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

• ClinicalTrials.gov Identifier: NCT03280446
• Recruitment Status: Unknown
• First Posted: September 12, 2017
• Last Update Posted: March 23, 2018
• Sponsor: SHERRY Thomas
• Information provided by (Responsible Party): SHERRY Thomas, The American Association of Female Pelvic Medicine Specialists, Inc.

Tracking Information

• First Submitted Date: September 1, 2017
• First Posted Date: September 12, 2017
• Last Update Posted Date: March 23, 2018
• Actual Study Start Date: August 23, 2017
• Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 10, 2017)

To evaluate the efficacy of transcutaneous Fractional Radiofrequency Device (TFRF) for the treatment of vaginal laxity using the vaginal laxity questionnaire (VLQ). [ Time Frame: 12 month ]

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 10, 2017)

To evaluate the efficacy of transcutaneous Fractional Radiofrequency Device (TFRF) for the treatment of urogynecological symptoms. [ Time Frame: 12 month ]

To seasures improvement in subject sexual satisfaction and Urogynecological symptoms using sexual satisfaction Questionnaire (SSQ) and GRA (Global Response Assessment)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluation Using Intragen Fractional Radiofrequency With NeuViVa for the Treatment of Vaginal Laxity and Urogynecology Symptoms.
• Official Title: Evaluation Using Intragen Fractional Radiofrequency With NeuViVa for the Treatment of Vaginal Laxity and Urogynecology Symptoms.
• 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.

Detailed Description

A total of thirty (30) subjects will be enrolled and assigned to a single treatment arm, receiving active treatment clinic, with the visits consisting of three (3) treatment administrations and post-procedure visits days 30, 180 and 360. Pre-menopausal and post-menopausal women between ages over 18, vaginal delivery, with up to moderate pelvic prolapse 2 cm past the hymen, and self-reported vaginal laxity score of "very loose", moderately loose", or "slightly loose" as defined by theVaginal Laxity Questionnaire (VLQ) will be evaluated and enrolled after having met all inclusion and exclusion criteria.

The treatment administration phase will consist of three (3) treatments,delivered approximately on-month apart. Subjects will be placed on the treatment table in the dorsal lithotomy position. The monopolar return pad will be placed on the subject buttock and to the RF generator.Coupling fluid will be used as a lubricant and will be reapplied throughout the treatment as needed. The treatment area is approximately 20+ cm2 and consist of the outside perineum and entire vaginal circumference along the length of the vagina to include the apex. For treatment of the labia majora, the treatment tip will be applied across the entire anatomical region. The treatment tip is applied to the perineum bilaterally from the lowest edge of the mons pubis to the perineal body and laterally to the crural folds to achieve vulvar and perineal temperatures of between 40-45 degrees celsius for approximately 5 minutes or more of total heat time per area. The labia majora and perineal areas will take approximately 10-15 minutes to complete. This is followed by treating the epithelial surface of the vaginal opening and advancing to the length of the vaginal canal with the treatment occurring along the vaginal walls, floor, and ceiling. The entire vaginal area will be treated in a circumferential area by delivering the RF in a systematic fashion at 5 separate delivery position starting the most distal portion of the vagina. The probe is slowly retracted at 1 cm intervals and circumferentially delivered again at 5 positions on another circumferentially manner moving the probe clockwise or counter clockwise or counter clockwise. To include the entire length of the urethra and bladder will be included in the treatment. Total vaginal treatment time will be 15-20 minutes. Safety measures will include monitoring of adverse events including pain or burns or infections during and after the procedure. Evaluations will be conducted with the visits at days 30, 90 and 150 days post-procedure.

During and after treatment administration, subjects will be asked to assess the self- reported pain experience using a 10 scale VAS, with "0" being no pain and "10" being the worst pain imaginable. Descriptive statistics will be generated on all demographic, medical history, and physical examination findings including means and standard deviations, for continuous, and frequencies and percentages for categorical variables.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Vaginal Laxity
• Urinary Incontinence
• Sexual Dysfunction

Intervention

Device: Intragen fractional radiofrequency with NeuViVa

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.

Study Arms

Experimental: 30 pre-menopause and post-menopause women

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

Intervention: Device: Intragen fractional radiofrequency with NeuViVa

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: September 10, 2017): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 2019
• Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

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., 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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03280446
• Other Study ID Numbers: IG-VL-101
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: SHERRY Thomas, The American Association of Female Pelvic Medicine Specialists, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: SHERRY Thomas
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: The American Association of Female Pelvic Medicine Specialists, Inc.
• Verification Date: March 2018