Vaginal AtrophyNCT03520426
Evaluation of Efficacy and Safety of Votiva for Vaginal Rejuvenation
A study testing Votiva RF in people with Vaginal Atrophy and Vaginal Relaxation, run by Walden, Jennifer L., M.D.,P.L.L.C. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Atrophy, Vaginal Relaxation, Stress Urinary Incontinence
- What is being tested?
- Votiva RF
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Mar 2018to 30 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 30Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Jennifer L. Walden MD., P.L.L.C.
Austin, Texas, 78746
Sherilyn Garcia, BS, 512-328-4100, Sherilyn.Drwalden@gmail.com
- Recruiting
Preminger Plastic Surgery
New York, New York, 10028
Aviva Preminger, MD, 512-328-4100, premingermd@gmail.com
About this study
Official title: A Randomized Controlled Trial for the Evaluation of Efficacy and Safety of Votiva for Vaginal Rejuvenation
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).
Read the 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.
- Being tested
- Votiva RF
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Votiva RFDevice
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 group | Role | What they receive |
|---|---|---|
| Votiva RF | Experimental | 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. Receives: Device: Votiva RF |
| Votiva RF Sham | Sham comparator | 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. Receives: Device: Votiva RF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual-impact of vulvovaginal symptoms in postmenopausal women
Assessed and measured by: The Vulvovaginal Symptoms Questionnaire (VVSQ)
Measured: 6 months
Improved Vaginal Laxity
Vaginal laxity/tightness assessed and measured by: Vaginal Laxity Questionnaire (VLQ)
Measured: 6 months
Improved Sexual Function
Sexual dysfunction assessed and measured by: Female Sexual Function Index (FSFI)
Measured: 6 months
Measuring Sexually Related Personal Distress in Women With Female Sexual Dysfunction
Assess distress associated with impaired sexual function assessed and measured by: Female Sexual Distress Scale-Revised Questionnaire
Measured: 6 months
Urogenital Distress Inventory
Assessed and measured by: Urogenital Distress Inventory, Short Form (UDI-6) scores
Measured: 6 months
Urinary Incontinence Impact
Assessed and measured by: Incontinence Impact Questionnaire Short Form (IIQ-7)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study start12 Mar 2018
- Primary completion30 Jan 2020 (estimated)
- Study completion30 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Vaginal AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walden, Jennifer L., M.D.,P.L.L.C.
- Collaborators
- Aviva Preminger, MD., P.L.L.C., InMode MD Ltd.
- Responsible party
- Principal investigator, Jennifer Walden, Walden, Jennifer L., M.D.,P.L.L.C.
- Investigators
- Jennifer L. Walden, MD, Principal investigator, OwnerAviva Preminger, MD, Principal investigator, Co-Site PI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03520426
- Sponsor's protocol ID
- 6198
- Status last verified
- Apr 2018
- First submitted
- 27 Apr 2018
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 20584127Sekiguchi 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.
PubMed 23952177Zerbinati 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.
PubMed 25410301Lee 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.
PubMed 25071312Committee 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.
PubMed 17766626Alinsod 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.
PubMed 27197701Coad 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.
PubMed 28161079Karcher 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.
PubMed 28492016Erekson 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.
PubMed 23481118Erekson 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.
PubMed 26645820Uebersax 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.
PubMed 7780440Rosen 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.
PubMed 10782451Derogatis 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.
PubMed 18042215
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial for the Evaluation of Efficacy and Safety of Votiva for Vaginal Rejuvenation
- ClinicalTrials.gov ID
- NCT03520426
- Acronym / sponsor ID
- 6198
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Walden, Jennifer L., M.D.,P.L.L.C.
- Collaborators
- Aviva Preminger, MD., P.L.L.C., InMode MD Ltd.
- Study start
- 12 Mar 2018 (actual)
- Primary completion
- 30 Jan 2020 (estimated)
- Study completion
- 30 Jan 2020 (estimated)
- First posted
- 9 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Votiva RF | Experimental | Device: Votiva RFPatients 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. |
| Votiva RF Sham | Sham comparator | Device: Votiva RFPatients 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. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (30 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Votiva RFThe 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. | Device | Votiva RF, Votiva RF Sham |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
- Background: PubMed 20584127Millheiser 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.
- Background: PubMed 23952177Sekiguchi 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.
- Background: PubMed 25410301Zerbinati 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.
- Background: PubMed 25071312Lee 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.
- Background: PubMed 17766626Committee 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.
- Background: PubMed 27197701Alinsod 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.
- BackgroundCoad 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.
- Background: PubMed 28161079Krychman 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.
- Background: PubMed 28492016Karcher 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.
- Background: PubMed 23481118Erekson 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.
- Background: PubMed 26645820Erekson 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.
- Background: PubMed 7780440Uebersax 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer L. Walden, MD principal investigator
Owner
Aviva Preminger, MD principal investigator
Co-Site PI
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Votiva RF in people with Vaginal Atrophy and Vaginal Relaxation, run by Walden, Jennifer L., M.D.,P.L.L.C. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sherilyn D. Garcia, BS ((512) 328-4100, Sherilyn.Drwalden@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual-impact of vulvovaginal symptoms in postmenopausal women (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03520426, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2018.