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Transgender Post-reassignment Urogynecologic Measures and Perceptions

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ClinicalTrials.gov Identifier: NCT03293771
Recruitment Status : Recruiting
First Posted : September 26, 2017
Last Update Posted : April 23, 2019
Sponsor:
Collaborators:
Icahn School of Medicine at Mount Sinai
The Cleveland Clinic
Boston Medical Center
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Gender Identity Disorder of Adult Voiding Disorders Sexual Dysfunction Other: Focus group interviews Diagnostic Test: Questionnaire packet

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration: 6 Weeks
Official Title: Assessment of Postoperative Urologic and Pelvic Floor Complaints in Male-to-female Transgender Patients: a Mixed Methods Study
Actual Study Start Date : December 27, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Stage 1 Focus Groups
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.
Other: Focus group interviews
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.

Stage 2 Questionnaire Groups
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.
Diagnostic Test: Questionnaire 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.




Primary Outcome Measures :
  1. Stage 1: Focus groups [ Time Frame: 3 months ]
    Characterization of genital, urologic, bowel, and sexual symptoms following male-to-female gender confirmation surgery

  2. Stage 2: Questionnaire testing [ Time Frame: 12 months ]
    Validity and reliability testing of new questionnaire


Secondary Outcome Measures :
  1. Frequency and severity of symptoms [ Time Frame: 15 months ]
    Frequency and severity of symptoms

  2. Relationship between surgical technique and symptoms [ Time Frame: 15 months ]
    Relationship between surgical technique and symptoms

  3. Effect of hormonal therapy usage and symptoms [ Time Frame: 15 months ]
    Effect of hormonal therapy usage and symptoms

  4. Length of time since surgery and development of symptoms [ Time Frame: 15 months ]
    Length of time since surgery and development of symptoms



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Study participants involve transgender individuals who were born phenotypically male but identify as female.
Accepts Healthy Volunteers:   Yes
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03293771


Contacts
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Contact: Sarah Huber, MD 212-746-5352 sah2757@med.cornell.edu

Locations
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United States, New York
Weill Cornell Medicine Recruiting
New York, New York, United States, 10065
Contact: Sarah Huber, MD    212-746-5352    sah2757@med.cornell.edu   
Sponsors and Collaborators
Weill Medical College of Cornell University
Icahn School of Medicine at Mount Sinai
The Cleveland Clinic
Boston Medical Center
Investigators
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Principal Investigator: Sarah Huber, MD Weill Cornell Medicine

Additional Information:

Publications:

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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03293771     History of Changes
Other Study ID Numbers: 1708018495
First Posted: September 26, 2017    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Weill Medical College of Cornell University:
Transgender women
Male-to-female
Gender confirmation surgery
Voiding disorder
Vaginal dysfunction
Additional relevant MeSH terms:
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Disease
Pathologic Processes