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Vaginal erbium laser versus pelvic floor exercises for the treatment of pelvic organ prolapse: a randomised controlled trial [with consumer summary]
Page A-S, Borowski E, Bauters E, Housmans S, Van der Aa F, Deprest J
European Journal of Obstetrics, Gynecology, and Reproductive Biology 2024 Dec;303:165-170
clinical trial
This trial has not yet been rated.

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 to 6 applications) to PFE (9 to 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 to 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 to 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.
With permission from Excerpta Medica Inc.

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