Original Title: Efectividad y seguridad de la faloplastia como cirugía genital masculinizante: revisión sistemática

Authors' objectives: To carry out a systematic review to assess the clinical utility, in terms of safety and effectiveness, of phalloplasty as masculinising genital surgery in adults with gender dysphoria (FTM).

Authors' results and conclusions: Prioritisation of outcomes: Of the 30 outcomes assessed by healthcare professionals, only 1 was considered not important for decision making, 13 were considered important, and 16 were assessed as critical. It was decided to summarise the information available in the SRs of those outcomes wich an average rating above 6 the (22 outcomes in total). Available evidence: The specific SR literature search retrieved a total of 39 SRs, of which 3 moderate-quality SRs met the selection criteria for inclusion: Wang et al., Ozer et al. and Ortengren et al. The SRs included 39, 6 and 18 studies, respectively, regarding the phalloplasty procedure, with a case series design. The SRs reported on 11 of the outcomes prioritised (4 safety outcomes and 7 effectiveness outcomes). The range of the number of cases included in each of the studies varied between 5 and 280 cases. The update of the SR by Wang et al. identified 11 studies, all of them with a retrospective case series design. The range of the number of cases oscillated between 44 and 551 cases. Safety: Two of the SRs (Ortengren et al. and Wang et al.), with 41 studies and 1,752 patients, included results on the percentage of flap loss (both total and partial) and/or the percentage of urethral complications, such as development of urinary stenosis or fistulae. Additionally, 9 studies (1,169 patients) from the update of the SR by Wang et al. provided information on some of the aforementioned outcomes. The results of 25 studies (1,587 patients) were meta-analysed for the outcomes of total flap loss, and the overall pooled data was 3.3% (95% CI: 2.0–5.0%), with high heterogeneity. For the variable of partial flap loss, the results of 28 studies (1,717 studies) were meta-analysed, and the overall pooled data was 11.6% (95% CI: 8–15.9%), with very high heterogeneity. In the case of the variable of urethral fistula rate, the results of 32 studies (2,296 patients) were meta-analysed, and the overall pooled data was 34.4% (95% CI: 27.4–41.7%), with very high heterogeneity. For the variable of urethral stenosis rate, the results of 29 studies (2,186 patients) were meta-analysed, and the overall pooled data was 27.7% (95% CI: 22.1–33.7%), with very high heterogeneity. Effectiveness: Two of the SRs (Wang et al. and Ozer et al. ), with 30 studies and 1,692 patients, provided data on the tactile and erogenous sensitivity of the neophallus, the ability to orgasm, the erection ability of the neophallus or penetration ability during intercourse, satisfaction with the aesthetics of the neophallus, general satisfaction, and standing micturition ability. Additionally, two primary studies (100 patients) also provided information in this domain. With regard to the tactile sensitivity of the neophallus, this result was reported by a total of 14 studies (1,260 patients), although with great heterogeneity in the reporting. The range of percentages of patients with tactile sensitivity in the neophallus oscillated from 0% to 100% among the studies. With regard to the erogenous sensitivity of the neophallus, this result was reported by a total of 8 studies (266 patients), with the range reported among the studies oscillating from 0% to 100%. In relation to the ability to orgasm, this result was reported by a total of 10 studies (861 patients). However, it is complex to group the results owing to the heterogeneous reporting. Concerning the erection ability of the neophallus or the possibility for penetration during intercourse, a total of 10 studies reported this result (934 patients), with the range reported among the studies oscillating between 21.2% (29/137) and 100% (18/18). With respect to satisfaction with the aesthetics of the neophallus, a total of 8 studies reported this result (354 patients), with the range among the studies oscillating from 21.1% (4/19) to 97.4% (112/115). With regard to general satisfaction, a total of 3 studies reported this result (115 patients), with the range among the studies oscillating from 47.1% (16/34) to 93% (51/56). With regard to the ability to void while standing, a total of 9 studies reported this result (382 patients), with the range among the studies oscillating from 31.6% (6/19) to 100%. Conclusions • The surgical intervention of phalloplasty as masculinising genital surgery is a highly individualised procedure, depending on the objectives to be achieved: based on different flaps, composed of different subprocedures, with or without urethral lengthening, with or without an erectile prosthesis, performed in one or several stages, etc. This implies high variability in the intervention itself and makes it extremely difficult to homogenise and synthesise the results. • The evidence found regarding the effectiveness and safety of phalloplasty in individuals with gender dysphoria (female-to-male) comes from case series, so the reliability of its results is very low. • With regard to the safety outcomes, the intervention of phalloplasty might cause percentages of urethral complications of 34.4% (95% CI: 27.4 to 41.7) for fistulae, and 27.7% (95% CI: 22.1 to 33.7%) for stenosis; and percentages of total flap loss of 3.3% (95% CI: 2.0 to 5.0%), and of 11.6% (95% CI: 8 to 15.9%) for partial flap loss, but the evidence these results come from is very uncertain. • The disparity in the nature and measurement of the effectiveness outcomes among the studies, together with the lack of standardised questionnaires and the potential bias in the reporting of the results of some studies, renders it impossible to make a quantitative synthesis of the effectiveness results with minimum guarantees. • As a result of the low quality of the available evidence and the absence of a comparator group, it cannot be determined whether the risk–benefit balance is in favour of or against the phalloplasty versus the possible available alternatives (metaidoioplasty or other types of management of gender dysphoria).

Authors' methods: The research question was defined using predefined inclusion criteria for the population (adults undergoing masculinising [FTM] genital surgery who meet the criteria defined by the World Professional Association for Transgender Health [WPATH]), the intervention (phalloplasty), the comparator (standard of care, other surgery such as metaidoioplasty), outcomes of safety and effectiveness of the procedure and study design (PICOD). The outcomes were prioritised by means of a survey among health professionals involved in the provision of health care to individuals with gender dysphoria. A preliminary search was conducted in the main databases: Medline, Embase, Cochrane, Web of Science and CINAHL, among others, with a time limit (2012–2022) that did not retrieve any clinical trials or comparative studies. Subsequently, a search for systematic reviews (SR) was carried out in Medline and Epistemonikos (February 2023), which identified several SR that answered the PICOD question. In February 2024, the search strategy for the SR that had the best quality assessment and provided information on the highest number of relevant outcomes (Wang et al. ) was replicated in order to identify any primary studies published later on (January 2021–February 2024). Two independent reviewers reviewed and selected the articles following pre-established selection criteria. The information every SR selected and from every primary study selected was recorded on extraction sheets designed ad hoc for the synthesis and generation of evidence tables. The quality of evidence was assessed using AMSTAR (A MeaSurement Tool to Assess Reviews) for SRs, and using the quality of evidence appraisal scale for case series designed by the Institute of Health Economics (IHE), for primary studies. The safety outcomes, total and partial flap loss, and urethral fistulae and stenosis were meta-analysed by calculating the proportion of events for each of them. For the effectiveness outcomes, in view of their heterogeneous nature and levels of measurement in each study, it was not considered appropriate to perform a quantitative synthesis of the data, so a qualitative (narrative) synthesis was chosen.

Project Status: Completed

URL for project: https://redets.sanidad.gob.es/productos/buscarProductos.do?metodo=detalle&id=1286

Year Published: 2025

URL for published report: https://redets.sanidad.gob.es/productos/buscarProductos.do?metodo=detalle&id=1286

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Spain

Organisation Name: Scientific Advice Unit, avalia-t; The Galician Health Knowledge Agency (ACIS)

Contact Address: Conselleria de Sanidade, Xunta de Galicia, San Lazaro s/n 15781 Santiago de Compostela, Spain. Tel: 34 981 541831; Fax: 34 981 542854;

Contact Name: avalia_t.acis@sergas.es

Contact Email: avalia_t.acis@sergas.es

Copyright: Scientific Advice Unit, Avalia-t; The Galician Health Knowledge Agency (ACIS)