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

NCT03872648 | Unknown

• 1 other identifier: TransCare2019
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gender Dysphoria; Gender Identity Disorder; Transsexualism; Gender Identity

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Patient-Centeredness

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

Study Arms (2)

TW-VP (centralized delivery structure)

Trans women seeking penile inversion vaginoplasty (TW-VP) assessing THC in a specialized clinic with a centralized structure

TW-VP (decentralized delivery structure)

Trans women seeking penile inversion vaginoplasty (TW-VP) assessing THC from different medical locations (decentralized structure)

Eligibility Criteria

• Age: 16 Years+
• Gender Eligibility Details: Eligible participants must identify with a gender different from their male sex assigned at birth
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Trans woman seeking for surgical care at the Department of Urology at the University Medical Center Hamburg-Eppendorf

You may qualify if:

• 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

You may not qualify if:

• Under 16 years of age
• Missing informed consent
• Unable to speak German

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Medical Center Hamburg-Eppendorf, Institute for Sex Research, Sexual Medicine and Forensic Psychiatry

Hamburg, Germany

RECRUITING

MeSH Terms

Conditions

Gender Dysphoria; Transsexualism

Condition Hierarchy (Ancestors)

Sexual Dysfunctions, Psychological; Mental Disorders; Sexuality; Sexual Behavior; Behavior

Study Officials

• Timo Nieder, Dr. phil.

  University Medical Center Hamburg-Eppendorf, Institute for Sex Research, Sexual Medicine and Forensic Psychiatry

  PRINCIPAL INVESTIGATOR

• Peer Briken, Prof.

  University Medical Center Hamburg-Eppendorf, Institute for Sex Research, Sexual Medicine and Forensic Psychiatry

  STUDY DIRECTOR

Central Study Contacts

Andreas Köhler, M.Sc.

CONTACT

+4940 7410 57760; an.koehler@uke.de

Timo Nieder, Dr. phil.

CONTACT

+4940 7410 52226; t.nieder@uke.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: March 13, 2019
• Study Start: January 21, 2019
• Primary Completion: June 1, 2021
• Study Completion: December 1, 2021
• Last Updated: November 7, 2019

Record last verified: 2019-11

Locations

DE (1)