CONDITION AND TARGET POPULATION Abnormal
uterine bleeding is defined as an increase in the frequency of menstruation, duration of flow or amount of blood loss. (1) DUB is a diagnosis of exclusion when there is no pelvic pathology or underlying medical cause for the increased
bleeding. (1) It is characterized by heavy prolonged flow with or without
breakthrough bleeding. It may occur as frequent, irregular, or unpredictable
bleeding; lengthy menstrual periods;
bleeding between periods; or a heavy flow during periods.
Menorrhagia, cyclical HMB over several consecutive cycles during the reproductive years, is the most frequent form of DUB. The incidence of DUB has not been reported in the literature. For Ontario, an expert estimated that about 15% to 20% of women over 30 years have DUB. The prevalence increases with age and peaks just before menopause. (1) Using 2001 Ontario census-based population estimates, there are about 2 million women between the ages of 30 and 49 years; therefore, of these, about 290,965 to 387,953 may have DUB.
THE TECHNOLOGY BEING REVIEWED: THERMAL BALLOON
ENDOMETRIAL ABLATION Since the 1990s, second-generation
endometrial ablation (EA) techniques developed, the aim to provide simpler, quicker, and more effective treatment options for
menorrhagia compared with first-generation EA techniques and
hysterectomy. (2) Compared with first-generation techniques these depend less on the people operating them and more on the actual devices to ensure safety and efficacy.
TBEA relies on the transfer of heat from heated liquid within a balloon that is inserted into the uterus. (2) It does not require a
hysteroscope for direct visualization of the uterus and can be performed under
local anesthesia. In order to use
TBEA, patients with DUB cannot have a long (>10-12 cm) or irregularly shaped uterine cavity, because the balloon must be in direct contact with the uterine wall to cause ablation. For Ontario, an expert estimated that about 70% of patients with DUB considered for EA would have a uterus suitable for
TBEA based on these criteria. If 70% of Ontario women between 30 and 49 years of age with DUB have a uterus suitable for
TBEA, then about 203,675 to 271,567 women may be eligible. However, some of these women will be successfully treated by drugs or will want
amenorrhea (the cessation of their periods) and therefore choose to have a
hysterectomy.
REVIEW STRATEGY: A 2004 systematic review of the literature by Garside et al. (2) in the United Kingdom, found that overall, there were few significant differences between outcomes for first-generation techniques and
TBEA. The outcomes were
bleeding, postoperative complications, patient satisfaction, quality of life, and repeat surgery rates. Significant differences were reported most often by one study by Pellicano et al., (3) but this was a level 2 study with methodological weaknesses. Furthermore, according to Garside et al., there was considerable clinical and methodological heterogeneity among the studies in the systematic review. Therefore, a quantitative synthesis using meta-analysis was not done. In Garfield and colleagues' review:
TBEA had significantly shorter operating and theatre times (P < .05, < .01, and .0001).
TBEA had fewer intraoperative adverse effects (e.g., reported rates of
uterine perforation with RB ablation: from 1% to 5%;
TBEA: 0%; rates of cervical
laceration with RB: 2% to 5%;
TBEA 0%).They found no studies have directly compared second-generation techniques and
hysterectomy; therefore, the comparison can only be indirectly inferred from studies of first-generation techniques and
hysterectomy.Compared with
hysterectomy, TCRE and RB are quicker to perform and result in shorter hospitalization stays and a faster return to work.Hysterectomy results in more adverse effects.Satisfaction with
hysterectomy is initially higher, but there is no difference after 2 years.Studies (level 2 evidence) published after Garside's systematic review support these conclusions.A study with level 2 evidence reported a significantly higher risk overall of
intraoperative complications for RB compared with
TBEA (P < .001). This included
uterine perforation (RB, 5%;
TBEA, 0%) and suspicion of perforation (RB, 2%;
TBEA, 0%).A multicentre long-term case series (level 4 evidence) that examined avoidance of
hysterectomy after
TBEA for
menorrhagia reported that 86% of women who had
TBEA did not require a
hysterectomy, and 75% did not have any further surgery during a follow-up period of 4 to 6 years. (4)Several
TBEA studies did not provide justification for using
general anesthesia over
local anesthesia.Patient preferences for different treatments will depend on a woman's desire for
amenorrhea as an outcome and/or avoidance of major surgery.
Hysterectomy is the only procedure that can guarantee
amenorrhea.
TBEA will not totally replace
hysterectomy in the treatment of DUB, because some women may want cessation of menstruation.Ensuring that patient expectations are consistent with the outcomes achievable with
TBEA is important to obtain high levels of satisfaction. Vilos et al. (5) noted that up to one-half of patients who underwent a second attempt at
TBEA might have avoided the second procedure with proper preoperative counselling. Meyer et al. (6) noted that one consideration for patients with
menorrhagia (and no structural lesions) is to return to normal or less blood loss rather than
amenorrhea. Patients may have distinct concepts of menstrual
bleeding depending on cultural background, and maintaining an acceptable menstrual flow instead of
amenorrhea may represent a healthier status. (7)A budget impact analysis suggests that the net annual budget outlay for
TBEA would be between $1.4 million in savings and $2.8 million in additional outlays. (Note: Not all savings would be realized directly by the Ministry of Health and
Long-Term Care, because much of the savings would accrue to the global budgets of hospitals).
CONCLUSIONS: