Efficacy and Safety of Intravaginal EMS Treatments in Women With Exclusive or Predominant Stress Urinary Incontinence

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorIRCCS San Raffaele

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

Treatment groups

15 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators