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Updated: Jan 15, 2026
Anogenital Distance and Perineal Measurements of the Pelvic Organ Prolapse POP Quantification System
Published on: September 20, 2018
Patient-reported outcomes and measures for vaginal relaxation syndrome management: a systematic review
Hongqin Chen1,2, Jian Meng1,2, Qiao Li1,2
1Department of Gynecology and Obstetrics, West China Second Hospital, Sichuan University, South Renmin Road, Chengdu, Wuhou district, 610041, China.
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.
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