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.