- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04705571
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
Completed
Intervention / Treatment
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
Interventional
Enrollment (Actual)
41
Phase
- 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
-
-
Georgia
-
Alpharetta, Georgia, United States, 30005
- Miklos and Moore Urogynecology
-
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South Carolina
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Bluffton, South Carolina, United States, 29910
- Advanced Women's Care of the Lowcountry, PC
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-
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
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 |
Intervention / Treatment |
---|---|
Experimental: MorpheusV Applicator (active)
|
1 treatment with the MorpheusV Applicator
|
What is the study measuring?
Primary Outcome Measures
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
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
Investigators
- 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)
March 15, 2021
Primary Completion (Actual)
July 30, 2022
Study Completion (Actual)
July 30, 2022
Study Registration Dates
First Submitted
December 24, 2020
First Submitted That Met QC Criteria
January 8, 2021
First Posted (Actual)
January 12, 2021
Study Record Updates
Last Update Posted (Actual)
August 10, 2022
Last Update Submitted That Met QC Criteria
August 9, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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