Clinical trial NCT03872648: TransCare - Genital Surgery for Trans Women in Centralized vs. Decentralized Health Care Delivery Settings
Official title: TransCare - Genital Surgery for Trans Women in Centralized vs. Decentralized Health Care Delivery Settings
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gender Dysphoria
Gender Identity Disorder
Transsexualism
Gender Identity
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2019-03-13
Enrollment: 64
Sex: MALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility 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

Primary outcomes:
measure: Gender Dysphoria (1)
timeFrame: 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)
measure: Gender Dysphoria (2)
timeFrame: 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)
measure: Quality of Life (physical health, psychological health, social relationships, and environment)
timeFrame: 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)
measure: General symptoms related to mental health
timeFrame: 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)
measure: Sexuality
timeFrame: 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:
measure: Patient-Centeredness
timeFrame: After the first stage of penile inversion vaginoplasty (Baseline + 2 weeks), after the second stage of penile inversion vaginoplasty (Baseline + 6 months)
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf, Institute for Sex Research, Sexual Medicine and Forensic Psychiatry
Study officials:
affiliation: University Medical Center Hamburg-Eppendorf, Institute for Sex Research, Sexual Medicine and Forensic Psychiatry
name: Timo Nieder, Dr. phil.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Hamburg-Eppendorf, Institute for Sex Research, Sexual Medicine and Forensic Psychiatry
name: Peer Briken, Prof.
role: STUDY_DIRECTOR
References: