Outcome measures reported following feminizing genital gender affirmation surgery for transgender women and gender diverse individuals: A systematic review

Abstract

Background

Feminizing genital gender affirmation surgery (fgGAS) may be an essential adjunct in the care of some transgender women and gender diverse individuals with gender incongruence. However, the comparison of different techniques of fgGAS may be confounded by variable outcome reporting and the use of inconsistent outcomes in the literature. This systematic review provides the most in-depth examination of fgGAS studies to date, and summarizes all reported outcomes, definitions, and the times when outcomes were assessed following these surgical interventions.

Aims/Methods: This work intends to quantify the levels of outcome variability and definition heterogeneity in this expanding field and provides guidance on outcome reporting for future study authors. Candidate studies for this systematic review were sourced via an electronic, multi-database literature search. All primary, clinical research studies of fgGAS were included with no date limits. Paired collaborators screened each study for inclusion and performed data extraction to document the outcomes, definitions, and times of outcome assessment following fgGAS.

Results

After screening 1225 studies, 93 studies proceeded to data extraction, representing 7681 patients. 2621 separate individual outcomes were reported, 857 (32.7%) were defined, and the time of outcome assessment was given for 1856 outcomes (70.8%) but relied on nonspecific ranges of follow-up dates. “Attainment of orgasm”, “Neovaginal stenosis”, and “Neovaginal depth/length” were among the most commonly reported outcomes. Profound heterogeneity existed in the definitions used for these and for all outcomes reported in general.

Discussion

The results demonstrate a need for clear outcomes, agreed definitions, and times of outcome assessment following fgGAS in transgender women and gender diverse individuals. The adoption of a consistent set of outcomes and definitions reported by all future studies of fgGAS (a Core Outcome Set) will aid in improving treatment comparisons in this patient group. This review is the first step in that process.

Keywords:

• Feminizing genital gender affirmation surgery
• transgender persons
• outcomes
• variable outcome reporting

Acknowledgements

The authors would like to acknowledge the contribution of David Mcnulty (University Hospital Birmingham, UK) who provided assistance with statistical analysis of the data, and Jennifer Manders (University Hospital Birmingham, UK) who provided assistance with development of the search strategy.

Data sharing and accessibility

The authors are willing to make their data, analytic methods, and study materials available to other researchers upon enquiry to the corresponding author, provided this does not compromise other ongoing unpublished research.

Disclosure statement

After the initial presentation of this work at EPATH, Thomas Pidgeon and Tina Rashid were invited to join an international Study Steering Group for Core Outcome Set development in gender affirming genital surgery. The authors have no other conflicts of interest to declare.

Ethical approval

Not applicable as this article does not contain any studies with human participants performed by any of the authors.

Funding

This research did not receive any grants from funding agencies in the public, commercial, or not-for-profit sectors. The authors have no financial disclosures to declare, nor any financial interest in any product, device or drug mentioned in this manuscript.

List of all products, devices, drugs, etc., used

Microsoft Excel Software (Version 2007; Microsoft Corp, Redmond, WA, USA).