Comparison of the Effects of External Electrical Stimulation Protocols in Women With Overactive Bladder

Study Overview
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Brief Summary
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The aim of our study is a comparison of the effects of external electrical stimulation protocols in women with overactive bladder (OAB).

Detailed Description
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OAB is a condition defined by the International Continence Society as the presence of urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract infection or other obvious pathology. External electrical stimulation has positive effects on OAB. However, there are not enough studies on how often this stimulation is applied. Studies are needed on this subject.

Official Title
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Comparison of the Effects of External Electrical Stimulation Protocols in Women With Overactive Bladder

Conditions
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Overactive Bladder

Intervention / Treatment
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* Other: Electrical stimulation 1
* Other: Electrical stimulation 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being in the age range of 18-65 , Having diagnosed with OAB, Being a volunteer Exclusion Criteria: Being pregnant, presence of severe pelvic organ prolapse, malignant disease, urinary infection, neurological disease, have electronic and metal implant, loss of sensation, lumbosacral peripheral nerve lesion

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Group 1 will be applied external electric stimulation three days per week | Other: Electrical stimulation 1<br>* External electrical stimulation will be applied for 30 minutes 3 days a week during 6 weeks. Electrodes were placed around the pelvis.<br>|
| Active Comparator: Group 2<br>Group 2 will be applied external electric stimulation one day per week | Other: Electrical stimulation 2<br>* External electrical stimulation will be applied for 30 minutes one day a week during 6 weeks. Electrodes were placed around the pelvis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overactive bladder symptoms | Overactive bladder symptoms will be assessed with the Overactive Bladder-V8 Questionnaire | change from baseline at 3 weeks and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urgency severity | Urgency severity will be assessed with Patients' Perception of Intensity of Urgency Scale | change from baseline at 3 weeks and 6 weeks | 
| Bladder functions | Bladder functions will be assessed with voiding diary | change from baseline at 3 weeks and 6 weeks | 
| Life quality | Life quality will be assessed with the King's Health Questionnaire | change from baseline at 3 weeks and 6 weeks | 
| Strength of pelvic floor muscle | Strength of pelvic floor muscle will be assessed with Modified Oxford Scale | change from baseline at 3 weeks and 6 weeks | 
| Perception of recovery | Perception of recovery will be assessed with a 4-point Likert scale | change from baseline at 3 weeks and 6 weeks |