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

NCT ID: NCT03872648

Last Updated: 2019-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-21

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gender Dysphoria Gender Identity Disorder Transsexualism Gender Identity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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TW-VP (centralized delivery structure)

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

No interventions assigned to this group

TW-VP (decentralized delivery structure)

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Timo Nieder, Dr. phil.

Role: PRINCIPAL_INVESTIGATOR

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

Peer Briken, Prof.

Role: STUDY_DIRECTOR

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

Locations

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

Hamburg, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Andreas Köhler, M.Sc.

Role: CONTACT

+4940 7410 57760

Timo Nieder, Dr. phil.

Role: CONTACT

+4940 7410 52226

Facility Contacts

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Andreas Köhler, M.Sc.

Role: primary

+4940 7410 57760

Timo Nieder, Dr.phil.

Role: backup

+4940 7410 52226

Other Identifiers

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TransCare2019

Identifier Type: -

Identifier Source: org_study_id

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