Consequences of Sexual Violence Among Women Living in Democratic Republic of Congo

NCT05731297 | Unknown

• 1 other identifier: 2021-01
• Study Type: observational
• Target: 742
• Locations: 1 country
• Sites: 1

Brief Summary

In conflict situations, sexual violence (SV) used can take various forms, including rape and female genital mutilation (FGM). SV is used as a strategic weapon to shake, terrorize, and displace communities and thus take control of a particular population or territory. For two decades, the Great Lakes region of Central Africa, which includes the eastern part of the Democratic Republic of the Congo (DRC), has experienced a high degree of instability due to various armed conflicts. The attacks on civilians are illustrated by SV. In 2011, studies in DRC estimated that 1 150 women are raped every day and that 30% of women have experienced conflict-related sexual violence (CRSV) over the past 16 years. In addition to physical suffering, survivors of CRSV must live with psychological consequences. Traumatic fistula, one of the most extreme consequences of SV, is well described in the literature, as its surgical management. In contrast, the literature and the government illustrate a lack of accurate data on the physical consequences such as pelvic dysfunction and psychologic disorders following these attacks. To be able to put in place adequate care, it is necessary to identify the conditions and needs of the victims.

Conditions

Sexual Violence; Woman Abuse; Perineal Injury

Outcome Measures

Primary Outcomes (4)

• Urinary aspects

  Urinary aspects will be assessed by one questionnaire: International Consultation on Incontinence Questionnaire Female Lower Urinary Tract SymptomsModules (ICIQ-FLUTS)

  At the test time

• Sexual aspects

  Sexual aspects will be assessed by one questionnaire: Female Sexual Function Index (FSFI)

  At the test time

• Pelvic and Perineal aspect

  Pelvic and Perineal aspect will be assessed by clinical examination made by a women assistant of the research team, physiotherapist expert on pelvic floor field • Examen of observation: presence of scars, lesions, inflammation, type of FGM as described by WHO classification and types of scars during external exam; Perineal pain, intensity and localization with Haslam and Laycock ring of continence, pelvic floor muscle tone with the Reissing tone scale which have a good interrater reliability for intra-vaginal manual assessment of pubococcygeus tone for expert examinator. Laycock's power, endurance, repetitions, fast contractions, every contraction timed (PERFECT) scale will be used for pelvic floor muscle assessment. The PERFECT scheme has demonstrated good reliability and validity as an assessment tool. .

  At the test time

• Ano-rectal aspect

  Two questionnaires will be used; one to assess anal incontinence (AI) and one for constipation * The St. Mark's Incontinence Score (SMIS) * The Knowles, Eccersley, Scott Symptom Score (KESS

  At the test time

Secondary Outcomes (2)

• Psychological aspect: will assessing with be PCL-5 questionnaire

  At the test time

• Quality of Life (QoL)

  At the test time

Other Outcomes (1)

• Sociodemographic characteristic data

  At the test time

Study Arms (2)

women victims of CRSV

* Inclusion criteria: Women victims of CRSV living in the places of enrolment in RDC, aged over 18 years and giving their consent to participate to this study. * Exclusion criteria: Pregnant women and women under 18 years old.

women without a history of CRSV

* Inclusion criteria: women without a history of CRSV living in the places of enrolment in RDC, aged over 18 years and giving their consent to participate to this study. * Exclusion criteria: Pregnant women and women under 18 years old.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women in RDC

Sponsors & Collaborators

• Bertuit Jeanne: lead
• University of Kinshasa: collaborator

Study Sites (1)

Betty Miangindula

Kinshasa, Democratic Republic of the Congo

RECRUITING

Central Study Contacts

Jeanne Bertuit, PhD

CONTACT

+41633738178; jeanne.bertuit@hesav.ch

Jeanne.bertuit Bertuit, PhD

CONTACT

+41633738178; jeanne.bertuit@hesav.ch

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: February 16, 2023
• Study Start: September 1, 2021
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: February 16, 2023

Record last verified: 2023-02

Locations

DE (1)