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Not yet recruitingNCT07265700Updated Dec 5, 2025

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

An interventional study of Tesla-Chair and Physiotherapy in Urinary Incontinence, sponsored by Kantonsspital Winterthur KSW. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-05.

Sponsored by Kantonsspital Winterthur KSW · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Urinary Incontinence
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
  • Known or suspected non-compliance, drug or alcohol abuse
  • Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject
  • Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation
  • Previous enrolment into the current investigation
  • Enrolment of the Sponsor or PI, their family members, employees and other dependent persons
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Tesla-Chair

    Device: Tesla-Chair

  • Active comparator
    Pelvicfloor physiotherapy

    Procedure: Physiotherapy

Interventions

  • DeviceTesla-Chair

    Magnetic stimulation using the Tesla-Chair

  • ProcedurePhysiotherapy

    Pelvicfloor physiotherapy

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 3 months post-treatment (6 months from baseline)

  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 6 months after treatment

    Time frame: 6-months post-treatment (9 months from baseline)

Secondary outcomes

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

    Change in pelvic floor muscle strength, measured by the Oxford Scale, 0= no contraction, 5= movement against gravity with full resistance.

    Time frame: 3 months post-treatment (6 months from baseline)

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

    Change in pelvic floor muscle strength, measured by the Oxford Scale, 0= no contraction, 5= movement against gravity with full resistance.

    Time frame: 6 months post-treatment (9 months from baseline)

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07265700
Lead sponsor
Kantonsspital Winterthur KSW
Responsible party
Sponsor
First posted
Dec 5, 2025
Start date
Jan 2026 (estimated)
Primary completion
Jun 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Dec 5, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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