Noninvasive spinal neuromodulation mitigates symptoms of idiopathic overactive bladder.

Hui Zhong, Emilie Liu, Priya Kohli, Laura Perez, V Reggie Edgerton, David Ginsberg, Parag Gad, Evgeniy Kreydin
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Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusion: SCONE™ therapy represents the first of its kind therapy to treat symptoms of urgency, frequency and urge urinary incontinence in patients with OAB.

Trial registration: The study was listed on clinicaltrials.gov ( NCT03753750 ).

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无创脊神经调节减轻特发性膀胱过动症的症状。
背景:膀胱过动症(OAB)影响了世界上12%到30%的人口。伴随的尿急、尿频和尿失禁会对生活质量产生深远影响,导致抑郁、社会孤立、避免性活动和丧失生产力。保守措施,如生活方式的改变和盆底物理治疗是治疗膀胱过度活动的第一线。这些治疗失败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。药物虽然有效,但有副作用,而且依从性差。神经调节和肉毒杆菌毒素注射也是有效的,但对一些患者来说是侵入性的,不能接受。方法:我们开发了一种新的经皮脊髓神经调节剂(SCONE™),它可以在不需要插入或植入刺激电极的情况下向脊髓提供多频电刺激。以前,多次经皮刺激已被证明能穿透脊髓并导致逼尿肌和尿道外括约肌的运动激活。在这里,我们报告了8例特发性膀胱过动症患者,他们接受了12周的SCONE™治疗。结果:所有患者均报告尿急、尿频、急迫性尿失禁等膀胱过动症的多种症状有统计学意义的临床改善。此外,通过有效的临床调查,患者报告了显著的症状改善。结论:SCONE™疗法是首个治疗OAB患者急迫性、尿频性和急迫性尿失禁症状的同类疗法。试验注册:该研究已在clinicaltrials.gov (NCT03753750)上列出。
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CiteScore
6.90
自引率
0.00%
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0
审稿时长
8 weeks
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