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Procedure

DiVA for Vulvovaginal Atrophy

N/A
Waitlist Available
Led By Jeffrey Kenkel, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women should be between 40 and 65 years of age
Women should be post-menopausal
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 month post- treatments and 6 month post treatments
Awards & highlights

Study Summary

This trial is testing whether two different types of laser treatment can help with vulvovaginal symptoms. 100 people will be given one of four treatments, and then tested six and twelve months later to see if there are any improvements.

Eligible Conditions
  • Vulvovaginal Atrophy

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 month post- treatments and 6 month post treatments
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 month post- treatments and 6 month post treatments for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Vaginal Laxity Questionnaire
Vulvovaginal Symptoms Questionnaire
Secondary outcome measures
Female Sexual Function Index (FSFI)
Gene Expression- Col1A1 as Measured by Fold Change
Gene Expression- Col3A1 as Measured by Fold Change
+6 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: IntraGen RFExperimental Treatment1 Intervention
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.
Group II: Dual TreatmentExperimental Treatment2 Interventions
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.
Group III: DiVAExperimental Treatment1 Intervention
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.
Group IV: Placebo ArmPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IntraGen RF
2018
N/A
~60
DiVA
2018
N/A
~60

Find a Location

Who is running the clinical trial?

American Society for Aesthetic Plastic SurgeryUNKNOWN
University of Texas Southwestern Medical CenterLead Sponsor
1,039 Previous Clinical Trials
1,048,047 Total Patients Enrolled
Jeffrey Kenkel, MDPrincipal InvestigatorChair & Professor
11 Previous Clinical Trials
209 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elderly adults eligible for enrollment into this trial?

"The age requirements for potential candidates of this trial are between 40 and 65 years old."

Answered by AI

Are there still vacancies available for participants in this research?

"Per evidence hosted on clinicaltrials.gov, this experiment is not recruiting new participants at the moment as it was last updated on February 4th 2022. Nonetheless, 187 other trials are presently enrolling people in need of medical care."

Answered by AI

Do I fulfill the qualifications necessary to participate in this trial?

"This clinical trial calls for participants aged between 40 and 65 that have been diagnosed with atrophy. A total of 50 patients will be accepted into the program."

Answered by AI

What are the key goals of this experiment?

"Over the course of 1.5 years, this clinical trial will be monitoring a Vaginal Laxity Questionnaire to measure progress. Additionally, female sexual function is being evaluated using the FSFI, incontinence is assessed with an IIQ-7 survey, and vaginal wall elasticity is measured through Zimmern Probes."

Answered by AI
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~8 spots leftby Mar 2025