Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
ID06093724

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

Age: 18Years +
MALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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)

Follow-up

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

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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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