Overactive Bladder Syndrome
Conditions
Brief summary
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
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.
Interventions
DEVICETTNS
See section 'arms' Stimulation settings: 200 µS, 20 Hz, 1-20 V ( depending of sensory response) Home-therapy: Daily stimulation during 60 minutes.
DEVICETTNS Sham
See section 'arms'
Sponsors
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants are blinded for the given treatment ( Active TTNS vs. Sham TTNS) by the care provider ( Physiotherapist). The outcomes assessor (the pediatric urologist) isn't aware of the treatment neither.
Intervention model description
Prospective randomized-controlled superiority trial: TTNS(Active treatment) vs. Sham TTNS (placebo)
Eligibility
Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean voided volume per void | 12 weeks | Difference in mean voided volume per void in percentage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum voided volume (ml) | 12 weeks | Maximal voided volume per void ( ml) . |
| Number of urgency incontinence episodes / 24 h. | 12 weeks | Reduction in number of incontinence episodes per 24 hour |
| Daytime voiding frequency | 12 weeks | Mean voiding frequency per day |
| Satisfaction on urinary symptoms reported by parents | 12 weeks | 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? |
| Time to recurrence | At 12 weeks of treatment + at 6 weeks of observational period without treatment. | Time to complete or partial relapse to baseline symptoms after 12 weeks of treatment during the observational period of 6 weeks. |
Countries
Belgium
Outcome results
None listed