Clitoral Reconstruction (CR) in FGM/C Patients

Completed

• Conditions: Female Genital Mutilation / Cutting (FGM/C)
• Interventions: Other: Interview after one year or more from the treatment received

• Registration Number: NCT05026814
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief 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).

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-24
• Study First Submitted QC: 2021-08-24
• Study First Posted: 2021-08-30
• Study Start: 2021-11-19
• Primary Completion: 2022-02-15
• Study Completion: 2022-02-15
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-17
• Last Update Posted: 2023-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women with FGM/C	Interview after one year or more from the treatment received	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.

Primary Outcome Measures

Name	Time	Method
General satisfaction with multidisciplinary care	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 Outcome Measures

Name	Time	Method
General satisfaction with subdomain psychosexual care	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)
General satisfaction after CR with female identity	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)
Female Genital Self Image Scale (FGSIS)	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).
General satisfaction with subdomain CR and psychosexual care	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)
General satisfaction with subdomain CR alone	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)
General satisfaction after CR with sexual response	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)
General satisfaction after CR with genital image	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)
General satisfaction after CR with pain	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)
World Health Organization (WHO)-Five Well-Being Index	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

Trial Locations

Locations (1)

University Hospital of Geneva (HUG), Department of Obstetrics and Gynecology; 🇨🇭 Genève, Switzerland