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.
To identify the number of individual outcomes reported in published clinical research studies of all forms of gender-affirming fgGAS, including primary and revisional vaginoplasty (penile inversion, penoscrotal flap, enteric bowel/peritoneal, zero-depth), labiaplasty, vulvoplasty, and clitoroplasty, performed in transgender women and gender diverse people. To identify when these outcomes were measured post-operatively. To identify the proportion of these outcomes that were clearly defined. To identify the proportion of studies that declared a primary outcome.
ContributorsThomas E. Pidgeon, Thomas Franchi, Andre C. Q. Lo, Ginimol Mathew, Heer V. Shah, Despoina Iakovou, Mimi R. Borrelli, Catrin Sohrabi & Tina Rashid
Disease Category: Other
Disease Name:
Age Range: Unknown
Sex: Either
Nature of Intervention: Surgery
- Systematic review of outcomes measured in trials
- Systematic review
The databases that were searched using the above strategy included: PubMed, Medline, EMBASE (all using Ovid), The Cochrane Central Register of Controlled Trials (CENTRAL),
Clinicaltrials.gov, CINAHL (using EBSCO), AMED (Allied and Complementary Medicine),
PsycINFO (using HDAS), and the International Standard Randomized Control Trial Number
(ISRCTN) database.