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due to the corona pandemic, live patient contact was no longer possible. As a result, the study had to be stopped early.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active TTNS | Active Comparator | 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. |
|
| TTNS sham intervention | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TTNS | Device | See section 'arms' Stimulation settings: 200 µS, 20 Hz, 1-20 V ( depending of sensory response) Home-therapy: Daily stimulation during 60 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean voided volume per void | Difference in mean voided volume per void in percentage | 12 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne-Françoise Spinoit, Professor | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ghent | Ghent | East-Flanders | 9000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25979217 | Background | Boudaoud N, Binet A, Line A, Chaouadi D, Jolly C, Fiquet CF, Ripert T, Merol ML. Management of refractory overactive bladder in children by transcutaneous posterior tibial nerve stimulation: A controlled study. J Pediatr Urol. 2015 Jun;11(3):138.e1-10. doi: 10.1016/j.jpurol.2014.09.013. Epub 2015 Mar 31. | |
| 26279104 | Result |
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Prospective randomized-controlled superiority trial:
TTNS(Active treatment) vs. Sham TTNS (placebo)
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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.
|
| TTNS Sham | Device | See section 'arms' |
|
|
| 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. |
| Patidar N, Mittal V, Kumar M, Sureka SK, Arora S, Ansari MS. Transcutaneous posterior tibial nerve stimulation in pediatric overactive bladder: A preliminary report. J Pediatr Urol. 2015 Dec;11(6):351.e1-6. doi: 10.1016/j.jpurol.2015.04.040. Epub 2015 Jul 29. |
| 33810804 | Derived | Ghijselings L, Renson C, Van de Walle J, Everaert K, Spinoit AF. Clinical efficacy of transcutaneous tibial nerve stimulation (TTNS) versus sham therapy (part I) and TTNS versus percutaneous tibial nerve stimulation (PTNS) (part II) on the short term in children with the idiopathic overactive bladder syndrome: protocol for part I of the twofold double-blinded randomized controlled TaPaS trial. Trials. 2021 Apr 2;22(1):247. doi: 10.1186/s13063-021-05117-8. |