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

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ClinicalTrials.gov Identifier: NCT03872648
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

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.

Condition or disease
Gender Dysphoria Gender Identity Disorder Transsexualism Gender Identity

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Study Type : Observational
Estimated Enrollment : 64 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: TransCare - Genital Surgery for Trans Women in Centralized vs. Decentralized Health Care Delivery Settings
Actual Study Start Date : January 21, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Group/Cohort
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)



Primary Outcome Measures :
  1. Gender Dysphoria (1) [ 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 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.


  2. Gender Dysphoria (2) [ 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 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.


  3. Quality of Life (physical health, psychological health, social relationships, and environment) [ 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) ]

    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.


  4. General symptoms related to mental health [ 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) ]

    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.


  5. Sexuality [ 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) ]

    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.



Secondary Outcome Measures :
  1. Patient-Centeredness [ Time Frame: After the first stage of penile inversion vaginoplasty (Baseline + 2 weeks), after the second stage of penile inversion vaginoplasty (Baseline + 6 months) ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Eligible participants must identify with a gender different from their male sex assigned at birth
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03872648


Contacts
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Contact: Andreas Köhler, M.Sc. +4940 7410 57760 an.koehler@uke.de
Contact: Timo Nieder, Dr. phil. +4940 7410 52226 t.nieder@uke.de

Locations
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Germany
University Medical Center Hamburg-Eppendorf, Institute for Sex Research, Sexual Medicine and Forensic Psychiatry Recruiting
Hamburg, Germany
Contact: Andreas Köhler, M.Sc.    +4940 7410 57760    an.koehler@uke.de   
Contact: Timo Nieder, Dr.phil.    +4940 7410 52226    t.nieder@uke.de   
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
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Principal Investigator: Timo Nieder, Dr. phil. University Medical Center Hamburg-Eppendorf, Institute for Sex Research, Sexual Medicine and Forensic Psychiatry
Study Director: Peer Briken, Prof. University Medical Center Hamburg-Eppendorf, Institute for Sex Research, Sexual Medicine and Forensic Psychiatry

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Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT03872648     History of Changes
Other Study ID Numbers: TransCare2019
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gender Dysphoria
Sexual Dysfunctions, Psychological
Mental Disorders