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

Gender Dysphoria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03872648
• Other study ID #: TransCare2019
• Status: Recruiting
• Start date: January 21, 2019
• Est. completion date: December 2021

Study information

• Verified date: November 2019
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: Andreas Köhler, M.Sc.
• Phone: +4940 7410 57760
• Email: an.koehler[@]uke.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: December 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gender Dysphoria
• Gender Identity
• Gender Identity Disorder
• Transsexualism

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg-Eppendorf, Institute for Sex Research, Sexual Medicine and Forensic Psychiatry	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)