Efficacy and Safety of 6 Intravaginal EMS Treatments in Women With Exclusive or Predominant Stress Urinary Incontinence
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- IRCCS San Raffaele
- Enrollment
- 15
- Primary Endpoint
- Variation in patient bladder voiding diaries' results at follow up visits versus baseline
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Women with stress urinary incontinence treated with intravaginal electrical muscle stimulation
We will include women suffering from stress urinary incontinence who will be treated with intravaginal electrical muscle stimulation with a device called VTone. VTone is a small anatomically shaped applicator that delivers intravaginal electrical muscle stimulation This device includes an ogival, circular body, with a handle at one end of the body and a head at the other end of the body. The head includes a substantially flat, metallic surface. The device should be used with gel. The treatment will include 6 sessions (sessions will be planned once a week) and women will be asked to fill in a bladder voiding diary and validated questionnnaires at baseline and at follow up visits (one and three months after the last treatment).
Intervention: Electrical intravaginal muscle stimulation (Device)
Outcomes
Primary Outcomes
Variation in patient bladder voiding diaries' results at follow up visits versus baseline
Time Frame: Follow up visits: 1 month and 3 months after the last session of treatment
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Stefano Salvatore
Professor
IRCCS San Raffaele