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Gender DysphoriaNCT03872648

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

An observational study of Gender Dysphoria and Gender Identity Disorder, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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). Read more about this study

Who is it for?
Ages 16 years and older, men only
How many people
64 participants
Where
1 siteGermany
Study dates
21 Jan 2019to Dec 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Andreas Köhler, M.Sc. contact

+4940 7410 57760

an.koehler@uke.de

Timo Nieder, Dr. phil. contact

+4940 7410 52226

t.nieder@uke.de

Germany1 site, 1 recruiting

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

    Hamburg

    Andreas Köhler, M.Sc., +4940 7410 57760, an.koehler@uke.de

    Timo Nieder, Dr.phil., +4940 7410 52226, t.nieder@uke.de

    Recruiting

Other trials in Germany

About this study

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.

Medical subject headings
Gender Dysphoria, Transsexualism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03872648
Study groupRoleWhat they receive
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)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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)

  2. 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.

    Measured: 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)

  3. 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.

    Measured: 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)

  4. 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.

    Measured: 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)

  5. 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.

    Measured: 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)

  1. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2019
  2. Study start21 Jan 2019
  3. Primary completionJun 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03872648
Sponsor's protocol ID
TransCare2019
Status last verified
Nov 2019
First submitted
21 Feb 2019
Last updated
7 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Gender Dysphoria and Gender Identity Disorder, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Andreas Köhler, M.Sc. (+4940 7410 57760, an.koehler@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03872648.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2019.

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