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

Abstract

Purpose: This clinical study sought to evaluate the possible clinical effectiveness and practicality of URINO, an innovative, incisionless, 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 pessaries could potentially be an alternative treatment for patients with stress urinary incontinence who are seeking nonsurgical options or are unable to undergo surgery.Trial Registration: The study was registered as a clinical trial (KCT0008369).

Emerging Trends in Artificial Intelligence-Based Urological Imaging Technologies and Practical Applications

“…Furthermore, with the integration of artificial intelligence (AI) into medical imaging, its importance is on the rise [ 2 - 4 ]. In the field of urology, AI provides a wide range of applications from precise diagnosis achieved through image segmentation and anomaly detection, to procedures such as biopsies and surgical interventions where assisted navigation and robotic guidance tools are employed.…”

Dynamics in Neurourology

“…In this issue, we present three papers focusing on medical device advancements. First, Lee et al [ 1 ] investigated the effectiveness of a new, non-invasive disposable vaginal device for female stress urinary incontinence and its impact on quality of life. By assessing the efficiency of this innovative device, the authors were able to report on its clinical efficacy and practical feasibility.…”