A Randomized Controlled Trial of Posterior Tibial Nerve Stimulation for Children With Constipation Due to Pelvic Floor Dyssynergia
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 18
Healthy Volunteers: f
View:
• Patients 8-18 years of age
• Diagnosis of constipation due to pelvic floor dyssynergia
• Scheduled to start pelvic floor biofeedback therapy.
Locations
United States
Ohio
Nationwide Children's Hospital
RECRUITING
Columbus
Contact Information
Primary
Peter L Lu, MD, MS
peter.lu@nationwidechildrens.org
6147226169
Time Frame
Start Date: 2020-01-09
Estimated Completion Date: 2024-12-30
Participants
Target number of participants: 40
Treatments
Experimental: Posterior Tibial Nerve Stimulation (PTNS)
Patients in the PTNS arm will undergo 30-minute sessions of PTNS after their first four pelvic floor biofeedback therapy sessions.
Sham_comparator: Sham Stimulation
Patients in the PTNS arm will undergo 30-minute sessions of sham stimulation after their first four pelvic floor biofeedback therapy sessions.
Related Therapeutic Areas
Sponsors
Leads: Nationwide Children's Hospital