Methods

Protocol and guidance

This review was conducted in accordance to Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines30 and registered (May 19, 2021) in PROSPERO (CRD42021249785).

Eligibility criteria

Inclusion criteria : (i) original paper on surgical, complete neovagina creation; (ii) English; (iii) peer reviewed publication; (iv) discuss anatomy with complications, complaints, satisfaction, sexual functioning or Quality of Life; (v) ≥ 6 months Follow Up; (vi) ≥ 10 MRKH- or MtF-patients of (vii) ≥ 18 years during surgery.
Exclusion criteria : (i) unspecified technique, vaginoplasty as non-primary (or combined with other) treatment; (ii) merged results of patient types and/or control group; (iii) or merged vaginoplasty technique results.

Search strategy

A strategic, bibliography search in Medline, EMBASE, Web of Science and Scopus was performed by a medical information specialist (R.d.V.), on publications up to October 6, 2022 (Figure S1). The PICO-search (with MeSH and closely related terms), looked for Transgender personsand MRKH-patients (P articipants), Sex reassignment surgery and vaginoplasty (I ntervention), andneovagina combined with anatomy , complications ,complaints , satisfaction , sexual function orQuality of Life (O utcome). The reference ‘snowballing’ method and a Google Scholar search on initial 200 hits were performed (J.S.). A Mendeley 1.19.4 database was formed after duplicate removal.

Study selection

Two researchers (J.S. and F.G.) screened titles and abstract for eligibility with EndNote 20.1 and assessed remaining articles independently for full content. Discrepancies were resolved with a third reviewer (J.H.).

Data extraction

Data from included studies were extracted according to a predefined standard. Neovagina depth and surgery duration were pooled per surgical technique. Quantity of reported complications and complaints were categorized as hemorrhage (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 and excessive mucous production, (genital) pain, (vaginal) hair growth, fecal- and urinary issues with Clavien-Dindo classification.31,32 Patient-reported anatomical and aesthetic satisfaction, overall dissatisfaction and experienced regret were assessed. Sexual function included dyspareunia, experienced (erotic and orgasmic) sensation, sexual activity (sexually active patients) and satisfactory-graded sex life. Standardized questionnaires for aesthetics (Female Genital Self-Image Scale; FGSIS) and Quality of Life (QoL) were assessed but not included in the meta-analysis.

Risk of bias and quality of evidence

Methodological quality of included studies was assessed without filtering33,34 by the Newcastle Ottawa Scale (NOS).35 Potential bias was identified through the National Heart, Lung, and Blood Institute (NIH) Study Quality Assessment Tool for Observational Cohort and Cross-sectional Studies.11Checklist 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), surgery duration and anatomy were pooled bymetan , with 95% confidence interval (CI) and DerSimonian and Laird random-effect size calculation.36 Complications, complaints, satisfaction and sexual function were pooled bymetaprop , with 95% Wilson CI and DerSimonian and Laird random-effects,37 after variance stabilization by Freeman-Tukey double-arcsine-transformation and heterogeneity determination by I-square measures.38