An observational study in Gender Identity Disorder of Adult, Voiding Disorders and Sexual Dysfunction, sponsored by Weill Medical College of Cornell University. Status unknown at 1 site in United States. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-23.
Sponsored by Weill Medical College of Cornell University · Observational
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.
385 studies on the registry are indexed under Sexual Dysfunction, Physiological; 72 are open to participants now.
This study's planned enrollment of 200 is above the median of 176 across 113 observational studies indexed under Sexual Dysfunction, Physiological.
Browse Sexual Dysfunction, Physiological studies →Weill Medical College of Cornell University is the lead sponsor of 892 studies on the registry; 165 are open to participants now.
Of its 123 completed or terminated interventional studies of FDA-regulated products, 94 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
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.
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.
Stage 1: Focus groups
Characterization of genital, urologic, bowel, and sexual symptoms following male-to-female gender confirmation surgery
Time frame: 3 months
Stage 2: Questionnaire testing
Validity and reliability testing of new questionnaire
Time frame: 12 months
Frequency and severity of symptoms
Frequency and severity of symptoms
Time frame: 15 months
Relationship between surgical technique and symptoms
Relationship between surgical technique and symptoms
Time frame: 15 months
Effect of hormonal therapy usage and symptoms
Effect of hormonal therapy usage and symptoms
Time frame: 15 months
Length of time since surgery and development of symptoms
Length of time since surgery and development of symptoms
Time frame: 15 months
Plan to share: Undecided
Started Dec 2017 (actual). Primary completion is estimated for Dec 2019, 24 months after the start.
Of 37 non-industry observational studies under Sexual Dysfunction, Physiological, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 55. This study's planned 24 months is below that.
Counting every sponsor, half of 40 studies reached it within 42 months; a quarter within 11 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Sexual Dysfunction, Physiological →
Weill Medical College of Cornell University →