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Transgender Post-reassignment Urogynecologic Measures and Perceptions

Weill Cornell Medicine (WCM) logo

Weill Cornell Medicine (WCM)

Status

Unknown

Conditions

Gender Identity Disorder of Adult
Sexual Dysfunction
Voiding Disorders

Treatments

Diagnostic Test: Questionnaire packet
Other: Focus group interviews

Study type

Observational

Funder types

Other

Identifiers

NCT03293771
1708018495

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Exclusion criteria

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

Trial design

200 participants in 2 patient groups

Stage 1 Focus Groups
Description:
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.
Treatment:
Other: Focus group interviews
Stage 2 Questionnaire Groups
Description:
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.
Treatment:
Diagnostic Test: Questionnaire packet

Trial contacts and locations

1

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Central trial contact

Sarah Huber, MD

Data sourced from clinicaltrials.gov

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