Status:
COMPLETED
Radiofrequency and Hybrid Fractional Laser for Vaginal Rejuvenation
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
American Society for Aesthetic Plastic Surgery
Conditions:
Vaginal Atrophy
Eligibility:
FEMALE
40-65 years
Phase:
NA
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 ...
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, bu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 8 2021
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03316950
Start Date
June 15 2018
End Date
April 8 2021
Last Update
January 4 2023
Active Locations (1)
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1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390