Erectile Aid Use in Post-phalloplasty and Post-metoidioplasty Transgender Patients

NCT06639763 | Recruiting

• 1 other identifier: ONZ-2023-0606
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to explore the various methods used by transgender men for sexual intercourse following phalloplasty or metoidioplasty, focusing on their satisfaction with different erectile aids, as well as the satisfaction of their partners. Phalloplasty and metoidioplasty are gender-affirming surgeries that often require additional aids to achieve the desired sexual function, particularly for penetration. While internal erectile prostheses are common after phalloplasty, they come with high complication rates, leading some patients to opt for non-surgical aids. However, the effectiveness and comfort of these aids are not well-documented. This study aims to fill this gap by examining the types of aids transgender men use, how well these aids meet their sexual needs, and how satisfied both they and their partners are with the outcomes, providing much-needed insight for healthcare providers and patients alike.

Conditions

Transgenderism; Erectile Dysfunction; Gender Dysphoria; Sexual Dysfunction

Keywords

Gender dysphoria; Transgender; Phalloplasty; Metoidioplasty; Erectile dysfunction; Sexual function; Genital reconstruction; Reconstructive urology; Erectile aid; Patient Reported Outcome Measures (PROMs); Erection prosthesis; Penile epithesis

Outcome Measures

Primary Outcomes (2)

• Types of erectile aids used

  A series of closed and open-ended questions are asked meant to uncover what erectile aids are used by post-phalloplasty and post-metoidioplasty individuals and their partners.

  One time questionnaire at least six months after primary genital gender affirming phalloplasty or metoidioplasty

• Treatment satisfaction

  Assessed using Erectile Dysfunction Inventory of Treatment Satisfaction questionnaire (EDITS). The EDITS questionnaire provides two summative scores of 0-44 and 0-20 for patient and partner scores respectively. A higher score indicates a better treatment satisfaction. Higher scores indicate better outcome.

  One time questionnaire at least six months after primary genital gender affirming phalloplasty or metoidioplasty

Secondary Outcomes (2)

• Epidemiology

  One time questionnaire at least six months after primary genital gender affirming phalloplasty or metoidioplasty

• Quality of sexual experience

  One time questionnaire at least six months after primary genital gender affirming phalloplasty or metoidioplasty

Interventions

Questionnaire DIAGNOSTIC_TEST

Questionnaire containing a combination of basic epidemiological questions, questions regarding recent sexual activity, questions regarding sexual preference and sexual activity, questions regarding the use of different types of erectile aids, questions regarding satisfaction with the use of these different erectile aid and questions regarding the satisfaction with sexual functioning and the partner relation. Al patients at least 6 months after primary genital gender-affirming surgery and who are sexually active are eligible.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Transgender male individuals having undergone masculinizing genital gender affirming surgery at least six months ago and who are currently sexually active and are seeking sexual penetration are eligible.

You may qualify if:

• Patient and partner age ≥ 18 years.
• Transgender or gender non-conforming individuals (and their partners).
• Patients have undergone phalloplasty or metoidioplasty as a form of genital gender affirming surgery.
• ≥6 months after phalloplasty or metoidioplasty (any type of flap or technique is allowed).
• Sexually active or has been sexually active since phalloplasty or metoidioplasty with a partner or main sexual partner.
• Voluntarily agreed that the data may be used for an anonymized scientific study.

You may not qualify if:

• Patient age \< 18 years.
• Cisgender patients treated with phalloplasty or metoidioplasty for various reasons.
• \<6 months after phalloplasty or metoidioplasty.
• Not sexually active since phalloplasty/metoidioplasty.
• Patient and/or partner have no interest in penetrative sexual intercourse.

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Department of Urology, University Hospital Ghent

Ghent, East-Flanders, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Transsexualism; Erectile Dysfunction; Gender Dysphoria; Sexual Dysfunction, Physiological

Interventions

Pain Measurement

Condition Hierarchy (Ancestors)

Sexuality; Sexual Behavior; Behavior; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurologic Examination; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Anne-Françoise Spinoit, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wietse Claeys, MD

CONTACT

003293322276; wietse.claeys@ugent.be

Anne-Françoise Spinoit, MD, PhD

CONTACT

003293322276; anne-francoise.spinoit@uzgent.be

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: October 15, 2024
• Study Start: July 6, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)