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| Name | Class |
|---|---|
| American Society for Aesthetic Plastic Surgery | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IntraGen RF | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline, 3 Months Post Treatments and 6 Months Post Treatments |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 3 Months Post Treatment |
| Perceived Changes in Vaginal Laxity as Measured by Zimmern Probe at 6 Months Post Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Kenkel, MD | Chair & Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27197701 | Background | 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. | |
| 20584127 | Background | 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. |
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Of the 52 patients enrolled, 5 were screen failures. Hence, total 47 participants were assigned to the interventions. The Placebo Arms (DiVa Sham and IntraGen Sham) are combined here into one Placebo arm since this is how the data was assessed. The Dual Group includes all the Placebo arm participants who initially received 3 placebo treatments and then received 3 dual treatments (DIVA/IntraGen). All subjects assigned to each of the interventions didn't receive treatment between 3-6 months.
Subjects were recruited via flyers placed on the UT Southwestern Campus until recruitment concluded in 2020. The first participant was enrolled on June 15, 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hybrid Fractional Laser (HFL) Group | 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. 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. |
| FG001 | Radiofrequency (RF) Group | 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. 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. |
| FG002 | Placebo Arm | Participants from the DiVa Sham Group and Intragen Sham Group combined 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. |
| FG003 | Dual (HFL & RF) Group | 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. 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Initial Intervention (1 to 3 Months) |
|
| ||||||||||||||||||
| Dual Intervention (6 to 8 Months) |
|
The Placebo Arms (DiVa Sham and IntraGen Sham) are combined here into one Placebo arm since this is how the data was assessed unlike how it was initially listed in the protocol. The Dual Group includes all the Placebo arm participants who initially received 3 placebo treatments and then received 3 dual treatments (DIVA/IntraGen)
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| ID | Title | Description |
|---|---|---|
| BG000 | Hybrid Fractional Laser (HFL) Group | Patients randomized into this 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | During Initial intervention period there were 0 participants in the dual group. During the dual intervention period there were 14 participants included that were all from the placebo arm who underwent dual intervention and thus were analyzed. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Subjects originally in DIVA sham and IntraGen Sham arms were combined to create the dual treatment group- these subjects initially received 3 placebo treatments and then received 3 dual treatments (DIVA/IntraGen). Our data was not collected at the 6 Month time point for the placebo arm. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 Month Post- treatments and 6 Month Post Treatments |
|
15 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hybrid Fractional Laser (HFL) Group | 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. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vaginal Odor/Itching/Spotting | Reproductive system and breast disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Coordinator | UT Southwestern | 214-645-8907 | jennifer.barillas@utsouthwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 21, 2020 | Sep 20, 2022 | Prot_SAP_001.pdf |
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| 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. |
|
|
| DiVA | Device | 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. |
|
Perceived changes in vaginal laxity is measured by Zimmern probe which measures vaginal wall elasticity. |
| 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 | 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. | 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. | 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 | 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 | 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 | 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 | Baseline and 3 Months Post Treatments |
| 23952177 | Background | 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. |
| 25410301 | Background | 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. |
| 20835826 | Background | Paul 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. |
| Background | Peet 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]. |
| 40709601 | Derived | 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. |
| Physician Decision |
|
| Lost to Follow-up |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | Radiofrequency (RF) Group | 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. |
| BG002 | Placebo Group | Participants from the DiVa Sham Group and Intragen Sham Group combined 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. |
| BG003 | Dual (HFL & RF) Group | 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. |
| BG004 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | During Initial intervention period there were 0 participants in the dual group. During the dual intervention period there were 14 participants included that were all from the placebo arm who underwent dual intervention and thus were analyzed. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Total participants who enrolled and were assigned to the interventions have been included here. | During Initial intervention period there were 0 participants in the dual group. During the dual intervention period there were 14 participants included that were all from the placebo arm who underwent dual intervention and thus were analyzed. | Count of Participants | Participants |
|
| OG001 | Radiofrequency (RF) Group | 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. 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. |
| OG002 | Placebo Arm | Participants from the DiVa Sham Group and Intragen Sham Group combined 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. |
| OG003 | Dual (HFL & RF) Group | 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. 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. 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. |
|
|
| Primary | 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. | Subjects originally in DIVA sham and IntraGen Sham arms were combined to create the dual treatment group- these subjects initially received 3 placebo treatments and then received 3 dual treatments (DIVA/IntraGen). Our data was not collected at the 6 Month time point for the placebo arm. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 Months Post Treatments and 6 Months Post Treatments |
|
|
|
| Secondary | 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. | Subjects originally in DIVA sham and IntraGen Sham arms were combined to create the dual treatment group- these subjects initially received 3 placebo treatments and then received 3 dual treatments (DIVA/IntraGen). We were unable to collect data for some of the participants who were assigned to each of these arms due to an equipment malfunction and hence these subjects were not included in this analysis. | Posted | Mean | Standard Deviation | mmHg | Baseline and 3 Months Post Treatment |
|
|
|
| Secondary | 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. | Collected data were not considered valid due to an equipment malfunction. | Posted | Baseline and 6 Months Post Treatment |
|
|
| Secondary | 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 | Subjects originally in DIVA sham and IntraGen Sham arms were combined to create the dual treatment group- these subjects initially received 3 placebo treatments and then received 3 dual treatments (DIVA/IntraGen). Our data was not collected at the 6 Month time point for the placebo arm. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 Months Post Treatments and 6 Months Post Treatments |
|
|
|
| Secondary | 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. | Subjects originally in DIVA sham and IntraGen Sham arms were combined to create the dual treatment group- these subjects initially received 3 placebo treatments and then received 3 dual treatments (DIVA/IntraGen). Our data was not collected at the 6 Month time point for the placebo arm. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 Months Post Treatments and 6 Months Post Treatments |
|
|
|
| Secondary | 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. | Subjects originally in DIVA sham and IntraGen Sham arms were combined to create the dual treatment group- these subjects initially received 3 placebo treatments and then received 3 dual treatments (DIVA/IntraGen). Our data was not collected at the 6 Month time point for the placebo arm. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 Months Post Treatments and 6 Months Post Treatments |
|
|
|
| Secondary | 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 | Study staff was unable to collect a biopsy sample during all visits. Subjects originally in DIVA sham and IntraGen Sham arms were combined to create the dual treatment group- these subjects initially received 3 placebo treatments and then received 3 dual treatments (DIVA/IntraGen). | Posted | Mean | Standard Error | fold change | Baseline and 3 Months Post Treatments |
|
|
|
| Secondary | 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 | Study staff was unable to collect a biopsy sample during all visits. Subjects originally in DIVA sham and IntraGen Sham arms were combined to create the dual treatment group- these subjects initially received 3 placebo treatments and then received 3 dual treatments (DIVA/IntraGen). | Posted | Mean | Standard Error | fold change | Baseline and 3 Months Post Treatments |
|
|
|
| Secondary | 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 | Study staff was unable to collect a biopsy sample during all visits. Subjects originally in DIVA sham and IntraGen Sham arms were combined to create the dual treatment group- these subjects initially received 3 placebo treatments and then received 3 dual treatments (DIVA/IntraGen). | Posted | Mean | Standard Error | fold change | Baseline and 3 Months Post Treatments |
|
|
|
| Secondary | 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 | Study staff was unable to collect a biopsy sample during all visits. Subjects originally in DIVA sham and IntraGen Sham arms were combined to create the dual treatment group- these subjects initially received 3 placebo treatments and then received 3 dual treatments (DIVA/IntraGen). | Posted | Mean | Standard Deviation | fold change | Baseline and 3 Months Post Treatments |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 7 |
| 12 |
| EG001 | Radiofrequency (RF) Group | 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. 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. | 0 | 12 | 0 | 12 | 4 | 12 |
| EG002 | Placebo Arm | Participants from the DiVa Sham Group and Intragen Sham Group combined 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. | 0 | 23 | 0 | 23 | 6 | 23 |
| EG003 | Dual (HFL & RF) Group | 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. 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. 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. | 0 | 14 | 0 | 14 | 6 | 14 |
| UTI/Yeast Infection | Reproductive system and breast disorders | Systematic Assessment |
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| Urine Leakage | Reproductive system and breast disorders | Systematic Assessment |
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| Abdominal Discomfort | Reproductive system and breast disorders | Systematic Assessment |
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| Vaginal perspiration | Reproductive system and breast disorders | Systematic Assessment |
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| Other | Reproductive system and breast disorders | Systematic Assessment | Symptoms were unrelated to study arms/treatments. |
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Not provided
Not provided
| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Hispanic |
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| Black or African American |
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| Caucasian / Hispanic |
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| 3 Month Post Treatment |
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