UNC Project
Lilongwe, Malawi
NCT Number: NCT02685878
The purpose of this study is to describe the long-term surgical success, quality of life, prevalence of depression, fertility rates, and pregnancy outcomes of patients who have undergone obstetric fistula repair.
This will be a study involving up to 300 women 1-3 years after they have undergone obstetric fistula repair at the Fistula Care Center in Lilongwe, Malawi.
Patients who underwent obstetric fistula repair between January 1, 2012 and July 31, 2014 will be identified from an existing database of fistula patients. They will then be contacted and invited to participate in the study. Consented patients will complete a 1-hour pad weight to evaluate urinary continence, a demographic questionnaire, an incontinence-related quality of life metric, and a depression metric. The data will be analyzed and then disseminated to stakeholders.
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Notify Me18 year and older
Female
Observational
Lilongwe, Malawi
Eligible participants will be identified from an existing, secure database. Participants will be contacted and traced. They will then be invited to participate in the study. If a participant agrees to participate in the study, they will undergo informed consent by trained study staff, using IRB-approved informed consent forms. They will then undergo a 1-hour pad weight, complete demographic data, complete an incontinence-related quality of life metric, and complete a depression metric.
1-hour pad weight: Use of the 1-hour pad weights have been recommended as an objective measure of treatment outcome for anti-incontinence procedures. After a woman has agreed to enroll in the study and has given written consent, she will be asked to complete a 1-hour pad weight. Pad weights will be measured through having participants sit on a pre-weighed pad for exactly one hour and re-weighing the same pad. The weight of the pad before and after will be recorded and the difference between the two will be used as the pad weight. The pad weight represents the degree of urinary leakage a woman is experiencing. In continent populations, this weight is <1.5 grams. The research assistant will use a calibrated portable scale and stopwatch to ensure accurate recording of these weights. During this time, the remainder of the survey will be conducted.
Demographic Data: Demographic data for each participant will be collected at the time of enrollment and after a written consent has been obtained. This includes information about the patient's age, place of residence, HIV status, education attainment, living arrangement, number of pregnancies and living children, and symptoms of urinary or fecal leakage.
Incontinence-related Quality of Life Metric: To assess OF repair success and continence, participants will be asked about any leakage symptoms with the Kings' Health Questionnaire.
Depression Metric:The 9-question Patient Health Questionnaire (PHQ-9) will be used to assess repaired OF participants for depression.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 1 hour
To assess OF repair success and continence, patients will complete a 1-hour pad weight, which correlates to urinary incontinence.
Time frame: 1-3 years after obstetric fistula repair
The PHQ-9 will be administered and women who score a 10 or greater will be considered to have major depression.
Time frame: 1-3 years after obstetric fistula repair
The number of women with any pregnancy since repair divided by the number of married, fecund women.
Time frame: 1-3 years after obstetric fistula repair
The number of women with a score over 0 in the each of the following domains of the King's Health Questionnaire: general health, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, and sleep/energy.
University of North Carolina, Chapel Hill
Other
Physical, Psychological, and Reproductive Outcomes of Women After Obstetric Fistula Repair
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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