Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06528470
Status:
RECRUITING
Last Update Posted:
None
First Post:
2020-09-11
Brief Title:
Posterior Tibial Nerve Stimulation for Children With Pelvic Floor Dyssynergia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Controlled Trial of Posterior Tibial Nerve Stimulation for Children With Constipation Due to Pelvic Floor Dyssynergia
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overall objective of this study is to determine the effect of posterior tibial nerve stimulation PTNS on children with constipation due to pelvic floor dyssynergia Our main hypothesis is that PTNS effectively treats children with constipation secondary to pelvic floor dyssynergia through modulation of anorectal function We will perform a single-center randomized controlled pilot study comparing PTNS to sham stimulation in children with constipation secondary to pelvic floor dyssynergia
Detailed Description:
Constipation affects up to 30 of children in population-based studies and 15 of children with constipation will continue to have symptoms despite years of aggressive medical treatment Pelvic floor dyssynergia which involves abnormal coordination of pelvic floor muscles during defecation is a common finding during anorectal manometry testing for children with refractory constipation Treatment options for children with constipation refractory to medical treatment are limited and generally invasive Thus there is an urgent need for the identification and evaluation of non-invasive treatments for constipation refractory to medical treatment We have established through research at our institution that electrical stimulation delivered via gastric electrical stimulator and sacral nerve stimulator is feasible and effective in the treatment of gastrointestinal disease There is new evidence that posterior tibial nerve stimulation PTNS a non-invasive method of delivering electrical stimulation can be effective in the treatment of adults with constipation and fecal incontinence Our long-term goal is to identify and evaluate novel non-invasive treatment options for children with constipation refractory to medical treatment
The overall objective of this study is to determine the effect of PTNS on children with constipation due to pelvic floor dyssynergia Our main hypothesis is that PTNS effectively treats children with constipation secondary to pelvic floor dyssynergia through modulation of anorectal function We plan to objectively test our main hypothesis and attain the objective of this application by pursuing the following specific aims
AIM 1 Determine the efficacy of PTNS in the treatment of children with constipation due to pelvic floor dyssynergia The working hypothesis is that PTNS will lead to improvement in validated measures of constipation severity
AIM 2 Determine the effects of PTNS on anorectal function The working hypothesis is that PTNS will lead to improvement in pelvic floor dyssynergia
The expected outcome of Aim 1 is demonstration that PTNS is effective in decreasing the symptom severity of children with constipation due to pelvic floor dyssynergia Aim 2 will show that PTNS improves symptoms by modulating anorectal function Establishing that PTNS is an effective treatment option for children with constipation due to pelvic floor dyssynergia will have a significant positive impact on a population of children for which management is challenging and current therapeutic options are limited Determining the mechanism by which PTNS acts will further our understanding of the effect of electrical stimulation on the human body and could lead to identification of other applications of therapeutic electrical stimulation
The overall objective of this study is to determine the effect of PTNS on children with constipation due to pelvic floor dyssynergia Our main hypothesis is that PTNS effectively treats children with constipation secondary to pelvic floor dyssynergia through modulation of anorectal function We plan to objectively test our main hypothesis and attain the objective of this application by pursuing the following specific aims
AIM 1 Determine the efficacy of PTNS in the treatment of children with constipation due to pelvic floor dyssynergia The working hypothesis is that PTNS will lead to improvement in validated measures of constipation severity
AIM 2 Determine the effects of PTNS on anorectal function The working hypothesis is that PTNS will lead to improvement in pelvic floor dyssynergia
The expected outcome of Aim 1 is demonstration that PTNS is effective in decreasing the symptom severity of children with constipation due to pelvic floor dyssynergia Aim 2 will show that PTNS improves symptoms by modulating anorectal function Establishing that PTNS is an effective treatment option for children with constipation due to pelvic floor dyssynergia will have a significant positive impact on a population of children for which management is challenging and current therapeutic options are limited Determining the mechanism by which PTNS acts will further our understanding of the effect of electrical stimulation on the human body and could lead to identification of other applications of therapeutic electrical stimulation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None