TTNS Versus Sham Therapy for Children With iOAB (TaPaS Part I)

Study Overview
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Brief Summary
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Part I of the TaPaS trial forms part of a twofold clinical RCT: Part 1) A prospective RCT comparing the efficacy of transcutaneous tibial nerve stimulation (TTNS) with TTNS sham therapy for children with idiopathic overactive bladder on clinical and patient reported outcomes (PROMS). Part 2) A prospective RCT comparing TTNS versus Percutaneous tibial nerve stimulation (PTNS) on clinical outcomes and PROMS.

Detailed Description
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Non invasive neuromodulation therapy for children with the overactive bladder syndrome is a highly under investigated topic in medical literature. Only 2 studies ( Patidar et al. and Boudaouid et al.) investigated the use of tibial nerve stimulation with adhesive electrodes. 1) In the first trial the superiority of TTNS vs.Sham therapy for the therapeutic management of children with OAB naive to any pharmacological treatment will be examined. Clinical outcomes will be assessed by the use of daytime and nighttime bladder diaries. Assessment of outcomes at baseline, after 6 weeks and 12 weeks of treatment, and investigation of mean time to partial or complete relapse following 6 weeks observation. After a wash-out period of 6 weeks, patients from the part I Sham group will be able to be included for TaPaS part II.

Official Title
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A Randomized-controlled Trial Comparing Transcutaneous Tibial Nerve Stimulation (TTNS) Versus Sham Therapy on Short Term Continence Outcomes in Children With the Idiopathic Overactive Bladder Syndrome: the TaPaS Trial Part I

Conditions
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Overactive Bladder Syndrome

Intervention / Treatment
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* Device: TTNS
* Device: TTNS Sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children between 5 and 12 years old, clinically diagnosed with the idiopathic overactive bladder syndrome with urinary incontinence (daytime and/or nighttime) Untreated, except from urotherapy. Exclusion Criteria: Enuresis nocturna due to nocturnal polyuria Dysfunctional voiding Neurogenic bladder Psychiatric disorders, behavioural disturbances or mental disabilities Treated before with pharmacotherapy or invasive therapies for OAB Children with parents unable to record reliably micturition diaries.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

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
Interventional Model Description: Prospective randomized-controlled superiority trial: TTNS(Active treatment) vs. Sham TTNS (placebo)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active TTNS<br>Children treated by transcutaneous tibial nerve stimulation. TENS device connected to adhesive electrodes. Stimulation settings: 200 µS, 20 Hz, 1-20 V ( depending of sensory response) Home-therapy: Daily stimulation during 60 minutes. | Device: TTNS<br>* See section 'arms' Stimulation settings: 200 µS, 20 Hz, 1-20 V ( depending of sensory response) Home-therapy: Daily stimulation during 60 minutes.<br>* Other names: Transcutaneous tibial nerve stimulation;|
| Sham Comparator: TTNS sham intervention<br>Children treated by TTNS with same positioning as the active TTNS treatment. Stimulation settings: 200 µS, 20 Hz, 0-1 V. Patients and parents will be told that electric currence is given, but that no sensation will be feld. Home therapy: Daily stimulation during 60 minutes. | Device: TTNS Sham<br>* See section 'arms'<br>* Other names: Sham therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean voided volume per void | Difference in mean voided volume per void in percentage | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum voided volume (ml) | Maximal voided volume per void ( ml) . | 12 weeks | 
| Number of urgency incontinence episodes / 24 h. | Reduction in number of incontinence episodes per 24 hour | 12 weeks | 
| Daytime voiding frequency | Mean voiding frequency per day | 12 weeks | 
| Satisfaction on urinary symptoms reported by parents | Subjective satisfaction reported by the parents - on a 7 point likert scale- How satisfied of dissatisfied would you be if the bladder symptoms of your child would persist like this? | 12 weeks | 
| Time to recurrence | Time to complete or partial relapse to baseline symptoms after 12 weeks of treatment during the observational period of 6 weeks. | At 12 weeks of treatment + at 6 weeks of observational period without treatment. |