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

NCT ID: NCT07062133

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2027-03-31

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.

Detailed Description

This prospective, controlled clinical study aims to evaluate the therapeutic efficacy of "sacral four-needle" electrical pudendal nerve stimulation (EPNS) in children with neurogenic lower urinary tract dysfunction (NLUTD) following surgical untethering for tethered cord syndrome (TCS). TCS is a common spinal dysraphism in pediatrics, often resulting in bladder dysfunction postoperatively despite timely surgical intervention. Conventional management, including intermittent catheterization and pharmacotherapy, carries limitations such as poor adherence and persistent symptoms. EPNS, a non-invasive acupuncture-based neuromodulation technique targeting the pudendal nerve via anatomically guided deep needling and low-frequency electrical stimulation, has shown promise in adult neurogenic bladder cases. This study will enroll approximately 50 children aged 3-18 with confirmed TCS and persistent NLUTD after initial surgery. Participants will be assigned to receive either routine conservative therapy alone or combined with EPNS over a four-week period (three sessions per week). Treatment efficacy will be assessed through changes in the Neurogenic Bladder Symptom Score (NBSS), along with secondary endpoints including post-void residual volume, voiding frequency, episodes of incontinence, renal function, and incidence of urinary tract infections. Follow-up will continue for six months post-treatment to evaluate sustained effects. The study employs blinded outcome assessment, with standardized protocols for needling, stimulation parameters, and symptom tracking. It further includes subgroup analyses based on disease etiology and symptom type (storage vs. voiding dysfunction). The research integrates traditional acupuncture with neuroanatomical precision and modern bladder rehabilitation theory, aiming to establish a replicable, low-cost, and scalable pediatric bladder dysfunction intervention model. By addressing a current gap in pediatric urological rehabilitation, the study seeks to contribute evidence toward standardizing EPNS as a viable adjunct therapy in this vulnerable population.

Conditions

Postoperative Neurogenic Lower Urinary Tract Dysfunction Secondary to Tethered Cord Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

control group

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

Group Type: ACTIVE_COMPARATOR

Conventional conservative treatment

Intervention Type: OTHER

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

EPNS group

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

Group Type: EXPERIMENTAL

Electrical pudendal nerve stimulation

Intervention Type: 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.

Conventional conservative treatment

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: PROCEDURE

Conventional conservative treatment

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Pudong Hospital of Traditional Chinese Medicine

UNKNOWN

Sponsor Role: collaborator

Shanghai Institute of Acupuncture, Moxibustion and Meridian

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Pudong Hospital of Traditional Chinese Medicine

Shanghai, , China

Countries

China

Central Contacts

Wang Siyou, Professor

Role: CONTACT

wangsiyou1234@163.com

86-13916145894

Other Identifiers

pdzyy-2025-07

Identifier Type: -

Identifier Source: org_study_id