NEW YORK, April 21, 2015 /PRNewswire-USNewswire/ -- EngenderHealth, a leading global women's health organization, announced publication of study results in The Lancet that have the potential to dramatically improve standards of care following obstetric fistula repairs. By demonstrating that short-duration catheterization is safe and effective in appropriate cases, the large-scale study, conducted by EngenderHealth's Fistula Care Project (now Fistula Care Plus) in collaboration with the World Health Organization (WHO), will inform current clinical practice, improve quality of care and allow for greater access to surgery.
Although rare in many parts of the world, obstetric fistula remains a devastating childbirth injury among women who lack access to quality health care, primarily in Africa and Asia. To date, the evidence base for procedures related to fistula repair surgery is limited, and practices vary widely. Implementation of these findings will shorten the duration of catheterization, reduce discomfort and side effects for women, lower costs, shorten women's hospital stays, and enable treatment of more women at facilities limited by bed space.
"These findings provide a major step forward in standardizing care and improving treatment for women," said Dr. Joseph Ruminjo, clinical director of EngenderHealth's Fistula Care Plus project. "We hope that with continued research, along with enhanced prevention, access to treatment and reintegration efforts, we can along with our partners achieve the long-term goal: to make fistula a rare event for future generations."
Duration of bladder catheterization is the primary contributor to the length of a woman's hospital stay following fistula repair surgery. The trial randomized 524 participants in need of simple fistula repair to seven-day versus 14-day catheterization at eight sites across eight African countries. It found no negative consequences when seven-day catheterization was used and no advantages to catheterizing women for longer periods of time.
"We worked with a broad range of partners to prioritize research that will have the greatest immediate impact," said Dr. Ahmet Metin Gulmezoglu, WHO. "These findings can be easily put into practice, but will have the tremendous gain of allowing women to return to their daily lives more quickly and with less strain, as well as accommodating more surgical repairs."
This study's multicenter randomized controlled trial design provides one of the strongest types of research evidence. The Fistula Care Plus project is now developing a clinical guideline to enable health care providers to incorporate the study findings into their services for women with fistula.
Obstetric fistula is typically caused by obstructed labor, after which the infant is most often stillborn and the woman is left with a hole in the birth canal that makes her incontinent. While largely preventable, 1 to 2 million women are believed to be in current need of fistula repair. Women with obstetric fistula are sometimes abandoned or neglected by their husbands and families, often are unable to work, and may be ostracized by their communities.
This study was made possible through the U.S. Agency for International Development (USAID)-supported Fistula Care Plus project.
About the Study
This randomized, controlled, open-label, non-inferiority trial was performed at eight hospitals in eight African countries between January 2012 and August 2013. Participants diagnosed with simple fistula were randomized into two groups: bladder catheterization for seven days (n=261) or for 14 days (n=263) after fistula repair surgery. The primary outcome was fistula repair breakdown at any time between eight days following catheter removal and three months post-surgery. Results demonstrated that seven-day catheterization is not inferior to 14-day catheterization in women recuperating from uncomplicated fistula surgery. Rates of repair breakdown were 4.0% (10/250; 95% CI 2.1–7.5) in the seven-day group and 3.2% (8/251; 95% CI 1.5–6.4) in the 14-day group (RD 0.8%, 95% CI -2.8–4.5). There was no evidence of significant differences between the groups in such secondary outcomes as urinary retention during hospital stay, infections, febrile episodes, prolonged hospitalization, or residual incontinence at three months.
About Fistula Care Plus
Fistula Care Plus is a five-year fistula repair and prevention project managed by EngenderHealth and funded by the U.S. Agency for International Development. It builds on, enhances, and expands the work undertaken by the previous Fistula Care project (2007–2013). With appropriate resources, awareness, knowledge, and strong health systems for prevention, treatment, and reintegration, fistula can become a rare event for future generations. EngenderHealth's partners in Fistula Care Plus are the Population Council, Dimagi, Direct Relief, Fistula Foundation, the Maternal Health Task Force, and TERREWODE. Visit www.fistulacare.org for more information.
EngenderHealth is a leading global women's health organization committed to ensuring that every pregnancy is planned, every child is wanted, and every mother has the best chance at survival. In 20 countries around the world, we train health care professionals and partner with governments and communities to make high-quality family planning and sexual and reproductive health services available—today and for generations to come. Visit www.engenderhealth.org for more information.