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 two-fold double blinded randomized controlled TaPaS trial.
Background: Transcutaneous tibial nerve stimulation (TTNS) and percutaneous tibial nerve stimulation (PTNS) are effective and safe therapies for overactive bladder (OAB) syndrome in adults. However, few randomized sham-controlled trials have been conducted in a paediatric population. To our knowledge, both therapies never have been compared in children.
Aim: The aim of the complete study is twofold: 1) To assess the efficacy of TTNS therapy on bladder symptoms after 12 weeks of treatment in a paediatric population with idiopathic overactive bladder syndrome (iOAB) and/or nocturnal enuresis (part I). 2) To assess the effect of TTNS compared to PTNS (part II). In this article, we aim to present the protocol of the first part of the TaPaS trial (TTNS, PTNS, Sham therapy).
Methods: Part I of the TaPaS trial is set up as a single-centre randomized-controlled trial. Children, aged from 5 to 12 years with iOAB and/or nocturnal enuresis, are assigned to two groups by computer-generated randomization: TTNS therapy (intervention) and sham therapy (control). The primary outcome is the percentage difference in average voided volume (AVV) between baseline and after 12 weeks of treatment. Secondary endpoints are the percentage difference in supervoids volumes, number of urinary incontinence episodes/24 hours and in voiding frequency, the difference in parent reported outcomes between baseline and after 12 weeks of treatment and the duration of clinical response.
Discussion: We hypothesize that TTNS is a non-inferior treatment for iOAB in children compared to PTNS therapy. Since literature is inconclusive about the efficacy of TTNS in a paediatric population, a sham controlled RCT on TTNS will be conducted (part I). A protocol for a prospective randomized sham-controlled trial has been developed. Enrolment has started in November 2018. Study completion of part I is expected by August 2021.
Trial Registration: ClinicalTrials.gov NCT 04256876. Retrospectively registered on February 5, 2020. URL: https://clinicaltrials.gov/ct2/show/NCT04256876
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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 two-fold double blinded randomized controlled TaPaS trial.
Posted 10 Feb, 2021
Invitations sent on 05 Feb, 2021
On 01 Feb, 2021
On 01 Feb, 2021
Posted 26 Jan, 2021
On 26 Jan, 2021
Received 20 Jan, 2021
Received 20 Jan, 2021
On 13 Jan, 2021
On 13 Jan, 2021
On 13 Jan, 2021
Invitations sent on 13 Jan, 2021
On 13 Jan, 2021
Received 13 Jan, 2021
Received 13 Jan, 2021
On 11 Jan, 2021
On 11 Jan, 2021
On 12 Dec, 2020
Received 11 Dec, 2020
On 06 Dec, 2020
Received 06 Dec, 2020
Received 25 Nov, 2020
Received 24 Nov, 2020
On 17 Nov, 2020
On 11 Nov, 2020
Invitations sent on 10 Nov, 2020
On 10 Nov, 2020
On 05 Nov, 2020
On 11 Sep, 2020
On 23 Jul, 2020
Background: Transcutaneous tibial nerve stimulation (TTNS) and percutaneous tibial nerve stimulation (PTNS) are effective and safe therapies for overactive bladder (OAB) syndrome in adults. However, few randomized sham-controlled trials have been conducted in a paediatric population. To our knowledge, both therapies never have been compared in children.
Aim: The aim of the complete study is twofold: 1) To assess the efficacy of TTNS therapy on bladder symptoms after 12 weeks of treatment in a paediatric population with idiopathic overactive bladder syndrome (iOAB) and/or nocturnal enuresis (part I). 2) To assess the effect of TTNS compared to PTNS (part II). In this article, we aim to present the protocol of the first part of the TaPaS trial (TTNS, PTNS, Sham therapy).
Methods: Part I of the TaPaS trial is set up as a single-centre randomized-controlled trial. Children, aged from 5 to 12 years with iOAB and/or nocturnal enuresis, are assigned to two groups by computer-generated randomization: TTNS therapy (intervention) and sham therapy (control). The primary outcome is the percentage difference in average voided volume (AVV) between baseline and after 12 weeks of treatment. Secondary endpoints are the percentage difference in supervoids volumes, number of urinary incontinence episodes/24 hours and in voiding frequency, the difference in parent reported outcomes between baseline and after 12 weeks of treatment and the duration of clinical response.
Discussion: We hypothesize that TTNS is a non-inferior treatment for iOAB in children compared to PTNS therapy. Since literature is inconclusive about the efficacy of TTNS in a paediatric population, a sham controlled RCT on TTNS will be conducted (part I). A protocol for a prospective randomized sham-controlled trial has been developed. Enrolment has started in November 2018. Study completion of part I is expected by August 2021.
Trial Registration: ClinicalTrials.gov NCT 04256876. Retrospectively registered on February 5, 2020. URL: https://clinicaltrials.gov/ct2/show/NCT04256876
Figure 1
Figure 2