Clinical Outcomes and Measures for Vaginal Relaxation Syndrome: A Systematic Review.

Objectives: This study systematically investigates the application of clinical outcomes and measures reported in the management of Vaginal Relaxation Syndrome (VRS). It further analyzes and compares variations in clinical outcomes and measures across different interventions in VRS, with a focus on assessing their generalizability and applicability. The findings aim to inform the design of high-quality clinical trials and provide a foundation for developing a Core Outcome Set (COS) and a Core Outcome Measurement Set (COMS).

Methods: A systematic search of PubMed, Embase, Web of Science, and Cochrane databases (up to January 2025) identified clinical studies on VRS treatment. Two researchers independently screened studies, extracted data, and analyzed clinical outcomes, measurement tools, and assessment time points.

Results: Seventy-four studies (15 randomized controlled trials, 59 observational studies, 4866 patients) reported 113 outcomes using 85 measurement tools. The most frequently used were patient-reported outcome measures (FSFI, VLQ, VAS, PISQ-12), followed by clinician-reported outcome measures (VHI, biopsy). Most follow-ups lasted under six months. Surgical treatments uniquely assessed recurrence, aesthetic satisfaction, and partners' sexual satisfaction, while non-surgical approaches focused on overall efficacy, tolerability, and patients satisfaction with vaginal tightness.

Conclusions: Clinical outcomes and measures for VRS are overly complex, particularly PROs. Future research should focus on optimizing PROs by developing highly feasible, practical PROMs. Delphi surveys and expert consensus could establish a comprehensive VRS-specific COS and COMS, alongside standardized assessment time points, improving research consistency and evidence-based management of VRS.