Effectiveness of Transcutaneous Tibial Nerve Stimulation in Pediatric Patients With Neurogenic Bladder Secondary to Spina Bifida

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this research study is to determine the effectiveness of a treatment called transcutaneous tibial nerve stimulation or TTNS in the treatment of urinary leakage for patients with spina bifida. This treatment involves electrical stimulation of a nerve by the ankle. Participants will complete urodynamic testing and questionnaires prior to the treatments. Participants will then complete 6 weekly treatments of TTNS. Participants will learn how to do the treatment in the clinic, and then can complete the treatments at home. For patients with a good response, the treatments may be continued for another 6 weeks, for a total of 6 weeks.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 18
Healthy Volunteers: f
View:

• Age 8-18

• Patient at TSRH

• Diagnosis of lumbosacral spina bifida (myelomeningocele, meningocele, lipoma of spinal cord, myelocystocele, diastematomyelia, fatty/thickened filum)

• Incontinence refractory to compliant catheterization (compliance with catheterization as assessed by their treating provider)

• Patient able and willing to undergo urodynamic testing without sedation

• No surgical reconstruction with the exception of a single appendicovesicostomy (APV)

• No Botox treatments within 1 year of enrollment

• Patient willing and able to stop bladder medications (anticholinergics or beta agonists) 2 weeks prior to pre-intervention bladder diary, questionnaires and UDS

• Patient lives close enough to TSRH and CMC to be willing to return for UDS, teaching, and clinic visits as detailed above

• Patient/family speak English

Locations
United States
Texas
Scottish Rite for Children
RECRUITING
Dallas
Contact Information
Primary
Alexandra Carolan, MD
alexandra.carlon@utsouthwestern.edu
214-456-5632
Backup
Shreedhar Reddy
shreedhar.reddy@utsouthwestern.edu
Time Frame
Start Date: 2025-11-18
Estimated Completion Date: 2028-12
Participants
Target number of participants: 12
Treatments
Experimental: TTNS Treatment Arm
Treatments Patient will complete 6 weeks of 30 minute treatment sessions (these can be done at home after the first teaching session) During treatments, patient may experience a tingling sensation in the foot/ankle. Patient may have discomfort in the area when first adjusting to the correct amount of stimulation for patient.~Patient will have a visit with your doctor after 6 weeks of treatment at Scottish Rite. If patient have a good response to the treatments, they may be extended for another 6 weeks.~After treatments Bladder diary (completed at home, on paper over a 3-day period, recording catheterization volumes and amount of leakage by weighing pads/diapers) Complete questionnaires on paper (about 10 minutes) Complete urodynamic testing at Children's Medical Center (approximately 45-60 minutes).
Related Therapeutic Areas
Sponsors
Leads: University of Texas Southwestern Medical Center

This content was sourced from clinicaltrials.gov