TTNS Treatment for Urinary Leakage in Spina Bifida

Transcutaneous Tibial Nerve Stimulation (TTNS) Treatment in Spina Bifida Pediatric Patients With Neurogenic Bladder

Recruiting N/A Interventional Study
Spina Bifida
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
8 – 18
Sex
Any
Study type
Interventional
Purpose
Other
Participants needed
12 (estimated)
Sponsor
University of Texas Southwestern Medical Center · Other
Who this trial is looking for

This trial is looking for young patients with spina bifida who experience urinary leakage. Participants will receive a treatment called transcutaneous tibial nerve stimulation (TTNS) and complete tests and surveys to help evaluate the treatment's effectiveness.

Are You a Good Fit for This Trial?
Must not be taking AnticholinergicsBeta agonists

You may be able to join if

  • I am aged between 8 and 18 years old
  • I have been diagnosed with lumbosacral spina bifida
  • I have urinary leakage that has not improved with catheterization
  • I can and will undergo urodynamic testing without sedation
  • I have not had surgical reconstruction except for a single appendicovesicostomy
  • I can stop taking bladder medications 2 weeks before the study starts
  • I live close enough to return for visits and testing
  • My family and I speak English

You may not be able to join if

  • I am younger than 8 or older than 18 years old
  • I have a different diagnosis than those listed
  • I have had reconstructive surgeries except for a single appendicovesicostomy
  • I received Botox treatment in the last year
  • I cannot stop taking bladder medications
  • I have a high-risk bladder condition
  • I do not speak English
  • I am pregnant or nursing

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 comp…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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 assesse…
Contacts

Alexandra Carolan, MD

214-456-5632

alexandra.carlon@utsouthwestern.edu

CONTACT

Shreedhar Reddy

shreedhar.reddy@utsouthwestern.edu

CONTACT