Vaginal Atrophy
Conditions
Keywords
postmenopause, rejuvenation, radiofrequency, diva
Brief 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, 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.
Interventions
DEVICEIntraGen 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.
DEVICEDiVA
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.
DEVICEPlacebo (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.
Sponsors
American Society for Aesthetic Plastic Surgery
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 * Vulvar pain * Vulvar irritation * Vulvar dryness * Discharge from subject's vulva or vagina * Odor from subject's vulva or vagina
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vulvovaginal Symptoms Questionnaire | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urogenital Distress Short Form (UDI-6) | Baseline, 3 Months Post Treatments and 6 Months Post Treatments | 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 |
| Incontinence Impact Questionnaire Short Form (IIQ-7) | Baseline, 3 Months Post Treatments and 6 Months Post Treatments | 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. |
| Female Sexual Function Index (FSFI) | Baseline, 3 Months Post Treatments and 6 Months Post Treatments | 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. |
| Perceived Changes in Vaginal Laxity as Measured by Zimmern Probe at 3 Months Post Treatment | Baseline and 3 Months Post Treatment | Perceived changes in vaginal laxity is measured by Zimmern probe which measures vaginal wall elasticity. |
| Gene Expression- Col3A1 as Measured by Fold Change | Baseline and 3 Months Post Treatments | Biopsies taken of the anterior vaginal wall will be analyzed for gene expression Fold change= sample/average of the baseline |
| Gene Expression- ELN as Measured by Fold Change | Baseline and 3 Months Post Treatments | Biopsies taken of the anterior vaginal wall will be analyzed for gene expression Fold change= sample/average of the baseline |
| Gene Expression- LOX as Measured by Fold Change | Baseline and 3 Months Post Treatments | Biopsies taken of the anterior vaginal wall will be analyzed for gene expression Fold change= sample/average of the baseline |
| Gene Expression- Col1A1 as Measured by Fold Change | Baseline and 3 Months Post Treatments | Biopsies taken of the anterior vaginal wall will be analyzed for gene expression Fold change= sample/average of the baseline |
| Perceived Changes in Vaginal Laxity as Measured by Zimmern Probe at 6 Months Post Treatment | Baseline and 6 Months Post Treatment | Perceived changes in vaginal laxity is measured by Zimmern probe which measures vaginal wall elasticity. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| 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. | 12 |
| 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. | 23 |
| 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. | 14 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Initial Intervention (1 to 3 Months) | Lost to Follow-up | 0 | 2 | 5 | 0 |
| Initial Intervention (1 to 3 Months) | Physician Decision | 2 | 0 | 1 | 0 |
| Initial Intervention (1 to 3 Months) | Withdrawal by Subject | 1 | 2 | 3 | 0 |
Baseline characteristics
| Characteristic | Hybrid Fractional Laser (HFL) Group | Total | Dual (HFL & RF) Group | Placebo Group | Radiofrequency (RF) Group |
|---|---|---|---|---|---|
| Age, Categorical Dual Intervention <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Dual Intervention >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Dual Intervention Between 18 and 65 years | 0 Participants | 14 Participants | 14 Participants | 0 Participants | 0 Participants |
| Age, Categorical Initial Intervention <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Initial Intervention >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Initial Intervention Between 18 and 65 years | 12 Participants | 47 Participants | 0 Participants | 23 Participants | 12 Participants |
| Race/Ethnicity, Customized Dual Intervention Black or African American | 0 Participants | 4 Participants | 4 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Dual Intervention Caucasian | 0 Participants | 8 Participants | 8 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Dual Intervention Caucasian / Hispanic | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Dual Intervention Hispanic | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Initial Intervention Black or African American | 6 Participants | 13 Participants | 0 Participants | 5 Participants | 2 Participants |
| Race/Ethnicity, Customized Initial Intervention Caucasian | 5 Participants | 29 Participants | 0 Participants | 15 Participants | 9 Participants |
| Race/Ethnicity, Customized Initial Intervention Caucasian / Hispanic | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Initial Intervention Hispanic | 1 Participants | 4 Participants | 0 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Dual Intervention Female | 0 Participants | 14 Participants | 14 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Dual Intervention Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Initial Intervention Female | 12 Participants | 47 Participants | 0 Participants | 23 Participants | 12 Participants |
| Sex: Female, Male Initial Intervention Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 | 0 / 23 | 0 / 14 |
| other Total, other adverse events | 7 / 12 | 4 / 12 | 6 / 23 | 6 / 14 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 23 | 0 / 14 |
Outcome results
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.
Time frame: Baseline, 3 Months Post Treatments and 6 Months Post Treatments
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hybrid Fractional Laser (HFL) Group | Vaginal Laxity Questionnaire | Baseline | 3.57 score on a scale | Standard Deviation 2.51 |
| Hybrid Fractional Laser (HFL) Group | Vaginal Laxity Questionnaire | 3 Months Post Treatment | 4.44 score on a scale | Standard Deviation 1.74 |
| Hybrid Fractional Laser (HFL) Group | Vaginal Laxity Questionnaire | 6 Months Post Treatment | 3.83 score on a scale | Standard Deviation 1.72 |
| Radiofrequency (RF) Group | Vaginal Laxity Questionnaire | 3 Months Post Treatment | 3.75 score on a scale | Standard Deviation 2.19 |
| Radiofrequency (RF) Group | Vaginal Laxity Questionnaire | Baseline | 3.67 score on a scale | Standard Deviation 2.25 |
| Radiofrequency (RF) Group | Vaginal Laxity Questionnaire | 6 Months Post Treatment | 4.5 score on a scale | Standard Deviation 1.38 |
| Placebo Arm | Vaginal Laxity Questionnaire | 3 Months Post Treatment | 3.5 score on a scale | Standard Deviation 1.74 |
| Placebo Arm | Vaginal Laxity Questionnaire | Baseline | 2.79 score on a scale | Standard Deviation 1.93 |
| Dual (HFL & RF) Group | Vaginal Laxity Questionnaire | 3 Months Post Treatment | 3.93 score on a scale | Standard Deviation 1.82 |
| Dual (HFL & RF) Group | Vaginal Laxity Questionnaire | 6 Months Post Treatment | 4.2 score on a scale | Standard Deviation 1.4 |
| Dual (HFL & RF) Group | Vaginal Laxity Questionnaire | Baseline | 2.79 score on a scale | Standard Deviation 1.93 |
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.
Time frame: Baseline, 3 Month Post- treatments and 6 Month Post Treatments
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hybrid Fractional Laser (HFL) Group | Vulvovaginal Symptoms Questionnaire | Baseline | 8 score on a scale | Standard Deviation 5.5 |
| Hybrid Fractional Laser (HFL) Group | Vulvovaginal Symptoms Questionnaire | 3 Month Post Treatment | 3.22 score on a scale | Standard Deviation 2.77 |
| Hybrid Fractional Laser (HFL) Group | Vulvovaginal Symptoms Questionnaire | 6 Month Post Treatment | 3.43 score on a scale | Standard Deviation 3.87 |
| Radiofrequency (RF) Group | Vulvovaginal Symptoms Questionnaire | 3 Month Post Treatment | 5 score on a scale | Standard Deviation 6.12 |
| Radiofrequency (RF) Group | Vulvovaginal Symptoms Questionnaire | Baseline | 7.88 score on a scale | Standard Deviation 5.49 |
| Radiofrequency (RF) Group | Vulvovaginal Symptoms Questionnaire | 6 Month Post Treatment | 2.33 score on a scale | Standard Deviation 4.41 |
| Placebo Arm | Vulvovaginal Symptoms Questionnaire | 3 Month Post Treatment | 3 score on a scale | Standard Deviation 3.46 |
| Placebo Arm | Vulvovaginal Symptoms Questionnaire | Baseline | 5.93 score on a scale | Standard Deviation 4.67 |
| Dual (HFL & RF) Group | Vulvovaginal Symptoms Questionnaire | 3 Month Post Treatment | 1.86 score on a scale | Standard Deviation 2.51 |
| Dual (HFL & RF) Group | Vulvovaginal Symptoms Questionnaire | 6 Month Post Treatment | 1.7 score on a scale | Standard Deviation 2.36 |
| Dual (HFL & RF) Group | Vulvovaginal Symptoms Questionnaire | Baseline | 5.93 score on a scale | Standard Deviation 4.67 |
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.
Time frame: Baseline, 3 Months Post Treatments and 6 Months Post Treatments
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hybrid Fractional Laser (HFL) Group | Female Sexual Function Index (FSFI) | 3 Months Post Treatments | 21.38 score on a scale | Standard Deviation 11.62 |
| Hybrid Fractional Laser (HFL) Group | Female Sexual Function Index (FSFI) | Baseline | 14.96 score on a scale | Standard Deviation 9.23 |
| Hybrid Fractional Laser (HFL) Group | Female Sexual Function Index (FSFI) | 6 Months Post Treatments | 18.2 score on a scale | Standard Deviation 12.33 |
| Radiofrequency (RF) Group | Female Sexual Function Index (FSFI) | 3 Months Post Treatments | 18.73 score on a scale | Standard Deviation 12.72 |
| Radiofrequency (RF) Group | Female Sexual Function Index (FSFI) | Baseline | 15.69 score on a scale | Standard Deviation 10.34 |
| Radiofrequency (RF) Group | Female Sexual Function Index (FSFI) | 6 Months Post Treatments | 21.7 score on a scale | Standard Deviation 14.01 |
| Placebo Arm | Female Sexual Function Index (FSFI) | Baseline | 15.98 score on a scale | Standard Deviation 10.04 |
| Placebo Arm | Female Sexual Function Index (FSFI) | 3 Months Post Treatments | 17.28 score on a scale | Standard Deviation 10.98 |
| Dual (HFL & RF) Group | Female Sexual Function Index (FSFI) | 6 Months Post Treatments | 24.19 score on a scale | Standard Deviation 11.06 |
| Dual (HFL & RF) Group | Female Sexual Function Index (FSFI) | Baseline | 16.09 score on a scale | Standard Deviation 9.62 |
| Dual (HFL & RF) Group | Female Sexual Function Index (FSFI) | 3 Months Post Treatments | 20.67 score on a scale | Standard Deviation 10.88 |
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
Time frame: Baseline and 3 Months Post Treatments
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hybrid Fractional Laser (HFL) Group | Gene Expression- Col1A1 as Measured by Fold Change | 0.67 fold change | Standard Error 0.32 |
| Radiofrequency (RF) Group | Gene Expression- Col1A1 as Measured by Fold Change | 0.48 fold change | Standard Error 0.24 |
| Placebo Arm | Gene Expression- Col1A1 as Measured by Fold Change | 1 fold change | Standard Error 0.25 |
| Dual (HFL & RF) Group | Gene Expression- Col1A1 as Measured by Fold Change | 0.95 fold change | Standard Error 0.26 |
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
Time frame: Baseline and 3 Months Post Treatments
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hybrid Fractional Laser (HFL) Group | Gene Expression- Col3A1 as Measured by Fold Change | 0.95 fold change | Standard Error 0.41 |
| Radiofrequency (RF) Group | Gene Expression- Col3A1 as Measured by Fold Change | 0.82 fold change | Standard Error 0.55 |
| Placebo Arm | Gene Expression- Col3A1 as Measured by Fold Change | 1 fold change | Standard Error 0.35 |
| Dual (HFL & RF) Group | Gene Expression- Col3A1 as Measured by Fold Change | 1.23 fold change | Standard Error 0.25 |
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
Time frame: Baseline and 3 Months Post Treatments
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hybrid Fractional Laser (HFL) Group | Gene Expression- ELN as Measured by Fold Change | 0.40 fold change | Standard Error 0.18 |
| Radiofrequency (RF) Group | Gene Expression- ELN as Measured by Fold Change | 0.33 fold change | Standard Error 0.2 |
| Placebo Arm | Gene Expression- ELN as Measured by Fold Change | 1 fold change | Standard Error 0.16 |
| Dual (HFL & RF) Group | Gene Expression- ELN as Measured by Fold Change | 0.79 fold change | Standard Error 0.15 |
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
Time frame: Baseline and 3 Months Post Treatments
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hybrid Fractional Laser (HFL) Group | Gene Expression- LOX as Measured by Fold Change | 2.72 fold change | Standard Deviation 1.71 |
| Radiofrequency (RF) Group | Gene Expression- LOX as Measured by Fold Change | 0.75 fold change | Standard Deviation 0.28 |
| Placebo Arm | Gene Expression- LOX as Measured by Fold Change | 1 fold change | Standard Deviation 0.16 |
| Dual (HFL & RF) Group | Gene Expression- LOX as Measured by Fold Change | 0.95 fold change | Standard Deviation 0.17 |
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.
Time frame: Baseline, 3 Months Post Treatments and 6 Months Post Treatments
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hybrid Fractional Laser (HFL) Group | Incontinence Impact Questionnaire Short Form (IIQ-7) | 3 Month Post Treatment | 7.41 score on a scale | Standard Deviation 12.62 |
| Hybrid Fractional Laser (HFL) Group | Incontinence Impact Questionnaire Short Form (IIQ-7) | 6 Month Post Treatment | 11.9 score on a scale | Standard Deviation 14.04 |
| Hybrid Fractional Laser (HFL) Group | Incontinence Impact Questionnaire Short Form (IIQ-7) | Baseline | 22.75 score on a scale | Standard Deviation 18.1 |
| Radiofrequency (RF) Group | Incontinence Impact Questionnaire Short Form (IIQ-7) | 3 Month Post Treatment | 11.31 score on a scale | Standard Deviation 13.21 |
| Radiofrequency (RF) Group | Incontinence Impact Questionnaire Short Form (IIQ-7) | 6 Month Post Treatment | 10.32 score on a scale | Standard Deviation 18.42 |
| Radiofrequency (RF) Group | Incontinence Impact Questionnaire Short Form (IIQ-7) | Baseline | 22.02 score on a scale | Standard Deviation 29.01 |
| Placebo Arm | Incontinence Impact Questionnaire Short Form (IIQ-7) | 3 Month Post Treatment | 15.98 score on a scale | Standard Deviation 32.33 |
| Placebo Arm | Incontinence Impact Questionnaire Short Form (IIQ-7) | Baseline | 10.2 score on a scale | Standard Deviation 17 |
| Dual (HFL & RF) Group | Incontinence Impact Questionnaire Short Form (IIQ-7) | 6 Month Post Treatment | 10.48 score on a scale | Standard Deviation 31.49 |
| Dual (HFL & RF) Group | Incontinence Impact Questionnaire Short Form (IIQ-7) | Baseline | 10.2 score on a scale | Standard Deviation 17 |
| Dual (HFL & RF) Group | Incontinence Impact Questionnaire Short Form (IIQ-7) | 3 Month Post Treatment | 8.16 score on a scale | Standard Deviation 20.24 |
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.
Time frame: Baseline and 3 Months Post Treatment
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hybrid Fractional Laser (HFL) Group | Perceived Changes in Vaginal Laxity as Measured by Zimmern Probe at 3 Months Post Treatment | 0.44 mmHg | — |
| Radiofrequency (RF) Group | Perceived Changes in Vaginal Laxity as Measured by Zimmern Probe at 3 Months Post Treatment | 0.78 mmHg | Standard Deviation 1.3 |
| Placebo Arm | Perceived Changes in Vaginal Laxity as Measured by Zimmern Probe at 3 Months Post Treatment | 0.7 mmHg | Standard Deviation 2.47 |
| Dual (HFL & RF) Group | Perceived Changes in Vaginal Laxity as Measured by Zimmern Probe at 3 Months Post Treatment | 0.36 mmHg | Standard Deviation 1.33 |
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.
Time frame: Baseline and 6 Months Post Treatment
Population: Collected data were not considered valid due to an equipment malfunction.
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
Time frame: Baseline, 3 Months Post Treatments and 6 Months Post Treatments
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hybrid Fractional Laser (HFL) Group | Urogenital Distress Short Form (UDI-6) | Baseline | 36.11 score on a scale | Standard Deviation 17.92 |
| Hybrid Fractional Laser (HFL) Group | Urogenital Distress Short Form (UDI-6) | 3 Month Post Treatment | 25.65 score on a scale | Standard Deviation 18.93 |
| Hybrid Fractional Laser (HFL) Group | Urogenital Distress Short Form (UDI-6) | 6 Month Post Treatment | 25.69 score on a scale | Standard Deviation 21.8 |
| Radiofrequency (RF) Group | Urogenital Distress Short Form (UDI-6) | 3 Month Post Treatment | 41.15 score on a scale | Standard Deviation 31.61 |
| Radiofrequency (RF) Group | Urogenital Distress Short Form (UDI-6) | Baseline | 34.38 score on a scale | Standard Deviation 24.37 |
| Radiofrequency (RF) Group | Urogenital Distress Short Form (UDI-6) | 6 Month Post Treatment | 23.61 score on a scale | Standard Deviation 20.18 |
| Placebo Arm | Urogenital Distress Short Form (UDI-6) | 3 Month Post Treatment | 27.14 score on a scale | Standard Deviation 23.11 |
| Placebo Arm | Urogenital Distress Short Form (UDI-6) | Baseline | 28.15 score on a scale | Standard Deviation 23.23 |
| Dual (HFL & RF) Group | Urogenital Distress Short Form (UDI-6) | 3 Month Post Treatment | 21.13 score on a scale | Standard Deviation 23.2 |
| Dual (HFL & RF) Group | Urogenital Distress Short Form (UDI-6) | 6 Month Post Treatment | 24.63 score on a scale | Standard Deviation 19.16 |
| Dual (HFL & RF) Group | Urogenital Distress Short Form (UDI-6) | Baseline | 28.15 score on a scale | Standard Deviation 23.23 |