Posterior Tibial Nerve Stimulation for Children With Pelvic Floor Dyssynergia

NARecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

January 9, 2020

Primary Completion Date

November 1, 2024

Study Completion Date

December 30, 2024

Conditions
ConstipationFecal Incontinence in ChildrenPelvic 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.

Trial Locations (1)

43220

RECRUITING

Nationwide Children's Hospital, Columbus

All Listed Sponsors
lead

Nationwide Children's Hospital

OTHER