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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03872648
Other study ID # TransCare2019
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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)
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