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Behavioural Intervention

Nerve Stimulation for Childhood Constipation

N/A
Recruiting
Led By Peter L Lu, MD, MS
Research Sponsored by Nationwide Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients 8-18 years of age
Diagnosis of constipation due to pelvic floor dyssynergia
Must not have
Prior surgery for constipation (colonic resection, cecostomy, Malone appendicostomy, sacral nerve stimulator implantation, etc.)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks after starting treatment

Summary

This trial aims to see if a treatment called posterior tibial nerve stimulation (PTNS) can help children with constipation caused by pelvic floor muscle issues. The study will compare PTNS to a

Who is the study for?
This trial is for children aged 8-18 who have constipation because their pelvic floor muscles don't work together properly. They should be starting therapy to learn how to control these muscles. Kids who've had surgery for constipation aren't eligible.
What is being tested?
The study is testing if a treatment called Posterior Tibial Nerve Stimulation (PTNS) can help with constipation by improving muscle function in the lower body. It's compared against a fake stimulation in a randomized controlled pilot study.
What are the potential side effects?
While the document doesn’t specify side effects, PTNS generally may cause discomfort at the stimulation site, mild pain or skin inflammation, and potential temporary nerve issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 8 and 18 years old.
Select...
I have constipation caused by pelvic floor muscle issues.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had surgery for constipation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks after starting treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks after starting treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Cleveland Clinic Constipation Score (CCCS)
Fecal Incontinence Severity Index (FISI)

Side effects data

From 2023 Phase 4 trial • 54 Patients • NCT04907032
11%
transient leg swelling from PTNS
11%
Urinary Tract Infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Posterior Tibial Nerve Stimulation Plus Placebo
Posterior Tibial Nerve Stimulation With Mirabegron

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Posterior Tibial Nerve Stimulation (PTNS)Experimental Treatment1 Intervention
Patients in the PTNS arm will undergo 30-minute sessions of PTNS after their first four pelvic floor biofeedback therapy sessions.
Group II: Sham StimulationPlacebo Group1 Intervention
Patients in the PTNS arm will undergo 30-minute sessions of sham stimulation after their first four pelvic floor biofeedback therapy sessions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Posterior Tibial Nerve Stimulation (PTNS)
2021
Completed Phase 4
~60

Find a Location

Who is running the clinical trial?

Nationwide Children's HospitalLead Sponsor
348 Previous Clinical Trials
5,227,742 Total Patients Enrolled
Peter L Lu, MD, MSPrincipal InvestigatorNationwide Children's Hospital
~0 spots leftby Nov 2024
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