Evaluation of Efficacy and Safety of Votiva for Vaginal Rejuvenation

• ClinicalTrials.gov Identifier: NCT03520426
• Recruitment Status: Unknown
• First Posted: May 9, 2018
• Last Update Posted: May 9, 2018
• Sponsor: Walden, Jennifer L., M.D.,P.L.L.C.
• 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.

Tracking Information

• First Submitted Date: April 27, 2018
• First Posted Date: May 9, 2018
• Last Update Posted Date: May 9, 2018
• Actual Study Start Date: March 12, 2018
• Estimated Primary Completion Date: January 30, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 27, 2018)

• Sexual-impact of vulvovaginal symptoms in postmenopausal women [ Time Frame: 6 months ]
  Assessed and measured by: The Vulvovaginal Symptoms Questionnaire (VVSQ)
• Improved Vaginal Laxity [ Time Frame: 6 months ]
  Vaginal laxity/tightness assessed and measured by: Vaginal Laxity Questionnaire (VLQ)
• Improved Sexual Function [ Time Frame: 6 months ]
  Sexual dysfunction assessed and measured by: Female Sexual Function Index (FSFI)
• 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
• Urogenital Distress Inventory [ Time Frame: 6 months ]
  Assessed and measured by: Urogenital Distress Inventory, Short Form (UDI-6) scores
• Urinary Incontinence Impact [ Time Frame: 6 months ]
  Assessed and measured by: Incontinence Impact Questionnaire Short Form (IIQ-7)

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluation of Efficacy and Safety of Votiva for Vaginal Rejuvenation
• Official Title: A Randomized Controlled Trial for the Evaluation of Efficacy and Safety of Votiva for Vaginal Rejuvenation
• 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).

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment

Condition

• Vaginal Atrophy
• Vaginal Relaxation
• Stress Urinary Incontinence

Intervention

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.

Study 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.
  Intervention: Device: Votiva RF
• 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.
  Intervention: Device: Votiva RF

Publications *

• Millheiser LS, Pauls RN, Herbst SJ, Chen BH. Radiofrequency treatment of vaginal laxity after vaginal delivery: nonsurgical vaginal tightening. J Sex Med. 2010 Sep;7(9):3088-95. doi: 10.1111/j.1743-6109.2010.01910.x.
• Sekiguchi Y, Utsugisawa Y, Azekosi Y, Kinjo M, Song M, Kubota Y, Kingsberg SA, Krychman ML. Laxity of the vaginal introitus after childbirth: nonsurgical outpatient procedure for vaginal tissue restoration and improved sexual satisfaction using low-energy radiofrequency thermal therapy. J Womens Health (Larchmt). 2013 Sep;22(9):775-81. doi: 10.1089/jwh.2012.4123. Epub 2013 Aug 16.
• Zerbinati N, Serati M, Origoni M, Candiani M, Iannitti T, Salvatore S, Marotta F, Calligaro A. Microscopic and ultrastructural modifications of postmenopausal atrophic vaginal mucosa after fractional carbon dioxide laser treatment. Lasers Med Sci. 2015 Jan;30(1):429-36. doi: 10.1007/s10103-014-1677-2. Epub 2014 Nov 20.
• Lee MS. Treatment of Vaginal Relaxation Syndrome with an Erbium:YAG Laser Using 90 degrees and 360 degrees Scanning Scopes: A Pilot Study & Short-term Results. Laser Ther. 2014 Jul 1;23(2):129-38. doi: 10.5978/islsm.14-OR-11.
• Committee on Gynecologic Practice, American College of Obstetricians and Gynecologists. ACOG Committee Opinion No. 378: Vaginal "rejuvenation" and cosmetic vaginal procedures. Obstet Gynecol. 2007 Sep;110(3):737-8. doi: 10.1097/01.AOG.0000263927.82639.9b.
• Alinsod RM. Transcutaneous temperature controlled radiofrequency for orgasmic dysfunction. Lasers Surg Med. 2016 Sep;48(7):641-5. doi: 10.1002/lsm.22537. Epub 2016 May 19. Erratum In: Lasers Surg Med. 2017 Sep;49(7):727.
• 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.
• Krychman M, Rowan CG, Allan BB, DeRogatis L, Durbin S, Yacoubian A, Wilkerson D. Effect of Single-Treatment, Surface-Cooled Radiofrequency Therapy on Vaginal Laxity and Female Sexual Function: The VIVEVE I Randomized Controlled Trial. J Sex Med. 2017 Feb;14(2):215-225. doi: 10.1016/j.jsxm.2016.11.322.
• Karcher C, Sadick N. Vaginal rejuvenation using energy-based devices. Int J Womens Dermatol. 2016 Jun 21;2(3):85-88. doi: 10.1016/j.ijwd.2016.05.003. eCollection 2016 Sep.
• Erekson EA, Yip SO, Wedderburn TS, Martin DK, Li FY, Choi JN, Kenton KS, Fried TR. The Vulvovaginal Symptoms Questionnaire: a questionnaire for measuring vulvovaginal symptoms in postmenopausal women. Menopause. 2013 Sep;20(9):973-9. doi: 10.1097/GME.0b013e318282600b.
• Erekson EA, Li FY, Martin DK, Fried TR. Vulvovaginal symptoms prevalence in postmenopausal women and relationship to other menopausal symptoms and pelvic floor disorders. Menopause. 2016 Apr;23(4):368-75. doi: 10.1097/GME.0000000000000549.
• Uebersax JS, Wyman JF, Shumaker SA, McClish DK, Fantl JA. Short forms to assess life quality and symptom distress for urinary incontinence in women: the Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Continence Program for Women Research Group. Neurourol Urodyn. 1995;14(2):131-9. doi: 10.1002/nau.1930140206.
• Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597.
• Derogatis L, Clayton A, Lewis-D'Agostino D, Wunderlich G, Fu Y. Validation of the female sexual distress scale-revised for assessing distress in women with hypoactive sexual desire disorder. J Sex Med. 2008 Feb;5(2):357-64. doi: 10.1111/j.1743-6109.2007.00672.x. Epub 2007 Nov 27.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: April 27, 2018): 50
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 30, 2020
• Estimated Primary Completion Date: January 30, 2020 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 25 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03520426
• Other Study ID Numbers: 6198
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Jennifer Walden, Walden, Jennifer L., M.D.,P.L.L.C.
• Original Responsible Party: Same as current
• Current Study Sponsor: Walden, Jennifer L., M.D.,P.L.L.C.
• Original Study Sponsor: Same as current

Collaborators

• Aviva Preminger, MD., P.L.L.C.
• InMode MD Ltd.

Investigators

• Principal Investigator: Jennifer L. Walden, MD; Owner
• Principal Investigator: Aviva Preminger, MD; Co-Site PI

• PRS Account: Walden, Jennifer L., M.D.,P.L.L.C.
• Verification Date: April 2018