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

NCT07062133 | Not Yet Recruiting

• 1 other identifier: pdzyy-2025-07
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Neurogenic Lower Urinary Tract Dysfunction; Tethered Cord Syndrome; Electrical Pudendal Nerve Stimulation

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (4)

• Serum creatinine and estimated glomerular filtration rate (eGFR)

  Baseline, 4 weeks, and 6-month follow-up

• Change in post-void residual urine volume (PVR)

  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)

  Baseline and 6-month follow-up

Study Arms (2)

control group

ACTIVE COMPARATOR

Conventional conservative treatment including medications (e.g., oxybutynin), clean intermittent catheterization, and diaper use as needed, without EPNS intervention.

Other: Conventional conservative treatment

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

Procedure: Electrical pudendal nerve stimulation; Other: Conventional conservative treatment

Interventions

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.

EPNS group

Conventional conservative treatment OTHER

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

EPNS group; control group

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children aged 3-18 years
• Diagnosed with TCS (by spinal MRI) and NLUTD (by urodynamic study)
• First-time detethering surgery completed
• Be able to comply with acupuncture treatment and follow-up
• Informed consent obtained from legal guardian

You may not qualify if:

• Severe systemic diseases
• Current urinary tract infection, severe VUR, hydronephrosis, structural obstruction
• Prior aggressive urological surgery (e.g., augmentation cystoplasty)
• Prior or planned pudendal/sacral nerve implant
• Botulinum toxin injection within past 12 months
• Planned reoperation within 6 months

Sponsors & Collaborators

• Shanghai Institute of Acupuncture, Moxibustion and Meridian: lead
• Shanghai Pudong Hospital of Traditional Chinese Medicine: collaborator

Study Sites (1)

Shanghai Pudong Hospital of Traditional Chinese Medicine

Shanghai, China

Location

MeSH Terms

Conditions

Neural Tube Defects

Condition Hierarchy (Ancestors)

Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Wang Siyou, Professor

CONTACT

86-13916145894; wangsiyou1234@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 14, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: September 4, 2025

Record last verified: 2025-04

Locations

CN (1)