Acupuncture for neurogenic bladder urinary retention after spinal cord injury: a clinical plan for a randomized trial

Abstract Background: Neurogenic bladder urinary retention is one of the most common complications of spinal cord injury, severely affecting patient satisfaction and quality of life. The clinical treatment of urinary retention is generally targeted therapy with intermittent voiding using a urinary catheter combined with the etiology, but the overall treatment effect is not ideal. Men with prostatic hyperplasia also need medication or surgery to reduce bladder outlet obstruction, with cystostomy, suprapubic catheterization, or urethral diversion as a last resort. Acupuncture is accepted by patients because of its simplicity, safety, and effectiveness, and clinical studies have shown that acupuncture can reduce urinary retention and improve patients' quality of life. This study aims to provide scientific basis for the treatment of neurogenic bladder dysfunction after spinal cord injury by acupuncture Ciliao（BL32）、Sanyinjiao（SP6）、Pangguangshu（BL28）and Zhonglvshu（BL29）. Objective: This paper aims to explore the effectiveness of acupuncture in treating neurogenic bladder dysfunction after spinal cord injury, and to provide more high-quality empirical evidence for the clinical application of acupuncture in treating neurogenic bladder dysfunction after spinal cord injury. Methods: The study design was a single-blind, multicenter, randomized controlled trial. A total of 136 patients aged 18~70 years old with neurogenic bladderurourinary retention after spinal cord injury were randomly divided into two groups: the experimental group (N=68) adopted the treatment plan based on acupuncture of the Ciliao（BL32）,Sanyinjiao（SP6）,Pangguangshu（BL28）and Zhonglvshu（BL29）,and the control group (N=68) used intermittent urination, manipulative assisted urination and arranged drinking water plan according to the guidelines for urinary management and clinical rehabilitation of patients with spinal cord injury. The trial cycle for both regimens was two weeks, five times a week. The trial results were divided into primary and secondary outcomes. The primary outcome was differences in urinary symptoms before and after treatment, as reported by participants in voiding records or self-report questionnaires, which included mean urine output per 24 hours, number of participants with urinary retention, and number of participants requiring catheterization. Secondary outcomes mainly included the following: (1) changes in urodynamic testing before and after treatment, such as residual urine volume after voiding, maximum bladder capacity and maximum urine flow velocity; (2) changes in quality of life questionnaires before and after treatment; (3) the efficacy rate of treatment; (4) Changes in clinical evaluation before and after treatment. Discussion: The results of this experiment are helpful to provide scientific clinical evidence for the clinical efficacy and feasibility of acupuncture in the treatment of neurogenic bladder urinary retention after spinal cord injury. Test registration: Chinese Clinical Trial Registry, ChiCTR2100051049. Registered on 20 October 2023, https://www.chictr.org.cn/bin/project/edit?pid=209451