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NOT YET RECRUITING
NCT07062133
NA

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

Sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian

View on ClinicalTrials.gov

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.

Official title: Clinical Evaluation of Electrical Pudendal Nerve Stimulation in Children With Postoperative Neurogenic Lower Urinary Tract Dysfunction Secondary to Tethered Cord Syndrome

Key Details

Gender

All

Age Range

3 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-11-01

Completion Date

2027-03-31

Last Updated

2025-09-04

Healthy Volunteers

Yes

Interventions

PROCEDURE

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.

OTHER

Conventional conservative treatment

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

Locations (1)

Shanghai Pudong Hospital of Traditional Chinese Medicine

Shanghai, China