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

NCT03280446 | Unknown DMC FDA Device

• 1 other identifier: IG-VL-101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vaginal Laxity; Urinary Incontinence; Sexual Dysfunction

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy of transcutaneous Fractional Radiofrequency Device (TFRF) for the treatment of vaginal laxity using the vaginal laxity questionnaire (VLQ).

  The primary outcome measure is the mean change in the severity of the vaginal Laxity (VL) and in female Sexual Function Inventory (FSFI) by using VLQ, assessment and visual analog scale compared to base line.

  12 month

Secondary Outcomes (1)

• To evaluate the efficacy of transcutaneous Fractional Radiofrequency Device (TFRF) for the treatment of urogynecological symptoms.

  12 month

Study Arms (1)

30 pre-menopause and post-menopause women

EXPERIMENTAL

Thirty healthy women with mild to moderate pelvic prolapse above the ages of 18 seeking treatment for vaginal laxity

Device: Intragen fractional radiofrequency with NeuViVa

Interventions

Intragen fractional radiofrequency with NeuViVa DEVICE

The Transcutaneous Fractional Radiofrequency Device (TFRF) is a minimal risk device that is currently cleared by the FDA K142833.The device uses a non-invasive, transepithelial treatment probe to elevate epithelial tissue temperatures to 40-45 oC for the purpose of promoting tissue contracture. Real-time tissue impedance monitoring will be carried out using the treatment probe.

30 pre-menopause and post-menopause women

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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.

Sponsors & Collaborators

• SHERRY Thomas: lead

Study Sites (1)

The American Association of Female Pelvic Medicine Specialists, Inc.

Agoura Hills, California, 91301, United States

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases

Central Study Contacts

Sherry Thomas, MD

CONTACT

8189910988; drsherrythomas@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sherry Thomas, MD, MPH

Study Record Dates

• First Submitted: September 1, 2017
• First Posted: September 12, 2017
• Study Start: August 23, 2017
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2019
• Last Updated: March 23, 2018

Record last verified: 2018-03

Locations

US (1)