TTNS Versus Sham Therapy for Children With iOAB (TaPaS Part I)
- Conditions
- Overactive Bladder Syndrome
- Interventions
- Device: TTNS ShamDevice: TTNS
- Registration Number
- NCT04256876
- Lead Sponsor
- University Hospital, Ghent
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 6
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TTNS sham intervention TTNS Sham 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. Active TTNS TTNS 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.
- Primary Outcome Measures
Name Time Method Mean voided volume per void 12 weeks Difference in mean voided volume per void in percentage
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
University Hospital Ghent
🇧🇪Gent, East-Flanders, Belgium