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

NCT ID: NCT06093724

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-08
• Study Completion Date: 2026-07-15

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.

Conditions

Transgenderism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Anatomy reorganization after vaginoplasty in transgender women (MtF)

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.

Group Type: EXPERIMENTAL

Static and dynamic perineo-pelvic MRI

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Static and dynamic perineo-pelvic MRI

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

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Limoges

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital, Limoges

Limoges, Limoges, France

Site Status: RECRUITING

Countries

France

Facility Contacts

Muriel Mathonnet, Professor

Role: primary

muriel.mathonnet@chu-limoges.fr

+33 55 55 05 62 14

Other Identifiers

87RI23_005-TRANSPELV

Identifier Type: -

Identifier Source: org_study_id