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

NCT06025734 | Recruiting FDA Device

• 1 other identifier: STU-2023-0178
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spina Bifida

Keywords

Pediatrics; Neurogenic bladder; TTNS

Outcome Measures

Primary Outcomes (1)

• Number of leakage episodes

  Number of leakage episodes will be measured by 3 Day Bladder Diary

  12 weeks

Secondary Outcomes (5)

• Leak weight

  12 weeks

• Number of pads used

  12 weeks

• Number of diapers used

  12 weeks

• Quality of Life Assessment in Spina Bifida Score

  12 weeks

• Self assessment of improvement

  12 weeks

Study Arms (1)

TTNS Treatment Arm

EXPERIMENTAL

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).

Device: Transcutaneous Tibial Nerve Stimulation (TTNS) treatment

Interventions

Transcutaneous Tibial Nerve Stimulation (TTNS) treatment DEVICE

Spina Bifida pediatric patients with neurogenic bladder will be in Transcutaneous Tibial Nerve Stimulation (TTNS) treatment. Patient will complete 6 weeks of 30 minute treatment sessions (these can be done at home after the first teaching session)

TTNS Treatment Arm

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Scottish Rite for Children

Dallas, Texas, 75219, United States

RECRUITING

MeSH Terms

Conditions

Spinal Dysraphism; Urinary Bladder, Neurogenic

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Richard Adams, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra Carolan, MD

CONTACT

214-456-5632; alexandra.carlon@utsouthwestern.edu

Shreedhar Reddy

CONTACT

shreedhar.reddy@utsouthwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: September 6, 2023
• Study Start: November 18, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

US (1)