Department of Physical Medicine and Rehabilitation, UTHealth at Houston McGovern Medical School, Houston, Texas.
SCI Medicine, TIRR Memorial Hermann, Houston, Texas.
J Urol. 2024 Dec;212(6):800-810. doi: 10.1097/JU.0000000000004189. Epub 2024 Aug 2.
Our goal was to evaluate if self-administered bladder neuromodulation with transcutaneous tibial nerve stimulation could safely replace overactive bladder medications in people with spinal cord injury.
We performed a 3-month, randomized, investigator-blinded, tibial nerve stimulation vs sham-control trial in adults with spinal cord injury and neurogenic bladder performing intermittent catheterization and taking overactive bladder medications. The primary outcome was a reduction in bladder medications while maintaining stable bladder symptoms and quality of life based on pre/post Neurogenic Bladder Symptom Score and the Incontinence Quality of Life questionnaire, respectively. Secondary outcomes included changes in pre/post cystometrogram, 2-day voiding diaries, and an anticholinergic medication side effect survey.
Fifty people consented to the study, with 42 completing the trial. No dropouts were due to stimulation issues. All baseline demographics and surveys were comparable at baseline. Cystometrogram parameters were also comparable at baseline, except the stimulation group had a higher proportion of loss of bladder compliance compared to the control group. At the end of the trial, a significantly greater percentage of the tibial nerve stimulation group was able to reduce medications (95% vs 68%), by a 26.2% difference in medication reduction (95% CI 1.17%-51.2%). Function and quality of life surveys and cystometrograms at the end of the trial were alike between groups. Transcutaneous tibial nerve stimulation satisfaction surveys and adherence to protocol were high.
In people with chronic spinal cord injury performing intermittent catheterization, transcutaneous tibial nerve stimulation can be an option to reduce or replace overactive bladder medications.
Clinical Trial Registration No.: NCT03458871.
我们的目的是评估经皮胫神经刺激的自我管理膀胱神经调节是否可以安全地替代脊髓损伤患者的膀胱过度活动症药物。
我们进行了一项为期 3 个月的、随机的、研究者盲法的胫神经刺激与假刺激对照试验,纳入了接受间歇性导尿和膀胱过度活动症药物治疗的脊髓损伤和神经源性膀胱的成年人。主要结局是在保持稳定的膀胱症状和生活质量的前提下,减少膀胱药物的使用,分别基于神经源性膀胱症状评分和尿失禁生活质量问卷的前后变化来评估。次要结局包括尿动力学检查、2 天排尿日记和抗胆碱能药物副作用调查的变化。
共有 50 人同意参加研究,其中 42 人完成了试验。没有因刺激问题而退出的。所有基线人口统计学和调查在基线时均具有可比性。在基线时,尿动力学检查参数也具有可比性,除了刺激组的膀胱顺应性丧失比例高于对照组。在试验结束时,胫神经刺激组能够减少药物的比例明显更高(95% vs 68%),药物减少的差异为 26.2%(95%CI 1.17%-51.2%)。试验结束时的功能和生活质量调查以及尿动力学检查在组间相似。经皮胫神经刺激满意度调查和对方案的依从性均很高。
在接受间歇性导尿的慢性脊髓损伤患者中,经皮胫神经刺激可以作为减少或替代膀胱过度活动症药物的选择。
临床试验注册号:NCT03458871。