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| Name | Class |
|---|---|
| Shanghai Pudong Hospital of Traditional Chinese Medicine | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | Active Comparator | Conventional conservative treatment including medications (e.g., oxybutynin), clean intermittent catheterization, and diaper use as needed, without EPNS intervention. |
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| EPNS group | Experimental | Electrical 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. Apart from EPNS, intervention administered in this group also include conventional conservative treatment as sama as in the control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrical pudendal nerve stimulation | Procedure | Electrical 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 4 weeks (end of treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wang Siyou, Professor | Contact | 86-13916145894 | wangsiyou1234@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Pudong Hospital of Traditional Chinese Medicine | Shanghai | China |
This is an early-phase, single-center exploratory trial with a limited sample size. The primary goal is to generate pilot data for future large-scale studies. At present, there is no confirmed plan to share de-identified individual participant data (IPD). However, data sharing may be considered in the future depending on study outcomes, ethical approvals, and publication status.
If data are made available in the future, access will be provided to qualified researchers upon reasonable request and subject to institutional data use agreements and ethical oversight.
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| Conventional conservative treatment | Other | Conventional conservative treatment including medications (e.g., oxybutynin), clean intermittent catheterization, and diaper use as needed |
|
| Baseline, 4 weeks, and 6-month follow-up |
| 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. | 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) | 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. | Baseline and 6-month follow-up |
| ID | Term |
|---|---|
| D009436 | Neural Tube Defects |
| ID | Term |
|---|---|
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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