Role of Transcutaneous Electrical Nerve Stimulation in Treating Children With Overactive Bladder From Pooled Analysis of 8 Randomized Controlled Trials

Cui, Huanqin; Yi, Yunjeong; Xu, Zhunan; Gao, Zhenli; Wu, Jitao; Zhou, Zhongbao; Cui, Yuanshan

doi:10.5213/inj.1938232.116

Cited by 14 publications

(18 citation statements)

References 32 publications

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“…However, there are no SEA to be expected from TTNS, as previous studies in adults have proven its safety. (3) Frequency and plans for auditing trial conduct {23}…”

Section: Adverse Event Reporting and Harms {22}mentioning

confidence: 99%

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.

Ghijselings

Renson

Walle

et al. 2021

Preprint

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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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“…However, there are no SEA to be expected from TTNS, as previous studies in adults have proven its safety. (3) Frequency and plans for auditing trial conduct {23}…”

Section: Adverse Event Reporting and Harms {22}mentioning

confidence: 99%

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.

Ghijselings

Renson

Walle

et al. 2021

Preprint

View full text Add to dashboard Cite

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“…Different types of peripheral neuromodulation have been widely practiced in the paediatric population like transcutaneous electrical nerve stimulation (TENS) -on the sacrum or over the posterior tibial nerve (TTNS) and percutaneous tibial nerve stimulation (PTNS). (2,3) PTNS is the standard alternative treatment for OAB in our department. It is proven to be effective and safe in children with iOAB.…”

Section: Introductionmentioning

confidence: 99%

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 Randomized Controlled TaPas Trial

Ghijselings

Renson

Walle

et al. 2020

Preprint

View full text Add to dashboard Cite

Background: Transcutaneous tibial nerve stimulation (TTNS) and percutaneous tibial nerve stimulation (PTNS) are effective and safe therapies for the overactive bladder (OAB) syndrome in adults. However, few randomized sham-controlled trials have been conducted in a paediatric population. Both therapies have never been compared to our knowledge.. 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 (controls). 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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“…Thank you for reaching out to us with the letter from a reader regarding our recent article [ 1 ]. We have responded to the reader’s questions one-by-one and review the current progress in the treatment of overactive bladder (OAB) in children.…”

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confidence: 99%

Reply to Commentary on “Role of Transcutaneous Electrical Nerve Stimulation in Treating Children With Overactive Bladder From Pooled Analysis of 8 Randomized Controlled Trials”

Zhou

Cui

2020

Int Neurourol J

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Role of Transcutaneous Electrical Nerve Stimulation in Treating Children With Overactive Bladder From Pooled Analysis of 8 Randomized Controlled Trials

Cited by 14 publications

References 32 publications

Reply to Commentary on “Role of Transcutaneous Electrical Nerve Stimulation in Treating Children With Overactive Bladder From Pooled Analysis of 8 Randomized Controlled Trials”

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