NCT07466537

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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).

Timeline

• Start date: 2026-03-30
• Primary completion: 2027-02-02
• Completion: 2027-03-01
• First posted: 2026-03-12
• Last updated: 2026-03-13