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Clitoral Reconstruction (CR) in FGM/C Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05026814
Enrollment
20
Registered
2021-08-30
Start date
2021-11-19
Completion date
2022-02-15
Last updated
2023-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female Genital Mutilation / Cutting (FGM/C)

Keywords

Clitoral Reconstruction (CR), Psychosexual care (PC)

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.

Interventions

OTHERInterview after one year or more from the treatment received

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

Sponsors

University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
General satisfaction with multidisciplinary careone time assessment at baselineGeneral satisfaction with multidisciplinary care rated on a scale from 0 to 10 (0=totally unsatisfied, 10: totally satisfied)

Secondary

MeasureTime frameDescription
General satisfaction with subdomain CR aloneone time assessment at baselineGeneral satisfaction with subdomain CR alone rated on a scale from 0 to 10 (0=totally unsatisfied, 10: totally satisfied)
General satisfaction with subdomain psychosexual careone time assessment at baselineGeneral satisfaction with subdomain psychosexual care rated on a scale from 0 to 10 (0=totally unsatisfied, 10: totally satisfied)
General satisfaction after CR with sexual responseone time assessment at baselineGeneral 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 imageone time assessment at baselineGeneral satisfaction after CR with genital rated on a scale from 0 to 10 (0=totally unsatisfied, 10: totally satisfied)
General satisfaction with subdomain CR and psychosexual careone time assessment at baselineGeneral satisfaction with subdomain CR and psychosexual care rated on a scale from 0 to 10 (0=totally unsatisfied, 10: totally satisfied)
General satisfaction after CR with female identityone time assessment at baselineGeneral 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 baselineThe 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).
World Health Organization (WHO)-Five Well-Being Indexone time assessment at baselineThe 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
General satisfaction after CR with painone time assessment at baselineGeneral satisfaction after CR with pain rated on a scale from 0 to 10 (0=totally unsatisfied, 10: totally satisfied)

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026