Clinical Evaluation of Fractional Bi-Polar RF for Symptoms of SUI and Vulvovaginal Atrophy

NCT04705571 | Completed FDA Device

• 1 other identifier: DO609885A
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

Brief Summary

Clinical Evaluation of Fractional Bi-Polar Radio-Frequency for Symptoms of Stress Urinary Incontinence and Vulvovaginal Atrophy

Conditions

Stress Urinary Incontinence; Vulvovaginal Signs and Symptoms

Outcome Measures

Primary Outcomes (7)

• An objective change as measured by standardized cough stress test

  An objective change as measured by standardized cough stress test performed in standing position before treatment and at 6 months (6M FU) after the treatment

  Day 0, Month 6

• An objective evaluation of vaginal atrophy/estrogenization

  An objective evaluation of vaginal atrophy/estrogenization measured by the globally validated "Vaginal Health Index" (VHI) score at 6M FU compared to Baseline.

  Day 0, month 6

• The effect of the treatment on urinary symptoms and quality of life by means of the Incontinence Quality of Life (IQOL) Questionnaire

  The effect of the treatment on urinary symptoms and quality of life by means of the Incontinence Quality of Life (IQOL) Questionnaire. Administered at baseline and at 6M FU.

  Day 0, month 6

• The effect of the treatment on urinary symptoms by means of Urogenital Distress Inventory 6 Questionnaire

  The effect of the treatment on urinary symptoms by means of Urogenital Distress Inventory 6 Questionnaire. Administered at baseline and at 6M FU.

  day 0, month 6

• The effect of the treatment on urinary symptoms by means of Bladder voiding diary after the treatment

  The effect of the treatment on urinary symptoms by means of Bladder voiding diary after the treatment, and at 6M FU versus baseline.

  Day 0, month 6

• The effect of the treatment on urinary symptoms by means of Medical, Epidemiologic, and Social Aspects of Aging Urinary Incontinence (MESA) Questionnaire

  The effect of the treatment on urinary symptoms by means of Medical, Epidemiologic, and Social Aspects of Aging Urinary Incontinence (MESA) Questionnaire at 6M FU versus baseline.

  Day 0, month 6

• Evaluation of histological changes to vaginal canal tissue

  Evaluation of histological changes to vaginal canal tissue taken immediately post treatment and at 3M FU versus baseline. (for 5 subjects)

  Day 0, month 3

Secondary Outcomes (3)

• Occurrence of expected post treatment immediate response

  day 0, through study completion, on average 6 months

• Discomfort scale

  day 0

• Adverse Events

  Through study completion, an average of 6 months

Study Arms (1)

MorpheusV Applicator (active)

EXPERIMENTAL

Device: MorpheusV Applicator

Interventions

MorpheusV Applicator DEVICE

1 treatment with the MorpheusV Applicator

MorpheusV Applicator (active)

Eligibility Criteria

• Age: 35 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent to participate in the study.
• Female subjects, 35 and 75 years of age at the time of enrolment with primary and moderate to severe symptoms of SUI, who had scored at least 6 out of 12 according to severity index developed by Sandvik
• She has produced a leak during the bladder "cough" stress test.
• out of 27 for the Stress Incontinence Questions and were confirmed as having predominant SUI on the Medical, Epidemiologic, and Social Aspects of Aging Urinary Incontinence (MESA) Questionnaire completed at the screening assessment.
• General good health confirmed by medical history and skin examination of the treated area.
• The patients should be willing to comply with the study procedure and schedule, including the follow up visit, and will refrain from using any other aesthetic treatment methods for the last 6 months and during the entire study period.

You may not qualify if:

• \- Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
• Permanent implant in the treated area such as metal plates and screws, silicone implants or an injected chemical substance, unless deep enough in the periostal plane.
• Current or history of cancer, or premalignant condition in the treatment area.
• Severe concurrent conditions, such as cardiac disorders, epilepsy, uncontrolled hypertension, and liver or kidney diseases.
• Pregnancy and nursing.
• Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications.
• Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regimen.
• Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction.
• Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
• History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.
• History of bleeding coagulopathies or use of anticoagulants in the last 10 days.
• Any surgery in treated area within 3 months prior to treatment.
• Simultaneous participation in another investigator drug or device study or completion of the follow-up phase for the primary endpoint of any previous study less than 30 days prior to the first evaluation in this study.
• Six months delay is required if other recent treatments like light, CO2 laser or RF were performed on the same area.
• Use of Isotretinoin (Accutane®) within 6 months prior to treatment.

Sponsors & Collaborators

• InMode MD Ltd.: lead

Study Sites (2)

Miklos and Moore Urogynecology

Alpharetta, Georgia, 30005, United States

Location

Advanced Women's Care of the Lowcountry, PC

Bluffton, South Carolina, 29910, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; 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

Study Officials

• Tracy Blusewicz, MD

  Advanced Women's Care of the Lowcountry, PC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Eligible subjects will receive 1 treatment with the MorpheusV Applicator according to the study protocol.

Study Record Dates

• First Submitted: December 24, 2020
• First Posted: January 12, 2021
• Study Start: March 15, 2021
• Primary Completion: July 30, 2022
• Study Completion: July 30, 2022
• Last Updated: August 10, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)