Electroacupuncture at the Four Abdominal and Sacral Acupoints for Urinary Retention after Spinal Cord Injury: Study Protocol for a Randomized Controlled Trial
Abstract Background:Urinary retention is a general and serious refractory complication after spinal cord injury (SCI). However, effective therapeutic approaches remain limited. Previous clinical and animal research have clarified that acupuncture could be beneficial to the recovery of bladder function, however, most of the previous trials are of low quality and high-quality studies are still necessary.Methods: Here, we conduct a study design and protocol of a randomized, blinded, controlled study to evaluate the efficacy and safety of electroacupuncture at the “Four Abdominal and Sacral Acupoints” for urinary retention after SCI. A total of 90 patients with residual urine above 300ml will be recruited in the trial and randomized into treatment group or control group. Patients in the treatment group will receive Electroacupuncture at the “Four Abdominal and Sacral Acupoints” combined with conventional treatment while patients in the control group will receive conventional treatment alone for 4 weeks. The primary outcomes are changes of residual urine volume at baseline, after the final treatment and 4 weeks after the final treatment. The secondary outcome measures will be the proportions of participants with residual urine decline≥50% and efficacy rate after 4 weeks’ treatment, as well as the proportion of patients with catheterization, Short-Form Health Survey Questionnaire (SF-36) and the incidence of symptomatic urinary tract infection at baseline, after the final treatment and 4 weeks after the final treatment. The safety will also be assessed by monitoring the incidence of adverse events and changes in vital signs during the study.Discussion:Results from this trial will significantly support the application of electroacupuncture in the recovery of bladder function after SCI. If found to be effective and safe, electroacupuncture will be a valuable complementary option for patients with urinary retention after SCI.Trial registration: Chinese Clinical Trial Registry: ChiCTR 1900022089. Registered on 24 March 2019, http://www.chictr.org.cn/showproj.aspx?proj=37161.