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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorKantonsspital Winterthur KSW

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Urinary incontinence of first or second degree

Written informed consent

German speaking (Study information and IC available only in German)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tesla-Chair

    Device

    Magnetic stimulation using the Tesla-Chair

  • Physiotherapy

    Procedure/Surgery

    Pelvicfloor physiotherapy

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Tesla-ChairExperimental treatment 1 intervention
Group B: Pelvicfloor physiotherapyActive comparator 1 intervention

Trial outcomes

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)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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