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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University Hospital, Limoges · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Transgenderism

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Static and dynamic perineo-pelvic MRI	Static and dynamic perineo-pelvic MRI before surgery, and at 6 and 24 months after surgery.

Timeline

• Start date: 2023-09-08
• Primary completion: 2025-09-08
• Completion: 2026-07-15
• First posted: 2023-10-23
• Last updated: 2025-07-22

Locations

1 site across 1 country: France