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

August 9, 2022 updated by: InMode MD Ltd.

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The objective of this trial is to evaluate the safety and efficacy of the MorpheusV Applicator for Symptoms of Stress Urinary Incontinence and Vulvovaginal Atrophy

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
41

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Alpharetta, Georgia, United States, 30005
        • Miklos and Moore Urogynecology
    • South Carolina
      • Bluffton, South Carolina, United States, 29910
        • Advanced Women's Care of the Lowcountry, PC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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.
    • 18 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.

Exclusion Criteria:

  • - 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.
  • As per the practitioner's discretion, refrain from treating any condition that might make it unsafe for the patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MorpheusV Applicator (active)
Device: MorpheusV Applicator
1 treatment with the MorpheusV Applicator

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
An objective change as measured by standardized cough stress test
Time Frame: Day 0, Month 6
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
Time Frame: Day 0, month 6
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
Time Frame: 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. 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
Time Frame: day 0, month 6
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
Time Frame: Day 0, month 6
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
Time Frame: 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 at 6M FU versus baseline.
Day 0, month 6
Evaluation of histological changes to vaginal canal tissue
Time Frame: Day 0, month 3
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Occurrence of expected post treatment immediate response
Time Frame: day 0, through study completion, on average 6 months
Occurrence of expected post treatment immediate response including erythema and edema and during all study period based on predefined scale
day 0, through study completion, on average 6 months
Discomfort scale
Time Frame: day 0
A 10cm visual analog scale from 0 (no discomfort) to 10 (worst possible discomfort) to measure discomfort associated with probe insertion, and RF energy application
day 0
Adverse Events
Time Frame: Through study completion, an average of 6 months
Number, severity and type of any adverse event recorded throughout the course of the study.
Through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
InMode MD Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tracy Blusewicz, MD, Advanced Women's Care of the Lowcountry, PC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 10, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DO609885A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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