Bi-Polar Radio-Frequency and Electrical Muscle Stimulation for Symptoms of Mixed Urinary Incontinence (MUI)

NCT05287490 | Completed FDA Device

• 1 other identifier: DO609893A
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of this trial is to evaluate the safety and efficacy of the combined FormaV and VTone Applicators for Symptoms of Mixed Urinary Incontinence. Eligible subjects will receive 3 treatments(every 2 weeks) with the FormaV and VTone Applicators according to the study protocol. The subject will return for 3 follow-up visits: 4 weeks (1M FU), 3 months follow up (3M FU), 6 months follow up (6M FU) after the treatment.

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (6)

• Cough stress test

  Change as measured by standardized cough stress test performed in standing position before treatment and 6 months after the treatment

  Baseline through month 6

• 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.

  baseline through month 6

• Female Sexual Function Index questionnaire

  The effect of the treatment on female sexual function by means of Female Sexual Function Index

  baseline through month 6

• Urogenital Distress Inventory 6 Questionnaire

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

  baseline through month 6

• 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 (

  baseline through month 6

• Patient Global Impression of Improvement (PGI), using a 5-point Likert scale

  The rate of satisfaction of patients with treatment assessed by the Patient Global Impression of Improvement (PGI), using a 5-point Likert scale

  month 6

Secondary Outcomes (2)

• Discomfort scale

  post treatment

• Adverse events

  throughout the study

Study Arms (1)

treatment

EXPERIMENTAL

Device: FormaV and VTone

Interventions

FormaV and VTone DEVICE

Eligible subjects will receive 3 treatments(every 2 weeks) with the FormaV and VTone Applicators according to the study protocol.

treatment

Eligibility Criteria

• Age: 20 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, 20 to 75 years of age at the time of enrolment with moderate to severe symptoms of MUI, who had scored a relative even proportion of urge and stress subscale scores 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 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.
• Patients who have vaginal metal piercing, or intrauterine contraceptive device (IUCD or ICD or coil or any other device made of metal).
• 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.

Sponsors & Collaborators

• InMode MD Ltd.: lead

Study Sites (2)

Advanced Women's Care of the Lowcountry, PC

Bluffton, South Carolina, 29910, United States

Location

Lisa M Jukes MD

West Lake Hills, Texas, 78746, United States

Location

MeSH Terms

Conditions

Urinary Incontinence

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

Study Design

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

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: March 18, 2022
• Study Start: April 4, 2021
• Primary Completion: July 30, 2022
• Study Completion: July 30, 2022
• Last Updated: August 11, 2022

Record last verified: 2022-02

Locations

US (2)