Sahu Samantak, Venkataraman Srikumar, Chanu Asem Rangita, Singh U
Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.
Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, New Delhi, India.
J Spinal Cord Med. 2025 Jul;48(4):621-628. doi: 10.1080/10790268.2024.2370099. Epub 2024 Jul 3.
This study is a randomized, investigator-blinded, controlled trial with a non-inferiority design.
To investigate the effectiveness of neuromodulation by transcutaneous electrical stimulation of the somatic afferent nerves of the foot in neurogenic detrusor overactivity (NDO) in persons with spinal cord injury (SCI) and compare its effectiveness with oral oxybutynin.
The study was conducted in a rehabilitation in-patient ward of a tertiary care hospital.
Twenty-nine persons with SCI with NDO, either sex, aged 18 years and above were randomized into two groups, one group receiving oral oxybutynin (5 mg thrice a day for two weeks) and the other transcutaneous electrical stimulation (5 Hz, 200 µs pulse, biphasic, amplitude up to 60 mA, 30 min/day for two weeks). Bladder capacity was evaluated by clinical bladder evaluation (i.e. bladder capacity measured by adding leak volume, voiding volume if any, and post-void residue using a catheter) and cystometric bladder capacity by one-channel cystometry. Maximum cystometric pressure was evaluated by one-channel water cystometry. Data were analyzed with Fisher's Exact, t-test, and Wilcoxon rank sum tests.
Bladder capacity improved significantly in the oxybutynin and neuromodulation groups as measured by one-channel water cystometry (136 ml vs. 120.57 ml) and clinical evaluation (138.93 ml vs. 112 ml). The increase in the neuromodulation group achieved the pre-decided non-inferiority margin of 30 ml over the oxybutynin group when measured by one-channel water cystometry but not by clinical evaluation. Maximum cystometric pressure did not significantly improve in either group when compared with the baseline.
Transcutaneous neuromodulation and oxybutynin effectively increased bladder capacity in persons with SCI with NDO. Neuromodulation by once-a-day transcutaneous electrical stimulation was non-inferior to thrice-a-day oxybutynin when evaluated by one-channel water cystometry. Clinical Trials Registry India identifier: CTRI/2018/05/013735.
本研究为一项采用非劣效性设计的随机、研究者设盲的对照试验。
探讨经皮电刺激足部躯体传入神经进行神经调节对脊髓损伤（SCI）患者神经源性逼尿肌过度活动（NDO）的有效性，并将其有效性与口服奥昔布宁进行比较。
本研究在一家三级护理医院的康复住院病房进行。
29例患有NDO的SCI患者，年龄18岁及以上，性别不限，被随机分为两组，一组接受口服奥昔布宁（5mg，每日三次，共两周），另一组接受经皮电刺激（5Hz，200μs脉冲，双相，振幅高达60mA，每天30分钟，共两周）。通过临床膀胱评估（即通过添加漏尿量、排尿量（如有）和使用导尿管测量的残余尿量来测量膀胱容量）和单通道膀胱测压法评估膀胱容量。通过单通道水膀胱测压法评估最大膀胱测压压力。数据采用Fisher精确检验、t检验和Wilcoxon秩和检验进行分析。
通过单通道水膀胱测压法（136ml对120.57ml）和临床评估（138.93ml对112ml）测量，奥昔布宁组和神经调节组的膀胱容量均有显著改善。通过单通道水膀胱测压法测量时，神经调节组的增加量达到了预先确定的比奥昔布宁组高30ml的非劣效性界值，但通过临床评估未达到。与基线相比，两组的最大膀胱测压压力均未显著改善。
经皮神经调节和奥昔布宁可有效增加患有NDO的SCI患者的膀胱容量。通过单通道水膀胱测压法评估时，每日一次经皮电刺激进行的神经调节不劣于每日三次口服奥昔布宁。印度临床试验注册标识符：CTRI/2018/05/013735。
