Evaluation Using Intragen Fractional Radiofrequency With NeuViVa for the Treatment of Vaginal Laxity and Urogynecology Symptoms.

Status unconfirmed · Not applicable

Conditions studied: Vaginal Laxity, Urinary Incontinence, Sexual Dysfunction

In brief

This study will evaluate the clinical efficacy of a Transcutaneous Fractional Radiofrequency Device (TFRF) for the treatment of vaginal laxity (VL) and urogynecological symptoms.

Key facts

Study ID

NCT03280446

Run by

SHERRY Thomas

People needed

30

Starts

2017-08-23

Expected to finish

2019-08-01

Last updated by the study team

2018-03-23

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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., ibuprofen, aspirin and steroids) that can affect collagen or healing. Subject may qualify if willingly fulfills a 30-day washout period of such drugs prior to treatment.They were using anti-inflammatory drugs on a chronic basis (e.g., ibuprofen, aspirin and steroids) that can affect collagen or healing. Subject may qualify if willingly fulfills a 30 days washout period of such drugs prior to treatment.
• Those with clinically significant anxiety or depression that may prohibit completion of treatments and/or suffering a medical problem that might interfere with wound healing.
• All subjects on oral contraceptives prior to enrollment are encouraged to take these throughout the study.

Where it is running

• The American Association of Female Pelvic Medicine Specialists, Inc. — Agoura Hills, California, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.