NCT07265700

Is Treatment With FMS Tesla Chair Equal to Physiotherapy in First and Second-degree Urinary Incontinence?

Monocentric Prospective, Randomized, Non-blinded, Active-controlled Trial to Evaluate the Non-inferiority of Functional Magnetic Stimulation (FMS) on the Tesla Chair Compared to Physiotherapy in First or Second-degree Urinary Incontinence

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Kantonsspital Winterthur KSW · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

100 patients with mild to moderate urinary incontinence will be randomly divided into two groups. One half will receive functional magnetic stimulation with the Tesla Chair for three months, while the other half will be treated with pelvic floor physiotherapy for the same period. After three and six months, a comparison will be made to determine which patient groups experience an improvement in urinary incontinence and how their muscle strength improves.

Detailed description

Urinary incontinence is a debilitating condition that significantly impacts patients' quality of life, contributing to anxiety, depression, and social withdrawal. The severity of stress urinary incontinence (SUI) is directly correlated with increased physical and psychological burden. Although lifestyle modifications can offer moderate symptom relief, the current gold-standard first-line treatment is pelvic floor physiotherapy, with surgical intervention reserved for refractory cases. Functional magnetic stimulation (FMS) has demonstrated positive effects in patients with urinary incontinence, including improvements in urodynamic parameters. However, limited research has directly compared the efficacy of FMS as a first-line therapy with standard pelvic floor physiotherapy. Addressing this gap is essential for informing clinical practice and expanding evidence-based therapeutic options. The efficacy of pelvic floor physiotherapy is commonly evaluated using the Oxford Scale, which provides an objective measure of pelvic floor muscle contraction strength. Additionally, patient-reported outcomes are assessed using validated instruments, including the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF UI) and the German Pelvic Floor Questionnaire (Deutscher Beckenbodenfragebogen), capturing symptom severity and quality of life. Together, these endpoints-objective assessments and patient-reported outcomes-offer a comprehensive evaluation of treatment effectiveness.

Conditions

• Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	Tesla-Chair	Magnetic stimulation using the Tesla-Chair
PROCEDURE	Physiotherapy	Pelvicfloor physiotherapy

Timeline

• Start date: 2026-01-01
• Primary completion: 2028-06-01
• Completion: 2028-12-01
• First posted: 2025-12-05
• Last updated: 2025-12-05