About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Electrical intravaginal muscle stimulation