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

Efficacy and Safety of 6 Intravaginal EMS Treatments in Women With Exclusive or Predominant Stress Urinary Incontinence

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 Overview

• Status: Not yet recruiting
• Conditions: Stress Urinary Incontinence (SUI)
• Intervention / Treatment: Device: Electrical intravaginal muscle stimulation

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stefano Salvatore Prof.; Phone Number: 0039 3472757131; Email: salvatore.stefano@hsr.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.
• 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
• Ongoing complications of prior anti-incontinence surgery
• Received intravesical botulinum injection within the previous 12 months
• History of an implanted nerve stimulator for incontinence
• History of prior sling or vaginal mesh placement
• Previous diagnosis of interstitial cystitis, bladder cancer, or chronic pelvic pain
• Current participation in any other conflicting interventional or treatment study
• Active urinary tract or vaginal infection
• Current hydronephrosis or hydroureter
• Bladder outflow obstruction
• Active pelvic organ malignancy
• Urethral obstruction
• Urinary retention or prolonged catheter use
• Less than 12 months post-partum
• Untreated symptomatic urinary tract infection
• Unevaluated hematuria
• Not available for follow-up in 6 months
• Participation in other research trials that could influence results of this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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).

Device: Electrical intravaginal muscle stimulation; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele

Study record dates

Study Major Dates

• Study Start (Estimated): March 30, 2026
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: January 26, 2026
• First Submitted That Met QC Criteria: March 8, 2026
• First Posted (Actual): March 12, 2026

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Incontinence; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence, Stress
• Other Study ID Numbers: STONE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No