Effects of Repetitive Functional Magnetic Stimulation in the sacral nerve in patients with neurogenic detrusor overactivity after suprasacral spinal cord injury: a study protocol for a randomized controlled trial

Abstract

Abstract Background Neurogenic detrusor overactivity (NDO) is a serious and common complication after spinal cord injury, affecting patients' quality of life. Therefore we developed this research protocol to evaluate the efficacy of repetitive functional magnetic stimulation (rFMS) in the sacral nerve in patients with neurogenic detrusor overactivity (NDO) after suprasacral spinal cord injury (SCI) and provide more options for rFMS in treating NDO after suprasacral SCI. Methods This study is a single-center, randomized, parallel-group clinical trial. The sample size is 62, including 31 patients and 31 controls who will receive magnetic stimulation. We will recruit the patients with NDO after suprasacral SCI in the Rehabilitation Department of the Affiliated Hospital of Southwest Medical University from September 2022 to August 2023. They will be assigned to the rFMS group and the sham stimulation group randomly. The rFMS group will receive real rFMS treatment of the sacral nerve (100% stimulation intensity, 5 Hz, twenty minutes each time, five times a week), and the sham group will receive sham stimulation. Both groups will receive similar treatment strategies, including medication, standard urine management, acupuncture treatment, and health evangelism. The bladder capacity, maximum detrusor pressure (Pdet) and pudendal nerve electromyography will be evaluated at baseline, 8th week of treatment. The residual volume of the bladder and bladder diary will be recorded once a week during 8 weeks of treatments. SCI-QOL and NBSS will be evaluated at baseline, the 4th and 8th week of treatment. In addition, the above assessments will be followed up at 8 weeks after the end of treatment. Discussion It is expected that the bladder function, symptoms and quality of life might be significantly improved after rFMS of the sacral nerve. Trial registration: The China Clinical Trials Registry has approved this study, registration number: ChiCTR2100045148.