Outcomes of Women After Obstetric Fistula Repair
Physical, Psychological, and Reproductive Outcomes of Women After Obstetric Fistula Repair
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.
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Lilongwe, Malawi
- UNC Project
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Study participants who have had an obstetric fistula repair performed at the Fistula Care Center between January 1, 2012 and July 31, 2014
- Women that currently reside within the districts of Lilongwe, Dedza, Kasungu, Salima, Dowa, Ntcheu, Nkhotakota, Mchinji, Ntchisi, and Mzimba will be traced.
- Ability to speak Chichewa or English fluently
- Current age 18 years or above
Exclusion Criteria:
- Participants who did not have an obstetric fistula repair
- Participants who have deceased since their obstetric fistula repair
- Participants who do not currently reside within the districts of Lilongwe, Dedza, Kasungu, Salima, Dowa, Ntcheu, Nkhotakota, Mchinji, Ntchisi, and Mzimba
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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The prevalence of participants with a 1-hour pad weight over 1.5 grams (marker of incontinence) will be be calculated.
Tidsramme: 1 hour
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To assess OF repair success and continence, patients will complete a 1-hour pad weight, which correlates to urinary incontinence.
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1 hour
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Depression after obstetric fistula repair
Tidsramme: 1-3 years after obstetric fistula repair
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The PHQ-9 will be administered and women who score a 10 or greater will be considered to have major depression.
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1-3 years after obstetric fistula repair
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Number of fertile women able to achieve pregnancy after fistula repair
Tidsramme: 1-3 years after obstetric fistula repair
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The number of women with any pregnancy since repair divided by the number of married, fecund women.
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1-3 years after obstetric fistula repair
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Quality of life of women after fistula repair
Tidsramme: 1-3 years after obstetric fistula repair
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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.
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1-3 years after obstetric fistula repair
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Jennifer Tang, MD, University of North Carolina, Chapel Hill
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- UNCPM 21502
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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