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

Transgenderism Clinical Trial

— TRANSPELV  

Official 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06093724
• Other study ID #: 87RI23_005-TRANSPELV
• Status: Recruiting
• Phase: N/A
• Start date: September 8, 2023
• Est. completion date: July 15, 2026

Study information

• Verified date: May 2024
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 15, 2026
• Est. primary completion date: September 8, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Transgenderism

Intervention

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

Locations

Country	Name	City	State
France	University Hospital, Limoges	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rectocele	Describe the rectocele's mean size and it's progress	6 months and 24 months
Secondary	Rectocele	Describe the rectocele size's progress by class	6 months and 24 months
Secondary	Reproducibility in the rectocele's measurement	Evaluate intra and inter-operator reproducibility in the rectocele's measurement	6 months and 24 months
Secondary	Symptomatology pelvic fixity	Evaluate correlation between symptomatology and the rectocele assessment	6 months and 24 months
Secondary	Factors pelvic fixity	Evaluate correlation between factors and the rectocele assessment	6 months and 24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Post-operative issues	Epidemiologic census of post-operative issues	Instantly, 6 months and 24 months