Gender Identity Disorder of AdultNCT03293771
Transgender Post-reassignment Urogynecologic Measures and Perceptions
An observational study of Gender Identity Disorder of Adult and Voiding Disorders, run by Weill Medical College of Cornell University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Gender Identity Disorder of Adult, Voiding Disorders, Sexual Dysfunction
- What is being tested?
- Focus group interviews and Questionnaire packet
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Dec 2017to 31 Dec 2019
- How long will I take part?
- 6 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Preexisting pelvic pathology, including abnormal anatomy or baseline voiding dysfunction
- Urinary or intestinal problems prior to surgery lasting greater than 6 weeks
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Weill Cornell Medicine
New York, New York, 10065
Sarah Huber, MD, 212-746-5352, sah2757@med.cornell.edu
About this study
Official title: 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.
- Being tested
- Focus group interviews, Questionnaire packet
- Keywords
- Transgender women, Male-to-female, Gender confirmation surgery, Voiding disorder, Vaginal dysfunction
- Medical subject headings
- Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus group interviewsOther
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 packetDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Questionnaire packet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage 1: Focus groups
Characterization of genital, urologic, bowel, and sexual symptoms following male-to-female gender confirmation surgery
Measured: 3 months
Stage 2: Questionnaire testing
Validity and reliability testing of new questionnaire
Measured: 12 months
Secondary outcomes (4)
Frequency and severity of symptoms
Frequency and severity of symptoms
Measured: 15 months
Relationship between surgical technique and symptoms
Relationship between surgical technique and symptoms
Measured: 15 months
Effect of hormonal therapy usage and symptoms
Effect of hormonal therapy usage and symptoms
Measured: 15 months
Length of time since surgery and development of symptoms
Length of time since surgery and development of symptoms
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start27 Dec 2017
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Gender Identity Disorder of AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, The Cleveland Clinic, Boston Medical Center
- Responsible party
- Sponsor
- Investigators
- Sarah Huber, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03293771
- Sponsor's protocol ID
- 1708018495
- Status last verified
- Apr 2019
- First submitted
- 20 Sep 2017
- Last updated
- 23 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 21487386Clements-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.
PubMed 17135115Kailas 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.
PubMed 28448757Revol 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.
PubMed 16626849Hess 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.
PubMed 25487762Goddard 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.
PubMed 17669144Buncamper 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.
PubMed 27782992Jarolim 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.
PubMed 19473463Rossi 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.
PubMed 22397771Hoebeke 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.
PubMed 15716207Lawrence 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.
PubMed 17109225Horbach 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.
PubMed 25817066Kuhn 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.
PubMed 21458798Kuhn 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.
PubMed 16678333Dietrich 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.
PubMed 14966202
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Postoperative Urologic and Pelvic Floor Complaints in Male-to-female Transgender Patients: a Mixed Methods Study
- ClinicalTrials.gov ID
- NCT03293771
- Acronym / sponsor ID
- 1708018495
- Keywords
- Transgender women, Male-to-female, Gender confirmation surgery, Voiding disorder, Vaginal dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, The Cleveland Clinic, Boston Medical Center
- Study start
- 27 Dec 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 26 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 6 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stage 1 Focus Groups | – | Other: Focus group interviewsThe 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. |
| Stage 2 Questionnaire Groups | – | Diagnostic Test: Questionnaire packetStage 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Preexisting pelvic pathology, including abnormal anatomy or baseline voiding dysfunction
- Urinary or intestinal problems prior to surgery lasting greater than 6 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focus group interviewsFocus 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. | Other | Stage 1 Focus Groups |
| Questionnaire packetParticipants 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. | Diagnostic test | Stage 2 Questionnaire Groups |
Primary outcome
Stage 1: Focus groups
Time frame: 3 months
Characterization of genital, urologic, bowel, and sexual symptoms following male-to-female gender confirmation surgery
Stage 2: Questionnaire testing
Time frame: 12 months
Validity and reliability testing of new questionnaire
4 secondary outcomes
Frequency and severity of symptoms
Time frame: 15 months
Relationship between surgical technique and symptoms
Time frame: 15 months
Effect of hormonal therapy usage and symptoms
Time frame: 15 months
Length of time since surgery and development of symptoms
Time frame: 15 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
- Background: PubMed 21487386Selvaggi 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.
- Background: PubMed 17135115Clements-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.
- Background: PubMed 28448757Kailas 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.
- Background: PubMed 16626849Revol 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.
- Background: PubMed 25487762Hess 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.
- Background: PubMed 17669144Goddard 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.
- Background: PubMed 27782992Buncamper 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.
- Background: PubMed 19473463Jarolim 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.
- Background: PubMed 22397771Rossi 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.
- Background: PubMed 15716207Hoebeke 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.
- Background: PubMed 17109225Lawrence 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.
- Background: PubMed 25817066Horbach 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Huber, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gender Identity Disorder of Adult and Voiding Disorders, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah Huber, MD (212-746-5352, sah2757@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stage 1: Focus groups (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03293771, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2019.