Effectiveness of Transcutaneous Tibial Nerve Stimulation in Pediatric Patients With Neurogenic Bladder Secondary to Spina Bifida
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of leakage episodes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
TTNS Treatment Arm
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).
干预措施: Transcutaneous Tibial Nerve Stimulation (TTNS) treatment (Device)
结局指标
主要结局
Number of leakage episodes
时间窗: 12 weeks
Number of leakage episodes will be measured by 3 Day Bladder Diary
次要结局
- 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)
研究者
Richard Adams
Professor
University of Texas Southwestern Medical Center