Urinary IncontinenceNCT05287490
Bi-Polar Radio-Frequency and Electrical Muscle Stimulation for Symptoms of Mixed Urinary Incontinence (MUI)
A study testing FormaV and VTone in people with Urinary Incontinence, run by InMode MD Ltd. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- FormaV and VTone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Apr 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 20 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, 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.
Who cannot join
- 7.5 Exclusion criteria
- 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.
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- 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.
- Simultaneously participating in another investigator drug or device study or has completed the follow-up phase for the primary endpoint of any previous study less than 30 days prior to the first evaluation in this study.
- 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
Advanced Women's Care of the Lowcountry, PC
Bluffton, South Carolina, 29910
Lisa M Jukes MD
West Lake Hills, Texas, 78746
About this study
Official title: Clinical Evaluation of Combined Treatment With Bi-Polar Radio-Frequency and Electrical Muscle Stimulation for Symptoms of Mixed Urinary Incontinence (MUI)
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
- Being tested
- FormaV and VTone
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FormaV and VToneDevice
Eligible subjects will receive 3 treatments(every 2 weeks) with the FormaV and VTone Applicators according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | Not described Receives: Device: FormaV and VTone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cough stress test
Change as measured by standardized cough stress test performed in standing position before treatment and 6 months after the treatment
Measured: 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.
Measured: 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
Measured: 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
Measured: 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 (
Measured: 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
Measured: month 6
Secondary outcomes (2)
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/EMS energy application at the treatment visit
Measured: post treatment
Adverse events
Number, severity and type of any adverse event recorded throughout the course of the study.
Measured: throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start4 Apr 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 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
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- InMode MD Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05287490
- Sponsor's protocol ID
- DO609893A
- Status last verified
- Feb 2022
- First submitted
- 15 Feb 2022
- Last updated
- 11 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Combined Treatment With Bi-Polar Radio-Frequency and Electrical Muscle Stimulation for Symptoms of Mixed Urinary Incontinence (MUI)
- ClinicalTrials.gov ID
- NCT05287490
- Acronym / sponsor ID
- DO609893A
- Conditions
- Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- InMode MD Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Apr 2021 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 18 Mar 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Device: FormaV and VTone |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (19 listed)
- 7.5 Exclusion criteria
- 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.
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 |
|---|---|---|
| FormaV and VToneEligible subjects will receive 3 treatments(every 2 weeks) with the FormaV and VTone Applicators according to the study protocol. | Device | treatment |
Primary outcome
Cough stress test
Time frame: Baseline through month 6
Change as measured by standardized cough stress test performed in standing position before treatment and 6 months after the treatment
Quality of Life (IQOL) Questionnaire
Time frame: baseline through month 6
The effect of the treatment on urinary symptoms and quality of life by means of the Incontinence Quality of Life (IQOL) Questionnaire.
Female Sexual Function Index questionnaire
Time frame: baseline through month 6
The effect of the treatment on female sexual function by means of Female Sexual Function Index
Urogenital Distress Inventory 6 Questionnaire
Time frame: baseline through month 6
The effect of the treatment on urinary symptoms by means of Urogenital Distress Inventory 6 Questionnaire
Medical, Epidemiologic, and Social Aspects of Aging Urinary Incontinence (MESA) Questionnaire
Time frame: baseline through month 6
The effect of the treatment on urinary symptoms by means of Medical, Epidemiologic, and Social Aspects of Aging Urinary Incontinence (MESA) Questionnaire (
Patient Global Impression of Improvement (PGI), using a 5-point Likert scale
Time frame: month 6
The rate of satisfaction of patients with treatment assessed by the Patient Global Impression of Improvement (PGI), using a 5-point Likert scale
2 secondary outcomes
Discomfort scale
Time frame: post treatment
Adverse events
Time frame: throughout the study
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 11 Aug 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FormaV and VTone in people with Urinary Incontinence, 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 4 inclusion and 19 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 11 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?
Cough stress test (time frame: Baseline through month 6). The study lists 6 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 11 Aug 2022.