Efficacy and Safety of Intravaginal EMS Treatments in Women With Exclusive or Predominant Stress … (NCT07466537) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Efficacy and Safety of Intravaginal EMS Treatments in Women With Exclusive or Predominant Stress Urinary Incontinence
15 participantsStarted 2026-03-30
Plain-language summary
The investigator wants to evaluate the efficacy of a specific intravaginal Electrical Muscle Stimulation (EMS), in the treatment of exclusive or predominant stress urinary incontinence (SUI) symptoms in women. The investigator's aim is to determine the device's impact (the device is VTone) on reducing urinary incontinence episodes and on improving women's quality of life.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* Women with minimum age of 18 years .
* Documented clinical diagnosis of exclusive or predominant stress urinary incontinence.
* Willingness to comply with study procedures and follow-up visits.
* Signed informed consent to participate in the study.
* BMI \</= 30.
Exclusion Criteria:
* Pacemaker or internal defibrillator, or any other metallic or electronic implant anywhere in the body.
* Any permanent implant or an injected chemical substance in the treatment area.
* Superficial areas that have been injected with hyaluronic acid (HA)/collagen/fat injections or other augmentation methods with bio-material during last 6 months.
* Current or history of cancer, or current condition of any other type of cancer, or premalignant moles.
* Severe concurrent conditions, such as cardiac disorders, sensory disturbances, epilepsy, uncontrolled hypertension, and liver or kidney diseases.
* Pregnancy
* Impaired immune system due to immunosuppressive diseases such as AIDS and HIV or use of immunosuppressive medications.
* Patients with a 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 and hormonal virilization.
* Any active condition in the treatment area, such as sores, eczema, and rash.
* History of bleeding coagulopathies or use of anticoagulants in the last 10 days, as per the practi…
What they're measuring
1
Variation in patient bladder voiding diaries' results at follow up visits versus baseline
Timeframe: Follow up visits: 1 month and 3 months after the last session of treatment