Lima Salvador V C, Vilar Fábio O, Lustosa Eugênio S, Aragão Daniel C C, Calisto Fernanda C F S, Pinto Flávia C M
Department of Surgery, Center for Health Sciences, Federal University of Pernambuco, UFPE, Brazil.
Graduate Medical School, Federal University of Pernambuco, UFPE, Brazil.
J Pediatr Urol. 2017 Oct;13(5):453.e1-453.e6. doi: 10.1016/j.jpurol.2016.12.030. Epub 2017 Feb 16.
Urinary incontinence (UI) is a challenging problem for the urological community. Clean intermittent catheterization (CIC) is the most commonly used method to restore bladder emptying to the state close to the physiological condition. This procedure can cause negative aspects such as pain and possible urethral injury. In addition, there is a negative impact on self-image and decline in quality of patient's life. The aim of the present study was to evaluate the safety and efficacy of a new intraurethral self-retaining device (ISRD), in female children and adolescents, as an attractive alternative to CIC.
A prospective clinical pilot study was performed, in a single-institution, including female children and adolescent patients with urinary incontinence secondary to myelomeningocele who were already in an intermittent bladder catheterization program. Assessments included the use of a visual analogue scale in diagnosis of UI, reported adverse events, and the King's Health Questionnaire (KHQ) to evaluate quality of life, which was answered by patients and the caregivers of younger patients before and 6 months after enrolment.
The device was efficient and well tolerated by most patients (84%). The ISRD significantly improved quality of life in children and adolescents (p<0.0001 for both) (Table). The safe insertion and removal of the ISRD can be considered an advantage compared with CIC as eventual urethral trauma is significantly minimized. It was found that one of the main advantages of the ISRD is the possibility of management as an outpatient procedure both for initial insertion and replacement. The autonomy of patients to perform the bladder emptying process by themselves indicates the importance of this study, especially for school life and social interaction. ISRD use showed a tendency to improve the QoL.
This new bladder-draining device (ISRD) was effective and secure in terms of insertion technique, and improved QoL of patients with urinary retention and incontinence, according to domains evaluated in the KHQ.
尿失禁（UI）是泌尿外科领域一个具有挑战性的问题。清洁间歇性导尿（CIC）是恢复膀胱排空至接近生理状态最常用的方法。该操作可能会带来一些负面影响，如疼痛和可能的尿道损伤。此外，对自我形象有负面影响，患者生活质量下降。本研究的目的是评估一种新型尿道内自固定装置（ISRD）在女童和青少年中的安全性和有效性，作为CIC的一种有吸引力的替代方法。
在单一机构进行了一项前瞻性临床试点研究，纳入因脊髓脊膜膨出继发尿失禁且已在进行间歇性膀胱导尿计划的女童和青少年患者。评估包括使用视觉模拟量表诊断UI、报告的不良事件，以及使用国王健康问卷（KHQ）评估生活质量，该问卷由患者及低龄患者的护理人员在入组前和入组后6个月回答。
该装置效果良好，大多数患者（84%）耐受性良好。ISRD显著改善了儿童和青少年的生活质量（两者p均<0.0001）（表）。与CIC相比，ISRD安全的插入和取出可视为一个优势，因为最终的尿道创伤显著减少。发现ISRD的一个主要优势是初始插入和更换均可作为门诊手术进行处理。患者自行进行膀胱排空过程的自主性表明了本研究的重要性，尤其是对学校生活和社交互动而言。使用ISRD显示出改善生活质量的趋势。
根据KHQ评估的领域，这种新型膀胱引流装置（ISRD）在插入技术方面有效且安全，改善了尿潴留和尿失禁患者的生活质量。
