Using nerve stimulation to treat constipation in children
A Randomized Controlled Trial of Posterior Tibial Nerve Stimulation for Children With Constipation Due to Pelvic Floor Dyssynergia
This study is testing if a new nerve stimulation treatment can help children aged 8-18 with constipation caused by pelvic floor issues feel better when other treatments haven't worked.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 8 Years to 18 Years |
| Sex | All |
| Sponsor | Nationwide Children's Hospital Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT06528470 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of posterior tibial nerve stimulation (PTNS) in treating children aged 8-18 with constipation caused by pelvic floor dyssynergia. It is a single-center, randomized controlled pilot study comparing PTNS to sham stimulation. The research addresses a significant gap in non-invasive treatment options for children who have not responded to traditional medical therapies for constipation. The study will assess changes in anorectal function and overall symptom relief in the participants.
Who should consider this trial
Good fit: Ideal candidates are children aged 8-18 diagnosed with constipation due to pelvic floor dyssynergia who are about to start pelvic floor biofeedback therapy.
Not a fit: Patients who have undergone prior surgical interventions for constipation may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a non-invasive option for children suffering from constipation due to pelvic floor dyssynergia.
How similar studies have performed: Previous studies have shown that posterior tibial nerve stimulation can be effective in adults with similar conditions, indicating potential for success in this pediatric population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients 8-18 years of age * Diagnosis of constipation due to pelvic floor dyssynergia * Scheduled to start pelvic floor biofeedback therapy. Exclusion Criteria: - Prior surgery for constipation (colonic resection, cecostomy, Malone appendicostomy, sacral nerve stimulator implantation, etc.)
Where this trial is running
Columbus, Ohio
- Nationwide Children's Hospital — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Peter L Lu, MD, MS — Nationwide Children's Hospital
- Study coordinator: Peter L Lu, MD, MS
- Email: peter.lu@nationwidechildrens.org
- Phone: 6147226169
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.