Status:
RECRUITING
Efficacy of Sacral Nerve Modulation on Urinary and Defecation Dysfunction After Spinal Cord Injury：A Prospective, Single-arm Study
Lead Sponsor:
Qilu Hospital of Shandong University
Conditions:
Cystometry
Sacral Neuromodulation
Eligibility:
All Genders
18+ years
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...
Detailed Description
Spinal cord injury is a serious type of central nervous system injury that not only causes movement disorders, but also damages the bladder, intestines, and autonomic nervous circuits related to sexua...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT06553469
Start Date
December 1 2023
End Date
December 31 2025
Last Update
August 14 2024
Active Locations (1)
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1
Qilu Hospital of Shandong University
Jinan, Shandong, China