CompletedNCT03316950Updated Jan 4, 2023Results posted

Radiofrequency and Hybrid Fractional Laser for Vaginal Rejuvenation

An interventional study of IntraGen RF and DiVA in Vaginal Atrophy, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to female participants aged 40 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-04.

Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 52
Allocation: Randomized
Ages: 40 Years to 65 Years
Sex: Female

Study 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.

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 studied

Vaginal Atrophy

Browse trials for

Atrophy 830

Keywords

postmenopause
rejuvenation
radiofrequency
diva

Who can participate

Ages eligible: 40 Years to 65 Years
Sexes eligible: Female
Accepts 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

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 52 participants (actual)

Study arms

Experimental
IntraGen RF
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.
Device: IntraGen RF
Experimental
DiVA
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.
Device: DiVA
Sham comparator
Placebo Arm
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.
Device: Placebo (DIVA/IntraGen combined)
Experimental
Dual Treatment
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.
Device: IntraGen RF · Device: DiVA

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.

What researchers measure

Primary outcomes

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
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

Secondary outcomes

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
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
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
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
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
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
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
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
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

Results

Posted Jan 4, 2023

Participant flow

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.

Initial Intervention (1 to 3 Months)

Participant flow — Initial Intervention (1 to 3 Months)
Milestone	Hybrid Fractional Laser (HFL) Group	Radiofrequency (RF) Group	Placebo Arm
Started	12	12	23
Completed	9	8	14
Not completed	3	4	9
Withdrew: Withdrawal by subject	1	2	3
Withdrew: Physician decision	2	0	1
Withdrew: Lost to follow-up	0	2	5

Dual Intervention (6 to 8 Months)

Participant flow — Dual Intervention (6 to 8 Months)
Milestone	Hybrid Fractional Laser (HFL) Group	Radiofrequency (RF) Group	Placebo Arm	Dual (HFL & RF) Group
Started	0	0	0	14
Completed	0	0	0	14
Not completed	0	0	0	0

Outcome measures

PrimaryVulvovaginal 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
Reported as:: Mean · score on a scale

Vulvovaginal Symptoms Questionnaire
score on a scale	Hybrid Fractional Laser (HFL) Group	Radiofrequency (RF) Group	Placebo Arm	Dual (HFL & RF) Group
Baseline	8 ± 5.5	7.88 ± 5.49	5.93 ± 4.67	5.93 ± 4.67
3 Month Post Treatment	3.22 ± 2.77	5 ± 6.12	3 ± 3.46	1.86 ± 2.51
6 Month Post Treatment	3.43 ± 3.87	2.33 ± 4.41	—	1.7 ± 2.36

PrimaryVaginal 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
Reported as:: Mean · score on a scale

Vaginal Laxity Questionnaire
score on a scale	Hybrid Fractional Laser (HFL) Group	Radiofrequency (RF) Group	Placebo Arm	Dual (HFL & RF) Group
Baseline	3.57 ± 2.51	3.67 ± 2.25	2.79 ± 1.93	2.79 ± 1.93
3 Months Post Treatment	4.44 ± 1.74	3.75 ± 2.19	3.5 ± 1.74	3.93 ± 1.82
6 Months Post Treatment	3.83 ± 1.72	4.5 ± 1.38	—	4.2 ± 1.4

SecondaryPerceived 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
Reported as:: Mean · mmHg

Perceived Changes in Vaginal Laxity as Measured by Zimmern Probe at 3 Months Post Treatment
mmHg	Hybrid Fractional Laser (HFL) Group	Radiofrequency (RF) Group	Placebo Arm	Dual (HFL & RF) Group
Perceived Changes in Vaginal Laxity as Measured by Zimmern Probe at 3 Months Post Treatment	0.44 ± NA	0.78 ± 1.3	0.7 ± 2.47	0.36 ± 1.33

SecondaryPerceived 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

No measurements were reported for this outcome.

SecondaryUrogenital 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
Reported as:: Mean · score on a scale

Urogenital Distress Short Form (UDI-6)
score on a scale	Hybrid Fractional Laser (HFL) Group	Radiofrequency (RF) Group	Placebo Arm	Dual (HFL & RF) Group
Baseline	36.11 ± 17.92	34.38 ± 24.37	28.15 ± 23.23	28.15 ± 23.23
3 Month Post Treatment	25.65 ± 18.93	41.15 ± 31.61	27.14 ± 23.11	21.13 ± 23.2
6 Month Post Treatment	25.69 ± 21.8	23.61 ± 20.18	—	24.63 ± 19.16

SecondaryIncontinence 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
Reported as:: Mean · score on a scale

Incontinence Impact Questionnaire Short Form (IIQ-7)
score on a scale	Hybrid Fractional Laser (HFL) Group	Radiofrequency (RF) Group	Placebo Arm	Dual (HFL & RF) Group
Baseline	22.75 ± 18.1	22.02 ± 29.01	10.2 ± 17	10.2 ± 17
3 Month Post Treatment	7.41 ± 12.62	11.31 ± 13.21	15.98 ± 32.33	8.16 ± 20.24
6 Month Post Treatment	11.9 ± 14.04	10.32 ± 18.42	—	10.48 ± 31.49

SecondaryFemale 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
Reported as:: Mean · score on a scale

Female Sexual Function Index (FSFI)
score on a scale	Hybrid Fractional Laser (HFL) Group	Radiofrequency (RF) Group	Placebo Arm	Dual (HFL & RF) Group
Baseline	14.96 ± 9.23	15.69 ± 10.34	15.98 ± 10.04	16.09 ± 9.62
3 Months Post Treatments	21.38 ± 11.62	18.73 ± 12.72	17.28 ± 10.98	20.67 ± 10.88
6 Months Post Treatments	18.2 ± 12.33	21.7 ± 14.01	—	24.19 ± 11.06

SecondaryGene 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
Reported as:: Mean · fold change

Gene Expression- Col1A1 as Measured by Fold Change
fold change	Hybrid Fractional Laser (HFL) Group	Radiofrequency (RF) Group	Placebo Arm	Dual (HFL & RF) Group
Gene Expression- Col1A1 as Measured by Fold Change	0.67 ± 0.32	0.48 ± 0.24	1 ± 0.25	0.95 ± 0.26

SecondaryGene 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
Reported as:: Mean · fold change

Gene Expression- Col3A1 as Measured by Fold Change
fold change	Hybrid Fractional Laser (HFL) Group	Radiofrequency (RF) Group	Placebo Arm	Dual (HFL & RF) Group
Gene Expression- Col3A1 as Measured by Fold Change	0.95 ± 0.41	0.82 ± 0.55	1 ± 0.35	1.23 ± 0.25

SecondaryGene 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
Reported as:: Mean · fold change

Gene Expression- ELN as Measured by Fold Change
fold change	Hybrid Fractional Laser (HFL) Group	Radiofrequency (RF) Group	Placebo Group	Dual (HFL & RF) Group
Gene Expression- ELN as Measured by Fold Change	0.40 ± 0.18	0.33 ± 0.20	1 ± 0.16	0.79 ± 0.15

SecondaryGene 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
Reported as:: Mean · fold change

Gene Expression- LOX as Measured by Fold Change
fold change	Hybrid Fractional Laser (HFL) Group	Radiofrequency (RF) Group	Placebo Arm	Dual (HFL & RF) Group
Gene Expression- LOX as Measured by Fold Change	2.72 ± 1.71	0.75 ± .28	1 ± 0.16	0.95 ± 0.17

Adverse events

Collected over 15 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Hybrid Fractional Laser (HFL) Group	0/12 (0%)	0/12 (0%)	7/12 (58.3%)
Radiofrequency (RF) Group	0/12 (0%)	0/12 (0%)	4/12 (33.3%)
Placebo Arm	0/23 (0%)	0/23 (0%)	6/23 (26.1%)
Dual (HFL & RF) Group	0/14 (0%)	0/14 (0%)	6/14 (42.9%)

Most frequent other events

Most frequent other events
Event	Hybrid Fractional Laser (HFL) Group	Radiofrequency (RF) Group	Placebo Arm	Dual (HFL & RF) Group
OtherReproductive system and breast disorders	7/12	4/12	5/23	1/14
Vaginal Odor/Itching/SpottingReproductive system and breast disorders	1/12	0/12	1/23	5/14
UTI/Yeast InfectionReproductive system and breast disorders	0/12	2/12	2/23	0/14
Abdominal DiscomfortReproductive system and breast disorders	0/12	0/12	1/23	1/14
Vaginal perspirationReproductive system and breast disorders	0/12	0/12	0/23	1/14
Urine LeakageReproductive system and breast disorders	0/12	0/12	1/23	0/14

Baseline characteristics

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)

Age, Categorical
Age, Categorical(Participants)	Hybrid Fractional Laser (HFL) Group	Radiofrequency (RF) Group	Placebo Group	Dual (HFL & RF) Group	Total
Initial Intervention — <=18 years	0	0	0	0	0
Initial Intervention — Between 18 and 65 years	12	12	23	0	47
Initial Intervention — >=65 years	0	0	0	0	0
Dual Intervention — <=18 years	0	0	0	0	0
Dual Intervention — Between 18 and 65 years	0	0	0	14	14
Dual Intervention — >=65 years	0	0	0	0	0

Sex: Female, Male
Sex: Female, Male(Participants)	Hybrid Fractional Laser (HFL) Group	Radiofrequency (RF) Group	Placebo Group	Dual (HFL & RF) Group	Total
Initial Intervention — Female	12	12	23	0	47
Initial Intervention — Male	0	0	0	0	0
Dual Intervention — Female	0	0	0	14	14
Dual Intervention — Male	0	0	0	0	0

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Hybrid Fractional Laser (HFL) Group	Radiofrequency (RF) Group	Placebo Group	Dual (HFL & RF) Group	Total
Initial Intervention — Caucasian	5	9	15	0	29
Initial Intervention — Hispanic	1	1	2	0	4
Initial Intervention — Black or African American	6	2	5	0	13
Initial Intervention — Caucasian / Hispanic	0	0	1	0	1
Dual Intervention — Caucasian	0	0	0	8	8
Dual Intervention — Hispanic	0	0	0	1	1
Dual Intervention — Black or African American	0	0	0	4	4
Dual Intervention — Caucasian / Hispanic	0	0	0	1	1

Study locations

1 site

University of Texas Southwestern Medical Center
Dallas, Texas 75390, United States

References and documents

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. Erratum In: Lasers Surg Med. 2017 Sep;49(7):727. doi: 10.1002/lsm.22643. PubMed 27197701 ↗
Millheiser LS, Pauls RN, Herbst SJ, Chen BH. Radiofrequency treatment of vaginal laxity after vaginal delivery: nonsurgical vaginal tightening. J Sex Med. 2010 Sep;7(9):3088-95. doi: 10.1111/j.1743-6109.2010.01910.x. PubMed 20584127 ↗
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. PubMed 23952177 ↗
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. PubMed 25410301 ↗
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. PubMed 20835826 ↗
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].

Study documents

Protocol and statistical analysis plan · Apr 21, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT03316950
Lead sponsor: University of Texas Southwestern Medical Center
Collaborators: American Society for Aesthetic Plastic Surgery
Responsible party: Jeffrey M. Kenkel (Chair, University of Texas Southwestern Medical Center) — Principal investigator
First posted: Oct 23, 2017
Start date: Jun 15, 2018
Primary completion: Apr 8, 2021
Completion: Apr 8, 2021
Results posted: Jan 4, 2023
Last update: Jan 4, 2023

Study contacts

Jeffrey Kenkel, MD

principal investigator · Chair & Professor

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Atrophy→

Other studies from this sponsor

University of Texas Southwestern Medical Center

Start the discussion

Radiofrequency and Hybrid Fractional Laser for Vaginal Rejuvenation

Study summary

Conditions studied

Browse trials for

Keywords

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Publications

Study documents

Individual participant data

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria