Stress Urinary Incontinence (SUI)STONENCT07466537
Efficacy and Safety of Intravaginal EMS Treatments in Women With Exclusive or Predominant Stress Urinary Incontinence
A study testing Electrical intravaginal muscle stimulation in people with Stress Urinary Incontinence (SUI), run by IRCCS San Raffaele.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence (SUI)
- What is being tested?
- Electrical intravaginal muscle stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2026to 1 Mar 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Stress Urinary Incontinence (SUI)
- Being tested
- Electrical intravaginal muscle stimulation
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical intravaginal muscle stimulationDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Electrical intravaginal muscle stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Follow up visits: 1 month and 3 months after the last session of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start30 Mar 2026 (estimated)
- Primary completion2 Feb 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary Incontinence (SUI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Salvatore, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466537
- Sponsor's protocol ID
- STONE
- Acronym
- STONE
- Status last verified
- Mar 2026
- First submitted
- 26 Jan 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No