Erectile Aid Use in Post-phalloplasty and Post-metoidioplasty Transgender Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity Hospital, Ghent
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial 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.
Trial design
Design model
Ecologic or community
Time perspective
Cross-sectional
Treatments tested in this trial
Questionnaire
Diagnostic testQuestionnaire 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
One time questionnaire at least six months after primary genital gender affirming phalloplasty or metoidioplasty2
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.
Time frame
One time questionnaire at least six months after primary genital gender affirming phalloplasty or metoidioplastySecondary outcomes
1
Epidemiology
Baseline questions regarding speaking language, gender and current anatomy
Time frame
One time questionnaire at least six months after primary genital gender affirming phalloplasty or metoidioplasty2
Quality of sexual experience
Assessed using Quality of Sexual Experience questionnaire (QSE). The QSE questionnaire provides a summative score between 7 and 49. A higher score indicates a better sexual experience.
Time frame
One time questionnaire at least six months after primary genital gender affirming phalloplasty or metoidioplastySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov