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.
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
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
Parallel
Electrical pudendal nerve stimulation
Procedure/SurgeryElectrical Pudendal Nerve Stimulation (EPNS) delivered by four deep acupuncture needles targeting bilateral sacrococcygeal points near the pudendal nerve. Connected to G6805-2 electrical stimulator, 2 Hz, 60 minutes/session, three times per week for 4 weeks.
Conventional conservative treatment
Other interventionConventional conservative treatment including medications (e.g., oxybutynin), clean intermittent catheterization, and diaper use as needed
Change in Neurogenic Bladder Symptom Score (NBSS) from baseline to 4 weeks post-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.
Serum creatinine and estimated glomerular filtration rate (eGFR)
Serum creatinine and estimated glomerular filtration rate (eGFR) are standard laboratory measures used to evaluate renal function. Serum creatinine reflects the concentration of creatinine in the blood, a waste product filtered by the kidneys, while eGFR provides an estimate of kidney filtration efficiency adjusted for age, sex, and body size.
Change in post-void residual urine volume (PVR)
Post-void residual urine volume (PVR) is a clinical parameter used to assess the efficiency of bladder emptying. It is defined as the amount of urine remaining in the bladder immediately after voluntary urination. In this study, PVR will be measured using noninvasive bladder ultrasound (portable or bedside ultrasound device) performed by trained personnel.A reduction in PVR indicates improved bladder emptying function, which is a critical component of managing NLUTD.
Urinary leakage volume
Incidence or grade of vesicoureteral reflux (VUR)
Vesicoureteral reflux (VUR) is the retrograde flow of urine from the bladder into the ureters and potentially the kidneys, which can contribute to recurrent urinary tract infections and renal damage.The outcome will include (1) the presence or absence of VUR and (2) any change in VUR grade among participants with reflux at baseline. The primary interest is in identifying any improvement (reduction in grade or resolution) or worsening of VUR following the intervention.
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Shanghai Institute of Acupuncture, Moxibustion and Meridian
Lead sponsor
Shanghai Pudong Hospital of Traditional Chinese Medicine
Collaborator
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