Transvaginal Doppler-guided uterine artery occlusion for the treatment of symptomatic fibroids: summary results from two pilot studies.

OBJECTIVE: To evaluate the feasibility, safety, and short-term efficacy of bilateral uterine artery occlusion, using a transvaginal Doppler-guided vascular clamp as a minimally invasive therapy for symptomatic uterine leiomyomas. METHODS: We conducted two prospective, non-randomized, phase I pilot studies (Canadian Task Force Classification II-2) at a university-affiliated teaching hospital. Between June 2004 and May 2005, 30 premenopausal women with symptomatic uterine leiomyomas underwent bilateral uterine artery occlusion using a transvaginal Doppler-guided vascular clamp. Bilateral uterine artery occlusion was performed for 5.8 +/- 1.4 hours in the first 17 patients (Group 1) and from 6 to 9 hours (mean 7.05 +/- 1.0 hours) in the latter 13 patients (Group 2). Outcome measures included dominant fibroid volume (cm(3)), uterine volume (cm(3)), and improvement of menorrhagia at one, three, and six months. RESULTS: Bilateral occlusion of the uterine arteries was achieved in all 30 patients. In Group 1, the Ruta Menorrhagia Severity Scores decreased from baseline by 16%, 22% and 39% at one, three, and six months respectively. The dominant fibroid (DF) and uterine volumes decreased by 24% and 16% respectively at six months. In Group 2, the Ruta scores changed from baseline by +3%, -24%, and -42% at one, three, and six months respectively. The DF and uterine volumes decreased by 29% and 16%, respectively at six months. CONCLUSION: Following bilateral uterine artery occlusion using a transvaginal Doppler clamp, the dominant fibroid volume decreased by an average of 24%, uterine volume decreased by 12%, and menorrhagia symptoms were reduced by up to 42%. Uterine artery occlusion may provide the gynaecologist with an alternative to uterine artery embolization (UAE). The system is simple, easy to apply, and short-term efficacy may be equivalent to UAE.

Economic evaluation of uterine artery embolization versus hysterectomy in the treatment of symptomatic uterine fibroids: results from the randomized EMMY trial.

PURPOSE: To investigate whether uterine artery embolization (UAE) is a cost-effective alternative to hysterectomy for patients with symptomatic uterine fibroids, the authors performed an economic evaluation alongside the multicenter randomized EMMY (EMbolization versus hysterectoMY) trial. MATERIALS AND METHODS: Between February 2002 and February 2004, 177 patients were randomized to undergo UAE (n = 88) or hysterectomy (n = 89) and followed up until 24 months after initial treatment allocation. Conditional on the equivalence of clinical outcome, a cost minimization analysis was performed according to the intention to treat principle. Costs included health care costs inside and outside the hospital as well as costs related to absence from work (societal perspective). Cumulative standardized costs were estimated as volumes multiplied with prices. The nonparametric bootstrap method was used to quantify differences in mean (95% confidence interval [CI]) costs between the strategies. RESULTS: In total, 81 patients underwent UAE and 75 underwent hysterectomy. In the UAE group, 19 patients (23%) underwent secondary hysterectomies. The mean total costs per patient in the UAE group were significantly lower than those in the hysterectomy group ($11,626 vs $18,563; mean difference, -$6,936 [-37%], 95% CI: -$9,548, $4,281). The direct medical in-hospital costs were significantly lower in the UAE group: $6,688 vs $8,313 (mean difference, -$1,624 [-20%], 95% CI: -$2,605, -$586). Direct medical out-of-hospital and direct nonmedical costs were low in both groups (mean cost difference, $156 in favor of hysterectomy). The costs related to absence from work differed significantly between the treatment strategies in favor of UAE (mean difference, -$5,453; 95% CI: -$7,718, -$3,107). The costs of absence from work accounted for 79% of the difference in total costs. CONCLUSIONS: The 24-month cumulative cost of UAE is lower than that of hysterectomy. From a societal economic perspective, UAE is the superior treatment strategy in women with symptomatic uterine fibroids.

Uterine arterial embolization for the management of leiomyomas: quality-of-life assessment and clinical response.

PURPOSE: To determine the effectiveness of uterine arterial embolization as a primary therapy in the management of symptomatic leiomyomas. MATERIALS AND METHODS: Uterine arterial embolization was performed in 53 patients (age range, 33-58 years) with menorrhagia, bulk-related symptoms (frequency of urination, sensation of pressure, sensation of mass), or both, due to leiomyomas. The effectiveness of this therapy in the control of symptoms and the patients' acceptance of the treatment were measured by means of the information from patient interviews 3 months after the procedure. RESULTS: Fifty-two (98%) of the 53 patients had technically successful procedures and were interviewed 3 months after embolization. Forty-six (88%) of these patients reported marked improvement in their abnormal bleeding. Twenty-nine (94%) of the 31 patients with bulk-related symptoms reported marked improvement in these symptoms. Follow-up ultrasonographic examinations showed a mean 46% reduction in uterine volume. Forty-one patients interviewed (79%) would choose this procedure again, eight (15%) would consider choosing this procedure again, and only three (6%) would choose another treatment option. CONCLUSION: Uterine arterial embolization is an effective therapy in the management of symptomatic leiomyomas and may prove to be a valuable alternative to myomectomy, hysterectomy, or other surgical procedures. Further investigation is warranted.

Other medical management of uterine fibroids.

Several medicines are emerging with the potential to treat symptomatic uterine fibroids. Anti-progesterone compounds seem particularly promising. These drugs have been widely used for nearly 20 years and are known to be safe; medical politics have prevented their proper investigation for uterine fibroids. In particular, the value of mifepristone, 50 mg per day for 3 months, seems particularly promising. Further investigation is clearly warranted for this medicine. Several anti-oestrogen compounds have recently become available and may also be useful for the medical treatment of symptomatic uterine fibroids. This includes the possibility of the use of selective oestrogen receptor modulators as well as the prospect of the use of pure anti-oestrogens. On a longer time frame, inhibitors of angiogenesis may be useful. These medicines would act upon the blood supply to uterine fibroids. Physicians also have an obligation to investigate scientifically any promising naturopathic treatment that appears to have possible activity for symptomatic fibroids.