An observational study in Transgenderism, Erectile Dysfunction and Prosthesis Durability, sponsored by University Hospital, Ghent. Recruiting at 1 site in Belgium. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by University Hospital, Ghent · Observational
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
Gender dysphoria is defined as a discomfort or dissatisfaction because of a discordance between the individual\'s assigned sex and their gender identity. A national survey of transgender adults in the United States has shown that 39% of their respondents experience psychological distress, which is eight times the rate in the United States population. Transition-related treatment contains counseling, psychotherapy, hormone therapy and gender-affirming surgery depending on what the individual desires. Gender-affirming surgery aims to change an individual's physical characteristics concordant with their gender identity and results in a reduction of psychological distress.
A part of this population will eventually undergo genital gender affirming surgery (GGAS) to align the appearance of the external genitalia as well. In transgender men, GGAS can be performed as metoidioplasty or phalloplasty with or without the removal of the native external genitalia. In metoidioplasty, the goal is to create anatomically looking but undersized external genitalia in which the clitoris forms the base of a micro-penis. In phalloplasty, anatomically sized external genitalia (phallus with or without urethra, scrotum, and perineum) are created using on the one hand a donor skin flap and on the other hand tissues from the original genitals. As there is no erectile tissue present in the neophallus after phalloplasty, it is usually not possible to penetrate a sexual partner without the use of external or internal erectile aids. In patients having undergone phalloplasty, a multitude of methods for obtaining phallic rigidity are available. One option can be the implantation of an internal erectile prosthesis.
Most types of erectile prostheses used in the transgender community have originally been designed for cisgender men. However, implanting such a prosthesis in the neophallus presents a number of challenges due to the differences with the anatomy of a native penis. As there are no cavernosal bodies with surrounding tunica albuginea that can be used as scaffold for anchoring of the prosthesis to the pubic bone there is an increased risk for distal extrusion, malposition and extensive mobility during use. Furthermore, vascularization of the neophallus is largely dependent on the one or two vessels supplying the flap(s), resulting in relative hypovascularization, delayed healing and an increased risk of infection. Finally, these types of prosthesis were originally made for an older population with erectile dysfunction. Most transgender patients are younger and sexually more active which could lead to mechanical failure of the erectile prosthesis; hence the life expectancy of implants is significantly reduced in this population. Consequently, penile implant surgery is associated with higher complications in a transgender population than in a cisgender population. The revision rate or explantation rate within 4 years follow-up ranges from 37.6% to 44% in several studies. Falcone et al. reported that up to 22% of the prostheses was explanted within 20 months. Within this study the patient and partner satisfaction were surveyed with a non-validated questionnaire. Up to 88% of patients were completely satisfied with the outcome of the phalloplasty and the erectile prosthesis, despite a significant complication rate. However, the partner satisfaction rate is significantly lower and rated at 60%. Without further discussion, Falcone et al. stated that his result should be explored in the future.
Recently, the Swiss company Zephyr Surgical Implants created the ZSITM 475 female-to-male (FTM) (Switzerland, Europe), the first erectile prosthesis specifically designed for transgender men after phalloplasty surgery. It contains several functions such as a large base plate for pubic bone fixation, a glans shaped tip, and a testicle-shaped pump, that have been conceived to answer several of the difficulties of prosthesis implantation. Recent publications on this prosthesis continue to report high complication rates. Verla et al. reported postoperative complications in 32% of the patients. Moreover, 23% of the devices were explanted within 18 months follow-up due to distal cylinder protrusion, infection, malpositioning, mechanical failure and urinary retention. In the paper of Neuville et al., the overall revision rate was 19% with a mean follow-up of 8.9 months, resulting from infection, mechanical failure and malpositioning. However, 92.8% of patients reported to be either satisfied or very satisfied with the erectile prosthesis and a mean EDITS score of 82 of 100.
To date, it is not possible to state which prosthesis is performing better in terms of complications and sexual satisfaction. A more comprehensive questionnaire is needed to understand the reported satisfaction of the patient according to the different types of prosthesis. As observed in the publication of Falcone et al., the low partner satisfaction rate should be explored further as this may impact patients' and partners' relational functioning. The current study aims to explore in more detail the sexual satisfaction in both transgender patients and their partners regarding erectile prosthesis placement using validated and non-validated questionnaires. 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
701 studies on the registry are indexed under Erectile Dysfunction; 125 are open to participants now.
This study's planned enrollment of 150 is above the median of 130 across 125 observational studies indexed under Erectile Dysfunction.
Browse Erectile Dysfunction studies →University Hospital, Ghent is the lead sponsor of 689 studies on the registry; 160 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Compared within Erectile Dysfunction, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Transsexualism. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All 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 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 placement
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 placement
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 placement
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 placement
• 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 placement
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 placement
Prosthesis related complications.
Prosthesis related complications are extracted from medical files. These will be correlated with the patients satisfaction score from the questionnaire.
Time frame: One-time questionnaire at least 6 months after erection prosthesis placement
Plan to share: No
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Started Jul 2024 (actual). Primary completion is estimated for Dec 2024, 5 months after the start.
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