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Search / Trial NCT06528470

Posterior Tibial Nerve Stimulation for Children With Pelvic Floor Dyssynergia

Launched by NATIONWIDE CHILDREN'S HOSPITAL · Jul 25, 2024

Trial Information

Current as of August 25, 2025

Recruiting

Keywords

Posterior Tibial Nerve Stimulation Neuromodulation Constipation Fecal Incontinence Pelvic Floor Dyssynergia Children

ClinConnect Summary

This clinical trial is studying a treatment called posterior tibial nerve stimulation (PTNS) to help children who have constipation caused by a condition known as pelvic floor dyssynergia. This condition can make it difficult for children to have regular bowel movements. Researchers believe that PTNS might improve how the muscles in the rectum work, helping children feel better. The study will compare the effects of PTNS with a placebo treatment (which does not provide real therapy) in children between the ages of 8 and 18 who are diagnosed with this type of constipation and are starting pelvic floor biofeedback therapy.

To participate in this trial, children must be between 8 and 18 years old and have constipation linked to pelvic floor dyssynergia. However, they cannot have had previous surgeries for constipation. Those who join the study can expect to receive either the PTNS treatment or the placebo while being monitored by healthcare professionals. This research aims to find out if PTNS is a helpful option for treating constipation in children, which could lead to better care and outcomes for those affected.

Gender

ALL

Eligibility 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.)

About Nationwide Children's Hospital

Nationwide Children's Hospital is a leading pediatric healthcare institution dedicated to advancing child health through innovative clinical research and trials. As a prominent sponsor, the hospital leverages its expertise in pediatric medicine to design and conduct rigorous clinical studies aimed at improving treatment outcomes for children. Committed to excellence in research and patient care, Nationwide Children's Hospital collaborates with a network of healthcare professionals and institutions to translate scientific discoveries into effective therapies, ensuring that the latest advancements in pediatric healthcare are accessible to young patients across the nation.

Locations

Columbus, Ohio, United States

Patients applied

0 patients applied

Trial Officials

Peter L Lu, MD, MS

Principal Investigator

Nationwide Children's Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported