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 tri...
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| Format: | Article |
| Language: | English |
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Korean Continence Society
2023-05-01
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| Series: | International Neurourology Journal |
| Subjects: | |
| Online Access: | http://einj.org/upload/pdf/inj-2346092-046.pdf |
| _version_ | 1797809938934792192 |
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| author | Chung Lyul Lee Jong Mok Park Ji Yong Lee Seung Woo Yang Hyun Seok Na Jaegeun Lee Sunkyung Jung Ju Hyun Shin |
| author_facet | Chung Lyul Lee Jong Mok Park Ji Yong Lee Seung Woo Yang Hyun Seok Na Jaegeun Lee Sunkyung Jung Ju Hyun Shin |
| author_sort | Chung Lyul Lee |
| collection | DOAJ |
| 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). |
| first_indexed | 2024-03-13T07:00:29Z |
| format | Article |
| id | doaj.art-c9f5c54efdc74babafe412c65be0d13c |
| institution | Directory Open Access Journal |
| issn | 2093-4777 2093-6931 |
| language | English |
| last_indexed | 2024-03-13T07:00:29Z |
| publishDate | 2023-05-01 |
| publisher | Korean Continence Society |
| record_format | Article |
| series | International Neurourology Journal |
| spelling | doaj.art-c9f5c54efdc74babafe412c65be0d13c2023-06-07T04:12:55ZengKorean Continence SocietyInternational Neurourology Journal2093-47772093-69312023-05-0127Suppl 1S404810.5213/inj.2346092.0461054A Novel Incisionless Disposable Vaginal Device for Female Stress Urinary Incontinence: Efficacy and Quality of LifeChung Lyul Lee0Jong Mok Park1Ji Yong Lee2Seung Woo Yang3Hyun Seok Na4Jaegeun Lee5Sunkyung Jung6Ju Hyun Shin7 Department of Urology, Chungnam National University Hospital, Daejeon, Korea Department of Urology, Chungnam National University Sejong Hospital, Sejong, Korea Department of Urology, Chungnam National University Hospital, Daejeon, Korea Department of Urology, Chungnam National University Hospital, Daejeon, Korea Department of Urology, Chungnam National University Hospital, Daejeon, Korea Department of Urology, Chungnam National University Hospital, Daejeon, Korea Department of Urology, Chungnam National University Sejong Hospital, Sejong, Korea Department of Urology, Chungnam National University Hospital, Daejeon, KoreaPurpose 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).http://einj.org/upload/pdf/inj-2346092-046.pdfurinary incontinence, stresspessariesmidurethra |
| spellingShingle | Chung Lyul Lee Jong Mok Park Ji Yong Lee Seung Woo Yang Hyun Seok Na Jaegeun Lee Sunkyung Jung Ju Hyun Shin A Novel Incisionless Disposable Vaginal Device for Female Stress Urinary Incontinence: Efficacy and Quality of Life International Neurourology Journal urinary incontinence, stress pessaries midurethra |
| 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 | urinary incontinence, stress pessaries midurethra |
| url | http://einj.org/upload/pdf/inj-2346092-046.pdf |
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