Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2025-12-24 @ 4:50 PM
NCT ID:
NCT03316950
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT03316950
Study Brief:
Protocol Section:
NCT03316950