Evaluation Using Intragen Fractional Radiofrequency With NeuViVa for the Treatment of Vaginal Lax… (NCT03280446) | Clinical Trial Compass
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Evaluation Using Intragen Fractional Radiofrequency With NeuViVa for the Treatment of Vaginal Laxity and Urogynecology Symptoms.
United States30 participantsStarted 2017-08-23
Plain-language summary
This study will evaluate the clinical efficacy of a Transcutaneous Fractional Radiofrequency Device (TFRF) for the treatment of vaginal laxity (VL) and urogynecological symptoms.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
Healthy female adult subjects presenting, clinically, with VL, and has expressed interest in treatment will be considered eligible for the study. Enrollment of subject will depend on meeting the following criteria:
* Voluntarily signed informed consent form
* Ages ≥ 18
* Completed urine pregnancy examination with negative result if premenopausal
* Self-reported perceptions of vaginal laxity defined as "very loose," "moderately loose," or slightly loose" on the Vaginal Laxity Questionnaire.
* Up to Baden-Walker Grade 2 or Stage 2 Pelvic Organ Prolapse (≤ 1 cm past hymen)
* Papanicolaou smear cytology within 36 months prior to treatment showing no dysplasia
* Subject willing to take valacyclovir at 100 mg PO q12h x 3 for history recurrent episode of HSV
* or 1000mg PO q daily x 5 days
Exclusion Criteria:
* Baden-Walker System Severe pelvic prolapse (≥ Stage 3); Pelvic organ prolapse up to
1 cm beyond the hymenal ring.
* Active STD (e.g. genital herpes, condylomata)
* Body mass index ≥ 35
* Previous reconstructive vaginal surgery, vaginal lasers, or vaginal injections of fat or fillers within 6 months.
* Current urinary tract infection
* Actively participating in, or planning on participating in, pelvic floor muscle strengthening exercises.
* Presence of pacemaker, AICD, or other electrical health maintenance device.
* Immunosuppression (pathological or medication induced, such as steroids, methotrexate) inflammatory drugs on a chronic basis (e.g., ibupr…
What they're measuring
1
To evaluate the efficacy of transcutaneous Fractional Radiofrequency Device (TFRF) for the treatment of vaginal laxity using the vaginal laxity questionnaire (VLQ).