Posterior Tibial Nerve Stimulation for Children With Pelvic Floor Dyssynergia

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

Interventions

DEVICE

Posterior Tibial Nerve Stimulation (PTNS)

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.

DEVICE

Sham Stimulation

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.

Sponsors & Collaborators

• Nationwide Children's Hospital

  lead OTHER

Principal Investigators

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

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

8 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-01-09

Primary Completion

2024-11-01

Completion

2024-12-30

FDA Device

Yes

Countries

• United States

Study Locations