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논문 기본 정보

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학술저널
저자정보
이충렬 (충남대학교병원 비뇨의학과) 박종목 (충남대학교병원) 이지용 (충남대학교) 양승우 (충남대학교) 나현석 (충남대학교병원 비뇨의학과) 이재근 (충남대학교병원 비뇨의학과) 정선경 (충남대학교세종병원 비뇨의학과) 신주현 (충남대학교)
저널정보
대한배뇨장애요실금학회 International Neurourology Journal International Neurourology Journal 제27권
발행연도
2023.5
수록면
40 - 48 (9page)
DOI
10.5213/inj.2346092.046

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Purpose: This clinical study sought to evaluate the possible clinical effectiveness and practicality of URINO, an innovative, in cisionless, and disposable intravaginal device, designed for patients suffering from stress urinary incontinence. Methods: A prospective, multicenter, single-arm clinical trial was carried out, involving women diagnosed with stress urinary incontinence who used a self-inserted, disposable intravaginal pessary device. Comparisons were made between the results of the 20-minute pad-weight gain (PWG) test at baseline and visit 3, where the device was applied. After 1 week of device usage, compliance, satisfaction, the sensation of a foreign body, and adverse events were assessed. Results: Out of 45 participants, 39 completed the trial and expressed satisfaction within the modified intention-to-treat group. The average 20-minute PWG of participants was 17.2±33.6 g at baseline and significantly dropped to 5.3±16.2 g at visit 3 with device application. A total of 87.2% of participants exhibited a reduction ratio of PWG by 50% or more, surpassing the clinical trial success benchmark of 76%. The mean compliance was recorded as 76.6%±26.6%, the average visual analogue scale score for patient satisfaction was 6.4±2.6, and the sensation of a foreign body, measured on a 5-point Likert scale, was 3.1±1.2 after 1 week of device use. No serious adverse events were reported; there was 1 instance of microscopic hematuria and 2 cases of pyuria, all of which recovered. Conclusions: The investigated device demonstrated significant clinical effectiveness and safety for patients with stress urinary incontinence. It was easy to use, showing favorable patient compliance. We propose that these disposable intravaginal pessa ries could potentially be an alternative treatment for patients with stress urinary incontinence who are seeking nonsurgical op tions or are unable to undergo surgery. Trial Registration: The study was registered as a clinical trial (KCT0008369).

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