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

NCT07466537 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-03-13

No results posted yet for this study

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)

Interventions

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).

Sponsors & Collaborators

  • IRCCS San Raffaele

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-30
Primary Completion
2027-02-02
Completion
2027-03-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07466537 on ClinicalTrials.gov