Prospective Imaging Assessment of Perineo-pelvic Static's Evolution After Sexual Reassignment Surgery in MtF Transgender Patient, by Peno-scrotal Inversion Vaginoplasty Technique (TRANSPELV)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Static and dynamic perineo-pelvic MRI.
- Who it may be relevant to
- Registry conditions: Transgenderism. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Diagnostic test Static and dynamic perineo-pelvic MRI
Static and dynamic perineo-pelvic MRI before surgery, and at 6 and 24 months after surgery.
Primary outcome measures
- Measurement comparison of the rectal bulge's size and classification [Time frame: 6 months and 24 months]
Secondary outcome measures (11)
- Rectocele [Time frame: 6 months and 24 months]
- Rectocele [Time frame: 6 months and 24 months]
- Reproducibility in the rectocele's measurement [Time frame: 6 months and 24 months]
- Symptomatology pelvic fixity [Time frame: 6 months and 24 months]
- Factors pelvic fixity [Time frame: 6 months and 24 months]
- Skin-graft's neo-vagina's sizes [Time frame: 6 months and 24 months]
- Imaging measures [Time frame: 6 months and 24 months]
- Urinary quality [Time frame: 6 months and 24 months]
- Self-imaging [Time frame: 6 months and 24 months]
- Sexual quality [Time frame: 6 months and 24 months]
- Post-operative issues [Time frame: Instantly, 6 months and 24 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 1 center
- University Hospital, Limoges — Limoges
Identifiers
NCT: NCT06093724 · 87RI23_005-TRANSPELV