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The aim of this prospective, randomized controlled study is to evaluate and compare efficacy between the most available conservative treatment (magnetic stimulation and Kegel exercise) for stress urinary incontinence in Croatia. We will assess quality-of-life, patient global improvement, and vaginal pressure measured with perineometer in three different time points: at the enrollment, after 8 weeks of treatment and 3 months after the both treatments are done.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kegel exercise | Active Comparator | Using high-intensity Kegel exercise regimen for 8 weeks (5 times a week; 3 times a day involved; 3 sets of 10-12 contractions) |
|
| Magnetic stimulation | Active Comparator | Using 16 extracorporeal magnetic innervation treatments during 8 weeks (2 times a week). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peritron perineometer | Device | Perineometry will be used to assess quality of each observed treatment modality. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Greater proportion of reduced ICIQ-SF score in magnetic stimulation arm group after 8 weeks of treatment | We assume that after 8 weeks of treatment, in magnetic stimulation arm of study, we will observe more treatment ''responders'' - with at least 4-point reduction in overall ICIQ-SF score | 8 weeks from the start of the treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Greater proportion of increased perineometry value in magnetic stimulation arm group | We assume that after 8 weeks of treatment, in magnetic stimulation arm of study, we will observe more treatment ''responders'' - at least more than 30% of increase in overall vaginal pressure, measured by a Peritron perineometer | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Hospital Centre Zagreb, Croatia | Recruiting | Zagreb | 10 000 | Croatia |
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From February 2021.
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| Greater proportion of better patient global improvement in magnetic stimulation arm group |
We assume that after 3 months of treatment finish, in magnetic stimulation arm of study, we will observe more women who are satisfied with the treatment, compared to Kegel exercise arm - using Patient Global Improvement Score (PGI-I) |
| 3 months from treatment finish |
| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| 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 |
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