Postoperative Neurogenic Lower Urinary Tract Dysfunction Secondary to Tethered Cord SyndromeNCT07062133
Effectiveness of Electrical Pudendal Nerve Stimulation for Neurogenic Lower Urinary Tract Dysfunction in Pediatric Tethered Cord Syndrome Post-Surgery
A study testing Electrical pudendal nerve stimulation and Conventional conservative treatment in people with Postoperative Neurogenic Lower Urinary Tract Dysfunction Secondary to Tethered Cord Syndrome, run by Shanghai Institute of Acupuncture, Moxibustion and Meridian at 1 site in China.
Trial 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 . Read more about this study
- Who is it for?
- Ages 3 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Neurogenic Lower Urinary Tract Dysfunction Secondary to Tethered Cord Syndrome
- What is being tested?
- Electrical pudendal nerve stimulation and Conventional conservative treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2025to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Evaluation of Electrical Pudendal Nerve Stimulation in Children With Postoperative Neurogenic Lower Urinary Tract Dysfunction Secondary to Tethered Cord Syndrome
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:
Read more
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.
Read the 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
- Being tested
- Electrical pudendal nerve stimulation, Conventional conservative treatment
- Keywords
- Neurogenic Lower Urinary Tract Dysfunction, Tethered Cord Syndrome, Electrical Pudendal Nerve Stimulation
- Medical subject headings
- Neural Tube Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical pudendal nerve stimulationProcedure or surgery
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 treatmentOther
Conventional conservative treatment including medications (e.g., oxybutynin), clean intermittent catheterization, and diaper use as needed
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Conventional conservative treatment including medications (e.g., oxybutynin), clean intermittent catheterization, and diaper use as needed, without EPNS intervention. Receives: 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 Receives: Procedure: Electrical pudendal nerve stimulation; Other: Conventional conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 4 weeks (end of treatment)
Secondary outcomes (4)
Serum creatinine and estimated glomerular filtration rate (eGFR)
Serum creatinine and estimated glomerular filtration rate (eGFR) are standard laboratory measures used to evaluate renal function. Serum creatinine reflects the concentration of creatinine in the blood, a waste product filtered by the kidneys, while eGFR provides an estimate of kidney filtration efficiency adjusted for age, sex, and body size.
Measured: Baseline, 4 weeks, and 6-month follow-up
Change in post-void residual urine volume (PVR)
Post-void residual urine volume (PVR) is a clinical parameter used to assess the efficiency of bladder emptying. It is defined as the amount of urine remaining in the bladder immediately after voluntary urination. In this study, PVR will be measured using noninvasive bladder ultrasound (portable or bedside ultrasound device) performed by trained personnel.A reduction in PVR indicates improved bladder emptying function, which is a critical component of managing NLUTD.
Measured: Baseline, after 5th session, 10th session, end of treatment (week 4), and at 2-, 4-, 6-month follow-up
Urinary leakage volume
Measured: Baseline to 4 weeks, and at 2-, 4-, and 6-month follow-up
Incidence or grade of vesicoureteral reflux (VUR)
Vesicoureteral reflux (VUR) is the retrograde flow of urine from the bladder into the ureters and potentially the kidneys, which can contribute to recurrent urinary tract infections and renal damage.The outcome will include (1) the presence or absence of VUR and (2) any change in VUR grade among participants with reflux at baseline. The primary interest is in identifying any improvement (reduction in grade or resolution) or worsening of VUR following the intervention.
Measured: Baseline and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start1 Nov 2025 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Neurogenic Lower Urinary Tract Dysfunction Secondary to Tethered Cord SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Institute of Acupuncture, Moxibustion and Meridian
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Pudong Hospital of Traditional Chinese Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07062133
- Sponsor's protocol ID
- pdzyy-2025-07
- Status last verified
- Apr 2025
- First submitted
- 2 Jul 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This is an early-phase, single-center exploratory trial with a limited sample size. The primary goal is to generate pilot data for future large-scale studies. At present, there is no confirmed plan to share de-identified individual participant data (IPD). However, data sharing may be considered in the future depending on study outcomes, ethical approvals, and publication status. If data are made available in the future, access will be provided to qualified researchers upon reasonable request and subject to institutional data use agreements and ethical oversight.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Electrical Pudendal Nerve Stimulation in Children With Postoperative Neurogenic Lower Urinary Tract Dysfunction Secondary to Tethered Cord Syndrome
- ClinicalTrials.gov ID
- NCT07062133
- Acronym / sponsor ID
- pdzyy-2025-07
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai Institute of Acupuncture, Moxibustion and MeridianUniversity, hospital or other
- Collaborators
- Shanghai Pudong Hospital of Traditional Chinese Medicine
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: Conventional conservative treatmentConventional conservative treatment including medications (e.g., oxybutynin), clean intermittent catheterization, and diaper use as needed, without EPNS intervention. |
| EPNS group | Experimental | Procedure: Electrical pudendal nerve stimulation, Other: Conventional conservative treatmentElectrical 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 |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical pudendal nerve stimulationElectrical 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. | Procedure or surgery | EPNS group |
| Conventional conservative treatmentConventional conservative treatment including medications (e.g., oxybutynin), clean intermittent catheterization, and diaper use as needed | Other | EPNS group, control group |
Primary outcome
Change in Neurogenic Bladder Symptom Score (NBSS) from baseline to 4 weeks post-treatment
Time frame: Baseline to 4 weeks (end of 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.
4 secondary outcomes
Serum creatinine and estimated glomerular filtration rate (eGFR)
Time frame: Baseline, 4 weeks, and 6-month follow-up
Change in post-void residual urine volume (PVR)
Time frame: Baseline, after 5th session, 10th session, end of treatment (week 4), and at 2-, 4-, 6-month follow-up
Urinary leakage volume
Time frame: Baseline to 4 weeks, and at 2-, 4-, and 6-month follow-up
Incidence or grade of vesicoureteral reflux (VUR)
Time frame: Baseline and 6-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: Undecided. This is an early-phase, single-center exploratory trial with a limited sample size. The primary goal is to generate pilot data for future large-scale studies. At present, there is no confirmed plan to share de-identified individual participant data (IPD). However, data sharing may be considered in the future depending on study outcomes, ethical approvals, and publication status. If data are made available in the future, access will be provided to qualified researchers upon reasonable request and subject to institutional data use agreements and ethical oversight.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical pudendal nerve stimulation and Conventional conservative treatment in people with Postoperative Neurogenic Lower Urinary Tract Dysfunction Secondary to Tethered Cord Syndrome, run by Shanghai Institute of Acupuncture, Moxibustion and Meridian at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wang Siyou, Professor (86-13916145894, wangsiyou1234@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Neurogenic Bladder Symptom Score (NBSS) from baseline to 4 weeks post-treatment (time frame: Baseline to 4 weeks (end of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.