Erectiele functie, seksuele functioneren Erectile dysfunction sexual problems
Conditions
Interventions
The intervention group in this study will recieve a penile epithesis (penile
attachment) to enable penetration during sexual intercourse instead of an
internal erection prosthesis.
Sponsors
Universitair Ziekenhuis Gent
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Participant and partner age >= 18 years. - Transgender or gender non-conforming individuals diagnosed according to the DSM-5 diagnostic criteria for gender dysphoria. - Participants have undergone phalloplasty as a form of genital gender affirming surgery. - >= 1 year after phalloplasty (any type of flap combination is allowed), performed at the Ghent University Hospital or Amsterdam UMC. - >= 3 months after coronaplasty and having reasonably pronounced coronal ridge, as defined by the surgeons* expert opinion (This criterion is only obligatory in the eptithesis group, not in the prosthesis group). - Absence of urethral stricture or other structural problem resulting in voiding dysfunction. - Established (primary) sexual relationship with partner who is willing to take part in the study. - Participant is unable to penetrate the partner (anal or vaginal) adequately sexually without the aid of supportive measures (condom, taping, penile sleeve, penile epithesis or any other measure defined as supportive by the investigators). - Fit and eligible for erection prosthesis surgery, based on the surgeons* expert opinion. - No history of erection prosthesis surgery. - Treatment naïve in the use of the Elatortm or Erektortm epithesis.
Exclusion criteria
Exclusion criteria: - Participant age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Percentage of participants choosing either for the prosthesis or the epithesis at the start of study. o At baseline, participants will get information on both the prosthesis and the epithesis and will be free to choose between them. This difference in percentage and the reasons for choosing between either will be noted. - Capability of vaginal and/or anal penetration of the participant*s partner at 1 and 4 months. o Capability will be defined as full repetitive anal and/or vaginal penetration of the partner while using the epithesis or prosthesis, which was not possible before use or implantation, without pain to participant and/or partner, until the end of the intended sexual intercourse. o If penetration is not possible, the reasons for this incapacity will be noted o These measures will be evaluated at 1 and 4 months after start of use and compared between epithesis and prosthesis groups | — |
Secondary
| Measure | Time frame |
|---|---|
| - Feasibility of epithesis use by the participants. o Feasibility will be defined as the proportion of participants in the epithesis arm with interest in and willingness to continue use of the external penile epithesis after the study period by both participant and partner. - Quality of sexual experience (QSE) + specific questions added on experience during diary entry. o Quality of Sexual Experience questionnaire (15) o The QSE provides a summative score between 7 and 49. A higher score indicates a better sexual experience. o At 1, 2, 3 and 4 months the difference between respectively 1m-, 2m-, 3m- and 4m-scores and the baseline score will be calculated. The changes in QEQ-scores will be compared between epithesis and prosthesis groups in both participants and their partners. - Treatment satisfaction (EDITS) at 1 and 4 months. o Erectile Dysfunction Inventory of Treatment Satisfaction (16) o The EDITS provides two summative scores of 0-44 and 0-20 for participant and partner scores respectively. A higher score indicates a better treatment satisfaction. Higher scores indicate better outcome. o At 4 months the differences in QEQ-scores will be compared between epithesis and prosthesis groups in both participants and their partners. - Relationship satisfaction, sexual satisfaction, and quality of life (MMQ) at 1 and 4 months. o The Maudsley Marital Questionnaire (17) o 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. o At 1 and 4 months the difference between respectively 1m- and 4m-scores and the baseline score will be calculated. The changes in MMQ-scores will be compared between epithesis and prosthesis groups in both participants and their partners. - Lower urinary tract symptoms (ICIQ-MLUTS) at 1 and 4 months. o International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptom | — |
Countries
Netherlands
Outcome results
None listed