Physical, Psychological, and Reproductive Outcomes of Women After Obstetric Fistula Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 297
- 试验地点
- 1
- 主要终点
- The prevalence of participants with a 1-hour pad weight over 1.5 grams (marker of incontinence) will be be calculated.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
The prevalence of participants with a 1-hour pad weight over 1.5 grams (marker of incontinence) will be be calculated.
时间窗: 1 hour
To assess OF repair success and continence, patients will complete a 1-hour pad weight, which correlates to urinary incontinence.
次要结局
- Depression after obstetric fistula repair(1-3 years after obstetric fistula repair)