Transgender Post-reassignment Urogynecologic Measures and Perceptions
NCT ID: NCT03293771
Last Updated: 2019-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2017-12-27
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
OTHER
Study Groups
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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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Urinary or intestinal problems prior to surgery lasting greater than 6 weeks
18 Years
MALE
Yes
Sponsors
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Icahn School of Medicine at Mount Sinai
OTHER
The Cleveland Clinic
OTHER
Boston Medical Center
OTHER
Weill Medical College of Cornell University
OTHER
Responsible Party
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Principal Investigators
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Sarah Huber, MD
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Locations
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Weill Cornell Medicine
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Selvaggi G, Bellringer J. Gender reassignment surgery: an overview. Nat Rev Urol. 2011 May;8(5):274-82. doi: 10.1038/nrurol.2011.46. Epub 2011 Apr 12.
Clements-Nolle K, Marx R, Katz M. Attempted suicide among transgender persons: The influence of gender-based discrimination and victimization. J Homosex. 2006;51(3):53-69. doi: 10.1300/J082v51n03_04.
Kailas M, Lu HMS, Rothman EF, Safer JD. PREVALENCE AND TYPES OF GENDER-AFFIRMING SURGERY AMONG A SAMPLE OF TRANSGENDER ENDOCRINOLOGY PATIENTS PRIOR TO STATE EXPANSION OF INSURANCE COVERAGE. Endocr Pract. 2017 Jul;23(7):780-786. doi: 10.4158/EP161727.OR. Epub 2017 Apr 27.
Revol M, Servant JM, Banzet P. [Surgical treatment of male-to-female transsexuals: a ten-year experience assessment]. Ann Chir Plast Esthet. 2006 Dec;51(6):499-511. doi: 10.1016/j.anplas.2006.02.006. Epub 2006 Apr 19. French.
Hess J, Rossi Neto R, Panic L, Rubben H, Senf W. Satisfaction with male-to-female gender reassignment surgery. Dtsch Arztebl Int. 2014 Nov 21;111(47):795-801. doi: 10.3238/arztebl.2014.0795.
Goddard JC, Vickery RM, Qureshi A, Summerton DJ, Khoosal D, Terry TR. Feminizing genitoplasty in adult transsexuals: early and long-term surgical results. BJU Int. 2007 Sep;100(3):607-13. doi: 10.1111/j.1464-410X.2007.07017.x.
Buncamper ME, van der Sluis WB, van der Pas RSD, Ozer M, Smit JM, Witte BI, Bouman MB, Mullender MG. Surgical Outcome after Penile Inversion Vaginoplasty: A Retrospective Study of 475 Transgender Women. Plast Reconstr Surg. 2016 Nov;138(5):999-1007. doi: 10.1097/PRS.0000000000002684.
Jarolim L, Sedy J, Schmidt M, Nanka O, Foltan R, Kawaciuk I. Gender reassignment surgery in male-to-female transsexualism: A retrospective 3-month follow-up study with anatomical remarks. J Sex Med. 2009 Jun;6(6):1635-1644. doi: 10.1111/j.1743-6109.2009.01245.x. Epub 2009 Mar 30.
Rossi Neto R, Hintz F, Krege S, Rubben H, Vom Dorp F. Gender reassignment surgery--a 13 year review of surgical outcomes. Int Braz J Urol. 2012 Jan-Feb;38(1):97-107. doi: 10.1590/s1677-55382012000100014.
Hoebeke P, Selvaggi G, Ceulemans P, De Cuypere G, T'Sjoen G, Weyers S, Decaestecker K, Monstrey S. Impact of sex reassignment surgery on lower urinary tract function. Eur Urol. 2005 Mar;47(3):398-402. doi: 10.1016/j.eururo.2004.10.008. Epub 2004 Dec 2.
Lawrence AA. Patient-reported complications and functional outcomes of male-to-female sex reassignment surgery. Arch Sex Behav. 2006 Dec;35(6):717-27. doi: 10.1007/s10508-006-9104-9. Epub 2006 Nov 16.
Horbach SE, Bouman MB, Smit JM, Ozer M, Buncamper ME, Mullender MG. Outcome of Vaginoplasty in Male-to-Female Transgenders: A Systematic Review of Surgical Techniques. J Sex Med. 2015 Jun;12(6):1499-512. doi: 10.1111/jsm.12868. Epub 2015 Mar 26.
Kuhn A, Santi A, Birkhauser M. Vaginal prolapse, pelvic floor function, and related symptoms 16 years after sex reassignment surgery in transsexuals. Fertil Steril. 2011 Jun;95(7):2379-82. doi: 10.1016/j.fertnstert.2011.03.029. Epub 2011 Apr 2.
Kuhn A, Hiltebrand R, Birkhauser M. Do transsexuals have micturition disorders? Eur J Obstet Gynecol Reprod Biol. 2007 Apr;131(2):226-30. doi: 10.1016/j.ejogrb.2006.03.019. Epub 2006 May 5.
Dietrich W, Haitel A, Huber JC, Reiter WJ. Expression of estrogen receptors in human corpus cavernosum and male urethra. J Histochem Cytochem. 2004 Mar;52(3):355-60. doi: 10.1177/002215540405200306.
Huber S, Ferrando C, Safer JD, Pang JHY, Streed CG Jr, Priestley J, Culligan P. Development and Validation of Urological and Appearance Domains of the Post-Affirming Surgery Form and Function Individual Reporting Measure (AFFIRM) for Transwomen following Genital Surgery. J Urol. 2021 Dec;206(6):1445-1453. doi: 10.1097/JU.0000000000002141. Epub 2021 Jul 21.
Other Identifiers
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1708018495
Identifier Type: -
Identifier Source: org_study_id
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