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

NCT07466537 | Not Yet Recruiting

• 1 other identifier: STONE
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stress Urinary Incontinence (SUI)

Outcome Measures

Primary Outcomes (1)

• 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.

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

Study Arms (1)

Women with stress urinary incontinence treated with intravaginal electrical muscle stimulation

EXPERIMENTAL

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).

Device: Electrical intravaginal muscle stimulation

Interventions

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).

Women with stress urinary incontinence treated with intravaginal electrical muscle stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 practitioner's discretion.
• Non-Italian speakers
• Severely impaired mobility or cognition
• Spinal cord injury or advanced/severe neurologic condition including Multiple Sclerosis, Parkinson's Disease
• Repair of pelvic organ prolapse or incontinence procedure in the previous 6 months

Sponsors & Collaborators

• IRCCS San Raffaele: lead

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Stefano Salvatore Prof.

CONTACT

0039 3472757131; salvatore.stefano@hsr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: March 12, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share