Transgender Post-reassignment Urogynecologic Measures and Perceptions

• Conditions: Voiding Disorders; Sexual Dysfunction; Gender Identity Disorder of Adult
• Interventions: Diagnostic Test: Questionnaire packet; Other: Focus group interviews

• Registration Number: NCT03293771
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

The intent of this mixed methods study for transgender women after gender confirmation surgery is to characterize and subsequently create a validated screening questionnaire for postoperative urologic and pelvic floor symptoms. For individuals who seek gender-confirming treatment, about 13% undergo genital surgery for cosmetic purposes with or without gonadectomy, and this number is increasing. Patient satisfaction following surgery is high, particularly regarding sexual and cosmetic outcomes; however, unexpected negative functional outcomes such as bowel and bladder dysfunction and pelvic organ prolapse impact overall patient satisfaction. The available information suggests that 16-33% of patients experience incontinence postoperatively, with stress predominance, 32-47% experience abnormal voiding, and 24-66% experience overactive bladder symptoms. Outside of the typically assessed voiding symptoms, unique complaints of MTF postoperative patients include obstructive voiding symptoms due to urethral stenosis, persistent perimeatal erectile tissue, prostatic hypertrophy, and irritation from neovaginal tissue. Additionally, may of these patients develop symptomatic neovaginal prolapse, requiring re-suspension. We suggest that further clarification regarding MTF postoperative urologic and pelvic floor complaints can be achieved via a mixed methods approach. By using focus group interviews to create specific evaluative questions for this unique population, we can then prospectively assess patients undergoing surgery via a national multicenter sampling strategy. The goal of the study is to better understand the unique symptoms these women experience and create a validated, reliable screening questionnaire to monitor patients after surgery.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-09-20
• Study First Submitted QC: 2017-09-20
• Study First Posted: 2017-09-26
• Study Start: 2017-12-27
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-22
• Last Update Posted: 2019-04-23
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 200

Inclusion Criteria

• Stage 1 -- Male-to-female transgender women who are at least 4 weeks postoperative following genital surgery for gender confirmation
• Stage 2 -- Male-to-female transgender women who are scheduled to undergo surgery or are within 4 weeks postoperative
• Both stages -- Minimum age 18 years old
• Both stages -- English fluency
• Both stages -- Reliable contact information and/or permanent residence

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Exclusion Criteria

• Preexisting pelvic pathology, including abnormal anatomy or baseline voiding dysfunction
• Urinary or intestinal problems prior to surgery lasting greater than 6 weeks

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stage 2 Questionnaire Groups	Questionnaire packet	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.
Stage 1 Focus Groups	Focus group interviews	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.

Primary Outcome Measures

Name	Time	Method
Stage 1: Focus groups	3 months	Characterization of genital, urologic, bowel, and sexual symptoms following male-to-female gender confirmation surgery
Stage 2: Questionnaire testing	12 months	Validity and reliability testing of new questionnaire

Secondary Outcome Measures

Name	Time	Method
Frequency and severity of symptoms	15 months	Frequency and severity of symptoms
Relationship between surgical technique and symptoms	15 months	Relationship between surgical technique and symptoms
Effect of hormonal therapy usage and symptoms	15 months	Effect of hormonal therapy usage and symptoms
Length of time since surgery and development of symptoms	15 months	Length of time since surgery and development of symptoms

Trial Locations

Locations (1)

Weill Cornell Medicine; 🇺🇸 New York, New York, United States