Medical Devices & Surgical Technology Week

Federally-Funded Study Shows More Women Can Avoid Hysterectomy for Common Problem

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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 menometrorrhagia.

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 problem.

"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.

Keywords: Abnormal Bleeding, Bleeding Disorder, Clinical Trial Research, Contraception, Ecology, Endometrial Ablation, Fatigue, Gynecology, Hematology, Hysterectomy, Iron Deficiency, Iron-Deficiency Anemia, Menstruation, Obstetrics, Pharmaceuticals, Pharmacological, Quality of Life, Surgery, Therapy, Treatment, Women's Health, AAGL.

This article was prepared by Medical Devices & Surgical Technology Week editors from staff and other reports. Copyright 2008, Medical Devices & Surgical Technology Week via NewsRx.com.