Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-26 @ 1:11 AM
Study NCT ID:
NCT06025734
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-26
First Post:
2023-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transcutaneous Tibial Nerve Stimulation (TTNS) Treatment in Spina Bifida Pediatric Patients with Neurogenic Bladder
Sponsor:
University of Texas Southwestern Medical Center
Organization:
Study Overview
Official Title:
Effectiveness of Transcutaneous Tibial Nerve Stimulation in Pediatric Patients with Neurogenic Bladder Secondary to Spina Bifida
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
This study is designed to determine the outcomes of spina bifida patients with neurogenic bladder who receive Transcutaneous Tibial Nerve Stimulation (TTNS) treatment.
To identify patients that may receive the most benefit from TTNS treatment.
Patients with neurogenic bladder secondary to spina bifida with low-risk bladders, who are compliant with catheterizing, will see decreased urinary leakage and improved urodynamic parameters when used in combination with TTNS treatment.
Posterior tibial nerve stimulation via percutaneous (PTNS) or transcutaneous (TTNS) approaches have been effective in treating urinary incontinence from overactive bladder (OAB) and voiding dysfunction in adults. While the exact mechanism of action remains under evaluation, it is a standard of care for adults with OAB refractory to behavioral modifications. Studies have shown PTNS to be effective in children with overactive bladder disease and urinary retention secondary to non-neurogenic causes. TTNS has been shown to be effective for OAB symptoms in children compared to sham intervention, and further studies are ongoing. Moreover, it has been demonstrated that TTNS is non-inferior to PTNS in treating OAB in adults. TTNS is appealing due to its less invasive nature compared to PTNS.
Posterior tibial nerve stimulation implementation in the pediatric population is increasing. To date, few studies have evaluated the efficacy of posterior tibial nerve stimulation in children with spina bifida as some believe the spinal dysraphism may disrupt the mechanism of the technique. However, another form of neuromodulation, surgically-implanted sacral neuromodulation (Interstim), has been shown to be effective for urinary and bowel parameters for some patients with neurogenic bladder secondary to spina bifida. The hypothesis in the proposed study is that TTNS may benefit a subset of patients with less severe spina bifida and may be a treatment option in managing their refractory urinary incontinence.
Pre-intervention
If patient is on bladder medication(s) (anticholinergics or beta agonists), they will stop the bladder medication 2-4 weeks (minimum of 2 weeks) before pre-intervention urodynamic study (UDS)
Patient will complete 3 Day Bladder Diary at home prior to intervention (must be done at least 2 weeks after stopping bladder medications)
Patients will be provided scales for measuring diaper/pad weights at home.
At least 2 weeks after stopping bladder medications (if applicable), patient completes UDS (standard, not video) at Children's Medical Center (CMC)
At this visit, patient completes pre-intervention questionnaires (detailed below in Section 7)
Intervention Period
Intervention overview: Patients will complete weekly 30-minute sessions of TTNS. Intervention procedure described below.
The intervention period will start as 6 weeks for all patients, with extension to 12 weeks for patients who meet any of the measures of success as defined below in the "Post-intervention" section
After patient has completed pre-intervention 3 Day Bladder Diary, UDS and questionnaires, they will proceed with TTNS nursing teaching visit and the first TTNS session at Texas Scottish Rite Hospital (TSRH) or Children's Medical Center Dallas (therefore, if they have completed the Bladder Diary prior to their UDS appointment, the TTNS nursing teaching visit can be completed the same day as their UDS appointment)
At the teaching visit, patient/parent will be shown how to perform the TTNS treatment. They will then demonstrate the process of placing the electrodes and starting the treatment. The first 30-minute session will then be done at this visit. If understanding of process is demonstrated, further treatments will be done at home. If not, they will return the following week for further teaching and the second treatment. Nursing visits will be continued until proficiency is demonstrated by the patient/family, as assessed by the nurse conducting the visit.
The patient will be contacted by phone by the research team weekly after their nursing visit when proficiency was demonstrated, in order to answer questions and monitor compliance. Patients will return for additional teaching sessions as needed.
To identify patients that may receive the most benefit from TTNS treatment.
Patients with neurogenic bladder secondary to spina bifida with low-risk bladders, who are compliant with catheterizing, will see decreased urinary leakage and improved urodynamic parameters when used in combination with TTNS treatment.
Posterior tibial nerve stimulation via percutaneous (PTNS) or transcutaneous (TTNS) approaches have been effective in treating urinary incontinence from overactive bladder (OAB) and voiding dysfunction in adults. While the exact mechanism of action remains under evaluation, it is a standard of care for adults with OAB refractory to behavioral modifications. Studies have shown PTNS to be effective in children with overactive bladder disease and urinary retention secondary to non-neurogenic causes. TTNS has been shown to be effective for OAB symptoms in children compared to sham intervention, and further studies are ongoing. Moreover, it has been demonstrated that TTNS is non-inferior to PTNS in treating OAB in adults. TTNS is appealing due to its less invasive nature compared to PTNS.
Posterior tibial nerve stimulation implementation in the pediatric population is increasing. To date, few studies have evaluated the efficacy of posterior tibial nerve stimulation in children with spina bifida as some believe the spinal dysraphism may disrupt the mechanism of the technique. However, another form of neuromodulation, surgically-implanted sacral neuromodulation (Interstim), has been shown to be effective for urinary and bowel parameters for some patients with neurogenic bladder secondary to spina bifida. The hypothesis in the proposed study is that TTNS may benefit a subset of patients with less severe spina bifida and may be a treatment option in managing their refractory urinary incontinence.
Pre-intervention
If patient is on bladder medication(s) (anticholinergics or beta agonists), they will stop the bladder medication 2-4 weeks (minimum of 2 weeks) before pre-intervention urodynamic study (UDS)
Patient will complete 3 Day Bladder Diary at home prior to intervention (must be done at least 2 weeks after stopping bladder medications)
Patients will be provided scales for measuring diaper/pad weights at home.
At least 2 weeks after stopping bladder medications (if applicable), patient completes UDS (standard, not video) at Children's Medical Center (CMC)
At this visit, patient completes pre-intervention questionnaires (detailed below in Section 7)
Intervention Period
Intervention overview: Patients will complete weekly 30-minute sessions of TTNS. Intervention procedure described below.
The intervention period will start as 6 weeks for all patients, with extension to 12 weeks for patients who meet any of the measures of success as defined below in the "Post-intervention" section
After patient has completed pre-intervention 3 Day Bladder Diary, UDS and questionnaires, they will proceed with TTNS nursing teaching visit and the first TTNS session at Texas Scottish Rite Hospital (TSRH) or Children's Medical Center Dallas (therefore, if they have completed the Bladder Diary prior to their UDS appointment, the TTNS nursing teaching visit can be completed the same day as their UDS appointment)
At the teaching visit, patient/parent will be shown how to perform the TTNS treatment. They will then demonstrate the process of placing the electrodes and starting the treatment. The first 30-minute session will then be done at this visit. If understanding of process is demonstrated, further treatments will be done at home. If not, they will return the following week for further teaching and the second treatment. Nursing visits will be continued until proficiency is demonstrated by the patient/family, as assessed by the nurse conducting the visit.
The patient will be contacted by phone by the research team weekly after their nursing visit when proficiency was demonstrated, in order to answer questions and monitor compliance. Patients will return for additional teaching sessions as needed.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: