Effect of sacral nerve modulation on urinary and bowel dysfunction after spinal cord injury
Efficacy of Sacral Nerve Modulation on Urinary and Defecation Dysfunction After Spinal Cord Injury
This study is testing if a surgery that stimulates the sacral nerve can help people with bladder and bowel problems caused by spinal cord injuries feel better over the long term.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 41 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Qilu Hospital of Shandong University Academic / other |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT06553469 on ClinicalTrials.gov |
What this trial studies
This study investigates the long-term effectiveness of sacral nerve modulation surgery for treating neurogenic lower urinary tract dysfunction resulting from incomplete spinal cord injury. It evaluates urodynamic parameters such as maximum bladder capacity and detrusor leak point pressure, alongside renal function and urinary ultrasound results. Follow-up assessments will occur at 6 and 12 months post-implantation, allowing for comparisons with baseline data to assess the safety and efficacy of the intervention.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with urinary and defecation dysfunction due to spinal cord injury, specifically classified as ASIA B, C, or D.
Not a fit: Patients with urinary and defecation dysfunction not caused by spinal cord injury may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could significantly improve bladder and bowel function for patients with spinal cord injuries.
How similar studies have performed: While sacral nerve modulation has shown promise in treating various bladder dysfunctions, its specific application for spinal cord injury-related dysfunction is still being explored and lacks extensive prior validation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Jinan, Shandong
- Qilu Hospital of Shandong University — Jinan, Shandong, China (Recruiting)
Study contacts
- Study coordinator: Yan Li, Dortor
- Email: yanli@sdu.edu.cn
- Phone: 18560089113
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.