TransgenderismTRANSPELVNCT06093724
Prospective Imaging Assessment of Perineo-pelvic Static's Evolution After Sexual Reassignment Surgery in MtF Transgender Patient, by Peno-scrotal Inversion Vaginoplasty Technique (TRANSPELV)
A study testing Static and dynamic perineo-pelvic MRI in people with Transgenderism, run by University Hospital, Limoges at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Transgenderism
- What is being tested?
- Static and dynamic perineo-pelvic MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 8 Sep 2023to 15 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient admitted for vulvoplasty surgery
- Patient admitted for second vaginoplasty surgical gesture
- Contraindication of realizing an MRI
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Hospital, Limoges
Limoges, Limoges, 87042
Muriel Mathonnet, Professor, +33 55 55 05 62 14, muriel.mathonnet@chu-limoges.fr
About this study
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.
Read the 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.
- Conditions
- Transgenderism
- Being tested
- Static and dynamic perineo-pelvic MRI
- Keywords
- MtF, transgender, vaginoplasty, penoscrotal inversion, MRI
- Medical subject headings
- Transsexualism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Static and dynamic perineo-pelvic MRIDiagnostic test
Static and dynamic perineo-pelvic MRI before surgery, and at 6 and 24 months after surgery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Static and dynamic perineo-pelvic MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement comparison of the rectal bulge's size and classification
Comparison and classification by pre-operative and post-operative MRI
Measured: 6 months and 24 months
Secondary outcomes (11)
Rectocele
Describe the rectocele's mean size and it's progress
Measured: 6 months and 24 months
Rectocele
Describe the rectocele size's progress by class
Measured: 6 months and 24 months
Reproducibility in the rectocele's measurement
Evaluate intra and inter-operator reproducibility in the rectocele's measurement
Measured: 6 months and 24 months
Symptomatology pelvic fixity
Evaluate correlation between symptomatology and the rectocele assessment
Measured: 6 months and 24 months
Factors pelvic fixity
Evaluate correlation between factors and the rectocele assessment
Measured: 6 months and 24 months
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
Measured: 6 months and 24 months
Imaging measures
Evaluate modifications of imaging measures size in cm² and the neo-vagina's sizes (lenght, width) in cm
Measured: 6 months and 24 months
Urinary quality
Evaluate evolution of unrinary quality of life with Urinary Symptom Profile (USP) score, from 0 (best) to 39 (worst)
Measured: 6 months and 24 months
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)
Measured: 6 months and 24 months
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)
Measured: 6 months and 24 months
Post-operative issues
Epidemiologic census of post-operative issues
Measured: Instantly, 6 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start8 Sep 2023
- Primary completion8 Sep 2025 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TransgenderismStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06093724
- Sponsor's protocol ID
- 87RI23_005-TRANSPELV
- Acronym
- TRANSPELV
- Status last verified
- Jul 2025
- First submitted
- 8 Sep 2023
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06093724
- Acronym / sponsor ID
- TRANSPELV / 87RI23_005-TRANSPELV
- Conditions
- Transgenderism
- Keywords
- MtF, transgender, vaginoplasty, penoscrotal inversion, MRI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 8 Sep 2023 (actual)
- Primary completion
- 8 Sep 2025 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anatomy reorganization after vaginoplasty in transgender women (MtF) | Experimental | Diagnostic Test: Static and dynamic perineo-pelvic MRIThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Patient admitted for vulvoplasty surgery
- Patient admitted for second vaginoplasty surgical gesture
- Contraindication of realizing an MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Static and dynamic perineo-pelvic MRIStatic and dynamic perineo-pelvic MRI before surgery, and at 6 and 24 months after surgery. | Diagnostic test | Anatomy reorganization after vaginoplasty in transgender women (MtF) |
Primary outcome
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
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Static and dynamic perineo-pelvic MRI in people with Transgenderism, run by University Hospital, Limoges at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement comparison of the rectal bulge's size and classification (time frame: 6 months and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.