NCT06553469 Efficacy of Sacral Nerve Modulation on Urinary and Defecation Dysfunction After Spinal Cord Injury：A Prospective, Single-arm Study
| NCT ID | NCT06553469 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Qilu Hospital of Shandong University |
| Condition | Cystometry |
| Study Type | OBSERVATIONAL |
| Enrollment | 41 participants |
| Start Date | 2023-12-01 |
| Primary Completion | 2025-12-01 |
Trial Parameters
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Brief Summary
The aim of this study is to investigate the long-term efficacy of sacral nerve modulation surgery in the treatment of neurogenic lower urinary tract dysfunction caused by incomplete spinal cord injury, as well as its preventive effect on complications of neurogenic lower urinary tract dysfunction. We will use urodynamic examination results such as maximum bladder capacity and detrusor leak point pressure, combined with renal function and urinary ultrasound results, as our evaluation indicators. Follow up evaluations will be conducted at 6 and 12 months after permanent implantation, and periodic comparisons will be made with baseline data to gain a more comprehensive understanding of the effectiveness and safety of sacral nerve regulation surgery.
Eligibility Criteria
Inclusion Criteria: * Age over 18 years old, gender not limited * Diagnosed with urinary and defecation dysfunction caused by spinal cord injury * Urodynamic examination suggests bladder dysfunction * ASIA spinal cord injury classification: B, C, or D * Safe bladder capacity\>100ml * Patients who can undergo sacral nerve regulation surgery after evaluation * If you plan not to combine medication during the study period, you need to stop taking the medication for at least 7 days before the screening period. If you plan to continue drug treatment during the study period, you need to maintain the same dosage or stop taking the medication after evaluation by a doctor. * Voluntarily participate in this clinical study, and the subjects sign a written informed consent form before the start of the study. * After testing treatment, if any of the following conditions are met, permanent implantation of a sacral nerve stimulator is feasible① The average daily frequency of urination during the last