Transgender Post-reassignment Urogynecologic Measures and Perceptions
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03293771|
Recruitment Status : Recruiting
First Posted : September 26, 2017
Last Update Posted : April 23, 2019
|Condition or disease||Intervention/treatment|
|Gender Identity Disorder of Adult Voiding Disorders Sexual Dysfunction||Other: Focus group interviews Diagnostic Test: Questionnaire packet|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||200 participants|
|Target Follow-Up Duration:||6 Weeks|
|Official Title:||Assessment of Postoperative Urologic and Pelvic Floor Complaints in Male-to-female Transgender Patients: a Mixed Methods Study|
|Actual Study Start Date :||December 27, 2017|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Stage 1 Focus Groups
The focus groups will involve transgender women who have completed gender confirmation surgery who volunteer to discuss their postoperative experience regarding bladder function, genital complaints, and sexual function.
Other: Focus group interviews
Focus group participants will be asked about their postoperative urogynecologic experience. Confidentiality will be enforced and participants will be made aware that they may opt out of answering any questions.
Stage 2 Questionnaire Groups
Stage 2 participants will be asked to complete a questionnaire packet after surgery followed by a second questionnaire completion 2 weeks later. Participants' operative notes and postoperative visit records will be reviewed.
Diagnostic Test: Questionnaire packet
Participants will be asked to complete a questionnaire packet comprised of three previously validated questionnaires and one newly created focused questionnaire. They will be asked to complete the new questionnaire again 2 weeks later. We estimate about 10 minutes will be required to complete the packet.
- Stage 1: Focus groups [ Time Frame: 3 months ]Characterization of genital, urologic, bowel, and sexual symptoms following male-to-female gender confirmation surgery
- Stage 2: Questionnaire testing [ Time Frame: 12 months ]Validity and reliability testing of new questionnaire
- Frequency and severity of symptoms [ Time Frame: 15 months ]Frequency and severity of symptoms
- Relationship between surgical technique and symptoms [ Time Frame: 15 months ]Relationship between surgical technique and symptoms
- Effect of hormonal therapy usage and symptoms [ Time Frame: 15 months ]Effect of hormonal therapy usage and symptoms
- Length of time since surgery and development of symptoms [ Time Frame: 15 months ]Length of time since surgery and development of symptoms
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): NCT03293771
|Contact: Sarah Huber, MDfirstname.lastname@example.org|
|United States, New York|
|Weill Cornell Medicine||Recruiting|
|New York, New York, United States, 10065|
|Contact: Sarah Huber, MD 212-746-5352 email@example.com|
|Principal Investigator:||Sarah Huber, MD||Weill Cornell Medicine|