-- Potential to Impact Treatment of 2 Million Women Living
with Devastating Childbirth Injury
NEW YORK, April 22, 2015 /PRNewswire/
-- 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.
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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.
About EngenderHealth
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.