Actively Recruiting
Prospective Imaging Assessment of Perineo-pelvic Static's Evolution After Sexual Reassignment Surgery in MtF Transgender Patient by Peno-scrotal Inversion Vaginoplasty Technique (TRANSPELV)
Led by University Hospital, Limoges · Updated on 2025-07-22
50
Participants Needed
1
Research Sites
44 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying transgender women undergoing male-to-female (MtF) sexual reassignment surgery using the peno-scrotal inversion vaginoplasty technique. The study focuses on assessing changes in the perineo-pelvic area by using static and dynamic MRI scans to observe the development and progression of rectocele, a pelvic condition. This prospective study aims to better understand the anatomical and functional outcomes after surgery, which is important because the surgery affects pelvic structures and their stability over time. Participants will receive static and dynamic perineo-pelvic MRI scans before surgery, then again at 6 months and 24 months after surgery. These imaging sessions are added to the usual care patients receive during their vaginoplasty treatment. The study looks at the evolution of pelvic anatomy, especially the appearance and size of rectocele, to evaluate how pelvic fixity changes post-surgery. Throughout the study, patients will attend several consultations that include clinical assessments, questionnaires, and monitoring of any post-operative issues. Researchers will measure outcomes such as rectal bulge size, pelvic symptoms, urinary and sexual quality, and graft sizes at 6 and 24 months. This follow-up allows for careful tracking of anatomical and functional changes over two years after the surgery.
CONDITIONS
Brief 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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Patient admitted for vulvoplasty surgery
- Patient admitted for second vaginoplasty surgical gesture
- Contraindication of realizing an MRI
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 months
Participants undergo peno-scrotal inversion vaginoplasty surgery and have static and dynamic perineo-pelvic MRI before surgery and at 6 and 24 months after surgery to assess pelvic anatomy and function.
3 MRI visits (1 before surgery, 2 post-operative visits at 6 and 24 months)
Duration - Up to 24 months post-surgery
Participants have several consultations including post-operative MRI, clinical measures, assessment of post-operative issues, and questionnaires to monitor pelvic fixity and functional outcomes after surgery.
Several post-operative visits including MRI and clinical assessments at 6 and 24 months
Trial Site Locations
Total: 1 location
1
University Hospital, Limoges
Limoges, Limoges, France, 87042
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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