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

Launched by QILU HOSPITAL OF SHANDONG UNIVERSITY · Aug 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a procedure called sacral nerve modulation to see how well it helps people with urinary and bowel problems caused by spinal cord injuries. The goal is to find out if this treatment can improve bladder control and prevent complications related to these issues over the long term. Researchers will assess how effective the surgery is by measuring things like how much the bladder can hold and how well it functions, before and after the procedure, over a period of 6 to 12 months.

To participate in this study, individuals must be at least 18 years old and have been diagnosed with urinary and bowel dysfunction due to a spinal cord injury. They should have certain signs of bladder dysfunction and be able to safely undergo the surgery. Participants can expect to undergo evaluations before and after the procedure to track their progress. It's important to note that anyone with other serious health issues or certain conditions may not be eligible. This trial is currently recruiting participants, and those who join will need to give informed consent before starting.

Gender

ALL

Eligibility 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