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

ConditionStress Urinary Incontinence (SUI)

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

Electrical intravaginal muscle stimulation
Device
The device includes an ogival, circular body, with a handle at one end of the body, a head at the other end of the body. The head includes a substantially flat, metallic surface. The device and the head are sized and configured to be received in a patient's vagina. The device should be used with gel. Patients will be trated with six sessions (planned once a week for a total of six week).

Treatment groups

15 Participants

are divided into 1 treatment group

Group A: Women with stress urinary incontinence treated with intravaginal electrical muscle stimulationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Variation in patient bladder voiding diaries' results at follow up visits versus baseline

Eligible subjects will receive a total of 8 treatments (once a week) using the transvaginal electrical stimulation. All subjects will be required to return to the clinic at 1 month and 3 months after the last treatment. At baseline and during the two follow up visits patients will be asked to fill in a bladder voiding diary.

Time frame

Follow up visits: 1 month and 3 months after the last session of treatment

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IRCCS San Raffaele

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: