RF
The Votiva system is approved by the U.S. Food and Drug Administration for treatment of sexual dysfunction as well as in combination with Kegel exercises for tightening of the muscles of the pelvic floor to increase muscle tone. One part of the system, the fractora handpiece, is approved for tissue coagulation for the purpose of skin rejuvenation. The Votiva has two hand pieces, Forma and Fractora, which have been cleared by the United States Food and Drug Administration (FDA) and are used during dermatological procedures.

Sham Comparator: Votiva RF Sham
Patients will undergo the acts of receiving radiofrequency treatment with the Votiva FormaV and FractoraV hand pieces, but no direct energy will be applied. Patients will have 3 treatments spaced 3-4 weeks apart and 2 follow-up visits. Duration of each treatment visit is approximately 1-1.5 hours. Prior to treatment and follow-up visit, each patient will be assessed using standardized photos, perineometry, and validated questionnaires.
Device: Votiva RF
The Votiva system is approved by the U.S. Food and Drug Administration for treatment of sexual dysfunction as well as in combination with Kegel exercises for tightening of the muscles of the pelvic floor to increase muscle tone. One part of the system, the fractora handpiece, is approved for tissue coagulation for the purpose of skin rejuvenation. The Votiva has two hand pieces, Forma and Fractora, which have been cleared by the United States Food and Drug Administration (FDA) and are used during dermatological procedures.




Primary Outcome Measures :
  1. Sexual-impact of vulvovaginal symptoms in postmenopausal women [ Time Frame: 6 months ]
    Assessed and measured by: The Vulvovaginal Symptoms Questionnaire (VVSQ)

  2. Improved Vaginal Laxity [ Time Frame: 6 months ]
    Vaginal laxity/tightness assessed and measured by: Vaginal Laxity Questionnaire (VLQ)

  3. Improved Sexual Function [ Time Frame: 6 months ]
    Sexual dysfunction assessed and measured by: Female Sexual Function Index (FSFI)

  4. Measuring Sexually Related Personal Distress in Women With Female Sexual Dysfunction [ Time Frame: 6 months ]
    Assess distress associated with impaired sexual function assessed and measured by: Female Sexual Distress Scale-Revised Questionnaire

  5. Urogenital Distress Inventory [ Time Frame: 6 months ]
    Assessed and measured by: Urogenital Distress Inventory, Short Form (UDI-6) scores

  6. Urinary Incontinence Impact [ Time Frame: 6 months ]
    Assessed and measured by: Incontinence Impact Questionnaire Short Form (IIQ-7)



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:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women aged 25-65 years with symptoms of vaginal relaxation syndrome and/or urinary incontinence who desire vaginal rejuvenation treatment.
  • Informed Consent Form, Photo Release and sharing of assessments signed by the subject.
  • Ability and willingness to follow the study visits schedule.
  • Ability and willingness to adhere to prescribed medication regime.

Exclusion Criteria:

  • Unable to commit to future appointments within one year
  • Planning on moving away from the New York or Austin area within one year
  • History of other energy-based vaginal therapy within one year
  • Intermittent vaginal hormone replacement therapy. If patients are on hormone replacement therapy, they should maintain their dosing throughout the study. (If using systemic HRT, shouldn't change it during the whole study period)
  • Prior labiaplasty
  • Prior anti-incontinence surgery in the last 12 months
  • Urinary incontinence requiring more than 2 pads/day
  • Urinary tract infection in the past 3 months
  • Immunodeficiency status (steroid intake, ongoing chemotherapy)
  • Diffuse pain syndrome or chronic pain requiring daily narcotics
  • Chronic vaginitis including bacterial vaginosis, HPV, herpes, or other active STI
  • Abnormal Papanicolaou test result in the last 2 years
  • Abnormal pelvic exam (i.e. concerning lesions) or anterior or posterior vaginal prolapse in the last 2 years
  • Undiagnosed abnormal genital bleeding
  • If of child-bearing potential or less than two years postmenopausal, not using a medically approved method of contraception (i.e. oral, transdermal, implanted contraceptives, intrauterine device, diaphragm, condom, etc.)
  • If patients are using a Nuvaring, they must use an alternate form of contraception during the three treatment months
  • Pregnancy (determined by urine HCG prior to procedure) or lactating
  • Psychiatric conditions
  • Pacemaker or internal defibrillator, or other implanted metallic or electronic device.
  • Permanent implant in the treated area such as metal plates and screws or silicone.
  • Current or history of any type of cancer, or pre-malignant conditions.
  • Severe concurrent conditions, such as cardiac disorders.
  • History of or current diseases stimulated by heat, such as recurrent Herpes Simplex, in the area of the vagina where the study device will be applied. This area may be included in the study only following a prophylactic regimen.
  • Poorly controlled endocrine disorders, such as diabetes.
  • Any active skin condition in the treatment area, such as sores, infection, eczema, and rash. History of skin disorders, keloids (irregularly shaped scars), abnormal wound healing, as well as very dry and fragile skin.
  • History of a bleeding disorder in which the blood's ability to form clots is impaired.
  • Any treatment or surgery performed in the treatment area within a year prior to treatment.
  • Use of Isotretinoin (Accutane®) within 6 months prior to treatment.
  • Any therapies or medications which may interfere with the use of the study device.
  • Compromised health as determined by the study doctor.

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 ClinicalTrials.gov identifier (NCT number): NCT03520426


Contacts
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Contact: Sherilyn D. Garcia, BS (512) 328-4100 Sherilyn.Drwalden@gmail.com
Contact: Jennifer L. Walden, MD (512) 328-4100 DrJenniferWalden@hotmail.com

Locations
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United States, New York
Preminger Plastic Surgery Recruiting
New York, New York, United States, 10028
Contact: Aviva Preminger, MD    512-328-4100    premingermd@gmail.com   
United States, Texas
Jennifer L. Walden MD., P.L.L.C. Recruiting
Austin, Texas, United States, 78746
Contact: Sherilyn Garcia, BS    512-328-4100    Sherilyn.Drwalden@gmail.com   
Sponsors and Collaborators
Walden, Jennifer L., M.D.,P.L.L.C.
Aviva Preminger, MD., P.L.L.C.
InMode MD Ltd.
Investigators
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Principal Investigator: Jennifer L. Walden, MD Owner
Principal Investigator: Aviva Preminger, MD Co-Site PI
Publications:
Coad JE, Vos JA, Curtis A, Krychman M. Safety and mechanisms of action supporting nonablative radiofrequency thermal therapy for vaginal introitus laxity occurring in women after childbirth: Histological study in the sheep vaginal model. J Sex Med 2013;10(Supplement 2):175.

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Responsible Party: Jennifer Walden, Jennifer L. Walden, MD, FACS, Walden, Jennifer L., M.D.,P.L.L.C.
ClinicalTrials.gov Identifier: NCT03520426    
Other Study ID Numbers: 6198
First Posted: May 9, 2018    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.: Yes
Additional relevant MeSH terms:
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Urinary Incontinence
Urinary Incontinence, Stress
Atrophy
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Pathological Conditions, Anatomical