Effectiveness of Electrical Pudendal Nerve Stimulation for Neurogenic Lower Urinary Tract Dysfunc… (NCT07062133) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effectiveness of Electrical Pudendal Nerve Stimulation for Neurogenic Lower Urinary Tract Dysfunction in Pediatric Tethered Cord Syndrome Post-Surgery
China50 participantsStarted 2025-11-01
Plain-language 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.
Who can participate
Age range
3 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Neurogenic Bladder Symptom Score (NBSS) from baseline to 4 weeks post-treatment
Timeframe: Baseline to 4 weeks (end of treatment)
Trial details
NCT IDNCT07062133
SponsorShanghai Institute of Acupuncture, Moxibustion and Meridian