Transgender Post-reassignment Urogynecologic Measures and Perceptions

NCT03293771 | Unknown

• 1 other identifier: 1708018495
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Gender Identity Disorder of Adult; Voiding Disorders; Sexual Dysfunction

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Frequency and severity of symptoms

  15 months

• Relationship between surgical technique and symptoms

  15 months

• Effect of hormonal therapy usage and symptoms

  15 months

• Length of time since surgery and development of symptoms

  15 months

Study Arms (2)

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

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

Interventions

Focus group interviews OTHER

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 1 Focus Groups

Questionnaire packet DIAGNOSTIC_TEST

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 2 Questionnaire Groups

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Study participants involve transgender individuals who were born phenotypically male but identify as female.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Preexisting pelvic pathology, including abnormal anatomy or baseline voiding dysfunction
• Urinary or intestinal problems prior to surgery lasting greater than 6 weeks

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Icahn School of Medicine at Mount Sinai: collaborator
• The Cleveland Clinic: collaborator
• Boston Medical Center: collaborator

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

RECRUITING

Related Publications (16)

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  PMID: 17135115 BACKGROUND

• 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.

  PMID: 28448757 BACKGROUND

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  PMID: 16626849 BACKGROUND

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  PMID: 25487762 BACKGROUND

• 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.

  PMID: 17669144 BACKGROUND

• 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.

  PMID: 27782992 BACKGROUND

• 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.

  PMID: 19473463 BACKGROUND

• 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.

  PMID: 22397771 BACKGROUND

• 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.

  PMID: 15716207 BACKGROUND

• 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.

  PMID: 17109225 BACKGROUND

• 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.

  PMID: 25817066 BACKGROUND

• 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.

  PMID: 21458798 BACKGROUND

• 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.

  PMID: 16678333 BACKGROUND

• 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.

  PMID: 14966202 BACKGROUND

• 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.

  PMID: 34288738 DERIVED

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Sarah Huber, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Huber, MD

CONTACT

212-746-5352; sah2757@med.cornell.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 6 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2017
• First Posted: September 26, 2017
• Study Start: December 27, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: April 23, 2019

Record last verified: 2019-04

Locations

US (1)