{"title":"Clinical Outcomes and Measures for Vaginal Relaxation Syndrome: A Systematic Review.","authors":"Hongqin Chen, Jian Meng, Qiao Li, Yajing Wang, Yueyue Chen, Xiaoyu Niu, Dongmei Wei","doi":"10.1016/j.jval.2025.08.012","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>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).</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>A total of 74 studies (15 randomized controlled trials, 59 observational studies, and 4866 patients) reported 113 outcomes using 85 measurement tools. The most frequently used were patient-reported outcome measures (Female Sexual Function Index, Vaginal Laxity Questionnaire, VAS, and PISQ-12), followed by clinician-reported outcome measures (VHI and biopsy). Most follow-ups lasted under 6 months. Surgical treatments uniquely assessed recurrence, aesthetic satisfaction, and partners' sexual satisfaction, whereas nonsurgical approaches focused on overall efficacy, tolerability, and patients satisfaction with vaginal tightness.</p><p><strong>Conclusions: </strong>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 Core Outcome Set and Core Outcome Measurement Set, alongside standardized assessment time points, improving research consistency and evidence-based management of VRS.</p>","PeriodicalId":23508,"journal":{"name":"Value in Health","volume":" ","pages":""},"PeriodicalIF":6.0000,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Value in Health","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.jval.2025.08.012","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ECONOMICS","Score":null,"Total":0}
引用次数: 0
Abstract
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: A total of 74 studies (15 randomized controlled trials, 59 observational studies, and 4866 patients) reported 113 outcomes using 85 measurement tools. The most frequently used were patient-reported outcome measures (Female Sexual Function Index, Vaginal Laxity Questionnaire, VAS, and PISQ-12), followed by clinician-reported outcome measures (VHI and biopsy). Most follow-ups lasted under 6 months. Surgical treatments uniquely assessed recurrence, aesthetic satisfaction, and partners' sexual satisfaction, whereas nonsurgical 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 Core Outcome Set and Core Outcome Measurement Set, alongside standardized assessment time points, improving research consistency and evidence-based management of VRS.
目的：本研究系统地探讨了阴道松弛综合征（VRS）治疗的临床结果和措施的应用。它进一步分析和比较了VRS中不同干预措施的临床结果和措施的差异，重点是评估其普遍性和适用性。研究结果旨在为高质量临床试验的设计提供信息，并为制定核心结果集（COS）和核心结果测量集（COMS）提供基础。方法：系统检索PubMed、Embase、Web of Science和Cochrane数据库（截至2025年1月），确定VRS治疗的临床研究。两名研究人员独立筛选研究，提取数据，分析临床结果、测量工具和评估时间点。结果：74项研究（15项随机对照试验，59项观察性研究，4866例患者）使用85种测量工具报告了113项结果。最常用的是患者报告的结果测量（FSFI， VLQ， VAS, PISQ-12），其次是临床报告的结果测量（VHI，活检）。大多数随访持续不到6个月。手术治疗独特地评估复发率、审美满意度和性伴侣的性满意度，而非手术方法侧重于总体疗效、耐受性和患者对阴道紧绷度的满意度。结论：VRS的临床结果和措施过于复杂，尤其是PROs。未来的研究应侧重于通过开发高度可行、实用的prom来优化pro。德尔菲调查和专家共识可以建立全面的VRS特异性COS和COMS，以及标准化的评估时间点，提高VRS研究的一致性和循证管理。
期刊介绍：
Value in Health contains original research articles for pharmacoeconomics, health economics, and outcomes research (clinical, economic, and patient-reported outcomes/preference-based research), as well as conceptual and health policy articles that provide valuable information for health care decision-makers as well as the research community. As the official journal of ISPOR, Value in Health provides a forum for researchers, as well as health care decision-makers to translate outcomes research into health care decisions.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
