Federally-Funded Study Shows More Women Can Avoid Hysterectomy for Common Problem
CYPRESS, Calif., Dec. 27 /PRNewswire/ — A minimally invasive procedure
called endometrial ablation is as effective as hysterectomy in solving a
common female complaint called “dysfunctional uterine bleeding” or DUB,
according to a new federally-funded study published in the Journal of
Obstetrics and Gynecology.
DUB (dysfunctional uterine bleeding) can be described as abnormal
bleeding which cannot be attributed to abnormalities of the female
reproductive system, pharmacological interaction, intrauterine
contraception, or bleeding disorders. It is also referred to
The condition affects up to a third of all women at some point during
their reproductive years, usually women over age 30. It is characterized by
extremely heavy, erratic menstrual bleeding and is often accompanied by
fatigue, pelvic pain and decreased quality of life. The excessive blood
loss in DUB can provoke iron deficiency anemia.
“This is a very important study, proving that a minimally invasive
procedure — endometrial ablation — can solve the problem of excessive
bleeding as well as hysterectomy,” commented Franklin D. Loffer, M.D.,
Executive Vice President/Medical Director of AAGL, the professional
organization dedicated to the advancement of minimally-invasive gynecologic
surgery. “Women should always be offered the least invasive, effective
approach to solving her medical problems.”
While hysterectomy (the removal of the uterus and in some cases the
ovaries and cervix) has a long history of use to cure DUB, newer, less
invasive procedures have become available in recent years. These have
stirred controversy over whether hysterectomy is overused, particularly for
conditions such as DUB for which more conservative approaches may be just
as effective and cause fewer complications.
The new study, bearing the acronym of StopDUB for “Surgical Treatments
Outcomes Project for Dysfunctional Uterine Bleeding,” was a multi-center,
randomized, controlled trial in the U.S. and Canada involving 237 women at
25 treatment centers. The primary complaint causing women to seek surgery
was excessive bleeding that had not been mitigated by medical therapy.
These women were randomly assigned to receive either hysterectomy or
endometrial ablation, a minimally invasive technique that removes only the
lining of the uterus (the lining cells are responsible for the bleeding),
not the entire organ.
The primary measure of success in the study was women’s satisfaction
with their treatment, rather than just a clinical endpoint. After three
years of follow-up, the vast majority of patients in both groups (93-95%)
reported that their problem was solved. The secondary endpoints of pain and
fatigue were also similar between the hysterectomy group and the
endometrial ablation group.
“Using women’s satisfaction as the study goal, rather than clinical
endpoints alone, was very astute from our perspective, because the most
important outcome is the woman’s opinion, not the doctor’s,” said Dr.
Loffer. “Our view at AAGL is always patient-focused: how much pain will
there be, how much trauma, how much time lost, what impact on the quality
of life? These are the measures that count.”
Advantages of the less invasive procedure include shorter hospital
stays (hours instead of days), less blood loss, fewer complications and
quicker recovery. In many cases endometrial ablation causes menstrual
periods to become much lighter and more regular, rather than eliminating
them altogether. Many women consider this to be a satisfactory outcome and
would prefer to have normal periods rather than lose their uterus.
“Both endometrial ablation and hysterectomy are effective treatments in
women with dysfunctional uterine bleeding. However, hysterectomy was
associated with about four times more adverse events and six times as many
postoperative infections,” said Malcolm Munro, MD, an investigator in the
StopDUB Research Group at the David Geffen School of Medicine, University
of California Los Angeles. Dr. Munro is also an advisor to the AAGL.
The American College of Obstetricians and Gynecologists (ACOG)
recommends that treatment for menorrhagia begin with the least invasive
therapy. But, for some women, endometrial ablation may not solve their
“In this study about two thirds of women were able to avoid
hysterectomy by having an endometrial ablation procedure while about a
third of the patients who had received endometrial ablation ended up having
a hysterectomy several years later. This rate is comparable to that seen in
other studies,” said Munro.
About 600,000 hysterectomies are performed annually in the U.S., making
it the second most common major surgery performed on women of reproductive
age. There is controversy about how many of these hysterectomies are really
necessary. Clearly, 120,000 hysterectomies performed each year for DUB
(without uterine pathology) are amenable to endometrial ablation. Moreover,
many patients with uterine fibroids and abnormal bleeding can be treated
via endometrial ablation. Fibroids account for 40% of hysterectomies each
While some doctors may look for anemia as a diagnostic indicator for
DUB, in the StopDUB study women’s perception of their problem was the main
criterion, supported by clinical measures of excess duration, amount, or
unpredictability of flow. “We felt that women should not have to be anemic
in order to seek help and have their problem taken seriously,” said Munro.
“Based on our results, it is reasonable to recommend that women should
select the type of surgery they want for DUB, based on their preferences
and situations,” concluded Munro.
The AAGL is the first and largest organization in the world dedicated
to gynecologic endoscopic surgery. Founded in 1971, AAGL works to advance
the safest and most efficacious diagnostic and therapeutic techniques that
afford less invasive treatments for gynecologic conditions through the
integration of clinical practice, research, innovation, and dialogue. For
the past 36 years, the organization has educated the world’s finest
surgeons while improving the lives of women everywhere. This global
commitment to women’s health care is embodied in their continuing medical
education of physicians and professionals to further promote the
well-documented high standards of minimally invasive gynecologic surgery.
For more information visit http://www.aagl.org.