Rehabilitation Medicine Department, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, People's Republic of China.
Trials. 2023 Mar 17;24(1):199. doi: 10.1186/s13063-023-07207-1.
Neurogenic detrusor overactivity (NDO) is a serious and common complication after spinal cord injury, affecting patients' quality of life seriously. 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.
This study is a single-center, randomized, parallel-group clinical trial. 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 sample size is 66, with 33 patients in each group. The rFMS group will receive real rFMS treatment of the sacral nerve (100% stimulation intensity, 5 Hz, 20 min 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 education. The bladder compliance (bladder capacity/detrusor pressure) 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.
It is expected that the bladder function, symptoms, and quality of life might be significantly improved after rFMS of the sacral nerve.
The China Clinical Trials Registry has approved this study, registration number: ChiCTR2100045148. Registered on April 7, 2021.
神经源性逼尿肌过度活动（NDO）是脊髓损伤后的一种严重且常见的并发症，严重影响患者的生活质量。因此，我们制定了这项研究方案，以评估重复性功能磁刺激（rFMS）对骶神经治疗脊髓损伤（SCI）后 NDO 的疗效，并为 rFMS 治疗 SCI 后 NDO 提供更多选择。
这是一项单中心、随机、平行组临床试验。我们将于 2022 年 9 月至 2023 年 8 月在西南医科大学附属医院康复科招募 SCI 后 NDO 患者，将他们随机分配到 rFMS 组和假刺激组。样本量为 66 例，每组 33 例。rFMS 组将接受真实的骶神经 rFMS 治疗（刺激强度 100%，5Hz，每次 20 分钟，每周 5 次），假刺激组将接受假刺激。两组将接受类似的治疗策略，包括药物治疗、标准尿液管理、针刺治疗和健康教育。在基线、治疗第 8 周评估膀胱顺应性（膀胱容量/逼尿肌压力）和阴部神经肌电图。在 8 周的治疗过程中，每周记录一次膀胱残余量和膀胱日记。在基线、治疗第 4 周和第 8 周评估 SCI-QOL 和 NBSS。此外，在治疗结束后 8 周还将进行上述评估。
预计骶神经 rFMS 后膀胱功能、症状和生活质量可能会显著改善。
中国临床试验注册中心已批准该研究，注册号：ChiCTR2100045148。于 2021 年 4 月 7 日注册。
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