Vaginal erbium laser versus pelvic floor exercises for the treatment of pelvic organ prolapse: A randomised controlled trial

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 (3–6 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.