A Novel Incisionless Disposable Vaginal Device for Female Stress Urinary Incontinence: Efficacy and Quality of Life

• DOI: 10.5213/inj.2346092.046
• Publication Date: 2023-05-29T21:12:35Z
• Authors: Chung Lyul Lee; Jong Mok Park; Ji Yong Lee; Seung Woo Yang; Hyun Seok Na; Jaegeun Lee; Sunkyung Jung; Ju Hyun Shin
• Keywords: midurethra; pessaries; Original Article; RC870-923; 16. Peace & justice; urinary incontinence, stress; Diseases of the genitourinary system. Urology; 3. Good health

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