NCT05952258

Magnetic Stimulation as a Treatment for Stress Urinary Incontinence

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 158 (estimated)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to determine the efficacy of electromagnetic stimulation treatment of the pelvic floor muscles in adult females with stress urinary incontinence.

Detailed description

A double-blinded randomized controlled clinical trial with a treatment arm and a sham treatment arm will be conducted; followed by an open label trial at 3 months for any sham treatment arm participants who do not meet treatment success. The primary goal is to compare the subjective success rates for the resolution of stress urinary incontinence (SUI) for the magnetic stimulation treatment at 3 months. Secondary aims include an assessment of complications, resolution of SUI symptoms, patient bother from UI, quality of life and patient satisfaction. The proposed sample size is 158 patients. At the 3-month post treatment evaluation, the treatment allocation will be unmasked. Patients will be followed post treatment up to 2 years.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	Magnetic stimulation	The magnetic stimulation to the pelvic floor muscle will be provided by the Emsella® chair: which will be activated for 28 minutes at each treatment session. The treatment arm will receive up to 100% intensity at each treatment session.
DEVICE	Sham Magnetic stimulation	The sham arm will receive up to 5% intensity at each treatment session

Timeline

• Start date: 2023-09-01
• Primary completion: 2025-07-31
• Completion: 2026-07-31
• First posted: 2023-07-19
• Last updated: 2024-02-15

Locations

1 site across 1 country: Canada