University Hospital of Geneva (HUG), Department of Obstetrics and Gynecology
Geneva, 1205, Switzerland
Completed
NCT Number: NCT05026814
Clitoral Reconstruction (CR) in FGM/C Patients
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
Female
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Interview after one year or more from the treatment received
OtherQuestionnaires to evaluate the satisfaction with treatment, the motivations and expectations for the treatment, the general well-being, the sexual function and the genital selfimage
Primary outcomes
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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)
Secondary outcomes
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General satisfaction with subdomain CR and psychosexual care
Time frame: one time assessment at baseline
General satisfaction with subdomain CR and psychosexual care rated on a scale from 0 to 10 (0=totally unsatisfied, 10: totally satisfied)
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General satisfaction with subdomain CR alone
Time frame: one time assessment at baseline
General satisfaction with subdomain CR alone rated on a scale from 0 to 10 (0=totally unsatisfied, 10: totally satisfied)
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General satisfaction with subdomain psychosexual care
Time frame: one time assessment at baseline
General satisfaction with subdomain psychosexual care rated on a scale from 0 to 10 (0=totally unsatisfied, 10: totally satisfied)
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General satisfaction after CR with sexual response
Time frame: one time assessment at baseline
General satisfaction after CR with sexual rated on a scale from 0 to 10 (0=totally unsatisfied, 10: totally satisfied)
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General satisfaction after CR with genital image
Time frame: one time assessment at baseline
General satisfaction after CR with genital rated on a scale from 0 to 10 (0=totally unsatisfied, 10: totally satisfied)
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General satisfaction after CR with pain
Time frame: one time assessment at baseline
General satisfaction after CR with pain rated on a scale from 0 to 10 (0=totally unsatisfied, 10: totally satisfied)
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General satisfaction after CR with female identity
Time frame: one time assessment at baseline
General satisfaction after CR with female identity rated on a scale from 0 to 10 (0=totally unsatisfied, 10: totally satisfied)
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Female Genital Self Image Scale (FGSIS)
Time frame: one time assessment at baseline
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).
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World Health Organization (WHO)-Five Well-Being Index
Time frame: one time assessment at baseline
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
Sponsors and collaborators
Lead sponsor
University Hospital, Basel, Switzerland
Other
Registry information
Official study title
Clitoral Reconstruction (CR) in FGM/C Patients: Assessment of Multidisciplinary Care
Important dates
- Study start
- 2021
- Primary completion
- 2022
- Study completion
- 2022
- First posted
- Aug 30, 2021
- Registry last updated
- Oct 18, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)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.