Assessing pelvic changes after vaginoplasty in transgender women
Prospective Imaging Assessment of Perineo-pelvic Static's Evolution After Sexual Reassignment Surgery in MtF Transgender Patient, by Peno-scrotal Inversion Vaginoplasty Technique (TRANSPELV)
This study is testing how the body changes after vaginoplasty in transgender women to see how well the surgery works and what effects it has over time.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University Hospital, Limoges Academic / other |
| Locations | 1 site (Limoges, Limoges) |
| Trial ID | NCT06093724 on ClinicalTrials.gov |
What this trial studies
This research evaluates the evolution of perineo-pelvic anatomy in male-to-female transgender patients undergoing vaginoplasty using the peno-scrotal inversion technique. Participants will undergo static and dynamic MRI scans before surgery and at 6 and 24 months post-operation to monitor changes and the potential development of rectocele. The study aims to provide insights into the functional and aesthetic outcomes of this surgical approach, which is currently under-researched. Follow-up will include clinical assessments and questionnaires to gather comprehensive data on post-operative experiences.
Who should consider this trial
Good fit: Ideal candidates are male-to-female transgender patients over 18 years old scheduled for vaginoplasty at Limoges' University Hospital.
Not a fit: Patients undergoing vulvoplasty or those with contraindications for MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of pelvic anatomy changes and improve surgical outcomes for transgender women undergoing vaginoplasty.
How similar studies have performed: While few studies have explored imaging in vaginoplasty, this prospective approach focusing on pelvic anatomy evolution is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Limoges, Limoges
- University Hospital, Limoges — Limoges, Limoges, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.