Clinical Evaluation of Electrical Pudendal Nerve Stimulation in Children With Postoperative Neurogenic Lower Urinary Tract Dysfunction Secondary to Tethered Cord Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Neurogenic Bladder Symptom Score (NBSS) from baseline to 4 weeks post-treatment
研究概览
简要总结
The goal of this prospective observational study is to evaluate whether the addition of electrical pudendal nerve stimulation (EPNS) to standard conservative treatment can improve bladder function in pediatric patients with postoperative neurogenic bladder secondary to tethered cord syndrome . The study population consists of 50 children diagnosed with neurogenic bladder of various etiologies.
The main questions this study aims to answer are:
Does EPNS lead to significant improvement in neurogenic bladder symptom scores?
How does EPNS affect secondary clinical outcomes such as renal function, post-void residual volume, urinary leakage, and vesicoureteral reflux?
Researchers will compare clinical indicators before and after the addition of EPNS, on the background of consistent conservative management, to assess its therapeutic contribution.
Participants will:
Receive routine conservative therapy for neurogenic bladder (e.g., medications, bladder training)
Undergo EPNS sessions over a specified treatment period
Be evaluated using standardized scales and imaging or laboratory tests to monitor changes in bladder and renal function
The study will also explore whether treatment effects differ by underlying cause or symptom pattern.
详细描述
This prospective, controlled clinical study aims to evaluate the therapeutic efficacy of "sacral four-needle" electrical pudendal nerve stimulation (EPNS) in children with neurogenic lower urinary tract dysfunction (NLUTD) following surgical untethering for tethered cord syndrome (TCS). TCS is a common spinal dysraphism in pediatrics, often resulting in bladder dysfunction postoperatively despite timely surgical intervention. Conventional management, including intermittent catheterization and pharmacotherapy, carries limitations such as poor adherence and persistent symptoms. EPNS, a non-invasive acupuncture-based neuromodulation technique targeting the pudendal nerve via anatomically guided deep needling and low-frequency electrical stimulation, has shown promise in adult neurogenic bladder cases. This study will enroll approximately 50 children aged 3-18 with confirmed TCS and persistent NLUTD after initial surgery. Participants will be assigned to receive either routine conservative therapy alone or combined with EPNS over a four-week period (three sessions per week). Treatment efficacy will be assessed through changes in the Neurogenic Bladder Symptom Score (NBSS), along with secondary endpoints including post-void residual volume, voiding frequency, episodes of incontinence, renal function, and incidence of urinary tract infections. Follow-up will continue for six months post-treatment to evaluate sustained effects. The study employs blinded outcome assessment, with standardized protocols for needling, stimulation parameters, and symptom tracking. It further includes subgroup analyses based on disease etiology and symptom type (storage vs. voiding dysfunction). The research integrates traditional acupuncture with neuroanatomical precision and modern bladder rehabilitation theory, aiming to establish a replicable, low-cost, and scalable pediatric bladder dysfunction intervention model. By addressing a current gap in pediatric urological rehabilitation, the study seeks to contribute evidence toward standardizing EPNS as a viable adjunct therapy in this vulnerable population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 3-18 years
- •Diagnosed with TCS (by spinal MRI) and NLUTD (by urodynamic study)
- •First-time detethering surgery completed
- •Be able to comply with acupuncture treatment and follow-up
- •Informed consent obtained from legal guardian
排除标准
- •Severe systemic diseases
- •Current urinary tract infection, severe VUR, hydronephrosis, structural obstruction
- •Prior aggressive urological surgery (e.g., augmentation cystoplasty)
- •Prior or planned pudendal/sacral nerve implant
- •Botulinum toxin injection within past 12 months
- •Planned reoperation within 6 months
结局指标
主要结局
Change in Neurogenic Bladder Symptom Score (NBSS) from baseline to 4 weeks post-treatment
时间窗: Baseline to 4 weeks (end of treatment)
The Neurogenic Bladder Symptom Score (NBSS) is a validated, patient-reported questionnaire specifically designed to evaluate urinary symptoms and quality of life in individuals with neurogenic lower urinary tract dysfunction (NLUTD). It includes domains assessing incontinence, storage and voiding symptoms, complications (such as infections or catheter use), and the impact on daily life. In this study, the NBSS will be administered at baseline (prior to treatment initiation) and again after the 4-week intervention period. The primary outcome measure will be the change in total NBSS score between these two time points. A decrease in NBSS score reflects symptom improvement. Assessments will be completed by participants or their guardians under guidance from trained study personnel.
次要结局
- Serum creatinine and estimated glomerular filtration rate (eGFR)(Baseline, 4 weeks, and 6-month follow-up)
- Change in post-void residual urine volume (PVR)(Baseline, after 5th session, 10th session, end of treatment (week 4), and at 2-, 4-, 6-month follow-up)
- Urinary leakage volume(Baseline to 4 weeks, and at 2-, 4-, and 6-month follow-up)
- Incidence or grade of vesicoureteral reflux (VUR)(Baseline and 6-month follow-up)
- Incidence or grade of vesicoureteral reflux (VUR)(Baseline and 6-month follow-up)