Stress Urinary IncontinenceNCT04705571
Clinical Evaluation of Fractional Bi-Polar RF for Symptoms of SUI and Vulvovaginal Atrophy
A study testing MorpheusV Applicator in people with Stress Urinary Incontinence and Vulvovaginal Signs and Symptoms, run by InMode MD Ltd. at 2 sites in United States.
Trial summary
Clinical Evaluation of Fractional Bi-Polar Radio-Frequency for Symptoms of Stress Urinary Incontinence and Vulvovaginal Atrophy Read more about this study
- Who is it for?
- Ages 35 to 75 years, women only
- Conditions the study is for
- Stress Urinary Incontinence, Vulvovaginal Signs and Symptoms
- What is being tested?
- MorpheusV Applicator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Mar 2021to 30 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- - 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.
Show all 16Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Miklos and Moore Urogynecology
Alpharetta, Georgia, 30005
Advanced Women's Care of the Lowcountry, PC
Bluffton, South Carolina, 29910
About this study
Official title: 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
Read the 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
- Being tested
- MorpheusV Applicator
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorpheusV ApplicatorDevice
1 treatment with the MorpheusV Applicator
| Study group | Role | What they receive |
|---|---|---|
| MorpheusV Applicator (active) | Experimental | Not described Receives: Device: MorpheusV Applicator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: Day 0, month 3
Secondary outcomes (3)
Occurrence of expected post treatment immediate response
Occurrence of expected post treatment immediate response including erythema and edema and during all study period based on predefined scale
Measured: day 0, through study completion, on average 6 months
Discomfort scale
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
Measured: day 0
Adverse Events
Number, severity and type of any adverse event recorded throughout the course of the study.
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start15 Mar 2021
- Primary completion30 Jul 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Eligible subjects will receive 1 treatment with the MorpheusV Applicator according to the study protocol.
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- InMode MD Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tracy Blusewicz, MD, Principal investigator, Advanced Women's Care of the Lowcountry, PC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04705571
- Sponsor's protocol ID
- DO609885A
- Status last verified
- Jan 2022
- First submitted
- 24 Dec 2020
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Fractional Bi-Polar Radio-Frequency for Symptoms of Stress Urinary Incontinence and Vulvovaginal Atrophy
- ClinicalTrials.gov ID
- NCT04705571
- Acronym / sponsor ID
- DO609885A
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- InMode MD Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 12 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical Evaluation of Fractional Bi-Polar Radio-Frequency for Symptoms of Stress Urinary Incontinence and Vulvovaginal Atrophy
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Eligible subjects will receive 1 treatment with the MorpheusV Applicator according to the study protocol.
| Arm | Type | Receives |
|---|---|---|
| MorpheusV Applicator (active) | Experimental | Device: MorpheusV Applicator |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed informed consent to participate in the study.
Key exclusion criteria (16 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MorpheusV Applicator1 treatment with the MorpheusV Applicator | Device | MorpheusV Applicator (active) |
Primary outcome
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
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.
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.
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.
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.
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.
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)
3 secondary outcomes
Occurrence of expected post treatment immediate response
Time frame: day 0, through study completion, on average 6 months
Discomfort scale
Time frame: day 0
Adverse Events
Time frame: Through study completion, an average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tracy Blusewicz, MD principal investigator
Advanced Women's Care of the Lowcountry, PC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MorpheusV Applicator in people with Stress Urinary Incontinence and Vulvovaginal Signs and Symptoms, run by InMode MD Ltd. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
An objective change as measured by standardized cough stress test (time frame: Day 0, Month 6). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022.