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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 41 participants in total. It began in 2023-12-01 with a primary completion date of 2025-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 3 days of experiential therapy decreased by ≥ 50% compared to baseline;② The average urinary urgency score for the last 3 days of experiential therapy decreased by ≥ 50% compared to baseline; ③ The number of urinary incontinence episodes in the last 3 days of experiential therapy decreased by ≥ 50% compared to baseline;④ The average urine output per session during the last 3 days of experiential therapy increased by ≥ 50% compared to baseline;⑤ The patient requires permanent implantation due to improvement in intestinal and sexual function, and after evaluation by the researcher, can undergo phase II treatment Exclusion Criteria: * Other causes of lower urinary tract dysfunction cannot be ruled out, or other diseases that may lead to lower urinary tract dysfunction cannot be ruled out * Pregnant women, lactating women, women of childbearing age who plan to conceive or have no safe contraceptive measures during the study period * Patients with mental and cognitive impairments, as well as those who are unable to cooperate with the experimental process * Patients with untreated infections, coagulation disorders, malignant tumors, and other serious illnesses * Individuals who have undergone other relevant surgical treatments within 3 months prior to enrollment (including but not limited to bladder wall injection of botulinum toxin type A), or have participated in other clinical trials * Other situations that researchers consider inappropriate to participate in the study
Contact & Investigator
Lipeng Chen, Dortor
STUDY CHAIR
Qilu Hospital of Shandong University
Frequently Asked Questions
Who can join the NCT06553469 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cystometry. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06553469 currently recruiting?
Yes, NCT06553469 is actively recruiting participants. Contact the research team at yanli@sdu.edu.cn for enrollment information.
Where is the NCT06553469 trial being conducted?
This trial is being conducted at Jinan, China.
Who is sponsoring the NCT06553469 clinical trial?
NCT06553469 is sponsored by Qilu Hospital of Shandong University. The principal investigator is Lipeng Chen, Dortor at Qilu Hospital of Shandong University. The trial plans to enroll 41 participants.