Effectiveness of Electrical Pudendal Nerve Stimulation for Neurogenic Lower Urinary Tract Dysfunction in Pediatric Tethered Cord Syndrome Post-Surgery

Condition(s) studied

Investigational drug(s) / intervention(s)

Electrical pudendal nerve stimulation: 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.

Conventional conservative treatment: Conventional conservative treatment including medications (e.g., oxybutynin), clean intermittent catheterization, and diaper use as needed

Study summary

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.

Eligibility

Primary outcome measure(s)

• Change in Neurogenic Bladder Symptom Score (NBSS) from baseline to 4 weeks post-treatment — 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.

Trial sites (1)

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