NCT06093724

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Sep 2023Jul 2026

First Submitted

Initial submission to the registry

September 8, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

September 8, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2026

Expected
Last Updated

July 22, 2025

Status Verified

July 1, 2025

Enrollment Period

2 years

First QC Date

September 8, 2023

Last Update Submit

July 18, 2025

Conditions

Transgenderism

Keywords

MtF, transgender, vaginoplasty, penoscrotal inversion, MRI

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Rectocele

    6 months and 24 months

  • Rectocele

    6 months and 24 months

  • Reproducibility in the rectocele's measurement

    6 months and 24 months

  • Symptomatology pelvic fixity

    6 months and 24 months

  • Factors pelvic fixity

    6 months and 24 months

  • +6 more secondary outcomes

Study Arms (1)

Anatomy reorganization after vaginoplasty in transgender women (MtF)

EXPERIMENTAL

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.

Diagnostic Test: Static and dynamic perineo-pelvic MRI

Interventions

Static and dynamic perineo-pelvic MRIDIAGNOSTIC_TEST

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

Anatomy reorganization after vaginoplasty in transgender women (MtF)

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsPatient admitted in urology ward at Limoges' University Hospital for MtF sexual reassignment surgery by vaginoplasty
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patient admitted for vulvoplasty surgery
  • Patient admitted for second vaginoplasty surgical gesture
  • Contraindication of realizing an MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Limoges

Limoges, Limoges, 87042, France

RECRUITING

MeSH Terms

Conditions

Transsexualism

Condition Hierarchy (Ancestors)

SexualitySexual BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2023

First Posted

October 23, 2023

Study Start

September 8, 2023

Primary Completion

September 8, 2025

Study Completion (Estimated)

July 15, 2026

Last Updated

July 22, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)