Transcutaneous Tibial Nerve Stimulation for Idiopathic Overactive Bladder

Study Overview
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Brief Summary
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This study was designed to assess the efficacy of trans cutaneous tibial nerve stimulation on symptoms of overactive bladder in women with idiopathic overactive bladder

Detailed Description
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Idiopathic overactive bladder is defined the presence of a sense of urgency with or without accompanying urinary incontinence without an organic pathology or urinary infection. Its prevalence was reported to be between 7.7 to 31 % in women. In this prospective randomized controlled study, we aim to assess the efficacy of trans cutaneous tibial nerve stimulation on symptoms of overactive bladder in women with idiopathic overactive bladder.

Official Title
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The Efficacy of Transcutaneous Tibial Nerve Stimulation on Symptoms of Overactive Bladder and Quality of Life in Women With Idiopathic Overactive Bladder

Conditions
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Overactive Bladder, Overactive Bladder Syndrome, Overactive Detrusor

Intervention / Treatment
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* Behavioral: Bladder training
* Device: Transcutaneous tibial nerve stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Overactive Bladder Questionnaire Validation Study questionnaire 8 scores higher than 11. Post voiding residue levels less than 100 ml. Women aged between 18-70 Exclusion Criteria: Prior history of pelvic surgery Pelvic organ prolapsus of grade 2 or more. Current urinary tract infection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcutaneous tibial nerve stimulation plus bladder training<br>Patients will receive transcutaneous tibial nerve stimulation for 30 minutes, twice a week, for 6 weeks. Application will be done in an outpatient setting, using disposable surface electrodes. | Behavioral: Bladder training<br>* Bladder training has 4 components, educating the patient about anatomy, fluid intake control, pelvic floor muscle contractions and increasing the interval between visits to the bathroom<br>Device: Transcutaneous tibial nerve stimulation<br>* A combined electrotherapy device capable of applying transcutaneous electrical nerve stimulation will be used. Each session will take 30 minutes. Patient will visit the hospital twice a week for 6 weeks. An electrical current of 0-50 amperes with a frequency of 20 herz, and a duration of 200 micro seconds will be applied using 50x50 mm surface electordes. The aim is to create a tingling sensation without causing any pain on the tibial nerve, at the ankle level.<br>|
| Other: Bladder training<br>patients will receive only the routine education program that is given to every patient with idiopathic overactive bladder syndrome. This includes education about the anatomy of the urinary system, patient motivation, and frequent bathroom visits in order to avoid incontinence with gradual increase between each visit to the bathroom. | Behavioral: Bladder training<br>* Bladder training has 4 components, educating the patient about anatomy, fluid intake control, pelvic floor muscle contractions and increasing the interval between visits to the bathroom<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urination frequency | The frequency of urination will be recorded by using a bladder diary. Urination frequency will be questioned before and after the study period. | 1 day | 
| Severity of overactive bladder symptoms. Overactive Bladder Questionnaire Validation Study questionnaire | This questionnaire assesses the severity of overactive bladder symptoms in 8 items. Each item is scored from 0 to 5. Higher scores denote worse symptom severity. Maximum score is 40. A score over 11 denotes presence of overactive bladder symptoms. Questionnaire will be answered before and after the treatment period. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life. King's quality of life questionnaire | This questionnaire includes a total of 19 questions assessing general quality of life and also questions related to urinary symptoms. Maximum score is 100 and higher scores denote lower levels of quality of life. Questionnaire will be answered before and after the treatment period. | 1 day | 
| Level of satisfaction with the treatment. Visual analog scale | After the completion of the study period, patients will be asked to assess their levels of satisfaction with the treatment they received on a visual analog scale. | 1 day | 
| Incontinence impact questionnaire-7. | This 7 item questionnaire assesses the impact of urinary incontinence on the patients' daily lives. Maximum score is 100. Higher scores denote worse outcomes. Questionnaire will be answered before and after the treatment period. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tibial nerve stimulation