Vaginal AtrophyNCT03316950
Radiofrequency and Hybrid Fractional Laser for Vaginal Rejuvenation
A study testing IntraGen RF and DiVA in people with Vaginal Atrophy, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This is a single-center, randomized, prospective study designed to evaluate the efficacy of radiofrequency and hybrid fractional laser for vaginal rejuvenation. 120 subjects will be screened with 100 undergoing a three-part treatment of the vulvovaginal area IntraGen RF unit, IntraGen RF unit placebo, DiVa HFL unit… Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Atrophy
- What is being tested?
- IntraGen RF and DiVA
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2018to 8 Apr 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women should be between 40 and 65 years of age
- Women should be post-menopausal
- Women should be amenorrheic for at least 12 months
- Postmenopausal women presenting with one or more of the following:
- Vulvar itching
- Vulvar burning or stinging
Show all 11Show fewer
- Vulvar pain
- Vulvar irritation
- Vulvar dryness
- Discharge from subject's vulva or vagina
- Odor from subject's vulva or vagina
Who cannot join
- Unable to commit to future appointments within one year
- Planning on moving away from Dallas within one year
- History of other energy-based vaginal therapy within one year
- Vaginal hormone replacement therapy must have a one month washout period prior to treatment and discontinued use for duration of study, systemic replacement is not excluded
- Prior labiaplasty, or vaginal injections of fat or fillers within 6 months
- Prior anti-incontinence surgery in the last 12 months
Show all 25Show fewer
- Urinary incontinence requiring more than 2 pads/day
- Clinically significant pelvic organ prolapse (POP)
- Urinary tract infection in the past 3 months
- Unstable diabetes
- Ongoing chemotherapy
- 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
- Recent abnormal Papanicolaou test result
- Recent abnormal pelvic exam (i.e. concerning lesions)
- Vulvar dermatologic pathology requiring local steroid use
- Undiagnosed abnormal genital bleeding
- If less than two years postmenopausal, not using a medically approved method of contraception (i.e. oral, transdermal, implanted contraceptives, intrauterine device, diaphragm, condom, etc.)
- Pregnancy
- History of genital fistula or a thin rectovaginal septum
- Uncontrolled psychiatric conditions (well-controlled depression/anxiety is not excluded)
- Body Mass Index > 35
- Actively participating in or planning on participating in pelvic floor muscle strengthening exercise
- Presence of pacemaker, AICD, or other electrical health maintenance device
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
Official title: A Randomized, Placebo-Controlled Trial Evaluating Radiofrequency and Hybrid Fractional Laser for Vaginal Rejuvenation
This is a single-center, randomized, prospective study designed to evaluate the efficacy of radiofrequency and hybrid fractional laser for vaginal rejuvenation. 120 subjects will be screened with 100 undergoing a three-part treatment of the vulvovaginal area IntraGen RF unit, IntraGen RF unit placebo, DiVa HFL unit, or DiVa HFL unit placebo. These treatments will be spaced one month apart and last about 25 minutes each. Each subject will be screened, undergo testing at baseline, and will be followed conservatively with no further therapy until they reach 6 months after the initiation of the designated treatment. At that time, all subjects will undergo subjective and objective testing. Those in the treatment group will be followed to 9 and 12 months after the initiation of treatment with appropriate analysis. Those in the placebo group will be provided a three-part treatment of the vulvovaginal area with the IntraGen RF unit and DiVA HFL unit. These treatments will be spaced one month apart and last about 25 minutes each. Six months after receiving three treatments of the dual therapy these patients will undergo subjective and objective testing. The primary outcome measure is improvement in vulvovaginal symptoms measured by the validated Vulvovaginal Symptoms Questionnaire. Data obtained from each investigation will be recorded in a password-protected digital spreadsheet, REDCap database and descriptive statistics will be obtained.
Read the detailed description
Vaginal rejuvenation is a catch-all term of trendy 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 labial appearance, amongst others2,3. Several companies have emerged with non-invasive or minimally-invasive technologies to alleviate these conditions which operate by radiofrequency delivery (IntraGen by Jeisys), Hybrid Fractional Laser (diVa by Sciton), or fractional CO2 laser (Mona Lisa Touch by Cynosure and Femi Lift by Alma Laser)4.
All of these technologies work theoretically by remodeling extracellular matrix configuration. It is of important note that radiofrequency therapies are typically delivered at 45-55 degrees Celsius in the tissues whereas the laser based products heat up to 60-70 degrees Celsius5. It is believed that "neocollagenesis" may only start if the temperatures are high enough and that such changes in the collagen matrix of the vagina could lead to durable vaginal wall changes. Sciton's diVa is hybrid fractional laser with wavelengths of 2940 nm and 1470 nm for ablation and coagulation, respectively, to treat vaginal tissue6. It is not known whether the changes experienced by patients are due to the reconfiguration of the extracellular matrix (ECM) deep in the vaginal wall or related to the acute swelling and inflammatory processes that occur at the surface of the vagina after these rejuvenation procedures.
The early anecdotal success reported on some user websites might be attributable to surface changes that may not be lasting or to possibly more lasting deeper muscular vaginal wall changes, which may or may not be beneficial. Based on the answer to this first set of questions, we might possibly surmise how such changes will ultimately improve vaginal dryness and/or stress urinary incontinence complaints.
An overriding question and concern is: Assuming these treatments induce collagen changes in the vagina, is it safe to induce such changes? If changes occur, are they long lasting? Can it age the vagina instead of making it "younger"? What are the long-term effects of doing so? Is tissue tightening really scar formation that may be deleterious in the future? The histological, genetic and dynamic changes following vaginal rejuvenation have never been studied.
- Conditions
- Vaginal Atrophy
- Being tested
- IntraGen RF, DiVA, Placebo (DIVA/IntraGen combined)
- Keywords
- postmenopause, rejuvenation, radiofrequency, diva
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntraGen RFDevice
IntraGen is a radiofrequency vaginal rejuvenation device FDA approved for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. The hand piece is a disposable monopolar applicator that is used to apply energy internally and externally.
DiVADevice
DiVA device utilizes a hybrid fractional laser technology in a wand hand piece. The hand piece is covered by a single use strengthened quartz dilator that allows the hand piece to rotate and provide treatment in a uniform manner.
Placebo (DIVA/IntraGen combined)Device
(DIVA/IntraGen combined) IntraGen RF: IntraGen is a radiofrequency vaginal rejuvenation device FDA approved for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. The hand piece is a disposable monopolar applicator that is used to apply energy internally and externally.
DiVA: DiVA device utilizes a hybrid fractional laser technology in a wand hand piece. The hand piece is covered by a single use strengthened quartz dilator that allows the hand piece to rotate and provide treatment in a uniform manner.
| Study group | Role | What they receive |
|---|---|---|
| IntraGen RF | Experimental | Patients will undergo treatment with radiofrequency device, using the device's standard protocol. Patients will have 3 treatments space one month apart. Each treatment will be a total of 20 minutes for internal treatment only. Prior to treatment, the Zimmern probe will be used to measure vaginal wall elasticity and a 0.33mm biopsy will be taken. At each visit, the Zimmern probe will be used. Biopsies will be taken 3 months after final treatment. Receives: Device: IntraGen RF |
| DiVA | Experimental | Patients randomized into the DiVA treatment group will receive treatment per DiVA protocol. Patients will have a total of 3 treatments, space 1 month apart. Each treatment will last approximately 10 minutes. Prior to treatment, the Zimmern probe will be used to measure vaginal wall elasticity and a 0.33mm biopsy will be taken. At each visit, the Zimmern probe will be used. Biopsies will be taken 3 months after final treatment. Receives: Device: DiVA |
| Placebo Arm | Sham comparator | Patients randomized into the Placebo arm will include participants from the DiVa PlaceboGroup and IntraGen Placebo Group combined and will receive treatment based on the DiVA Sham and IntraGen Sham protocols.
DiVa Placebo: patients will undergo a three-part placebo treatment, spaced 1 month apart (+/- 10 days) of the vulvovaginal area. The vaginal HFL handpiece will be inserted into the vaginal canal but sub-therapeutic energy will not be delivered to the tissue.
IntraGen Placebo: patients will undergo a three-part placebo treatment, space 1 month apart (+/- 10 days) of the vulvovaginal area. This will be achieved through application of the probe, but with applying sub-therapeutic energy to the tissue. Receives: Device: Placebo (DIVA/IntraGen combined) |
| Dual Treatment | Experimental | Patients previously randomized into the DiVA Sham and IntraGen Sham groups will be placed in the Dual Treatment group. Patients will have a total of 3 dual treatments, spaced 1 month apart. Each treatment will last approximately 20 minutes. Prior to dual treatments, the Zimmern probe will be used to measure vaginal wall elasticity and a 0.33mm biopsy will be taken. At each visit, the Zimmern probe will be used. Biopsies will be taken at follow up visits. Receives: Device: IntraGen RF; Device: DiVA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vulvovaginal Symptoms Questionnaire
VSQ is a 21-item validated survey designed to assess postmenopausal quality-of-life parameters, namely vulvovaginal symptoms, emotions, life and sexual impact.
Min: 0; Max: 21 Higher score would indicate greater number of symptoms.
Measured: Baseline, 3 Month Post- treatments and 6 Month Post Treatments
Vaginal Laxity Questionnaire
The VLQ is a Likert scale with seven responses regarding self-reported vaginal laxity; answer option range from "Very Loose" to "Very Tight".
Min: 1; Max: 7 A higher score would indicate "Very Tight" response provided by the subject.
Measured: Baseline, 3 Months Post Treatments and 6 Months Post Treatments
Secondary outcomes (9)
Perceived Changes in Vaginal Laxity as Measured by Zimmern Probe at 3 Months Post Treatment
Perceived changes in vaginal laxity is measured by Zimmern probe which measures vaginal wall elasticity.
Measured: Baseline and 3 Months Post Treatment
Perceived Changes in Vaginal Laxity as Measured by Zimmern Probe at 6 Months Post Treatment
Perceived changes in vaginal laxity is measured by Zimmern probe which measures vaginal wall elasticity.
Measured: Baseline and 6 Months Post Treatment
Urogenital Distress Short Form (UDI-6)
UDI-6 measures multiple domains to assess for presence and severity of physical symptoms such as frequency in urination, urine leakage and pain/discomfort.
Min: 0; Max: 100 Higher score would indicate a higher disability
Measured: Baseline, 3 Months Post Treatments and 6 Months Post Treatments
Incontinence Impact Questionnaire Short Form (IIQ-7)
The Incontinence Impact Questionnaire assesses the impact and extent of incontinence on patients' everyday lives.
Min: 0; Max: 100 Higher scores corresponds to greater degree of disability.
Measured: Baseline, 3 Months Post Treatments and 6 Months Post Treatments
Female Sexual Function Index (FSFI)
The FSFI is a 19-item validated questionnaire that assesses several domains of sexual function including, desire, arousal, lubrication, orgasm, satisfaction and pain.
Min: 2; Max: 36 Higher scores indicate fewer symptoms and greater sexual satisfaction.
Measured: Baseline, 3 Months Post Treatments and 6 Months Post Treatments
Gene Expression- Col1A1 as Measured by Fold Change
Biopsies taken of the anterior vaginal wall will be analyzed for gene expression
Fold change= sample/average of the baseline
Measured: Baseline and 3 Months Post Treatments
Gene Expression- Col3A1 as Measured by Fold Change
Biopsies taken of the anterior vaginal wall will be analyzed for gene expression
Fold change= sample/average of the baseline
Measured: Baseline and 3 Months Post Treatments
Gene Expression- ELN as Measured by Fold Change
Biopsies taken of the anterior vaginal wall will be analyzed for gene expression
Fold change= sample/average of the baseline
Measured: Baseline and 3 Months Post Treatments
Gene Expression- LOX as Measured by Fold Change
Biopsies taken of the anterior vaginal wall will be analyzed for gene expression
Fold change= sample/average of the baseline
Measured: Baseline and 3 Months Post Treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start15 Jun 2018
- Primary completion8 Apr 2021
- Study completion8 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Vaginal AtrophyStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Society for Aesthetic Plastic Surgery
- Responsible party
- Principal investigator, Jeffrey M. Kenkel, University of Texas Southwestern Medical Center
- Investigators
- Jeffrey Kenkel, MD, Principal investigator, Chair & Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03316950
- Sponsor's protocol ID
- STU 012017-006
- Status last verified
- Dec 2022
- First submitted
- 17 Oct 2017
- Last updated
- 4 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 27197701Millheiser 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 25410301Paul M, Blugerman G, Kreindel M, Mulholland RS. Three-dimensional radiofrequency tissue tightening: a proposed mechanism and applications for body contouring. Aesthetic Plast Surg. 2011 Feb;35(1):87-95. doi: 10.1007/s00266-010-9564-0. Epub 2010 Sep 11.
PubMed 20835826Peet J. Evaluation of the Safety and Efficacy of Hybrid Fractional 2940 nm and 1470 nm Lasers for Treatment of Vaginal Tissue: Pilot Study. [White paper].
Ippolito GM, Crescenze IM, Sitto H, Palanjian RR, Raza D, Barboglio Romo P, Wallace SA, Orozco Leal G, Clemens JQ, Dahm P, Gupta P. Vaginal lasers for treating stress urinary incontinence in women. Cochrane Database Syst Rev. 2025 Jul 25;7(7):CD013643. doi: 10.1002/14651858.CD013643.pub2.
PubMed 40709601
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled Trial Evaluating Radiofrequency and Hybrid Fractional Laser for Vaginal Rejuvenation
- ClinicalTrials.gov ID
- NCT03316950
- Acronym / sponsor ID
- STU 012017-006
- Conditions
- Vaginal Atrophy
- Keywords
- postmenopause, rejuvenation, radiofrequency, diva
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- American Society for Aesthetic Plastic Surgery
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 8 Apr 2021 (actual)
- Study completion
- 8 Apr 2021 (actual)
- First posted
- 23 Oct 2017 (actual)
- Results
- Posted 4 Jan 2023
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 single-center, randomized, prospective study designed to evaluate the efficacy of radiofrequency and hybrid fractional laser for vaginal rejuvenation. 120 subjects will be screened with 100 undergoing a three-part treatment of the vulvovaginal area IntraGen RF unit, IntraGen RF unit placebo, DiVa HFL unit, or DiVa HFL unit placebo. These treatments will be spaced one month apart and last about 25 minutes each. Each subject will be screened, undergo testing at baseline, and will be followed conservatively with no further therapy until they reach 6 months after the initiation of the designated treatment. At that time, all subjects will undergo subjective and objective testing. Those in the treatment group will be followed to 9 and 12 months after the initiation of treatment with appropriate analysis. Those in the placebo group will be provided a three-part treatment of the vulvovaginal area with the IntraGen RF unit and DiVA HFL unit. These treatments will be spaced one month apart and last about 25 minutes each. Six months after receiving three treatments of the dual therapy these patients will undergo subjective and objective testing. The primary outcome measure is improvement in vulvovaginal symptoms measured by the validated Vulvovaginal Symptoms Questionnaire. Data obtained from each investigation will be recorded in a password-protected digital spreadsheet, REDCap database and descriptive statistics will be obtained.
Detailed description
Vaginal rejuvenation is a catch-all term of trendy 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 labial appearance, amongst others2,3. Several companies have emerged with non-invasive or minimally-invasive technologies to alleviate these conditions which operate by radiofrequency delivery (IntraGen by Jeisys), Hybrid Fractional Laser (diVa by Sciton), or fractional CO2 laser (Mona Lisa Touch by Cynosure and Femi Lift by Alma Laser)4.
All of these technologies work theoretically by remodeling extracellular matrix configuration. It is of important note that radiofrequency therapies are typically delivered at 45-55 degrees Celsius in the tissues whereas the laser based products heat up to 60-70 degrees Celsius5. It is believed that "neocollagenesis" may only start if the temperatures are high enough and that such changes in the collagen matrix of the vagina could lead to durable vaginal wall changes. Sciton's diVa is hybrid fractional laser with wavelengths of 2940 nm and 1470 nm for ablation and coagulation, respectively, to treat vaginal tissue6. It is not known whether the changes experienced by patients are due to the reconfiguration of the extracellular matrix (ECM) deep in the vaginal wall or related to the acute swelling and inflammatory processes that occur at the surface of the vagina after these rejuvenation procedures.
The early anecdotal success reported on some user websites might be attributable to surface changes that may not be lasting or to possibly more lasting deeper muscular vaginal wall changes, which may or may not be beneficial. Based on the answer to this first set of questions, we might possibly surmise how such changes will ultimately improve vaginal dryness and/or stress urinary incontinence complaints.
An overriding question and concern is: Assuming these treatments induce collagen changes in the vagina, is it safe to induce such changes? If changes occur, are they long lasting? Can it age the vagina instead of making it "younger"? What are the long-term effects of doing so? Is tissue tightening really scar formation that may be deleterious in the future? The histological, genetic and dynamic changes following vaginal rejuvenation have never been studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IntraGen RF | Experimental | Device: IntraGen RFPatients will undergo treatment with radiofrequency device, using the device's standard protocol. Patients will have 3 treatments space one month apart. Each treatment will be a total of 20 minutes for internal treatment only. Prior to treatment, the Zimmern probe will be used to measure vaginal wall elasticity and a 0.33mm biopsy will be taken. At each visit, the Zimmern probe will be used. Biopsies will be taken 3 months after final treatment. |
| DiVA | Experimental | Device: DiVAPatients randomized into the DiVA treatment group will receive treatment per DiVA protocol. Patients will have a total of 3 treatments, space 1 month apart. Each treatment will last approximately 10 minutes. Prior to treatment, the Zimmern probe will be used to measure vaginal wall elasticity and a 0.33mm biopsy will be taken. At each visit, the Zimmern probe will be used. Biopsies will be taken 3 months after final treatment. |
| Placebo Arm | Sham comparator | Device: Placebo (DIVA/IntraGen combined)Patients randomized into the Placebo arm will include participants from the DiVa PlaceboGroup and IntraGen Placebo Group combined and will receive treatment based on the DiVA Sham and IntraGen Sham protocols. DiVa Placebo: patients will undergo a three-part placebo treatment, spaced 1 month apart (+/- 10 days) of the vulvovaginal area. The vaginal HFL handpiece will be inserted into the vaginal canal but sub-therapeutic energy will not be delivered to the tissue. IntraGen Placebo: patients will undergo a three-part placebo treatment, space 1 month apart (+/- 10 days) of the vulvovaginal area. This will be achieved through application of the probe, but with applying sub-therapeutic energy to the tissue. |
| Dual Treatment | Experimental | Device: IntraGen RF, Device: DiVAPatients previously randomized into the DiVA Sham and IntraGen Sham groups will be placed in the Dual Treatment group. Patients will have a total of 3 dual treatments, spaced 1 month apart. Each treatment will last approximately 20 minutes. Prior to dual treatments, the Zimmern probe will be used to measure vaginal wall elasticity and a 0.33mm biopsy will be taken. At each visit, the Zimmern probe will be used. Biopsies will be taken at follow up visits. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Women should be between 40 and 65 years of age
- Women should be post-menopausal
- Women should be amenorrheic for at least 12 months
- Postmenopausal women presenting with one or more of the following:
- Vulvar itching
Key exclusion criteria (25 listed)
- Unable to commit to future appointments within one year
- Planning on moving away from Dallas within one year
- History of other energy-based vaginal therapy within one year
- Vaginal hormone replacement therapy must have a one month washout period prior to treatment and discontinued use for duration of study, systemic replacement is not excluded
- Prior labiaplasty, or vaginal injections of fat or fillers within 6 months
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 |
|---|---|---|
| IntraGen RFIntraGen is a radiofrequency vaginal rejuvenation device FDA approved for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. The hand piece is a disposable monopolar applicator that is used to apply energy internally and externally. | Device | Dual Treatment, IntraGen RF |
| DiVADiVA device utilizes a hybrid fractional laser technology in a wand hand piece. The hand piece is covered by a single use strengthened quartz dilator that allows the hand piece to rotate and provide treatment in a uniform manner. | Device | DiVA, Dual Treatment |
| Placebo (DIVA/IntraGen combined)(DIVA/IntraGen combined) IntraGen RF: IntraGen is a radiofrequency vaginal rejuvenation device FDA approved for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. The hand piece is a disposable monopolar applicator that is used to apply energy internally and externally. DiVA: DiVA device utilizes a hybrid fractional laser technology in a wand hand piece. The hand piece is covered by a single use strengthened quartz dilator that allows the hand piece to rotate and provide treatment in a uniform manner. | Device | Placebo Arm |
Primary outcome
Vulvovaginal Symptoms Questionnaire
Time frame: Baseline, 3 Month Post- treatments and 6 Month Post Treatments
VSQ is a 21-item validated survey designed to assess postmenopausal quality-of-life parameters, namely vulvovaginal symptoms, emotions, life and sexual impact. Min: 0; Max: 21 Higher score would indicate greater number of symptoms.
Vaginal Laxity Questionnaire
Time frame: Baseline, 3 Months Post Treatments and 6 Months Post Treatments
The VLQ is a Likert scale with seven responses regarding self-reported vaginal laxity; answer option range from "Very Loose" to "Very Tight". Min: 1; Max: 7 A higher score would indicate "Very Tight" response provided by the subject.
9 secondary outcomes
Perceived Changes in Vaginal Laxity as Measured by Zimmern Probe at 3 Months Post Treatment
Time frame: Baseline and 3 Months Post Treatment
Perceived Changes in Vaginal Laxity as Measured by Zimmern Probe at 6 Months Post Treatment
Time frame: Baseline and 6 Months Post Treatment
Urogenital Distress Short Form (UDI-6)
Time frame: Baseline, 3 Months Post Treatments and 6 Months Post Treatments
Incontinence Impact Questionnaire Short Form (IIQ-7)
Time frame: Baseline, 3 Months Post Treatments and 6 Months Post Treatments
Female Sexual Function Index (FSFI)
Time frame: Baseline, 3 Months Post Treatments and 6 Months Post Treatments
Gene Expression- Col1A1 as Measured by Fold Change
Time frame: Baseline and 3 Months Post Treatments
Gene Expression- Col3A1 as Measured by Fold Change
Time frame: Baseline and 3 Months Post Treatments
Gene Expression- ELN as Measured by Fold Change
Time frame: Baseline and 3 Months Post Treatments
Gene Expression- LOX as Measured by Fold Change
Time frame: Baseline and 3 Months Post Treatments
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
- 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 20835826Paul M, Blugerman G, Kreindel M, Mulholland RS. Three-dimensional radiofrequency tissue tightening: a proposed mechanism and applications for body contouring. Aesthetic Plast Surg. 2011 Feb;35(1):87-95. doi: 10.1007/s00266-010-9564-0. Epub 2010 Sep 11.
- BackgroundPeet J. Evaluation of the Safety and Efficacy of Hybrid Fractional 2940 nm and 1470 nm Lasers for Treatment of Vaginal Tissue: Pilot Study. [White paper].
- Derived from this study: PubMed 40709601Ippolito GM, Crescenze IM, Sitto H, Palanjian RR, Raza D, Barboglio Romo P, Wallace SA, Orozco Leal G, Clemens JQ, Dahm P, Gupta P. Vaginal lasers for treating stress urinary incontinence in women. Cochrane Database Syst Rev. 2025 Jul 25;7(7):CD013643. doi: 10.1002/14651858.CD013643.pub2.
- Individual participant dataSharing planned: No
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Vulvar Atrophy, Vulvovaginal Signs and Symptoms
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.
Jeffrey Kenkel, MD principal investigator
Chair & Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IntraGen RF and DiVA in people with Vaginal Atrophy, run by University of Texas Southwestern Medical Center at 1 site 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 11 inclusion and 25 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: finished, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 4 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vulvovaginal Symptoms Questionnaire (time frame: Baseline, 3 Month Post- treatments and 6 Month Post Treatments). The study lists 2 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 NCT03316950, which also lists 7 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 4 Jan 2023.