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Clinical Trials/NCT03293771
NCT03293771UnknownNot Applicable

Assessment of Postoperative Urologic and Pelvic Floor Complaints in Male-to-female Transgender Patients: a Mixed Methods Study

Weill Medical College of Cornell University1 site in 1 country200 target enrollmentStarted: December 27, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
200
Locations
1
Primary Endpoint
Stage 1: Focus groups

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Other

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Frequency and severity of symptoms(15 months)
  • Effect of hormonal therapy usage and symptoms(15 months)
  • Relationship between surgical technique and symptoms(15 months)
  • Length of time since surgery and development of symptoms(15 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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