Zhong Hui, Liu Emilie, Kohli Priya, Perez Laura, Edgerton V Reggie, Ginsberg David, Gad Parag, Kreydin Evgeniy
Department of Neurobiology, University of California, Los Angeles, CA, 90095, USA.
Rancho Research Institute, Rancho Los Amigos National Rehabilitation Center, Downey, CA, 90242, USA.
Bioelectron Med. 2022 Mar 23;8(1):5. doi: 10.1186/s42234-022-00087-x.
Overactive bladder (OAB) affects 12 to 30% of the world's population. The accompanying urinary urgency, frequency and incontinence can have a profound effect on quality of life, leading to depression, social isolation, avoidance of sexual activity and loss of productivity. Conservative measures such as lifestyle modification and pelvic floor physical therapy are the first line of treatment for overactive bladder. Patients who fail these may go on to take medications, undergo neuromodulation or receive injection of botulinum toxin into the bladder wall. While effective, medications have side effects and suffer from poor adherence. Neuromodulation and botulinum toxin injection are also effective but are invasive and not acceptable to some patients.
We have developed a novel transcutaneous spinal cord neuromodulator (SCONE™) that delivers multifrequency electrical stimulation to the spinal cord without the need for insertion or implantation of stimulating electrodes. Previously, multifrequency transcutaneous stimulation has been demonstrated to penetrate to the spinal cord and lead to motor activation of detrusor and external urethral sphincter muscles. Here, we report on eight patients with idiopathic overactive bladder, who underwent 12 weeks of SCONE™ therapy.
All patients reported statistically significant clinical improvement in multiple symptoms of overactive bladder, such as urinary urgency, frequency and urge incontinence. In addition, patients reported significant symptomatic improvements as captured by validated clinical surveys.
SCONE™ therapy represents the first of its kind therapy to treat symptoms of urgency, frequency and urge urinary incontinence in patients with OAB.
The study was listed on clinicaltrials.gov ( NCT03753750 ).
膀胱过度活动症(OAB)影响着全球12%至30%的人口。随之而来的尿急、尿频和尿失禁会对生活质量产生深远影响,导致抑郁、社交孤立、回避性行为以及生产力下降。诸如生活方式改变和盆底物理治疗等保守措施是膀胱过度活动症的一线治疗方法。未能通过这些方法治疗的患者可能会继续服用药物、接受神经调节或向膀胱壁注射肉毒杆菌毒素。虽然这些方法有效,但药物有副作用且依从性差。神经调节和肉毒杆菌毒素注射也有效,但具有侵入性,一些患者难以接受。
我们开发了一种新型经皮脊髓神经调制器(SCONE™),它无需插入或植入刺激电极即可向脊髓传递多频电刺激。此前,多频经皮刺激已被证明可穿透至脊髓并导致逼尿肌和尿道外括约肌的运动激活。在此,我们报告了8例特发性膀胱过度活动症患者,他们接受了为期12周的SCONE™治疗。
所有患者均报告膀胱过度活动症的多种症状在统计学上有显著临床改善,如尿急、尿频和急迫性尿失禁。此外,患者报告经有效临床调查显示有显著的症状改善。
SCONE™治疗是首例用于治疗膀胱过度活动症患者尿急、尿频和急迫性尿失禁症状的治疗方法。
该研究已在clinicaltrials.gov上登记(NCT03753750)。