Clitoral Reconstruction (CR) in FGM/C Patients

Study Overview
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Brief Summary
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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.

Official Title
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Clitoral Reconstruction (CR) in FGM/C Patients: Assessment of Multidisciplinary Care

Conditions
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Female Genital Mutilation / Cutting (FGM/C)

Intervention / Treatment
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* Other: Interview after one year or more from the treatment received


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent of the present study French and / or English speaking Exclusion Criteria: Insufficient knowledge of project language (French/English) No informed consent Inability to sign consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women with FGM/C<br>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. | Other: Interview after one year or more from the treatment received<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General satisfaction with multidisciplinary care | General satisfaction with multidisciplinary care rated on a scale from 0 to 10 (0=totally unsatisfied, 10: totally satisfied) | one time assessment at baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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). | 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 | one time assessment at baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clitoral Reconstruction (CR), Psychosexual care (PC)