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NCT Number: NCT06093724

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Static and dynamic perineo-pelvic MRI

Diagnostic Test

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

Primary outcomes

  1. Measurement comparison of the rectal bulge's size and classification

    Time frame: 6 months and 24 months

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

Secondary outcomes

  1. Rectocele

    Time frame: 6 months and 24 months

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

  2. Rectocele

    Time frame: 6 months and 24 months

    Describe the rectocele size's progress by class

  3. Reproducibility in the rectocele's measurement

    Time frame: 6 months and 24 months

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

  4. Symptomatology pelvic fixity

    Time frame: 6 months and 24 months

    Evaluate correlation between symptomatology and the rectocele assessment

  5. Factors pelvic fixity

    Time frame: 6 months and 24 months

    Evaluate correlation between factors and the rectocele assessment

  6. Skin-graft's neo-vagina's sizes

    Time frame: 6 months and 24 months

    Evaluate correlation between the skin-graft's size in cm² and the neo-vagina's sizes (lenght, width) in cm

  7. Imaging measures

    Time frame: 6 months and 24 months

    Evaluate modifications of imaging measures size in cm² and the neo-vagina's sizes (lenght, width) in cm

  8. Urinary quality

    Time frame: 6 months and 24 months

    Evaluate evolution of unrinary quality of life with Urinary Symptom Profile (USP) score, from 0 (best) to 39 (worst)

  9. Self-imaging

    Time frame: 6 months and 24 months

    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)

  10. Sexual quality

    Time frame: 6 months and 24 months

    Evaluate evolution of sexual quality of life with Operated Male-to-Female Sexual Function Index (OmtFSFI) score, from 18 (best) to 72 (worst)

  11. Post-operative issues

    Time frame: Instantly, 6 months and 24 months

    Epidemiologic census of post-operative issues

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Acronym: TRANSPELV

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Oct 23, 2023
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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