Urinary IncontinenceNCT07265700
Is Treatment With FMS Tesla Chair Equal to Physiotherapy in First and Second-degree Urinary Incontinence?
A study testing Tesla-Chair and Physiotherapy in people with Urinary Incontinence, run by Kantonsspital Winterthur KSW.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Tesla-Chair and Physiotherapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Urinary incontinence of first or second degree
- Written informed consent
- German speaking (Study information and IC available only in German)
Who cannot join
- 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
Show all 20Show fewer
- 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
About this study
Official title: 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
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.
- Conditions
- Urinary Incontinence
- Being tested
- Tesla-Chair, Physiotherapy
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tesla-ChairDevice
Magnetic stimulation using the Tesla-Chair
PhysiotherapyProcedure or surgery
Pelvicfloor physiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Tesla-Chair | Experimental | Not described Receives: Device: Tesla-Chair |
| Pelvicfloor physiotherapy | Active comparator | Not described Receives: Procedure: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 6-months post-treatment (9 months from baseline)
Secondary outcomes (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.
Measured: 3 months post-treatment (6 months from baseline)
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.
Measured: 6 months post-treatment (9 months from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Winterthur KSW
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07265700
- Sponsor's protocol ID
- Tesla-UI
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07265700
- Acronym / sponsor ID
- Tesla-UI
- Conditions
- Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kantonsspital Winterthur KSWUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tesla-Chair | Experimental | Device: Tesla-Chair |
| Pelvicfloor physiotherapy | Active comparator | Procedure: Physiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Urinary incontinence of first or second degree
- Written informed consent
- German speaking (Study information and IC available only in German)
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tesla-ChairMagnetic stimulation using the Tesla-Chair | Device | Tesla-Chair |
| PhysiotherapyPelvicfloor physiotherapy | Procedure or surgery | Pelvicfloor physiotherapy |
Primary outcome
Change in ICIQ-SF UI Score
Time frame: 3 months post-treatment (6 months from baseline)
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
Change in ICIQ-SF UI Score
Time frame: 6-months post-treatment (9 months from baseline)
Change in the International Consultation on Incontinence Questionnaire - Short Form for Urinary Incontinence (ICIQ-SF UI) score from baseline to 6 months after treatment
2 secondary outcomes
Change in pelvic floor muscle strength, measured by the Oxford Scale
Time frame: 3 months post-treatment (6 months from baseline)
Change in pelvic floor muscle strength, measured by the Oxford Scale
Time frame: 6 months post-treatment (9 months from baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Tesla-Chair and Physiotherapy in people with Urinary Incontinence, run by Kantonsspital Winterthur KSW.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ICIQ-SF UI Score (time frame: 3 months post-treatment (6 months from baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.