Transgender Post-reassignment Urogynecologic Measures and Perceptions

Sexual Dysfunction Clinical Trial

Official title:

Assessment of Postoperative Urologic and Pelvic Floor Complaints in Male-to-female Transgender Patients: a Mixed Methods Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03293771
• Other study ID #: 1708018495
• Status: Recruiting
• Start date: December 27, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: April 2019
• Source: Weill Medical College of Cornell University
• Contact: Sarah Huber, MD
• Phone: 212-746-5352
• Email: sah2757[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Gender Dysphoria
• Gender Identity Disorder of Adult
• Sexual Dysfunction
• Voiding Disorders

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Boston Medical Center, Icahn School of Medicine at Mount Sinai, The Cleveland Clinic

Country where clinical trial is conducted

United States, 

References & Publications (15)

Buncamper ME, van der Sluis WB, van der Pas RS, Özer 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Hess J, Rossi Neto R, Panic L, Rübben 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. — View Citation

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. Epub 2004 Dec 2. — View Citation

Horbach SE, Bouman MB, Smit JM, Özer 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. Review. — View Citation

Jarolím L, Šedý J, Schmidt M, Nanka O, Foltán 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. — View Citation

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. — View Citation

Kuhn A, Hiltebrand R, Birkhäuser M. Do transsexuals have micturition disorders? Eur J Obstet Gynecol Reprod Biol. 2007 Apr;131(2):226-30. Epub 2006 May 5. — View Citation

Kuhn A, Santi A, Birkhäuser 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. — View Citation

Lawrence AA. Patient-reported complications and functional outcomes of male-to-female sex reassignment surgery. Arch Sex Behav. 2006 Dec;35(6):717-27. Epub 2006 Nov 16. — View Citation

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. Epub 2006 Apr 19. French. — View Citation

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. — View Citation

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. Review. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stage 1: Focus groups	Characterization of genital, urologic, bowel, and sexual symptoms following male-to-female gender confirmation surgery	3 months
Primary	Stage 2: Questionnaire testing	Validity and reliability testing of new questionnaire	12 months
Secondary	Frequency and severity of symptoms	Frequency and severity of symptoms	15 months
Secondary	Relationship between surgical technique and symptoms	Relationship between surgical technique and symptoms	15 months
Secondary	Effect of hormonal therapy usage and symptoms	Effect of hormonal therapy usage and symptoms	15 months
Secondary	Length of time since surgery and development of symptoms	Length of time since surgery and development of symptoms	15 months