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Transgender Post-reassignment Urogynecologic Measures and Perceptions

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03293771
Enrollment
200
Registered
2017-09-26
Start date
2017-12-27
Completion date
2019-12-31
Last updated
2019-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gender Identity Disorder of Adult, Voiding Disorders, Sexual Dysfunction

Keywords

Transgender women, Male-to-female, Gender confirmation surgery, Voiding disorder, Vaginal dysfunction

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.

Interventions

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.

DIAGNOSTIC_TESTQuestionnaire 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.

Sponsors

Icahn School of Medicine at Mount Sinai
CollaboratorOTHER
The Cleveland Clinic
CollaboratorOTHER
Boston Medical Center
CollaboratorOTHER
Weill Medical College of Cornell University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Stage 1: Focus groups3 monthsCharacterization of genital, urologic, bowel, and sexual symptoms following male-to-female gender confirmation surgery
Stage 2: Questionnaire testing12 monthsValidity and reliability testing of new questionnaire

Secondary

MeasureTime frameDescription
Frequency and severity of symptoms15 monthsFrequency and severity of symptoms
Relationship between surgical technique and symptoms15 monthsRelationship between surgical technique and symptoms
Effect of hormonal therapy usage and symptoms15 monthsEffect of hormonal therapy usage and symptoms
Length of time since surgery and development of symptoms15 monthsLength of time since surgery and development of symptoms

Countries

United States

Contacts

Primary ContactSarah Huber, MD
sah2757@med.cornell.edu212-746-5352

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026