Ann-Sophie Page, Eline Borowski, Emma Bauters, Susanne Housmans, Frank Van der Aa, Jan Deprest
{"title":"Vaginal Erbium Laser Versus Pelvic Floor Muscle Training for Stress Urinary Incontinence: A Randomised Controlled Trial.","authors":"Ann-Sophie Page, Eline Borowski, Emma Bauters, Susanne Housmans, Frank Van der Aa, Jan Deprest","doi":"10.1007/s00192-025-06091-4","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction and hypothesis: </strong>Current studies on vaginal laser therapy for the management of stress urinary incontinence (SUI) are inconclusive, and many lack comparison with another conservative treatment. Therefore, we compared the efficacy of Er:YAG laser for SUI with that of pelvic floor muscle training (PFMT).</p><p><strong>Methods: </strong>Single-centre, randomised controlled trial comparing laser treatment (3-6 applications) with PFMT (9-18 sessions) in women with mild to moderate SUI. Main outcome measures included subjective change in urinary incontinence symptoms by change from baseline to 4 months after randomisation by Urogenital Distress Inventory-6 (UDI-6; primary), adverse events, and other subjective and objective outcomes up to 24 months. A priori sample size calculation for a non-inferiority study resulted in 28 patients per arm. Because of a higher than expected dropout early in the study, we increased our sample size from 56 to 60, without unblinding of the data.</p><p><strong>Results: </strong>Sixty women were enrolled. Two participants discontinued their allocated treatment (one in each group). At 4 months, mean difference in change in UDI-6 scores was -6.99 (95% CI = -22.34; 8.37), demonstrating non-inferiority of laser to PFMT (p = 0.023). Within groups, most patients improved, yet subjective cure was reached in only a minority (laser: 11% [3 out of 28]; PFMT: 8% [2 out of 26]). The mean number of treatment visits was 4.25 (SD 1.17) in the laser group and 10.04 (SD 6.36) in the PFMT group. There were no subjective or objective inter-group differences. At 24 months, the majority of patients requested additional, yet alternative treatment. There were no serious adverse events at any time point.</p><p><strong>Conclusions: </strong>Treatment effect of vaginal laser and PFMT in patients with mild and moderate SUI were comparable, limited and short lasting. No adverse events were reported.</p>","PeriodicalId":14355,"journal":{"name":"International Urogynecology Journal","volume":" ","pages":""},"PeriodicalIF":1.8000,"publicationDate":"2025-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Urogynecology Journal","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s00192-025-06091-4","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"OBSTETRICS & GYNECOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Introduction and hypothesis: Current studies on vaginal laser therapy for the management of stress urinary incontinence (SUI) are inconclusive, and many lack comparison with another conservative treatment. Therefore, we compared the efficacy of Er:YAG laser for SUI with that of pelvic floor muscle training (PFMT).
Methods: Single-centre, randomised controlled trial comparing laser treatment (3-6 applications) with PFMT (9-18 sessions) in women with mild to moderate SUI. Main outcome measures included subjective change in urinary incontinence symptoms by change from baseline to 4 months after randomisation by Urogenital Distress Inventory-6 (UDI-6; primary), adverse events, and other subjective and objective outcomes up to 24 months. A priori sample size calculation for a non-inferiority study resulted in 28 patients per arm. Because of a higher than expected dropout early in the study, we increased our sample size from 56 to 60, without unblinding of the data.
Results: Sixty women were enrolled. Two participants discontinued their allocated treatment (one in each group). At 4 months, mean difference in change in UDI-6 scores was -6.99 (95% CI = -22.34; 8.37), demonstrating non-inferiority of laser to PFMT (p = 0.023). Within groups, most patients improved, yet subjective cure was reached in only a minority (laser: 11% [3 out of 28]; PFMT: 8% [2 out of 26]). The mean number of treatment visits was 4.25 (SD 1.17) in the laser group and 10.04 (SD 6.36) in the PFMT group. There were no subjective or objective inter-group differences. At 24 months, the majority of patients requested additional, yet alternative treatment. There were no serious adverse events at any time point.
Conclusions: Treatment effect of vaginal laser and PFMT in patients with mild and moderate SUI were comparable, limited and short lasting. No adverse events were reported.
期刊介绍:
The International Urogynecology Journal is the official journal of the International Urogynecological Association (IUGA).The International Urogynecology Journal has evolved in response to a perceived need amongst the clinicians, scientists, and researchers active in the field of urogynecology and pelvic floor disorders. Gynecologists, urologists, physiotherapists, nurses and basic scientists require regular means of communication within this field of pelvic floor dysfunction to express new ideas and research, and to review clinical practice in the diagnosis and treatment of women with disorders of the pelvic floor. This Journal has adopted the peer review process for all original contributions and will maintain high standards with regard to the research published therein. The clinical approach to urogynecology and pelvic floor disorders will be emphasized with each issue containing clinically relevant material that will be immediately applicable for clinical medicine. This publication covers all aspects of the field in an interdisciplinary fashion