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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tesla-Chair | Experimental |
| |
| Pelvicfloor physiotherapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tesla-Chair | Device | Magnetic stimulation using the Tesla-Chair |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months post-treatment (6 months from baseline) |
| Change in pelvic floor muscle strength, measured by the Oxford Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Physiotherapy |
| Procedure |
Pelvicfloor physiotherapy |
|
Change in pelvic floor muscle strength, measured by the Oxford Scale, 0= no contraction, 5= movement against gravity with full resistance. |
| 6 months post-treatment (9 months from baseline) |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |