Methods

Protocol and guidance

This review was conducted in accordance to Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines.46 The protocol was registered (May 19, 2021) in PROSPERO (CRD42021249785).

Eligibility criteria

Studies had to meet all inclusion criteria : (i) original paper on surgical, complete neovagina creation; (ii) written in English; (iii) a peer reviewed journal publication; (iv) discuss anatomical outcome, Quality of Life, satisfaction, sexual functioning, complications and/or complaints; (v) ≥ 6 months Follow Up; (vi) patients ≥ 18 years during surgery; (vii) and ≥ 10 MRKHS patients or transwomen. Study exclusion for one or more satisfied Exclusion criteria : (i) unspecified surgical technique, vaginoplasty combined with other treatment or as non-primary surgery; (ii) merged results of patient and control group or of different patient types; (iii) or merged results of different vaginoplasty techniques.

Search strategy

A strategic, three-step search was performed in bibliographic databases Medline, EMBASE, Web of Science and Scopus (Core Collection) by a medical information specialist (R.d.V.), to identify relevant publications up to March 8, 2022. This PICO-search with (MeSH) terms (including synonyms and closely related words), looked forTransgender persons and MRKH patients (P articipants),Sex reassignment surgery and vaginoplasty(I ntervention), and neovagina combined with anatomy, satisfaction, sexual function, Quality of Life, complaints or complications (O utcome). Next, references were screened (‘snowball’ method) and a ‘related search’ on initial 200 Google Scholar hits was performed by a PhD candidate (J.S.). Duplicates were removed and a Mendeley 1.19.4 (Mendeley Ltd.) database was formed. The searches are included (Figure S12).

Study selection

Two researchers (J.S. and F.G.) independently screened titles and abstract for eligibility criteria using EndNote Library 20.1, with with discrepancies resolved by a third reviewer. Remaining articles were assessed independently for full content. Disagreements were resolved through discussion between the two authors.

Data extraction

Data from included studies was extracted according to a predefined standard. Neovagina lengths and operation times were pooled per surgical technique. Complications were reported as number of events and categorized hemorrhagic (transfusion and hematoma), gastrointestinal (rectal injury and recto-vaginal fistula), vaginal prolapse, tissue necrosis (of urethra, glans, clitoris and labia), (meatal or neovaginal) stenosis and revisions. Complaints included excessive mucous production, (genital) pain, (vaginal) hair growth, fecal- and urinary issues. Patient-reported satisfaction with anatomy and aesthetics, overall dissatisfaction and experienced regret were assessed. Sexual function included dyspareunia (pain during intercourse), experienced (erotic and orgasmic) sensation, sexual activity and satisfactory-graded sex life. Standardized questionnaires for aesthetics (Female Genital Self-Image Scale; FGSIS) and QoL were assessed separately and not included in the meta-analysis. Information was correlated and presented.

Risk of bias and quality of evidence

Methodological quality, for critical evaluation and not for methodological filtering,47,48 of included studies was assessed through the Newcastle Ottawa Scale (NOS).49 Potential bias was identified through the National Heart, Lung, and Blood Institute (NIH) Study Quality Assessment Tool for Observational Cohort and Cross-sectional Studies11Checklist at www.nhlbi.nih.gov/health-topics/study-quality-assessment-tools..

Data synthesis

By statistical analysis in Stata version 14.0 (StataCorp LLC, College Station, TX), operation times and anatomy were pooled by metan , with 95% confidence interval (CI) and effect size calculation by DerSimonian and Laird random-effects.50 Complications, complaints, satisfaction and sexual function were pooled bymetaprop , with 95% Wilson CI and DerSimonian and Laird random-effects,51 after variance stabilization by Freeman-Tukey double-arcsine-transformation and heterogeneity determination by I-square measures.52