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

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.

Study Overview

• Status: Unknown
• Conditions: Gender Identity Disorder of Adult; Voiding Disorders; Sexual Dysfunction
• Intervention / Treatment: Other: Focus group interviews; Diagnostic test: Questionnaire packet

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Sarah Huber, MD; Phone Number: 212-746-5352; Email: sah2757@med.cornell.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Weill Cornell Medicine
      • Contact: Sarah Huber, MD; Phone Number: 212-746-5352; Email: sah2757@med.cornell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stage 1: Focus groups	Characterization of genital, urologic, bowel, and sexual symptoms following male-to-female gender confirmation surgery	3 months
Stage 2: Questionnaire testing	Validity and reliability testing of new questionnaire	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency and severity of symptoms	Frequency and severity of symptoms	15 months
Relationship between surgical technique and symptoms	Relationship between surgical technique and symptoms	15 months
Effect of hormonal therapy usage and symptoms	Effect of hormonal therapy usage and symptoms	15 months
Length of time since surgery and development of symptoms	Length of time since surgery and development of symptoms	15 months

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: Icahn School of Medicine at Mount Sinai; The Cleveland Clinic; Boston Medical Center
• Investigators: Principal Investigator: Sarah Huber, MD, Weill Medical College of Cornell University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2017
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: September 20, 2017
• First Submitted That Met QC Criteria: September 20, 2017
• First Posted (Actual): September 26, 2017

Study Record Updates

• Last Update Posted (Actual): April 23, 2019
• Last Update Submitted That Met QC Criteria: April 22, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Transgender women; Male-to-female; Gender confirmation surgery; Voiding disorder; Vaginal dysfunction
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Sexual Dysfunctions, Psychological; Disease; Gender Dysphoria
• Other Study ID Numbers: 1708018495

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No