CompletedNot Applicable

Posterior Tibial Nerve Stimulation for Children With Pelvic Floor Dyssynergia

United States40 participantsStarted 2020-01-09

Plain-language 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.

Who can participate

Age range8 Years – 18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.)

What they're measuring

Cleveland Clinic Constipation Score (CCCS)

Timeframe: 4 weeks after starting treatment

Fecal Incontinence Severity Index (FISI)

Timeframe: 4 weeks after starting treatment

Trial details

NCT IDNCT06528470

SponsorNationwide Children's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-01

View on ClinicalTrials.gov More Constipation trials