European journal of obstetrics, gynecology, and reproductive biology · 2024
Vaginal erbium laser versus pelvic floor exercises for the treatment of pelvic organ prolapse: A randomised controlled trial.
СтатьяРандомизированное исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Page Ann-Sophie, Borowski Eline, Bauters Emma, Housmans Susanne, Van der Aa Frank, Deprest Jan
Аннотация
OBJECTIVES: To compare the efficacy of Er:YAG laser for mild to moderate pelvic organ prolapse (POP) to that of pelvic floor exercises (PFE).
DESIGN: Single center randomised controlled trial.
SETTING: Tertiary center, Belgium.
PARTICIPANTS: Forty-six women with mild to moderate prolapse were enrolled (23 in each group). There were no missing data for the primary outcome; three patients were lost to follow-up at 24-months.
INTERVENTIONS: Comparison of vaginal laser treatment (3-6 applications) to PFE (9-18 sessions).
MAIN OUTCOME MEASURES: Subjective change in prolapse symptoms at four months from baseline measured by the Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6) (primary), adverse events, other subjective outcomes and independent anatomical assessment up to 24 months.
RESULTS: The mean difference in POPDI-6 scores at 4 months was 1.09 (95 %CI = -6.02;8.12), showing non-inferiority of laser to PFE (p = 0.004). Within groups, the difference in mean POPDI-6 four months following the start of therapy tended to be lower for laser-treatment (65.2 % (15/23) of laser-participants were 'better' or 'much better') than for PFE (60.9 % (14/23) in the PFE group), yet without difference between groups (OR = 1.21; 95 %CI = 0.39-3.23). There were no obvious between group differences in any other subjective nor objective outcomes. At 24 months, 50 % (11/22) of laser-patients and 43 % (9/21) of PFE-patients requested additional, yet alternative treatment. There were no serious adverse events at any time-point.
CONCLUSIONS: Vaginal laser application and PFE improve symptoms of mild and moderate prolapse to a similar extent. Both treatments had a measurable yet not durable effect. There were no adverse events in either arm.
TRIAL REGISTRATION: ClinicalTrials.gov(NCT04523298).
FUNDING: The laser device was provided by Fotona, Slovenia for the duration of this trial.
DESIGN: Single center randomised controlled trial.
SETTING: Tertiary center, Belgium.
PARTICIPANTS: Forty-six women with mild to moderate prolapse were enrolled (23 in each group). There were no missing data for the primary outcome; three patients were lost to follow-up at 24-months.
INTERVENTIONS: Comparison of vaginal laser treatment (3-6 applications) to PFE (9-18 sessions).
MAIN OUTCOME MEASURES: Subjective change in prolapse symptoms at four months from baseline measured by the Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6) (primary), adverse events, other subjective outcomes and independent anatomical assessment up to 24 months.
RESULTS: The mean difference in POPDI-6 scores at 4 months was 1.09 (95 %CI = -6.02;8.12), showing non-inferiority of laser to PFE (p = 0.004). Within groups, the difference in mean POPDI-6 four months following the start of therapy tended to be lower for laser-treatment (65.2 % (15/23) of laser-participants were 'better' or 'much better') than for PFE (60.9 % (14/23) in the PFE group), yet without difference between groups (OR = 1.21; 95 %CI = 0.39-3.23). There were no obvious between group differences in any other subjective nor objective outcomes. At 24 months, 50 % (11/22) of laser-patients and 43 % (9/21) of PFE-patients requested additional, yet alternative treatment. There were no serious adverse events at any time-point.
CONCLUSIONS: Vaginal laser application and PFE improve symptoms of mild and moderate prolapse to a similar extent. Both treatments had a measurable yet not durable effect. There were no adverse events in either arm.
TRIAL REGISTRATION: ClinicalTrials.gov(NCT04523298).
FUNDING: The laser device was provided by Fotona, Slovenia for the duration of this trial.