Efficacy of Sacral Nerve Modulation on Urinary and Defecation Dysfunction After Spinal Cord Injury：A Prospective, Single-arm Study
Efficacy of Sacral Nerve Modulation on Urinary and Defecation Dysfunction After Spinal Cord Injury
Qilu Hospital of Shandong University
41 participants
Dec 1, 2023
OBSERVATIONAL
Conditions
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
Inclusion Criteria9
- 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 Criteria6
- 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
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Interventions
After screening according to the inclusion and exclusion criteria, the subjects were enrolled in the study. The sacral nerve regulation treatment was divided into two phases. Phase I was the testing phase, during which the sacral nerve stimulation electrode component was implanted. After the electrode was implanted, it was tested for 2-4 weeks. According to the urine diary and scale scores, if the symptoms improved by ≥ 50%, or if the patient requested to continue with Phase II and was evaluated by the researcher as suitable for implantation, Phase II (permanent implantation phase) treatment was performed, during which the sacral nerve stimulation pulse generator component was implanted
Locations(1)
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NCT06553469