Female Genital Mutilation / Cutting (FGM/C)NCT05026814
Clitoral Reconstruction (CR) in FGM/C Patients
An observational study of Female Genital Mutilation / Cutting (FGM/C), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Surgical interventions to reconstruct the vulva together with psychosexual care have been proposed as a multidisciplinary care concept for women who have undergone female genital mutilation/cutting (FGM/C). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Female Genital Mutilation / Cutting (FGM/C)
- What is being tested?
- Interview after one year or more from the treatment received
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 19 Nov 2021to 15 Feb 2022
- 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: FGM/C patients of the FGM/C outpatient clinic of HUG within the time frame of 01/2013 until 04/2021
Who may be able to join
- Signed informed consent of the present study
- French and / or English speaking
Who cannot join
- Insufficient knowledge of project language (French/English)
- No informed consent
- Inability to sign consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital of Geneva (HUG), Department of Obstetrics and Gynecology
Geneva, 1205
About this study
Official title: Clitoral Reconstruction (CR) in FGM/C Patients: Assessment of Multidisciplinary Care
Surgical interventions to reconstruct the vulva together with psychosexual care have been proposed as a multidisciplinary care concept for women who have undergone female genital mutilation/cutting (FGM/C).
This cross-sectional study is to assess the experiences of multidisciplinary care of women who request CR at Geneva University Hospital (HUG) in order to analyze the expectations and motivations for clitoral reconstruction, to study the reasons for deciding against or in favor of CR and to study the outcome of the care received (CR+ psychosexual care versus psychosexual care alone) in sexual response, eventual dyspareunia, genital self-image and overall satisfaction through questionnaires.
- Being tested
- Interview after one year or more from the treatment received
- Keywords
- Clitoral Reconstruction (CR), Psychosexual care (PC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interview after one year or more from the treatment receivedOther
Questionnaires to evaluate the satisfaction with treatment, the motivations and expectations for the treatment, the general well-being, the sexual function and the genital selfimage
| Study group | Role | What they receive |
|---|---|---|
| Women with FGM/C | Women who requested clitoral reconstruction after FGM/C between 01/2013 until 04/2021 and underwent multidisciplinary care consisting of psychosexual care (PC) with or without CR. To be included the women had to attend at least one session with the psychologist as part of psychosexual care. Receives: Other: Interview after one year or more from the treatment received |
What is being measured
The primary outcome is the main question the study is designed to answer.
General satisfaction with multidisciplinary care
General satisfaction with multidisciplinary care rated on a scale from 0 to 10 (0=totally unsatisfied, 10: totally satisfied)
Measured: one time assessment at baseline
Secondary outcomes (9)
General satisfaction with subdomain CR and psychosexual care
General satisfaction with subdomain CR and psychosexual care rated on a scale from 0 to 10 (0=totally unsatisfied, 10: totally satisfied)
Measured: one time assessment at baseline
General satisfaction with subdomain CR alone
General satisfaction with subdomain CR alone rated on a scale from 0 to 10 (0=totally unsatisfied, 10: totally satisfied)
Measured: one time assessment at baseline
General satisfaction with subdomain psychosexual care
General satisfaction with subdomain psychosexual care rated on a scale from 0 to 10 (0=totally unsatisfied, 10: totally satisfied)
Measured: one time assessment at baseline
General satisfaction after CR with sexual response
General satisfaction after CR with sexual rated on a scale from 0 to 10 (0=totally unsatisfied, 10: totally satisfied)
Measured: one time assessment at baseline
General satisfaction after CR with genital image
General satisfaction after CR with genital rated on a scale from 0 to 10 (0=totally unsatisfied, 10: totally satisfied)
Measured: one time assessment at baseline
General satisfaction after CR with pain
General satisfaction after CR with pain rated on a scale from 0 to 10 (0=totally unsatisfied, 10: totally satisfied)
Measured: one time assessment at baseline
General satisfaction after CR with female identity
General satisfaction after CR with female identity rated on a scale from 0 to 10 (0=totally unsatisfied, 10: totally satisfied)
Measured: one time assessment at baseline
Female Genital Self Image Scale (FGSIS)
The FGSIS is a measurement instrument consisting of seven items to assess female genital self-image. The questions relate to women's feelings and beliefs about their own genitals. A total score is calculated using a four-point response scale (strongly agree, agree, disagree, and strongly disagree).
Measured: one time assessment at baseline
World Health Organization (WHO)-Five Well-Being Index
The WHO-Five Well-Being Index is a questionnaire consisting of five questions to assess wellbeing. For each question, scores from 0 to 5 can be given. By adding up the values for the answers, a total value is obtained, whereby a low total value corresponds to low well-being
Measured: one time assessment at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start19 Nov 2021
- Primary completion15 Feb 2022
- Study completion15 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Female Genital Mutilation / Cutting (FGM/C)Studies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jasmine Abdulcadir, PD Dr. med., Principal investigator, Department of Obstetrics and Gynecology, University Hospital of Geneva (HUG)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05026814
- Sponsor's protocol ID
- 2021-01190; bb21Sartorius
- Status last verified
- Oct 2023
- First submitted
- 24 Aug 2021
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Meyer M, Sartorius G, Abdulcadir J. Clitoral reconstruction and psychosexual care after female genital mutilation/cutting: Assessment of multidisciplinary care. Womens Health (Lond). 2025 Jan-Dec;21:17455057251315814. doi: 10.1177/17455057251315814. Epub 2025 Mar 31.
PubMed 40162955
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clitoral Reconstruction (CR) in FGM/C Patients: Assessment of Multidisciplinary Care
- ClinicalTrials.gov ID
- NCT05026814
- Acronym / sponsor ID
- 2021-01190; bb21Sartorius
- Keywords
- Clitoral Reconstruction (CR), Psychosexual care (PC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 19 Nov 2021 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 30 Aug 2021 (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.
Surgical interventions to reconstruct the vulva together with psychosexual care have been proposed as a multidisciplinary care concept for women who have undergone female genital mutilation/cutting (FGM/C).
This cross-sectional study is to assess the experiences of multidisciplinary care of women who request CR at Geneva University Hospital (HUG) in order to analyze the expectations and motivations for clitoral reconstruction, to study the reasons for deciding against or in favor of CR and to study the outcome of the care received (CR+ psychosexual care versus psychosexual care alone) in sexual response, eventual dyspareunia, genital self-image and overall satisfaction through questionnaires.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with FGM/C | – | Other: Interview after one year or more from the treatment receivedWomen who requested clitoral reconstruction after FGM/C between 01/2013 until 04/2021 and underwent multidisciplinary care consisting of psychosexual care (PC) with or without CR. To be included the women had to attend at least one session with the psychologist as part of psychosexual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- FGM/C patients of the FGM/C outpatient clinic of HUG within the time frame of 01/2013 until 04/2021
Key inclusion criteria (2 listed)
- Signed informed consent of the present study
- French and / or English speaking
Key exclusion criteria (3 listed)
- Insufficient knowledge of project language (French/English)
- No informed consent
- Inability to sign consent
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 |
|---|---|---|
| Interview after one year or more from the treatment receivedQuestionnaires to evaluate the satisfaction with treatment, the motivations and expectations for the treatment, the general well-being, the sexual function and the genital selfimage | Other | Women with FGM/C |
Primary outcome
General satisfaction with multidisciplinary care
Time frame: one time assessment at baseline
General satisfaction with multidisciplinary care rated on a scale from 0 to 10 (0=totally unsatisfied, 10: totally satisfied)
9 secondary outcomes
General satisfaction with subdomain CR and psychosexual care
Time frame: one time assessment at baseline
General satisfaction with subdomain CR alone
Time frame: one time assessment at baseline
General satisfaction with subdomain psychosexual care
Time frame: one time assessment at baseline
General satisfaction after CR with sexual response
Time frame: one time assessment at baseline
General satisfaction after CR with genital image
Time frame: one time assessment at baseline
General satisfaction after CR with pain
Time frame: one time assessment at baseline
General satisfaction after CR with female identity
Time frame: one time assessment at baseline
Female Genital Self Image Scale (FGSIS)
Time frame: one time assessment at baseline
World Health Organization (WHO)-Five Well-Being Index
Time frame: one time assessment at baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Derived from this study: PubMed 40162955Meyer M, Sartorius G, Abdulcadir J. Clitoral reconstruction and psychosexual care after female genital mutilation/cutting: Assessment of multidisciplinary care. Womens Health (Lond). 2025 Jan-Dec;21:17455057251315814. doi: 10.1177/17455057251315814. Epub 2025 Mar 31.
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.
Jasmine Abdulcadir, PD Dr. med. principal investigator
Department of Obstetrics and Gynecology, University Hospital of Geneva (HUG)
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 Female Genital Mutilation / Cutting (FGM/C), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 2 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: finished, as of the sponsor's last update on 18 Oct 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General satisfaction with multidisciplinary care (time frame: one time assessment at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05026814, which also lists 1 linked publication.
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 18 Oct 2023.