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

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.

Study Overview

• Status: Recruiting
• Conditions: Transgenderism
• Intervention / Treatment: Diagnostic test: Static and dynamic perineo-pelvic MRI

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Limoges, France, 87042
    • Recruiting
    • University Hospital, Limoges
    • Contact: Muriel Mathonnet, Professor; Phone Number: +33 55 55 05 62 14; Email: muriel.mathonnet@chu-limoges.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Diagnostic test: Static and dynamic perineo-pelvic MRI; Static and dynamic perineo-pelvic MRI before surgery, and at 6 and 24 months after surgery.

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

Collaborators and Investigators

• Sponsor: University Hospital, Limoges

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2023
• Primary Completion (Estimated): September 8, 2025
• Study Completion (Estimated): July 15, 2026

Study Registration Dates

• First Submitted: September 8, 2023
• First Submitted That Met QC Criteria: October 17, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): July 22, 2025
• Last Update Submitted That Met QC Criteria: July 18, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: MtF, transgender, vaginoplasty, penoscrotal inversion, MRI
• Other Study ID Numbers: 87RI23_005-TRANSPELV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No