Clinical trial NCT03293771: Transgender Post-reassignment Urogynecologic Measures and Perceptions
Official title: Assessment of Postoperative Urologic and Pelvic Floor Complaints in Male-to-female Transgender Patients: a Mixed Methods Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gender Identity Disorder of Adult
Voiding Disorders
Sexual Dysfunction
Keywords: Transgender women
Male-to-female
Gender confirmation surgery
Voiding disorder
Vaginal dysfunction
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Icahn School of Medicine at Mount Sinai
name: The Cleveland Clinic
name: Boston Medical Center
First posted: 2017-09-26
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stage 1 (Focus group) participants will be comprised of healthy volunteers from the transgender community who have completed male-to-female gender confirmation surgery. They will be recruited through local clinics, physician referral, or community support groups.

Stage 2 (Questionnaire) participants will be recruited through multiple transgender centers at time of surgical scheduling or within 4 weeks after male-to-female gender confirmation surgery.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Stage 1: Focus groups
timeFrame: 3 months
measure: Stage 2: Questionnaire testing
timeFrame: 12 months
Secondary outcomes:
measure: Frequency and severity of symptoms
timeFrame: 15 months
measure: Relationship between surgical technique and symptoms
timeFrame: 15 months
measure: Effect of hormonal therapy usage and symptoms
timeFrame: 15 months
measure: Length of time since surgery and development of symptoms
timeFrame: 15 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Sarah Huber, MD
role: PRINCIPAL_INVESTIGATOR
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