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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity Hospital, Limoges

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patient admitted for vulvoplasty surgery

Patient admitted for second vaginoplasty surgical gesture

Contraindication of realizing an MRI

Trial design

Design model

Single group

Treatments tested in this trial

  • Static and dynamic perineo-pelvic MRI

    Diagnostic test

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

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Anatomy reorganization after vaginoplasty in transgender women (MtF)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Measurement comparison of the rectal bulge's size and classification

Comparison and classification by pre-operative and post-operative MRI

Time frame
6 months and 24 months

Secondary outcomes

1

Rectocele

Describe the rectocele's mean size and it's progress

Time frame
6 months and 24 months
2

Rectocele

Describe the rectocele size's progress by class

Time frame
6 months and 24 months
3

Reproducibility in the rectocele's measurement

Evaluate intra and inter-operator reproducibility in the rectocele's measurement

Time frame
6 months and 24 months
4

Symptomatology pelvic fixity

Evaluate correlation between symptomatology and the rectocele assessment

Time frame
6 months and 24 months

Other outcomes

Sponsors and contacts

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