Patient-reported outcomes and measures for vaginal relaxation syndrome management: a systematic review

Background
The heterogeneity of patient-reported outcomes (PROs) and patient-reported outcome measures (PROMs) in published clinical studies on vaginal relaxation syndrome (VRS) hinders cross-study comparisons and integration of evidence-based findings, impeding the development of robust clinical evidence.

Objective
To comprehensively investigate the current use of PROs and PROMs in VRS research, compile a comprehensive catalog, and provide guidance for selecting outcome measures and tools VRS patients.

Methods
This study systematically searched clinical studies on VRS treatment published up to December 2024 in PUBMED, EMBASE, Web of Science, and Cochrane databases, focusing primarily on pelvic floor muscle training, physical energy therapies, and surgical interventions. PROs and PROMs were extracted, organized into a structured catalog, and categorized by thematic domains. The COSMIN checklist was applied to assess the measurement properties of commonly used PROMs.

Results
A total of 69 studies were included, comprising 14 randomized controlled trials (1193 patients) and 55 observational studies (3327 patients), totaling 4520 participants. These studies reported 68 PROs and 57 PROMs. The most commonly used PROMs were the Female Sexual Function Index (FSFI, 47.83%), Vaginal Laxity Questionnaire (VLQ), Visual Analog Scale (VAS), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), and Sexual Satisfaction Questionnaire (SSQ). Notably, 42 PROMs (73.68%) appeared only once.

Conclusions
PROs for surgical and non-surgical VRS treatments are similar, but non-surgical interventions include additional outcomes, such as overall efficacy and patient’s vaginal tightness satisfaction. The high proportion of unvalidated PROMs (81.09%) underscores the need for standardized, disease-specific measures. Future Delphi surveys and expert consensus are anticipated to facilitate the development of a comprehensive core outcome set (COS) and core outcome measurement set (COMS) for VRS.

Contributors

Hongqin Chen, Jian Meng, Qiao Li, Xin Luo, Yajing Wang, Yueyue Chen, Xiaoyu Niu, Dongmei Wei

Publication

Journal: Health and Quality of Life Outcomes
Volume: 23
Issue:
Pages: -
Year: 2025
DOI: https://doi.org/10.1186/s12955-025-02432-5

Further Study Information

Current Stage: Completed
Date:
Funding source(s): This study was supported by the National Key Research and Development Program of China (No. 2022YFC2704600, 2022YFC2704604, 2021YFC2009100), Sichuan University (No. 21H0103), Science & Technology Department of Sichuan Province (No. 2019YFS0008), the Sichuan Provincial Health Commission Project (No. 21ZD002), Research Projects of Sichuan Science and Technology Department (No. 2023YFQ0070, No. 2023YFS0024), Key Research Projects of Sichuan Science and Technology Department (No. 2023YFG0128, No. 2023NSFSC1606, No. 23ZDYF2049).

Health Area

Disease Category: Gynaecology

Disease Name: Pelvic floor disorders, Vaginal relaxation syndrome (VRS)

Target Population

Age Range: Unknown

Sex: Female

Nature of Intervention: Non-surgical, Physical, Surgery

Stakeholders Involved

Study Type

- Systematic review of outcome measures/measurement instruments
- Systematic review of outcomes measured in trials

Method(s)

- Systematic review

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