Evaluation and Comparison of Efficacy Between Extracorporeal Magnetic Innervation and High-intensity Kegel Exercise Regimen in Treatment of Stress Urinary Incontinence in Female

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation and Comparison of Short-term Efficacy Between Extracorporeal Magnetic Innervation and High-intensity Kegel Exercise Regimen

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Device: Peritron perineometer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: urodinamically confirmed stress urinary incontinence, at least one vaginal delivery in gynecological history. Exclusion Criteria: urinary tract malignancies, vulvovaginitis, current uroinfection, previous pelvic surgeries, neurologic and psychiatric diseases, previous conservative treatment of stress urinary incontinence in less than 6 months, Stage III and IV of genital prolapse, latex allergy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Kegel exercise<br>Using high-intensity Kegel exercise regimen for 8 weeks (5 times a week; 3 times a day involved; 3 sets of 10-12 contractions) | Device: Peritron perineometer<br>* Perineometry will be used to assess quality of each observed treatment modality.<br>|
| Active Comparator: Magnetic stimulation<br>Using 16 extracorporeal magnetic innervation treatments during 8 weeks (2 times a week). | Device: Peritron perineometer<br>* Perineometry will be used to assess quality of each observed treatment modality.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |