Sexual TraumaRepair-SMNCT06183463
The Use of Reconstructive Surgery for Sexually Mutilated Women at the University Hospitals of Strasbourg
An observational study of Sexual Trauma, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Despite awareness since the 1980s and a legal framework to punish sexual mutilation, this tradition continues in many countries, particularly in Africa but not only in the Middle East, Malaysia and Indonesia. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Sexual Trauma
- How many people
- 29 participants
- Where
- 1 siteFrance
- Study dates
- 24 Nov 2022to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult woman (≥18 years old) having consulted sexology at the HUS for sexual mutilation between 01/01/2011 and 12/31/2021.
Who may be able to join
- Adult woman (≥18 years old)
- having consulted sexology at the HUS for sexual mutilation between 01/01/2011 and 12/31/2021.
- having had clitoral repair surgery at the HUS between 01/01/2011 and 12/31/2021
- not objecting, after information, to the reuse of their data for the purposes of this research
Who cannot join
- Woman who expressed her opposition to participating in the study
- impossibility of providing the subject with informed information (difficulties in understanding the subject, etc.)
- Woman under judicial protection or under guardianship or curatorship.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service d'Assistance Médicale à la Procréation - CHU de Strasbourg - France
Strasbourg, 67091
Jeanine OHL, MD, 33 3 69 55 34 49, jeanine.ohl@chru-strasbourg.fr
Virginie TEISSEYRE, MD, 33 3 69 55 34 49, virginie.teisseyre@chru-strasbourg.fr
About this study
Official title: Use of Reconstructive Surgery for Women Consulting in Sexology at the University Hospitals of Strasbourg for Sexual Mutilation
Despite awareness since the 1980s and a legal framework to punish sexual mutilation, this tradition continues in many countries, particularly in Africa but not only in the Middle East, Malaysia and Indonesia. This custom, carried out among increasingly young little girls, exposes them to infectious, hemorrhagic and even death risks and sometimes significant obstetric complications.
Every year, 3 million girls and young women are sexually mutilated around the world, or one woman every 15 seconds.
Read more
In recent years, a surgical repair technique has been created by a French urologist, Professor Foldès. This technique allows clitoral reconstruction. Sensory reacquisition after this intervention may take a few months, but the functional results are quite good.
There is little or no data concerning the use of reconstructive surgery for these mutilated patients consulting in sexology and the future of patients post-operatively or who have not had recourse to reconstructive surgery. The investigators then questioned the decision of these patients and their future.
- Conditions
- Sexual Trauma
- Keywords
- Sexual mutilation
- Medical subject headings
- Sexual Trauma
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the future of patients who consulted sexology for sexual mutilation between 2011 and 2021 at the HUS, whether or not they opted for reconstructive surgery.
This assessment is made via a questionnaire of nine questions relating to their future.
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start24 Nov 2022
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual TraumaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06183463
- Sponsor's protocol ID
- 8724
- Acronym
- Repair-SM
- Status last verified
- Dec 2023
- First submitted
- 13 Dec 2023
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Reconstructive Surgery for Women Consulting in Sexology at the University Hospitals of Strasbourg for Sexual Mutilation
- ClinicalTrials.gov ID
- NCT06183463
- Acronym / sponsor ID
- Repair-SM / 8724
- Conditions
- Sexual Trauma
- Keywords
- Sexual mutilation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 24 Nov 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 27 Dec 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.
Despite awareness since the 1980s and a legal framework to punish sexual mutilation, this tradition continues in many countries, particularly in Africa but not only in the Middle East, Malaysia and Indonesia. This custom, carried out among increasingly young little girls, exposes them to infectious, hemorrhagic and even death risks and sometimes significant obstetric complications.
Every year, 3 million girls and young women are sexually mutilated around the world, or one woman every 15 seconds.
In recent years, a surgical repair technique has been created by a French urologist, Professor Foldès. This technique allows clitoral reconstruction. Sensory reacquisition after this intervention may take a few months, but the functional results are quite good.
There is little or no data concerning the use of reconstructive surgery for these mutilated patients consulting in sexology and the future of patients post-operatively or who have not had recourse to reconstructive surgery. The investigators then questioned the decision of these patients and their future.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult woman (≥18 years old) having consulted sexology at the HUS for sexual mutilation between 01/01/2011 and 12/31/2021.
Key inclusion criteria (4 listed)
- Adult woman (≥18 years old)
- having consulted sexology at the HUS for sexual mutilation between 01/01/2011 and 12/31/2021.
- having had clitoral repair surgery at the HUS between 01/01/2011 and 12/31/2021
- not objecting, after information, to the reuse of their data for the purposes of this research
Key exclusion criteria (3 listed)
- Woman who expressed her opposition to participating in the study
- impossibility of providing the subject with informed information (difficulties in understanding the subject, etc.)
- Woman under judicial protection or under guardianship or curatorship.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of the future of patients who consulted sexology for sexual mutilation between 2011 and 2021 at the HUS, whether or not they opted for reconstructive surgery.
Time frame: Through study completion, an average of 6 months
This assessment is made via a questionnaire of nine questions relating to their future.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sexual Trauma, run by University Hospital, Strasbourg, France 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: status not confirmed, as of the sponsor's last update on 27 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeanine OHL, MD (33 3 69 55 34 49, jeanine.ohl@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the future of patients who consulted sexology for sexual mutilation between 2011 and 2021 at the HUS, whether or not they opted for reconstructive surgery. (time frame: Through study completion, an average of 6 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 27 Dec 2023; AzTrials last refreshed its copy on 8 Nov 2026.