Trial Information

A Randomized Trial Comparing Laparoscopic Bilateral Occlusion of Uterine Vessels to Uterine Fibroid Embolization for the Treatment of Symptomatic Uterine Fibroids

Uterine fibroid embolization (UFE)has become an alternative to hysterectomy for women with
symptoms of uterine fibroids.Follow up studies of this new method have reported relief of
menstrual bleeding by 85-90 % of the patients six to twelve months after treatment.Other
studies have suggested laparoscopic bilateral occlusion of uterine arteries as an equal
effective alternative, but to our knowledge there is no randomized studies published.

Patients recruitment : Women with symptoms of uterine fibroids referred to the clinic,who
express a desire to avoid hysterectomy.

Study hypothesis: Laparoscopic occlusion of uterine vessels and UFE have equal effect on
bleeding symptoms.

Gynecological examination, ultrasonography and magnetic resonance imaging (MRI) are
performed preoperatively and after 1,3 and 6 months. Clinical follow up is planned after
1,3,6,12,24,36 and 60 months.A validated bleeding chard, Pictorial Blood Assessment
Chart(PBAC)is filled in by the participants during the last menstruation period before
treatment and before each control. A standardized questionnaire to assess the bleeding
amount,pressure symptoms, pain, adverse events, other complains and patients satisfaction is
also used.