Faculty Bibliography

Gender-affirming care has emerged as a critical component of healthcare, addressing the specific medical and psychosocial needs of transgender and non-binary individuals. In this review article, we address what we see as the most pressing evidence gaps in the gender health literature: long-term effects of pubertal blockers and gender-affirming hormone therapy and the lack of standardised outcome measures of gender-affirming care. Substantial uncertainties persist regarding long-term effects of hormone therapy and the implications of gender-affirming therapy on cancer risk. Though there is some uncertainty about the long-term effects of gender-affirming medical therapy, providers must also consider the potential negative consequences of prolonging a dysphoric experience. Additionally, there is a dearth of validated measures for patient-reported outcomes and a lack of standardisation in the reporting of data that is detrimental to the progress of understanding the impacts of gender-affirming care.

BACKGROUND:The learning curve (LC) is the process of mastering a new technique. This study assesses the LC for robotic-assisted peritoneal flap gender-affirming vaginoplasty (RPGAV). METHODS:A retrospective chart review of all consecutive patients undergoing RPGAV between 09/2017 and 02/2023 at a single center was performed. Operative times (OT) were analyzed to describe the LC. A cutoff point was determined after which OT stabilized, and this was used to compare perioperative and postoperative outcomes. RESULTS:Five hundred RPGAVs were performed. Median OT was 125 (interquartile range 105-181) minutes and decreased significantly over time. The minimum number of cases required to observe a plateau in OT is 300 patients.After adjusting for the LC, 2 variables significantly affected OT: a 1-point increase in body mass index increased OT by 1.4 minutes [95% confidence interval (1.0, 1.9), P < 0.001] and the single port robot decreased OT by 34 minutes [95% CI 1 (-43.1, -25.0), P < 0.001] as compared to the traditional multiport Xi robot.When comparing the first 300 cases (learning phase) to the last 200 (expert phase), length of stay, blood transfusions, and rates of elective revision surgery were lower in the expert phase. CONCLUSIONS:The LC for RPGAV in this large cohort was 300 cases. Patient body mass index causes a dose-response increase in OT and the single port robot dramatically decreases OT. Although OT is just one facet of overall efficiency, differences between learning and expert phases are evident in decreased length of stay, transfusions, and rates of revision surgery.

IMPORTANCE/UNASSIGNED:There is an urgent need for a validated gender-affirming care-specific patient-reported outcome measure (PROM). OBJECTIVE/UNASSIGNED:To field test the GENDER-Q, a new PROM for gender-affirming care, in a large, international sample of transgender and gender diverse (TGD) adults and evaluate its psychometric properties. DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:This international cross-sectional study was conducted among TGD adults aged 18 years and older who were seeking or had received gender-affirming care within the past 5 years at 21 clinical sites across Canada, the United States, the Netherlands, and Spain; participants were also recruited through community groups (eg, crowdsourcing platform, social media). The study was conducted between February 2022 and March 2024. Participants had to be capable of completing the instrument in English, Danish, Dutch, or French-Canadian. Eligible participants accessed an online REDCap survey to complete sociodemographic questions and questions about gender-affirming care they had received or sought (ie, to look, function, or feel masculine, feminine, gender fluid, or another way). MAIN OUTCOME AND MEASURES/UNASSIGNED:Branching logic was used to assign relevant instrument scales. Rasch measurement theory (RMT) analysis was used to examine the fit of the observed data to the Rasch model for each scale. Test-retest reliability and hypothesis-based construct validity of instrument scales were examined. The hypothesis was that instrument scale scores would increase with better outcomes on corresponding categorical questions. RESULTS/UNASSIGNED:A total of 5497 participants (mean [SD] age, 32.8 [12.3] years; 1837 [33.4%] men; 1307 [23.8%] nonbinary individuals; and 2036 [37.0%] women) completed the field test survey. Participants sought or had the following types of gender-affirming care: 2674 (48.6%) masculinizing, 2271 (41.3%) femininizing, and 552 (10.0%) other. RMT analysis led to the development of 54 unidimensional scales and 2 checklists covering domains of health-related quality of life, sexual, urination, gender practices, voice, hair, face and neck, body, breasts, genital feminization, chest, genital masculinization, and experience of care. Test-retest reliability of the scales (intraclass correlation coefficient [average] >0.70) was demonstrated. Only 1 item (phalloplasty donor flap) had an ICC less than 0.70. As hypothesized, scores increased incrementally with better associated self-reported categorical responses. For example, among 661 participants who reported poor psychological well-being, the mean (SD) scale score was 45 (18) points; for those who reported excellent psychological well-being, the mean (SD) scale score was 85 (16) points (P < .001). CONCLUSIONS AND RELEVANCE/UNASSIGNED:In this cross-sectional study of 5497 TGD adults, the instrument demonstrated reliability and validity. The instrument was validated in an international sample and is designed to collect and compare evidence-based outcome data for gender-affirming care from the patients' perspective.

OBJECTIVE:Despite increasing incidence of genital gender-affirming surgery (GGAS), there is no systematic method of evaluating patient perspectives. The objective of this study is to elucidate transgender and non-binary patient perspectives on gender-affirming phalloplasty/metoidioplasty via structured focus groups and determine convergent themes as the first step towards the development of a GGAS patient-reported outcome measure. DESIGN/METHODS:We conducted a systematic qualitative study using a thematic content analysis of four focus groups from April 2021 to April 2022 comprising 8 patients undergoing phalloplasty/metoidioplasty and 10 patients post-phalloplasty/metoidioplasty. Focus groups were hosted virtually and recorded and transcribed. Discussions were guided by participant input and focused on goals, experiences, outcomes, satisfaction, and quality of life. SETTING/METHODS:This volunteer but purposive sample of patients was recruited directly in clinic, via email, and via social media at NYU Langone Health (primary site), Callen-Lorde Community Health Center (New York, New York, USA) and the San Francisco Community Health Center. PARTICIPANTS/METHODS:We conducted focus groups with 18 patients before/after undergoing gender-affirming phalloplasty/metoidioplasty. PRIMARY AND SECONDARY OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Transcripts were uploaded into ATLAS.ti, a qualitative data analysis software that facilitates coding for thematic content analysis. We performed deductive and inductive coding to identify the themes that were clustered into overarching domains. RESULTS:The mean duration of focus groups was 81.5 min. Seven themes and 19 subthemes were constructed. The major themes were (1) goals, expectations, and priorities before/after surgery; (2) sexual function; (3) urinary function; (4) peer support; (5) decision-making; (6) mental health and quality of life; and (7) gender dysphoria. Of the major themes, those determined before the study included themes 1-3 and 6-7. Limitations include small sample size and bias in patient selection. CONCLUSIONS:We conducted focus groups with 18 patients before/after undergoing gender-affirming phalloplasty/metoidioplasty. Mental health, quality of life, functional, and aesthetic outcomes are all critical to patients. Phalloplasty/metoidioplasty impact numerous aspects of patients' lives. Experiential components of the surgical process, mental health, and quality of life are important metrics to consider in addition to functional and aesthetic outcomes.

INTRODUCTION/BACKGROUND:With increased access to gender affirming care, the rate of vaginoplasties in the US has risen rapidly. Although some retrospective studies report high rates of lower urinary tract symptoms (LUTS) after gender affirming vaginoplasty, the type and severity of symptoms has not been well-described. The purpose of this study was to prospectively characterize postoperative changes in lower urinary tract function after robotic peritoneal flap vaginoplasty as measured by the American Urological Association Symptom Index questionnaire (AUASI), Urogenital Distress Inventory 6 (UDI6), and additional measures. METHODS:This was a prospective observational study of patients undergoing gender affirming robotic peritoneal flap vaginoplasty enrolled between August 2020 to September 2021. LUTS were evaluated pre- and postoperatively (1, 3, 6, and 12-month) via the AUASI, UDI6, uroflowmetry, and post void residual (PVR) measurements. Averages and 95% confidence intervals over time were estimated and compared through univariate mixed-effect linear regression models. RESULTS:A total of 43 patients were enrolled. The average patient age was 31.1 ± 9.1 years. Overall AUASI Score declined over time (p = 0.002; -0.42,-0.09), though the decrease was less than the clinically minimum importance difference (MID) of 3 points. Preoperative AUASI was 8.1 ± 5.2, 1 month: 8.1 (95% CI: -1.9,1.8); 3 months: 5.2 (-5.0,-1.2); 6 months: 5.7 (-4.6,-0.62); 12 months: 5.2 (-4.9,-0.81). Similarly, UDI6 score declined over time (p = 0.002; -1.12,-0.26), though the decrease was less than MID of 16.7 points. UDI6 score preoperatively was 16.3 ± 1.8; 1 month post op: 16.5 (-5.2,5.0); 3 months: 16.2 (-5.6,5.1); 6 months: 11.6 (-10,1.0), and at 12 months: 8.1 (-13,-2.3). Overall uroflowmetric outcomes measured at postoperative visits including post void residual volume, maximum flow velocity, and average flow velocity did not show any difference at any postoperative time point when compared with preoperative measurements. CONCLUSIONS:In this study both the AUASI and UDI6 declined over time from initial preoperative evaluation to the 12 month follow up period, although the changes in AUASI and UDI6 score did not reach MID. Additionally, urodynamic measurements remained unchanged postoperatively. This data suggests that robotic peritoneal flap vaginoplasty has no effect on lower urinary tract function.

OBJECTIVE:The objective of this study was to determine the outcomes of robotic peritoneal flap vaginoplasty. BACKGROUND:There is a lack of long-term outcomes data for gender-affirming vaginoplasty to inform patient decision-making. METHODS:A retrospective cohort of 500 consecutive patients undergoing robotic peritoneal flap vaginoplasty from 2017-2023 were reviewed. Complications requiring procedural intervention, self-reported vaginal dimensions, and orgasm were recorded at each follow up visit and analyzed as outcomes. RESULTS:487 (97%) of patients were followed to 3 months, and 425 (85%) to 1 year or greater. Twenty patients (4%) had a complication requiring procedural intervention, and 61(12%) had elective revision surgery. Median self-reported vaginal depth and width at 1 year was 14.5 cm (14.5-14.5) and 3.8 cm (3.8-3.8 cm). There were 12 patients (4%) no longer dilating using standard dilators at this pre-scheduled 1-year appointment, and at last follow-up ≥1 year, 8% were no longer dilating. Thirty-six (8%) of patients were considered anorgasmic at last follow up. Difficulty with orgasm prior to surgery was associated with lower rates of achieving orgasm after surgery and less consistent vaginal depth at 1 year, however 80% of these patients were able to orgasm after surgery. CONCLUSIONS:Clinician-observed and patient-reported outcomes for robotic gender-affirming peritoneal flap vaginoplasty were superior to those reported in the literature for penile inversion vaginoplasty. Patients who do not achieve orgasm prior to surgery are less likely to achieve orgasm and maintain vaginal depth afterwards, however the majority of these patients have improved sexual health after surgery.

CONTEXT.—/UNASSIGNED:The use of hormonal therapy and gender-affirming surgery in the transgender community has been rising during the last several years. Although it is generally safe, hormonal therapy's link to testicular cancer remains uncertain. OBJECTIVE.—/UNASSIGNED:To review the incidence of testicular cancer in specimens from gender-affirming orchiectomies at our institution and evaluate the tumors for histologic and genetic alterations. DESIGN.—/UNASSIGNED:Pathology reports for gender-affirming orchiectomies (January 1, 2018, to August 1, 2023) were reviewed for testicular neoplasms, with additional analysis for chromosome 12 abnormalities. Incidence and chromosome variations were compared with those in the general population. RESULTS.—/UNASSIGNED:Among 458 cases during 5.5 years, 5 germ cell neoplasms in 4 patients emerged. Our institution's annual incidence rate (159 per 100 000) is 26.5 times higher than the National Cancer Institute's previous report (6.0 per 100 000). Although they were morphologically no different from germ cell neoplasms in the general population, fluorescence in situ hybridization tests showed no i(12p) in 4 of 5 neoplasms (80%) in our cohort. CONCLUSIONS.—/UNASSIGNED:The cause behind this rise in incidence remains uncertain but may be due to long term pretreatment with hormones or blockers. The lower isochromosome 12p frequency suggests an alternative mechanism driving tumor development, which requires more detailed molecular studies.

PURPOSE/UNASSIGNED:High quality data regarding long-term clinical and patient-reported outcomes (PROs) of genital gender-affirming surgery (GGAS) are lacking, and transgender and non-binary (TGNB) community voices have not historically been included in research development. These factors limit the utility of current research for guiding patients, clinicians, payers, and other GGAS stakeholders in decision-making. The Transgender and Non-Binary Surgery (TRANS) Registry has been developed to meet the needs of GGAS stakeholders and address limitations of traditional GGAS research. METHODS/UNASSIGNED:Development of the TRANS Registry occurred over several developmental phases beginning in May 2019 to present. Stakeholder engagement was performed throughout these phases, including: determination of key clinical outcomes and PROs, creation and implementation of data collection tools within the electronic health record (EHR), and development of centralized registry infrastructure. RESULTS/UNASSIGNED:The TRANS Registry is a prospective observational registry of individuals seeking vaginoplasty and vulvoplasty. The EHR-enabled infrastructure allows patients and clinicians to contribute longitudinal outcomes data to the TRANS Registry. We describe our community engaged approach to designing the TRANS Registry, including lessons learned, challenges, and future directions. CONCLUSIONS/UNASSIGNED:The TRANS Registry is the first multicenter initiative to prospectively track the health of individuals seeking vaginoplasty and vulvoplasty using EHR-enabled methods, engaging TGNB community members and clinicians as partners in the process. This process may be used as a model for registry development in other emerging fields where high-quality longitudinal outcomes data are needed.

The 2 most common techniques for gender-affirming mastectomy are the double-incision free nipple graft and periareolar techniques. However, some patients are not well suited for either technique. When the nipples are high and on the pectoralis muscle, but there is marked breast tissue and skin redundancy, a double-incision free nipple graft would land the incision above the pectoral shadow, but a periareolar approach would not adequately remove the excess skin. In these patients, a nipple-preserving inferior-ellipse incision allows for appropriate chest contouring, leaving the nipple position unchanged and placing the incision in the pectoralis muscle shadow. A retrospective review identified all consecutive patients undergoing nipple-preserving inferior-ellipse mastectomy by the senior author (R.B.-L.). Indications were patients with moderate glandular tissue, skin excess, and a high nipple-areola complex (NAC) above the inferior border of the pectoralis major. Sixteen patients underwent inferior-ellipse mastectomy and were included. Mean follow-up was 203 days. Two patients (14%) required revision of the NAC. There was no partial or complete NAC loss. One patient (7%) developed postoperative seroma, which resolved with aspiration. For patients with moderate glandular tissue, excess skin in the inferior pole, and NAC position above the inferior border of the pectoralis major, the nipple-preserving inferior-ellipse mastectomy technique achieves excellent chest contour.