Transgenderism
Conditions
Keywords
MtF, transgender, vaginoplasty, penoscrotal inversion, MRI
Brief summary
The research consists of adding to the usual MtF transgender patient undergoing vaginoplasty care course, static and dynamic perineo-pelvic MRI before, and at 6 and 24 months. The aim is to assess perineo-pelvic static's evolution, based on the appearance of a rectocele.
Detailed description
Transgender people are estimated to be about 0,3 to 1 % of general population, and MtF reassignment surgery is raising. Vaginoplasty is not always necessary, but is usually an important step into gender transition. In France, surgical techniques' gold-standard is the peno-scrotal inversion vaginoplasty, which consists in the creation of a neo-vagina with peno-scrotal skin graft. Genital, perineum and pelvic anatomy is modified, without knowing in advance about functional and aesthetic results. MRI is the best way to assess soft tissue anatomy in the pelvis. Though, only few studies have assessed pre and post-operative imaging in patients undergoing vaginoplasty, and none have been prospective, neither have assessed the risk of rectocele. The issue is legitimate, because the surgery weakens elements of pelvic fixity, and fixity issues can appear secondarily. MtF transgender patients operated for a vaginoplasty are undergoing static and dynamic MRI before the surgery, at 6 and at 24 post-operative months. We look after the appearance of a rectocele and it's evolution in time, as criteria for the assessment of pelvic fixity. Follow-up is composed of several consultations including post-operative MRI, but also clinical measures, census of post-operative issues, and questionnaires for the assessment of secondary objectives.
Interventions
DIAGNOSTIC_TESTStatic and dynamic perineo-pelvic MRI
Static and dynamic perineo-pelvic MRI before surgery, and at 6 and 24 months after surgery.
Sponsors
University Hospital, Limoges
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient over 18 years old * Patient admitted in urology ward at Limoges' University Hospital for MtF sexual reassignment surgery by vaginoplasty * Patient affiliated or benefitting from a social security system * Patient free, informed, written and signed consent
Exclusion criteria
* Patient admitted for vulvoplasty surgery * Patient admitted for second vaginoplasty surgical gesture * Contraindication of realizing an MRI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement comparison of the rectal bulge's size and classification | 6 months and 24 months | Comparison and classification by pre-operative and post-operative MRI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reproducibility in the rectocele's measurement | 6 months and 24 months | Evaluate intra and inter-operator reproducibility in the rectocele's measurement |
| Symptomatology pelvic fixity | 6 months and 24 months | Evaluate correlation between symptomatology and the rectocele assessment |
| Factors pelvic fixity | 6 months and 24 months | Evaluate correlation between factors and the rectocele assessment |
| Skin-graft's neo-vagina's sizes | 6 months and 24 months | Evaluate correlation between the skin-graft's size in cm² and the neo-vagina's sizes (lenght, width) in cm |
| Rectocele | 6 months and 24 months | Describe the rectocele's mean size and it's progress |
| Urinary quality | 6 months and 24 months | Evaluate evolution of unrinary quality of life with Urinary Symptom Profile (USP) score, from 0 (best) to 39 (worst) |
| Self-imaging | 6 months and 24 months | Evaluate evolution of self-imaging with Body Image (BI-1) score, from 30 (no change) to 150 (change) ; and Female Genital Self-Image Scale (FGSIS) score, from 7 (worst) to 28 (best) |
| Sexual quality | 6 months and 24 months | Evaluate evolution of sexual quality of life with Operated Male-to-Female Sexual Function Index (OmtFSFI) score, from 18 (best) to 72 (worst) |
| Post-operative issues | Instantly, 6 months and 24 months | Epidemiologic census of post-operative issues |
| Imaging measures | 6 months and 24 months | Evaluate modifications of imaging measures size in cm² and the neo-vagina's sizes (lenght, width) in cm |
Countries
France
Outcome results
None listed