University Hospital, Limoges
Limoges, 87042, France
Location status: Recruiting
NCT Number: NCT06093724
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.
Interested in participating?
Request Info18 year and older
Male
Interventional
Not applicable
Limoges, 87042, France
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Static and dynamic perineo-pelvic MRI before surgery, and at 6 and 24 months after surgery.
Time frame: 6 months and 24 months
Comparison and classification by pre-operative and post-operative MRI
Time frame: 6 months and 24 months
Describe the rectocele's mean size and it's progress
Time frame: 6 months and 24 months
Describe the rectocele size's progress by class
Time frame: 6 months and 24 months
Evaluate intra and inter-operator reproducibility in the rectocele's measurement
Time frame: 6 months and 24 months
Evaluate correlation between symptomatology and the rectocele assessment
Time frame: 6 months and 24 months
Evaluate correlation between factors and the rectocele assessment
Time frame: 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
Time frame: 6 months and 24 months
Evaluate modifications of imaging measures size in cm² and the neo-vagina's sizes (lenght, width) in cm
Time frame: 6 months and 24 months
Evaluate evolution of unrinary quality of life with Urinary Symptom Profile (USP) score, from 0 (best) to 39 (worst)
Time frame: 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)
Time frame: 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)
Time frame: Instantly, 6 months and 24 months
Epidemiologic census of post-operative issues
University Hospital, Limoges
Other
Acronym: TRANSPELV
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