Efficacy of Sacral Nerve Modulation on Urinary and Defecation Dysfunction After Spinal Cord Injury：A Prospective, Single-arm Study

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 stoptaking the medication for at least 7 days before the screening period. If you planto continue drug treatment during the study period, you need to maintain the samedosage or stop taking the medication after evaluation by a doctor.

• Voluntarily participate in this clinical study, and the subjects sign a writteninformed consent form before the start of the study.

• After testing treatment, if any of the following conditions are met, permanentimplantation of a sacral nerve stimulator is feasible① The average daily frequencyof 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 ofexperiential therapy decreased by ≥ 50% compared to baseline; ③ The number ofurinary incontinence episodes in the last 3 days of experiential therapy decreasedby ≥ 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 patientrequires permanent implantation due to improvement in intestinal and sexualfunction, 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 otherdiseases that may lead to lower urinary tract dysfunction cannot be ruled out

• Pregnant women, lactating women, women of childbearing age who plan to conceive orhave no safe contraceptive measures during the study period

• Patients with mental and cognitive impairments, as well as those who are unable tocooperate with the experimental process

• Patients with untreated infections, coagulation disorders, malignant tumors, andother serious illnesses

• Individuals who have undergone other relevant surgical treatments within 3 monthsprior to enrollment (including but not limited to bladder wall injection ofbotulinum toxin type A), or have participated in other clinical trials

• Other situations that researchers consider inappropriate to participate in the study