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

NCT07062133 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-09-04

No results posted yet for this 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.

Conditions

  • Postoperative Neurogenic Lower Urinary Tract Dysfunction Secondary to Tethered Cord Syndrome

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

Sponsors & Collaborators

  • Shanghai Pudong Hospital of Traditional Chinese Medicine

    collaborator UNKNOWN

  • Shanghai Institute of Acupuncture, Moxibustion and Meridian

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2027-01-31
Completion
2027-03-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07062133 on ClinicalTrials.gov