TransCare - Genital Surgery for Trans Women in Centralized vs. Decentralized Health Care Delivery Settings

Study Overview
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Brief Summary
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Trans (i.e., transgender, transsexual) individuals experience a gender that does not match their sex assigned at birth (Gender Incongruence), which can lead to distress called gender dysphoria (formerly known as transsexualism). Trans health care (THC) is primarily focusing on transition-related medical interventions (e.g. genital surgery) to reduce gender dysphoria and improve the quality of life. To date, trans individuals access THC services in both decentralized (e.g., various transition-related interventions are spread over several locations) and centralized structures (e.g., gender affirmative medical treatments are provided by a single source). The TransCare study examines genital surgery for trans women (e.g. penile inversion vaginoplasty), focusing on the effect of different health care delivery settings (e.g., if patients received all treatments from a single source or spread over several locations) on psychosocial outcomes and the quality of healthcare.

Official Title
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TransCare - Genital Surgery for Trans Women in Centralized vs. Decentralized Health Care Delivery Settings

Conditions
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Gender Dysphoria, Gender Identity Disorder, Transsexualism, Gender Identity

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 16 years or older; Gender different from their assigned male sex at birth Current or new surgical care patient at Department of Urology at the University Medical Center Hamburg-Eppendorf Able to read, speak, and understand German Written informed consent after written and oral information Exclusion Criteria: Under 16 years of age Missing informed consent Unable to speak German

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TW-VP (centralized delivery structure)<br>Trans women seeking penile inversion vaginoplasty (TW-VP) assessing THC in a specialized clinic with a centralized structure | |
| TW-VP (decentralized delivery structure)<br>Trans women seeking penile inversion vaginoplasty (TW-VP) assessing THC from different medical locations (decentralized structure) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gender Dysphoria (1) | Gender Dysphoria is measured using the Transgender Congruence Scale (TCS; Kozee et al., 2012). The total scale score is calculated by averaging the responses of the items. Scaling: 1 (strongly disagree), 2 (somewhat disagree), 3 (neither agree nor disagree), 4 (somewhat agree); 5 (strongly agree) References: Kozee, H. B., Tylka, T. L., & Bauerband, L. A. (2012). Measuring transgender individuals' comfort with gender identity and appearance: Development and validation of the Transgender Congruence Scale. Psychology of Women Quarterly, 36(2), 179-196. | Change from Baseline Gender Dysphoria to the point of time after penile inversion vaginoplasty (Baseline + 6 months) and to the 12 month post-procedure time point (Long-term-follow-up, Baseline +18 month) | 
| Gender Dysphoria (2) | Gender Dysphoria is measured using the Gender Congruence and Life Satisfaction Scale (GCLS; Jones et al., 2018). A higher score indicates a more positive outcome. Scaling: 1 (Never), 2 (Rarely), 3 (Sometimes), 4 (Often), 5 (Always) References: Jones, B. A., Bouman, W. P., Haycraft, E., & Arcelus, J. (2018). The Gender Congruence and Life Satisfaction Scale (GCLS): Development and validation of a scale to measure outcomes from transgender health services. International Journal of Transgenderism, 1-18. | Change from Baseline Gender Dysphoria to the point of time after penile inversion vaginoplasty (Baseline + 6 months) and to the 12 month post-procedure time point (Long-term-follow-up, Baseline +18 month) | 
| Quality of Life (physical health, psychological health, social relationships, and environment) | QoL is measured using the WHOQOL-BREF (WHO, 1998). Reference: WHO (1998). Development of the World Health Organization WHOQOL-BREF quality of life assessment. Psychological medicine, 28(3), 551-558. | Change from Baseline QoL to the point of time after penile inversion vaginoplasty (Baseline + 6 months) and to the 12 month post-procedure time point (Long-term-follow-up, Baseline +18 month) | 
| General symptoms related to mental health | General symptoms related to mental health are measured using the Basic Symptom Checklist (BSCL; Franke, 2015), which is the German version of the BSI-18. Reference: Franke, G. H. (2015). BSCL-53®-S. Brief Symptom-Checklist-Standard-Deutsches Manual. | Change from Baseline Mental Health Symptoms to the point of time after penile inversion vaginoplasty (Baseline + 6 months) and to the 12 month post-procedure time point (Long-term-follow-up, Baseline +18 month) | 
| Sexuality | Sexuality (desire, arousal, lubrication, orgasm, satisfaction, and pain) is measured using the German Female Sexual Function Index (FSFI; Berner et al., 2004). Reference: Berner, M. M., Kriston, L., Zahradnik, H. P., Härter, M., & Rohde, A. (2004). Überprüfung der Gültigkeit und Zuverlässigkeit des deutschen Female Sexual Function Index (FSFI-d). Geburtshilfe und Frauenheilkunde, 64(03), 293-303. | Change from Baseline Sexuality to the point of time after penile inversion vaginoplasty (Baseline + 6 months) and to the 12 month post-procedure time point (Long-term-follow-up, Baseline +18 month) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-Centeredness | Five dimensions of patient-centredness (according to Scholl et al., 2014) Patient as a unique person Patient involvement in care Patient information Clinician-patient communication Patient empowerment Reference: Scholl, I., Zill, J. M., Härter, M., & Dirmaier, J. (2014). An integrative model of patient-centeredness-a systematic review and concept analysis. PloS one, 9(9), e107828. | After the first stage of penile inversion vaginoplasty (Baseline + 2 weeks), after the second stage of penile inversion vaginoplasty (Baseline + 6 months) |