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

Sexual Violence Clinical Trial

— SV-RDC  

Official title:

Perineal, Psychological and Well-beeing Consequences of Conflict-related Sexual Violence Among Women Living in Democratic Republic of Congo

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05731297
• Other study ID #: 2021-01
• Status: Recruiting
• Start date: September 1, 2021
• Est. completion date: September 2025

Study information

• Verified date: February 2023
• Source: University of Applied Sciences of Western Switzerland
• Contact: Jeanne Bertuit, PhD
• Phone: +41633738178
• Email: jeanne.bertuit[@]hesav.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The project to collaborate with the DRC is initiated from an ambition of the pelvic-perineal rehabilitation unit of the Department of Physical Medicine and Rehabilitation (Faculty of Medicine, University of Kinshasa) to change the situation in relation to women and to be able to offer adequate care for this population. The project is part of collaboration with two investigators: Professor Miangindula (Université de Kinshasa, UNIKIN) in DRC and Professor Bertuit (HESAV-HES-SO) in Lausanne (Switzerland). Four partners will take part in the project enabling a competent and strong team: Professor Feipel and Professor Foucart (Université Libre de Bruxelles, ULB) in Brussels (Belgium), Doctor Abdulcadir (Hôpital Universitaire de Genève, HUG) and Professor Mukwege in Bukavu (DRC). This project pursues two objectives: firstly, to assess clinical data of pelvic floor dysfunction (pelvic floor muscle function and urinary, sexual, gynaecological, and anal function) and psychological level in women victims of CRSV compared to women not victims of CRSV in the DRC. Secondly, to investigate the current care modalities and to analyse their needs (access to care, community integration, physiotherapy, etc.) and to understand the global context of care in DRC. The project will contribute to scientific capacity building by involving two PhD students in this research. A mixed method research will include a quantitative design, an observational study in a sample of women victims of CRSV (n = 371) and a control group of women not victims of CRSV (n = 371). Outcomes on urinary, sexual, gynaecological, anorectal and psychological aspects will be collected. This study includes a qualitative study with a phenomenological approach. Individual semi-structured interviews will be conducted with women victims of CRSV (n=10). Interview topics will be complemented with quantitative data and will lead to the following themes: experiences of CRSV, consequences of CRSV on body image, and modalities and needs for caring of these consequences. Two focus groups including eight medical health professionals will complete the qualitative data collection. The project will be realized over three years in the most affected provinces of the DRC: South and North Kivu. The method for cross-referencing data will be the Sequential Explanatory Method described by Creswell (2013).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 742
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:- Women victims of CRSV and 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.

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Exclusion Criteria:- Pregnant women and women under 18 years old.

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Related Conditions & MeSH terms

• Sexual Violence
• Woman Abuse

Locations

Country	Name	City	State
Congo, The Democratic Republic of the	Betty Miangindula	Kinshasa

Sponsors (2)

Lead Sponsor	Collaborator
Bertuit Jeanne	Université de Kinshasa

Country where clinical trial is conducted

Congo, The Democratic Republic of the, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sociodemographic characteristic data	Sociodemographic characteristic data will be collected with the following variables: age, marital status, the number of pregnancies, presence of traditional genital mutilation, presence of sexual violence and CRSV (age of aggression, type of sexual violence, the moment and number of sexual violence and aggressors), education, residence, parity, nationality and tribes.	At the test time
Primary	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
Primary	Sexual aspects	Sexual aspects will be assessed by one questionnaire: Female Sexual Function Index (FSFI)	At the test time
Primary	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
Primary	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	Psychological aspect: will assessing with be PCL-5 questionnaire	Psychological aspect: will assessing with be PCL-5 questionnaire The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)	At the test time
Secondary	Quality of Life (QoL)	The Medical Outcomes Study MOS 36-Item Short Form Health Survey (SF-36)	At the test time