Clinical trial NCT06093724: Prospective Imaging Assessment of Perineo-pelvic Static's Evolution After Sexual Reassignment Surgery in MtF Transgender Patient, by Peno-scrotal Inversion Vaginoplasty Technique (TRANSPELV)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Transgenderism
Keywords: MtF, transgender, vaginoplasty, penoscrotal inversion, MRI
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Measurement comparison of the rectal bulge's size and classification
timeFrame: 6 months and 24 months
Secondary outcomes:
measure: Rectocele
timeFrame: 6 months and 24 months
measure: Rectocele
timeFrame: 6 months and 24 months
measure: Reproducibility in the rectocele's measurement
timeFrame: 6 months and 24 months
measure: Symptomatology pelvic fixity
timeFrame: 6 months and 24 months
measure: Factors pelvic fixity
timeFrame: 6 months and 24 months
measure: Skin-graft's neo-vagina's sizes
timeFrame: 6 months and 24 months
measure: Imaging measures
timeFrame: 6 months and 24 months
measure: Urinary quality
timeFrame: 6 months and 24 months
measure: Self-imaging
timeFrame: 6 months and 24 months
measure: Sexual quality
timeFrame: 6 months and 24 months
measure: Post-operative issues
timeFrame: Instantly, 6 months and 24 months
Other outcomes:
Locations:
city: Limoges
country: France
facility: University Hospital, Limoges
Study officials:
References: