Transcutaneous tibial nerve stimulation for urinary leakage in children with spina bifida
Effectiveness of Transcutaneous Tibial Nerve Stimulation in Pediatric Patients With Neurogenic Bladder Secondary to Spina Bifida
This study will try mild electrical stimulation at the ankle (TTNS) to reduce urinary leakage in children aged 8–18 with spina bifida and neurogenic bladder.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 8 Years to 18 Years |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT06025734 on ClinicalTrials.gov |
What this trial studies
Participants will complete baseline urodynamic testing, bladder diaries, and questionnaires before starting therapy. They will receive clinic training and then complete six weekly TTNS sessions, performed at home after instruction, with an option to continue for responders. The intervention is a noninvasive form of posterior tibial nerve stimulation that has shown benefit in adults and some pediatric non-neurogenic bladder conditions. The study aims to measure changes in urinary leakage and urodynamic parameters to identify which spina bifida patients benefit most.
Who should consider this trial
Good fit: Ideal candidates are English-speaking children aged 8–18 with lumbosacral spina bifida and neurogenic bladder who are compliant with catheterization, can undergo urodynamic testing, have not had recent bladder Botox or major reconstructive surgery, and can attend visits at Scottish Rite for Children/CMC in Dallas.
Not a fit: Patients unlikely to benefit include those outside the 8–18 age range, with non-lumbosacral or surgically reconstructed high-risk bladders (e.g., augmentation), those unable to catheterize or undergo urodynamics, or who cannot stop bladder medications or attend required clinic visits.
Why it matters
Potential benefit: If successful, TTNS could reduce urinary leakage and improve bladder function in children with spina bifida without requiring surgery or injections.
How similar studies have performed: Posterior tibial nerve stimulation has shown benefit for adult overactive bladder and some pediatric non-neurogenic bladder conditions, and TTNS has been effective versus sham in children, but evidence specifically in spina bifida is limited.
Eligibility criteria
Show full inclusion / exclusion 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 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 Exclusion Criteria: * Ages \<8 or \>18 * Diagnosis not listed above * Patients that have received reconstructive surgeries (i.e. augmentation or bladder neck sling) with the exception for a single APV * Patient received Botox treatment within 1 year of enrollment * Patient unable or unwilling to stop bladder medications (anticholinergics or beta agonists) * Patients with high-risk bladders, as assessed by their treating provider (i.e. poorly compliant bladders with high end-fill pressures) * Non-English speaking * Patients who are pregnant * Patients who are suspected of being pregnant * Patients who are nursing
Where this trial is running
Dallas, Texas
- Scottish Rite for Children — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Richard Adams, MD — University of Texas Southwestern Medical Center
- Study coordinator: Alexandra Carolan, MD
- Email: alexandra.carlon@utsouthwestern.edu
- Phone: 214-456-5632
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.