Prospective Imaging Assessment of Perineo-pelvic Static's Evolution After Sexual Reassignment Surgery in MtF Transgender Patient, by Peno-scrotal Inversion Vaginoplasty Technique (TRANSPELV)

Study Overview
=================
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.

Official Title
-----------------
Prospective Imaging Assessment of Perineo-pelvic Static's Evolution After Sexual Reassignment Surgery in MtF Transgender Patient, by Peno-scrotal Inversion Vaginoplasty Technique (TRANSPELV)

Conditions
-----------------
Transgenderism

Intervention / Treatment
-----------------
* Diagnostic Test: Static and dynamic perineo-pelvic MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anatomy reorganization after vaginoplasty in transgender women (MtF)<br>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. | Diagnostic Test: Static and dynamic perineo-pelvic MRI<br>* Static and dynamic perineo-pelvic MRI before surgery, and at 6 and 24 months after surgery.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement comparison of the rectal bulge's size and classification | Comparison and classification by pre-operative and post-operative MRI | 6 months and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rectocele | Describe the rectocele's mean size and it's progress | 6 months and 24 months | 
| Rectocele | Describe the rectocele size's progress by class | 6 months and 24 months | 
| Reproducibility in the rectocele's measurement | Evaluate intra and inter-operator reproducibility in the rectocele's measurement | 6 months and 24 months | 
| Symptomatology pelvic fixity | Evaluate correlation between symptomatology and the rectocele assessment | 6 months and 24 months | 
| Factors pelvic fixity | Evaluate correlation between factors and the rectocele assessment | 6 months and 24 months | 
| Skin-graft's neo-vagina's sizes | Evaluate correlation between the skin-graft's size in cm² and the neo-vagina's sizes (lenght, width) in cm | 6 months and 24 months | 
| Imaging measures | Evaluate modifications of imaging measures size in cm² and the neo-vagina's sizes (lenght, width) in cm | 6 months and 24 months | 
| Urinary quality | Evaluate evolution of unrinary quality of life with Urinary Symptom Profile (USP) score, from 0 (best) to 39 (worst) | 6 months and 24 months | 
| Self-imaging | 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) | 6 months and 24 months | 
| Sexual quality | Evaluate evolution of sexual quality of life with Operated Male-to-Female Sexual Function Index (OmtFSFI) score, from 18 (best) to 72 (worst) | 6 months and 24 months | 
| Post-operative issues | Epidemiologic census of post-operative issues | Instantly, 6 months and 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MtF, transgender, vaginoplasty, penoscrotal inversion, MRI