Variation in outcome reporting and measurement tools in clinical trials of treatments for genitourinary symptoms in peri- and postmenopausal women: a systematic review

IMPORTANCE: Genitourinary symptoms affect 40% to 60% of postmenopausal women. Evidence-based approaches to diagnosing and managing these symptoms are limited by inconsistencies in outcomes and measures used in clinical trials.

OBJECTIVE: The aim of the study was to systematically review all outcomes and measurement tools reported in randomized clinical trials of interventions for genitourinary symptoms associated with menopause.

EVIDENCE REVIEW: We searched PubMed, Scopus, and the Cochrane Central Register of Controlled Trials (CENTRAL) up to December 2018. Randomized controlled trials with a primary or secondary outcome of genitourinary symptoms associated with menopause, English language, and sample size of 20 or more women per study arm were included. Study characteristics, outcomes, and measurement methods were collected.

FINDINGS: The search yielded 3,478 articles of which 109 met inclusion criteria. Forty-eight different outcomes were reported with "atrophy" as the most common (56/109, 51%) followed by measures of sexual function (19/109, 17%). Almost all (108/109, 99%) trials included patient-reported measures, with 21 different measures and 39 symptom combinations. Clinician-reported scales of vulvovaginal appearance were used in 36 of 109 (33%) trials, with extensive variation in what was measured and reported. Cytological measures from the vaginal epithelium were the most commonly used objective tools (76/109, 70%).

CONCLUSIONS AND RELEVANCE: There is heterogeneity in reported outcomes and measures used in clinical trials of treatments for genitourinary symptoms at menopause and uncertainty as to which outcomes best reflect patient priorities and symptoms. The findings from this systematic review have informed an international survey of stakeholders to determine priorities for outcome selection and reporting. This survey will then inform the development of a Core Outcome Set for use in future clinical trials by the COMMA (Core OutcoMes in MenopAuse) consortium. : Video Summary:


Christmas MM; Song B; Bell RJ; Iliodromiti S; Mitchell C; Hickey M


Journal: Menopause
Volume: 27
Issue: 9
Pages: 1070 - 1080
Year: 2020

Further Study Information

Current Stage: Completed
Date: 2018 - July 2019
Funding source(s): None

Health Area

Disease Category: Gynaecology

Disease Name:

Target Population

Age Range: Unknown

Sex: Female

Nature of Intervention: Any

Stakeholders Involved

- None

Study Type

- Systematic review of outcomes measured in trials


- Systematic review

We will include all RCTs of intervention studies with either a primary or secondary outcome of female menopausal vaginal symptoms and a sample size of at least 20 women per study arm. We will exclude quasi-randomized studies, secondary analyses of previously published RCTs, conference abstracts of RCTs, observational, analytical, or diagnostic studies, feasibility or pilot studies and studies not in English.