Sexual ViolenceSV-RDCNCT05731297
Consequences of Sexual Violence Among Women Living in Democratic Republic of Congo
An observational study of Sexual Violence and Woman Abuse, run by Bertuit Jeanne at 1 site in Democratic Republic of the Congo.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Sexual Violence, Woman Abuse, Perineal Injury
- How many people
- 742 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- 1 Sep 2021to Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Study population: Women in RDC
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.
-
Exclusion Criteria:- Pregnant women and women under 18 years old.
-
Trial locations and contacts
1 site in 1 country.
Democratic Republic of the Congo1 site, 1 recruiting
- Recruiting
Betty Miangindula
Kinshasa
Betty Miangindula, PhD, +41633738178, Betty Miangindula <betty.miangindula@unikin.ac.cd>
Jeanne Bertuit, PhD, +41633738178, jeanne.bertuit@hesav.ch
About this study
Official title: Perineal, Psychological and Well-beeing Consequences of Conflict-related Sexual Violence Among Women Living in Democratic Republic of Congo
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.
Read the detailed 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).
- Conditions
- Sexual Violence, Woman Abuse, Perineal Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary aspects
Urinary aspects will be assessed by one questionnaire: International Consultation on Incontinence Questionnaire Female Lower Urinary Tract SymptomsModules (ICIQ-FLUTS)
Measured: At the test time
Sexual aspects
Sexual aspects will be assessed by one questionnaire: Female Sexual Function Index (FSFI)
Measured: 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.
.
Measured: 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
Measured: At the test time
Secondary outcomes (2)
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)
Measured: At the test time
Quality of Life (QoL)
The Medical Outcomes Study MOS 36-Item Short Form Health Survey (SF-36)
Measured: At the test time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start1 Sep 2021
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual ViolenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 742 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bertuit Jeanne
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kinshasa
- Responsible party
- Sponsor-investigator, Bertuit Jeanne, University of Applied Sciences of Western Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05731297
- Sponsor's protocol ID
- 2021-01
- Acronym
- SV-RDC
- Status last verified
- Feb 2023
- First submitted
- 20 Jan 2023
- Last updated
- 16 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perineal, Psychological and Well-beeing Consequences of Conflict-related Sexual Violence Among Women Living in Democratic Republic of Congo
- ClinicalTrials.gov ID
- NCT05731297
- Acronym / sponsor ID
- SV-RDC / 2021-01
- Conditions
- Sexual Violence, Woman Abuse, Perineal Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 742 participants (estimated)
- Lead sponsor
- Bertuit JeanneUniversity, hospital or other
- Collaborators
- University of Kinshasa
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 16 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Women in RDC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Urinary aspects
Time frame: At the test time
Urinary aspects will be assessed by one questionnaire: International Consultation on Incontinence Questionnaire Female Lower Urinary Tract SymptomsModules (ICIQ-FLUTS)
Sexual aspects
Time frame: At the test time
Sexual aspects will be assessed by one questionnaire: Female Sexual Function Index (FSFI)
Pelvic and Perineal aspect
Time frame: At the test time
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. .
Ano-rectal aspect
Time frame: At the test time
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
2 secondary outcomes
Psychological aspect: will assessing with be PCL-5 questionnaire
Time frame: At the test time
Quality of Life (QoL)
Time frame: At the test time
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sexual Violence and Woman Abuse, run by Bertuit Jeanne at 1 site in Democratic Republic of the Congo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeanne Bertuit, PhD (+41633738178, jeanne.bertuit@hesav.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary aspects (time frame: At the test time). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.