Clinical Trial

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

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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-07-10.
Trial Details
NCT Number NCT07062133
Lead Sponsor Shanghai Institute of Acupuncture, Moxibustion and Meridian
Collaborators: Shanghai Pudong Hospital of Traditional Chinese Medicine
Conditions Postoperative Neurogenic Lower Urinary Tract Dysfunction Secondary to Tethered Cord Syndrome
Enrollment 50 participants
Start Date 2025-11-01
Primary Completion 2027-01-31 (estimated)
Study Completion 2027-03-31 (estimated)
Updated on ClinicalTrials.gov 2025-09-04