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Study protocol
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.
Lynn Ghijselings
Universiteit Gent
Corresponding Author
ORCiD: https://orcid.org/0000-0001-5144-4021
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This work is licensed under a CC BY 4.0 License. Read Full License
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
Keywords
Urinary Bladder, Overactive Bladder, Nocturnal Enuresis, Children, Transcutaneous electric nerve stimulation
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CURRENT STATUS: Under Review
Version 2
Posted 10 Feb, 2021
No community comments so far
Reviewers invited
Invitations sent on 05 Feb, 2021
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On 01 Feb, 2021
Submission checks complete
On 01 Feb, 2021
Version (no preprint)
Posted 26 Jan, 2021
Editorial decision: Minor revision
On 26 Jan, 2021
Review #3 received
Received 20 Jan, 2021
Review #4 received
Received 20 Jan, 2021
Reviewer #2 agreed
On 13 Jan, 2021
Reviewer #3 agreed
On 13 Jan, 2021
Reviewer #4 agreed
On 13 Jan, 2021
Reviewers invited
Invitations sent on 13 Jan, 2021
Reviewer #1 agreed
On 13 Jan, 2021
Review #2 received
Received 13 Jan, 2021
Review #1 received
Received 13 Jan, 2021
Editor assigned
On 11 Jan, 2021
Submission checks complete
On 11 Jan, 2021
This version was not preprinted
No comments provided
Editorial decision: Major revision
On 12 Dec, 2020
Review #3 received
Received 11 Dec, 2020
Reviewer #4 agreed
On 06 Dec, 2020
Review #4 received
Received 06 Dec, 2020
Review #1 received
Received 25 Nov, 2020
Review #2 received
Received 24 Nov, 2020
Reviewer #3 agreed
On 17 Nov, 2020
Reviewer #2 agreed
On 11 Nov, 2020
Reviewers invited
Invitations sent on 10 Nov, 2020
Reviewer #1 agreed
On 10 Nov, 2020
Editor assigned
On 05 Nov, 2020
Submission checks complete
On 11 Sep, 2020
First submitted
On 23 Jul, 2020
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This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
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.
Lynn Ghijselings
Universiteit Gent
Corresponding Author
ORCiD: https://orcid.org/0000-0001-5144-4021
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
Version 2
Posted 10 Feb, 2021
No community comments so far
Reviewers invited
Invitations sent on 05 Feb, 2021
Editor assigned
On 01 Feb, 2021
Submission checks complete
On 01 Feb, 2021
Version (no preprint)
Posted 26 Jan, 2021
Editorial decision: Minor revision
On 26 Jan, 2021
Review #3 received
Received 20 Jan, 2021
Review #4 received
Received 20 Jan, 2021
Reviewer #2 agreed
On 13 Jan, 2021
Reviewer #3 agreed
On 13 Jan, 2021
Reviewer #4 agreed
On 13 Jan, 2021
Reviewers invited
Invitations sent on 13 Jan, 2021
Reviewer #1 agreed
On 13 Jan, 2021
Review #2 received
Received 13 Jan, 2021
Review #1 received
Received 13 Jan, 2021
Editor assigned
On 11 Jan, 2021
Submission checks complete
On 11 Jan, 2021
This version was not preprinted
No comments provided
Editorial decision: Major revision
On 12 Dec, 2020
Review #3 received
Received 11 Dec, 2020
Reviewer #4 agreed
On 06 Dec, 2020
Review #4 received
Received 06 Dec, 2020
Review #1 received
Received 25 Nov, 2020
Review #2 received
Received 24 Nov, 2020
Reviewer #3 agreed
On 17 Nov, 2020
Reviewer #2 agreed
On 11 Nov, 2020
Reviewers invited
Invitations sent on 10 Nov, 2020
Reviewer #1 agreed
On 10 Nov, 2020
Editor assigned
On 05 Nov, 2020
Submission checks complete
On 11 Sep, 2020
First submitted
On 23 Jul, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
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