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

NCT07265700 | Not Yet Recruiting

• 1 other identifier: Tesla-UI
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (2)

• Change in ICIQ-SF UI Score

  Change in the International Consultation on Incontinence Questionnaire - Short Form for Urinary Incontinence (ICIQ-SF UI) score from baseline to 3 months after treatment; 1-5= slight incontinence, 19-21= very severe incontinence

  3 months post-treatment (6 months from baseline)

• Change in ICIQ-SF UI Score

  Change in the International Consultation on Incontinence Questionnaire - Short Form for Urinary Incontinence (ICIQ-SF UI) score from baseline to 6 months after treatment

  6-months post-treatment (9 months from baseline)

Secondary Outcomes (2)

• Change in pelvic floor muscle strength, measured by the Oxford Scale

  3 months post-treatment (6 months from baseline)

• Change in pelvic floor muscle strength, measured by the Oxford Scale

  6 months post-treatment (9 months from baseline)

Study Arms (2)

Tesla-Chair

EXPERIMENTAL

Device: Tesla-Chair

Pelvicfloor physiotherapy

ACTIVE COMPARATOR

Procedure: Physiotherapy

Interventions

Tesla-Chair DEVICE

Magnetic stimulation using the Tesla-Chair

Tesla-Chair

Physiotherapy PROCEDURE

Pelvicfloor physiotherapy

Pelvicfloor physiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Urinary incontinence of first or second degree
• Written informed consent
• German speaking (Study information and IC available only in German)

You may not qualify if:

• Pregnancy or desire to become pregnant
• Urinary incontinence of third degree
• Third or fourth degree pelvic organ prolapses
• no noticeable voluntary muscle activity according to Oxford = O/5
• Genital infections
• Malignant tumors
• Severe neurological diseases
• Cardiac arrhythmia
• Active internal medical devices e.g. cardiac pacemakers, medication pumps etc.
• Ferromagnetic implants at or near the site of stimulation
• Recent surgery at the site of stimulation
• Thrombosis or thrombophlebitis
• Epilepsy or suspected epilepsy
• Acute stages of kidney stones
• Gastrointestinal and internal disease at the site of stimulation

Sponsors & Collaborators

• Kantonsspital Winterthur KSW: lead

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 5, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share