R01HD101570

Identifying Opportunities for Prevention of Adverse Outcomes Following Female Genital Fistula Repair - Abstract

Female genital fistula is a debilitating injury that affects 2 to 3 million women, mostly in Sub-Saharan Africa. Women with fistula have uncontrollable leakage of urine and/or feces (among other physical symptoms), are heavily stigmatized, and experience high psychiatric morbidity.

Preliminary evidence has identified the risk of fistula recurrence, incontinence, and pregnancy complications following fistula repair. However, the evidence base regarding the factors contributing to these adverse outcomes is severely underdeveloped, limiting the development of clinical interventions to reduce these risks to women. This prevents them from re-experiencing the consequences of fistula and improving pregnancy outcomes and quality of life.

In an effort to improve the physical and psychosocial quality of life for women affected by fistula, we propose to address the critical gaps in knowledge on the risk of adverse outcomes following fistula repair. This will be done by conducting a longitudinal cohort study of 800 women repaired for fistula in 9 Ugandan facilities.

We seek to achieve the following aims:

1. Identify predictors of post-repair fistula breakdown and recurrence.
2. Identify predictors and characteristics of post-repair incontinence.
3. Engage key stakeholders in a theory-guided iterative process to develop a roadmap of intervention strategies likely to be feasible and acceptable within this setting.

Our approach overcomes limitations of prior research by employing a longitudinal design, focusing on a broad range of patient, fistula, and behavioral characteristics, and enrolling the largest number of women (800) with the longest follow-up (3 years) to date for robust estimation.

Data will be collected at the time of surgery and at 2 weeks, 6 weeks, 3 months, and quarterly thereafter for 3 years. This will be done through a combination of interview-administered patient questionnaires and structured medical record abstraction. Clinical exams will be conducted per standard of care and as necessary based on symptom experiences.

In-depth interviews with key stakeholders (approximately 80 participants, including longitudinal participants and a range of other important roles) guided by prevalent behavior and implementation change theories will help us understand facilitators and barriers of behavior and implementation targets. This will inform potential intervention strategies at multiple levels.

Our sample size will allow us to detect a minimum difference in effect of 20% for all outcomes. Analyses will describe and estimate the individual and joint effects of patient, fistula, fistula repair, and post-repair characteristics on the incidence of post-repair fistula breakdown and recurrence, as well as incontinence. Proportional hazards frailty survival models will be used for these analyses.

The findings of our study will inform counseling and clinical care models for optimizing post-repair outcomes for women following fistula repair.

San Francisco Regents Of The University Of California

TO CONDUCT AND SUPPORT LABORATORY RESEARCH, CLINICAL TRIALS, AND STUDIES WITH PEOPLE THAT EXPLORE HEALTH PROCESSES. NICHD RESEARCHERS EXAMINE GROWTH AND DEVELOPMENT, BIOLOGIC AND REPRODUCTIVE FUNCTIONS, BEHAVIOR PATTERNS, AND POPULATION DYNAMICS TO PROTECT AND MAINTAIN THE HEALTH OF ALL PEOPLE. TO EXAMINE THE IMPACT OF DISABILITIES, DISEASES, AND DEFECTS ON THE LIVES OF INDIVIDUALS. WITH THIS INFORMATION, THE NICHD HOPES TO RESTORE, INCREASE, AND MAXIMIZE THE CAPABILITIES OF PEOPLE AFFECTED BY DISEASE AND INJURY. TO SPONSOR TRAINING PROGRAMS FOR SCIENTISTS, DOCTORS, AND RESEARCHERS TO ENSURE THAT NICHD RESEARCH CAN CONTINUE. BY TRAINING THESE PROFESSIONALS IN THE LATEST RESEARCH METHODS AND TECHNOLOGIES, THE NICHD WILL BE ABLE TO CONDUCT ITS RESEARCH AND MAKE HEALTH RESEARCH PROGRESS UNTIL ALL CHILDREN, ADULTS, FAMILIES, AND POPULATIONS ENJOY GOOD HEALTH. THE MISSION OF THE NICHD IS TO ENSURE THAT EVERY PERSON IS BORN HEALTHY AND WANTED, THAT WOMEN SUFFER NO HARMFUL EFFECTS FROM REPRODUCTIVE PROCESSES, AND THAT ALL CHILDREN HAVE THE CHANCE TO ACHIEVE THEIR FULL POTENTIAL FOR HEALTHY AND PRODUCTIVE LIVES, FREE FROM DISEASE OR DISABILITY, AND TO ENSURE THE HEALTH, PRODUCTIVITY, INDEPENDENCE, AND WELL-BEING OF ALL PEOPLE THROUGH OPTIMAL REHABILITATION.

93.865 - Child Health and Human Development Extramural Research

National Institute of Child Health and Human Development (NICHD) [HHS - NIH]

San Francisco, California 94143 United States

Single Zip Code

Research Project Grant (Parent R01 Clinical Trial Not Allowed) (PA-19-056)

Amendment Since initial award the total obligations have increased 410% from $598,958 to $3,054,428.