Tibial Nerve Stimulation for Spina Bifida
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to assess the safety and effectiveness of a daily home treatment using a device that stimulates the tibial nerve in children with spina bifida. The focus is on those with a chronic neurogenic bladder (a bladder control problem due to nerve issues) who are already on stable medication for an overactive bladder. Participants will use either the actual device or a sham (fake) device for comparison. This study might be suitable for children with spina bifida and ongoing bladder issues despite medication. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could improve daily life for these children.
Will I have to stop taking my current medications?
The trial requires that you continue taking your current bladder medications, as they must be stable for at least 3 months before participating.
What prior data suggests that this tibial nerve stimulation protocol is safe for children with chronic neurogenic bladder?
Research has shown that tibial nerve stimulation is generally well-tolerated in children with bladder issues caused by nerve problems. A review of studies found that various electrical stimulation therapies, including tibial nerve stimulation, are effective and safe for young patients with these conditions. The studies reported no major side effects, indicating the treatment's safety for children. This non-invasive therapy typically involves gentle electric pulses, which most patients handle well without significant side effects.12345
Why are researchers excited about this trial?
Tibial nerve stimulation is unique because it targets the nervous system in a new way to help manage spina bifida symptoms. Unlike standard treatments like medication or surgery, this method uses electrical stimulation to activate the tibial nerve, potentially improving bladder function without invasive procedures. Researchers are excited about its potential for fewer side effects and the possibility of improving quality of life for patients with spina bifida. The addition of a sham comparator group in trials also helps ensure that any benefits observed are due to the stimulation itself, providing robust data on its effectiveness.
What evidence suggests that tibial nerve stimulation is effective for neurogenic bladder?
Research has shown that stimulating the tibial nerve can help manage symptoms of neurogenic bladder (NB) caused by spina bifida. Studies have found that this treatment decreases the number of daily wet episodes, reducing accidents for patients. In this trial, participants will receive either the Stamobil electric stimulator or a sham tTNS device. Some research has also shown that similar electrical stimulation therapies improve bladder control in children with spina bifida. This suggests that tibial nerve stimulation could be a promising option for enhancing the quality of life for those with NB. While more research is needed, early results are encouraging for those considering this treatment.12567
Who Is on the Research Team?
Argyrios Stampas, MD, MS
Principal Investigator
The University of Texas Health Science Center and Houston
Are You a Good Fit for This Trial?
This trial is for children with neurogenic bladder due to spina bifida or spinal cord injury. Participants will use a nerve stimulation device at home, applied by themselves or a caregiver for 4 weeks.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive daily home transcutaneous tibial nerve stimulation (tTNS) for 4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Tibial Nerve Stimulation
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Health Science Center, Houston
Lead Sponsor