Effectiveness of Bilateral PTNS Compared to Unilateral PTNS for the Treatment of Overactive Bladder/Urge Incontinence

Study Overview
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Brief Summary
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This study is designed to evaluate whether bilateral Posterior Tibial Nerve Stimulation is more effective than unilateral Posterior Tibial Nerve Stimulation at treating overactive bladder and urge urinary incontinence

Detailed Description
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Percutaneous tibial nerve stimulation (PTNS) is an accepted treatment for overactive bladder that can be accomplished in the office with minimal side effects. It is currently carried out by stimulating one of the posterior tibial nerves unilaterally. The aim of this study is to determine whether bilateral percutaneous tibial nerve stimulation is more effective than unilateral stimulation. Patients with a diagnosis of overactive bladder who have previously failed lifestyle changes and/or pharmacologic therapy will be offered percutaneous tibial nerve stimulation. Enrolled patients will be randomized into two groups. The control group will receive the traditional unilateral treatment of PTNS. The intervention group will receive bilateral PTNS treatment. Intervention success will be measured by improvement in overactive bladder symptoms assessed by improvement in the scores on the overactive bladder questionnaire symptoms bother and decrease in number of voids, nocturia episodes and incontinence episodes as reported in the voiding diary

Official Title
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Effectiveness of Bilateral PTNS Compared to Unilateral PTNS for the Treatment of Overactive Bladder/Urge Incontinence

Conditions
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Overactive Bladder Syndrome, Urinary Incontinence, Urge

Intervention / Treatment
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* Device: PTNS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients over the age of 18 who have previously tried and failed, or were unable to tolerate, behavioral therapy Patients who consent to participate in the study Patients on pharmacologic therapy at the time of recruitment can continue their treatment Exclusion Criteria: Pregnant patients Patients with pacemakers of implantable defibrillators Patients with neurogenic bladder Patients who have received Botox or have an implant for sacral nerve stimulation Patients with uncontrolled bleeding disorder Patients with unhealed ulcers or with leg edema surrounding medial malleolus

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Active Comparator: Unilateral PTNS<br>34 gauge needle inserted 3cm above the medial ankle on the ankle, and cables are connected to the PTNS stimulator device. Stimulation is provided, per manufacturer directions, over a 30-minute treatment period | Device: PTNS<br>* Use of PTNS on the ankle for 30 minutes<br>|
| Experimental: Bilateral PTNS<br>34 gauge needle inserted 3cm above the medial ankle on both ankles, and cables are connected to the PTNS stimulator device. Stimulation is provided, per manufacturer directions, over a 30-minute treatment period | Device: PTNS<br>* Use of PTNS on the ankle for 30 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in OAB symptom severity score | Overactive Bladder questionnaire short form symptom severity will be administered at baseline, 4 weeks, 8 weeks then 12 weeks. The questionnaire score ranges from 0 to 100. Those with more bothersome symptoms will have higher scores. The investigators expect more improvement in symptoms from participants receiving bilateral stimulation compared to those with unilateral stimulation. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in daily number of voids | Number of voids at baseline will be compared to the number of voids after completion of PTNS at 12 weeks | 12 weeks | 
| Change in number of incontinence episodes per 24 hours | The number of incontinence episodes will be calculated from the voiding diary | 12 weeks | 
| Change in nocturia episodes | A bladder diary will be used to determine how many episodes of voiding occurs at night (nocturia). Baseline nocturia will be compared to nocturia at 12 weeks | 12 weeks | 
| Evaluate impact of treatment on quality of life | The incontinence impact questionnaire will be used to measure impact on qualify of life. The questionnaire score range from 0 to 100 with higher scores indicating worse quality of life. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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overactive bladder, OAB, urge urinary incontinence, PTNS