Clitoral Reconstruction (CR) in FGM/C Patients

October 17, 2023 updated by: University Hospital, Basel, Switzerland

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Genève, Switzerland, 1205
        • University Hospital of Geneva (HUG), Department of Obstetrics and Gynecology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

FGM/C patients of the FGM/C outpatient clinic of HUG within the time frame of 01/2013 until 04/2021

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Interview 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
one time assessment at baseline

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Jasmine Abdulcadir, PD Dr. med., Department of Obstetrics and Gynecology, University Hospital of Geneva (HUG)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2021

Primary Completion (Actual)

February 15, 2022

Study Completion (Actual)

February 15, 2022

Study Registration Dates

First Submitted

August 24, 2021

First Submitted That Met QC Criteria

August 24, 2021

First Posted (Actual)

August 30, 2021

Study Record Updates

Last Update Posted (Actual)

October 18, 2023

Last Update Submitted That Met QC Criteria

October 17, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2021-01190; bb21Sartorius

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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