Sexual Functioning After Erection Prosthesis Placement in Post Phalloplasty Transgender Persons
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity Hospital, Ghent
About this trial
This study aims to explore sexual satisfaction among transgender men and their partners following the placement of erectile prostheses after phalloplasty. While phalloplasty can create a neophallus, the lack of natural erectile tissue often necessitates the use of erectile aids, including internal prostheses. However, these prostheses, originally designed for cisgender men, face challenges when used in transgender patients, such as higher risks of complications, infections, and mechanical failures. Despite these issues, some studies report high patient satisfaction, though partner satisfaction rates are significantly lower. The study will use validated and non-validated questionnaires to assess satisfaction with various types of erectile prostheses, addressing the gap in understanding how these devices impact the sexual and relational functioning of both transgender men and their partners. These questionnaires will be provided to all included patients that are minimum 6 months after placement of an internal erection prosthesis and have a functional erection prosthesis in place
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient and partner age ≥ 18 years.
Transgender or gender non-conforming individuals diagnosed according to the DSM-5 diagnostic criteria for gender dysphoria.
Patients have undergone phalloplasty as a form of genital gender affirming surgery (any type of flap combination or technique is allowed).
Erection prosthesis placement ≥ 6 months after phalloplasty, performed at the Ghent University Hospital. Any type of prosthesis is allowed.
Disqualifiers
Patient age < 18 years.
Cisgender patients treated with phalloplasty and/or erection prosthesis for various reasons.
The erection prosthesis has been explanted or the current prosthesis is nonfunctional at time of data assessment.
Erection prosthesis placement < 6 months before study start will be excluded.
Trial population
Post-phalloplasty transgender patients that have undergone erectile prosthesis placement at the Ghent University Hospital at least six months ago and in whom the erection prosthesis in place in functioning.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Questionnaire
Diagnostic testAll erection prosthesis placements in post-phalloplasty transgender and gender non-conforming individuals at Ghent University Hospital from start of the gender clinic until June 2023 will be evaluated. All patients that are at least 6 months after erection prosthesis placement and currently have a functioning prosthesis in place are eligible and will be contacted. Upon inclusion and informed consent, the patient's medical files will be used to gather all necessary underlying medical information that is relevant to this study. will receive an email asking them to complete a questionnaire for themselves. At the end of this questionnaire the patient will be asked if they have a sexual partner and if this partner is willing to participate as well. After affirmation, the partner will be contacted in the same way. Patients will receive a series of questionnaires reviewing recent sexual activity, sexual preference, satisfaction with the erectile prosthesis and quality partner relationship.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Treatment satisfaction
Assessed using the Erectile Dysfunction Inventory of Treatment Satisfaction questionnaire (EDITS) The EDITS 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. With this questionnaire a number of subgroup analyses will be conducted. The obtained scores for treatment satisfaction for different types of erectile prostheses will be compared. Besides that, the difference in scores between patients and their partners will be explored. Another possible subgroup analysis will compare patients with different number of erectile prostheses placed. It was decided not to use a specific question from the EDITS patient questionnaire. It applies to the participant\'s erectile dysfunction which is not relevant to this study. The maximum score will therefore be 40.
Time frame
One-time questionnaire at least 6 months after erection prosthesis placement2
Capability of vaginal and/or anal penetration of the participant and sexual functioning
Separate questions regarding penetration, sexual functioning and the experience of the patient and their optional partner are listed in the appendix for patient and their optional partner. Capability will be defined as full repetitive anal and/or vaginal penetration of the partner while using the prosthesis, which was not possible before implantation, without pain to patient and/or partner, until the end of the intended sexual intercourse. If penetration is not possible, the reasons for this incapacity will be noted. Patient and their optional partner indicate how desirable and/ or painful penetration was using a Likert slider question on a scale of 1 to 5.
Time frame
One-time questionnaire at least 6 months after erection prosthesis placementSecondary outcomes
1
Relationship satisfaction, sexual satisfaction, and quality of life
Assessed using the Maudsley Marital Questionnaire (MMQ). The MMQ provides three summative scores of 0-80, 0-40 and 0-40 on relationship satisfaction, sexual satisfaction, and overall quality of life. Lower scores indicate better outcome. Only if the participant has a stable sexual relationship, the questionnaire will be filled out.
Time frame
One-time questionnaire at least 6 months after erection prosthesis placement2
Patient willing to undergo redo surgery and recommendation to other patients
Assessed using separate Yes/No questions
Time frame
One-time questionnaire at least 6 months after erection prosthesis placement3
• Use of previous external devices or aids before placement of an erectile prosthesis
Specific questions regarding previous devices or aids other than erectile prostheses are listed in the appendix for patient and their optional partner. Patient and their optional partner indicate how desirable penetration was with other aids using a Likert slider question on a scale of 1 to 5. This answer will be compared to the slider question regarding the capability of penetration with an erectile prosthesis.
Time frame
One-time questionnaire at least 6 months after erection prosthesis placement4
Lower urinary tract symptoms (LUTS) and their impact on quality of life.
Assessed using the International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptoms (ICIQ-MLUTS) The ICIQ-MLUTS module, consisting of 13 questions, provides a summative score between 0 (asymptomatic) and 52 (most symptomatic). With this questionnaire, the severity of the lower urinary tract symptoms will be explored. These scores could possibly be correlated with the patient\'s satisfaction score, the urinary function and the prosthesis related complications.
Time frame
One-time questionnaire at least 6 months after erection prosthesis placementSponsors and contacts
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Source ClinicalTrials.gov