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

Universitätsklinikum Hamburg-Eppendorf64 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Gender Dysphoria Gender Identity Disorder Transsexualism Gender Identity

Eligibility

Sex: MALEMin age: 16 Years

Outcomes

Primary Outcomes

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.

Time frame: 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.

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.

Time frame: 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.

Time frame: 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.

Time frame: 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 Outcomes

Patient-Centeredness

Five dimensions of patient-centredness (according to Scholl et al., 2014) 1. Patient as a unique person 2. Patient involvement in care 3. Patient information 4. Clinician-patient communication 5. 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.

Time frame: After the first stage of penile inversion vaginoplasty (Baseline + 2 weeks), after the second stage of penile inversion vaginoplasty (Baseline + 6 months)