RECRUITING

Posterior Tibial Nerve Stimulation for Children With Pelvic Floor Dyssynergia

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Randomized Controlled Trial of Posterior Tibial Nerve Stimulation for Children With Constipation Due to Pelvic Floor Dyssynergia

Quick Facts

Study Start:2020-01-09
Study Completion:2024-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06528470

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:8 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients 8-18 years of age
  2. * Diagnosis of constipation due to pelvic floor dyssynergia
  3. * Scheduled to start pelvic floor biofeedback therapy.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Peter L Lu, MD, MS
CONTACT
6147226169
peter.lu@nationwidechildrens.org

Principal Investigator

Peter L Lu, MD, MS
PRINCIPAL_INVESTIGATOR
Nationwide Children's Hospital

Study Locations (Sites)

Nationwide Children's Hospital
Columbus, Ohio, 43220
United States

Collaborators and Investigators

Sponsor: Nationwide Children's Hospital

  • Peter L Lu, MD, MS, PRINCIPAL_INVESTIGATOR, Nationwide Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-01-09
Study Completion Date2024-12-30

Study Record Updates

Study Start Date2020-01-09
Study Completion Date2024-12-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Constipation
  • Fecal Incontinence in Children
  • Pelvic Floor Dyssynergia