Recruiting

Votiva

Sponsor:

Walden, Jennifer L., M.D.,P.L.L.C.

Code:

NCT03520426

Conditions

Vaginal Atrophy

Vaginal Relaxation

Stress Urinary Incontinence

Eligibility Criteria

Sex: Female

Age: 25 - 65

Healthy Volunteers: Accepted

Interventions

Votiva RF

Study Details

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).

Conditions

Vaginal Atrophy

Vaginal Relaxation

Stress Urinary Incontinence

Study ID

NCT03520426

Start date

Mar 12, 2018

Status verified date

Apr, 2018

Completion date

Jan 30, 2020

Anticipated

Primary completion date

Jan 30, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 25 - 65

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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 measure

  • Sexual-impact of vulvovaginal symptoms in postmenopausal women [ Time Frame: 6 months ]
  • Improved Vaginal Laxity [ Time Frame: 6 months ]
  • Improved Sexual Function [ Time Frame: 6 months ]
  • Measuring Sexually Related Personal Distress in Women With Female Sexual Dysfunction [ Time Frame: 6 months ]
  • Urogenital Distress Inventory [ Time Frame: 6 months ]
  • Urinary Incontinence Impact [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Sherilyn D. Garcia, BS

(512) 328-4100Sherilyn.Drwalden@gmail.com

Jennifer L. Walden, MD

(512) 328-4100DrJenniferWalden@hotmail.com

Locations

Preminger Plastic Surgery

Recruiting

New York, New York, United States, 10028

Contacts

Aviva Preminger, MD

512-328-4100premingermd@gmail.com

Jennifer L. Walden MD., P.L.L.C.

Recruiting

Austin, Texas, United States, 78746

Contacts

Sherilyn Garcia, BS

512-328-4100Sherilyn.Drwalden@gmail.com

More Information

Sponsor

Walden, Jennifer L., M.D.,P.L.L.C.

Last update posted

May 9, 2018

Last verified

Apr, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Walden, Jennifer L., M.D.,P.L.L.C. on 2018-05-09.