Treatment of women with vaginal laxity: systematic review with meta-analysis.

Abstract

Background: Despite several treatments that have been used for women reporting vaginal laxity (VL), to our knowledge no systematic review is available on the topic so far.

Aim: In this study, we sought to summarize the best available evidence about the efficacy and safety of interventions for treating VL, whether conservative or surgical.

Methods: A comprehensive search strategy was performed in Medline, Embase, Scopus, Web of Science, and Cochrane Library for reports of clinical trials published from database inception to September 2022. Studies selected for inclusion were in the English language and were performed to investigate any type of treatment for VL, with or without a comparator, whether nonrandomized studies or randomized controlled trials (RCTs). Case reports and studies without a clear definition of VL were excluded.

Outcomes: The outcomes were interventions (laser, radiofrequency, surgery, and topical treatment), adverse effects, sexual function, pelvic floor muscle (PFM) strength, and improvement of VL by the VL questionnaire (VLQ).

Results: From 816 records, 38 studies remained in the final analysis. Laser and radiofrequency (RF) were the energy-based treatment devices most frequently studied. Pooled data from eight observational studies have shown improved sexual function assessed by a Female Sexual Function Index score mean difference (MD) of 6.51 (95% CI, 5.61-7.42; i2 = 85%, P < .01) before and after intervention, whether by RF (MD, 6.00; 95% CI, 4.26-7.73; i2 = 80%; P < .001) or laser (MD, 6.83; 95% CI, 5.01-8.65; i2 = 92%; P < .01). However, this finding was not shown when only 3 RCTs were included, even when separated by type of intervention (RF or laser). When RF treatment was compared to sham controls, VLQ scores did not improve (MD, 1.01; 95% CI, -0.38 to 2.40; i2 = 94%; P < .001). Patient PFM strength improved after interventions were performed (MD, 4.22; 95% CI, 1.02-7.42; i2 = 77%; P < .001). The ROBINS-I (Risk Of Bias In Nonrandomized Studies of Interventions) tool classified all non-RCTs at serious risk of bias, except for 1 study, and the risk of bias-1 analysis found a low and unclear risk of bias for all RCTs. The GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) certainty of the evidence was moderate for sexual function and the VLQ questionnaire and low for PFM strength.

Clinical implications: Sexual function in women with VL who underwent RF and laser treatment improved in observational studies but not in RCTs. Improvement in PFM strength was observed in women with VL after the intervention.

Strengths and limitations: Crucial issues were raised for the understanding of VL, such as lack of standardization of the definition and for the development of future prospective studies. A limitation of the study was that the heterogeneity of the interventions and different follow-up periods did not make it possible to pool all available data.

Conclusions: Vaginal tightening did not improve sensation in women with VL after intervention, whereas RF and laser improved sexual function in women with VL according to data from observational studies, but not from RCTs. PFM strength was improved after intervention in women with VL.