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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Columbus, Ohio, United States
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