Posterior Tibial Nerve Stimulation for Children With Pelvic Floor Dyssynergia

NCT06528470 | Completed FDA Device

• 1 other identifier: STUDY00000403
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Constipation; Fecal Incontinence in Children; Pelvic Floor Dyssynergia

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Cleveland Clinic Constipation Score (CCCS)

  We will use the Cleveland Clinic Constipation Score (CCCS) to measure constipation severity.

  4 weeks after starting treatment

• Fecal Incontinence Severity Index (FISI)

  We will use the Fecal Incontinence Severity Index (FISI) to measure fecal incontinence severity.

  4 weeks after starting treatment

Secondary Outcomes (4)

• Cleveland Clinic Constipation Score (CCCS)

  5 weeks after starting treatment

• Cleveland Clinic Constipation Score (CCCS)

  8 weeks after starting treatment

• Fecal Incontinence Severity Index (FISI)

  5 weeks after starting treatment

• Fecal Incontinence Severity Index (FISI)

  8 weeks after starting treatment

Study Arms (2)

Posterior Tibial Nerve Stimulation (PTNS)

EXPERIMENTAL

Patients in the PTNS arm will undergo 30-minute sessions of PTNS after their first four pelvic floor biofeedback therapy sessions.

Device: Posterior Tibial Nerve Stimulation (PTNS)

Sham Stimulation

SHAM COMPARATOR

Patients in the PTNS arm will undergo 30-minute sessions of sham stimulation after their first four pelvic floor biofeedback therapy sessions.

Device: Sham Stimulation

Interventions

Posterior Tibial Nerve Stimulation (PTNS) DEVICE

The intervention will begin with application of a needle and a self-adhesive electrode. The electrodes will be connected to the electrical stimulator device. The stimulator will then be turned on and amplitude will be gradually increased until motor or sensory response is observed. The amplitude will then be decreased to the point when direct motor stimulation ceases and sensory stimulation is comfortable. Continuous stimulation will then be delivered for a 30-minute session. After 30 minutes, the device will be turned off and the adhesive electrodes removed. Pelvic floor biofeedback therapy is typically performed for a total of four or more weekly sessions. Participants in our study will undergo 30-minute sessions of PTNS or sham stimulation after their first four biofeedback therapy sessions.

Also known as: Urgent PC (Cogentix Medical, Minnetonka, MN)

Posterior Tibial Nerve Stimulation (PTNS)

Sham Stimulation DEVICE

The intervention will begin with application of a needle and a self-adhesive electrode. The electrodes will be connected to the electrical stimulator device. The stimulator will then be turned on and amplitude will be gradually increased until motor or sensory response is observed. The amplitude will then be decreased to the point when no stimulation is delivered. No stimulation will then be delivered for a 30-minute session. After 30 minutes, the device will be turned off and the adhesive electrodes removed. Pelvic floor biofeedback therapy is typically performed for a total of four or more weekly sessions. Participants in our study will undergo 30-minute sessions of PTNS or sham stimulation after their first four biofeedback therapy sessions.

Also known as: Urgent PC (Cogentix Medical, Minnetonka, MN)

Sham Stimulation

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients 8-18 years of age
• Diagnosis of constipation due to pelvic floor dyssynergia
• Scheduled to start pelvic floor biofeedback therapy.

You may not qualify if:

• \- Prior surgery for constipation (colonic resection, cecostomy, Malone appendicostomy, sacral nerve stimulator implantation, etc.)

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43220, United States

Location

MeSH Terms

Conditions

Constipation; Fecal Incontinence

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Peter L Lu, MD, MS

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Gastroenterologist

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: July 30, 2024
• Study Start: January 9, 2020
• Primary Completion: November 1, 2024
• Study Completion: December 30, 2024
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)