Actively Recruiting
Efficacy of Sacral Nerve Modulation on Urinary and Defecation Dysfunction After Spinal Cord Injury：A Prospective, Single-arm Study
Led by Qilu Hospital of Shandong University · Updated on 2024-08-14
41
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy of Sacral Nerve Modulation on Urinary and Defecation Dysfunction After Spinal Cord Injury：A Prospective, Single-arm Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years old
- Diagnosed with urinary and defecation dysfunction caused by spinal cord injury
- Urodynamic examination shows bladder dysfunction
- ASIA spinal cord injury classification of B, C, or D
- Safe bladder capacity greater than 100 ml
- Able to undergo sacral nerve modulation surgery after evaluation
- If no medication during study, must stop drugs for at least 7 days before screening; if continuing medication, dosage must remain stable or stop after doctor evaluation
- Voluntarily agree to participate and sign informed consent
- After testing phase, eligible for permanent implantation if symptoms improve by 50% or if researcher approves for Phase II due to intestinal or sexual function improvement
You will not qualify if you...
- Other causes of lower urinary tract dysfunction not ruled out
- Pregnant or breastfeeding women, women planning pregnancy, or without safe contraception during study
- Mental or cognitive impairments preventing cooperation
- Untreated infections, coagulation disorders, malignant tumors, or serious illnesses
- Other relevant surgeries within 3 months prior to enrollment, or participation in other clinical trials
- Any other conditions deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Qilu Hospital of Shandong University
Jinan, Shandong, China
Actively Recruiting
Research Team
Y
Yan Li, Dortor
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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