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

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 t...

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Autores principales: Lee, Chung Lyul, Park, Jong Mok, Lee, Ji Yong, Yang, Seung Woo, Na, Hyun Seok, Lee, Jaegeun, Jung, Sunkyung, Shin, Ju Hyun
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Korean Continence Society 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10263161/
https://www.ncbi.nlm.nih.gov/pubmed/37280759
http://dx.doi.org/10.5213/inj.2346092.046
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author Lee, Chung Lyul
Park, Jong Mok
Lee, Ji Yong
Yang, Seung Woo
Na, Hyun Seok
Lee, Jaegeun
Jung, Sunkyung
Shin, Ju Hyun
author_facet Lee, Chung Lyul
Park, Jong Mok
Lee, Ji Yong
Yang, Seung Woo
Na, Hyun Seok
Lee, Jaegeun
Jung, Sunkyung
Shin, Ju Hyun
author_sort Lee, Chung Lyul
collection PubMed
description 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).
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spelling pubmed-102631612023-06-15 A Novel Incisionless Disposable Vaginal Device for Female Stress Urinary Incontinence: Efficacy and Quality of Life Lee, Chung Lyul Park, Jong Mok Lee, Ji Yong Yang, Seung Woo Na, Hyun Seok Lee, Jaegeun Jung, Sunkyung Shin, Ju Hyun Int Neurourol J Original Article 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). Korean Continence Society 2023-05 2023-05-31 /pmc/articles/PMC10263161/ /pubmed/37280759 http://dx.doi.org/10.5213/inj.2346092.046 Text en Copyright © 2023 Korean Continence Society https://creativecommons.org/licenses/by-nc/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) ) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Article
Lee, Chung Lyul
Park, Jong Mok
Lee, Ji Yong
Yang, Seung Woo
Na, Hyun Seok
Lee, Jaegeun
Jung, Sunkyung
Shin, Ju Hyun
A Novel Incisionless Disposable Vaginal Device for Female Stress Urinary Incontinence: Efficacy and Quality of Life
title A Novel Incisionless Disposable Vaginal Device for Female Stress Urinary Incontinence: Efficacy and Quality of Life
title_full A Novel Incisionless Disposable Vaginal Device for Female Stress Urinary Incontinence: Efficacy and Quality of Life
title_fullStr A Novel Incisionless Disposable Vaginal Device for Female Stress Urinary Incontinence: Efficacy and Quality of Life
title_full_unstemmed A Novel Incisionless Disposable Vaginal Device for Female Stress Urinary Incontinence: Efficacy and Quality of Life
title_short A Novel Incisionless Disposable Vaginal Device for Female Stress Urinary Incontinence: Efficacy and Quality of Life
title_sort novel incisionless disposable vaginal device for female stress urinary incontinence: efficacy and quality of life
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10263161/
https://www.ncbi.nlm.nih.gov/pubmed/37280759
http://dx.doi.org/10.5213/inj.2346092.046
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