Detailed Search Results
| Author/Association: | Page A-S, Borowski E, Bauters E, Housmans S, Van der Aa F, Deprest J |
| Title: | Vaginal erbium laser versus pelvic floor exercises for the treatment of pelvic organ prolapse: a randomised controlled trial [with consumer summary] |
| Source: | European Journal of Obstetrics, Gynecology, and Reproductive Biology 2024 Dec;303:165-170 |
| Method: | clinical trial |
| Method Score: | 8/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
| Consumer Summary: | HIGHLIGHTS: Vaginal laser therapy is non-inferior to physiotherapy in treating bothersome prolapse. The limited and short term treatment effect however, questions its use as it comes at a higher cost. After two years, the majority of patients sought additional, yet alternative treatments. There were no serious adverse events. |
| Abstract: | 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. Full text (sometimes free) may be available at these link(s):  help |
