Outcomes of Women After Obstetric Fistula Repair
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|ClinicalTrials.gov Identifier: NCT02685878|
Recruitment Status : Completed
First Posted : February 19, 2016
Last Update Posted : November 13, 2018
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.
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||297 participants|
|Official Title:||Physical, Psychological, and Reproductive Outcomes of Women After Obstetric Fistula Repair|
|Study Start Date :||September 2015|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||November 5, 2018|
- The prevalence of participants with a 1-hour pad weight over 1.5 grams (marker of incontinence) will be be calculated. [ Time Frame: 1 hour ]To assess OF repair success and continence, patients will complete a 1-hour pad weight, which correlates to urinary incontinence.
- Depression after obstetric fistula repair [ 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.
- Number of fertile women able to achieve pregnancy after fistula repair [ 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.
- Quality of life of women after fistula repair [ 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02685878
|Principal Investigator:||Jennifer Tang, MD||University of North Carolina, Chapel Hill|