OBJECTIVE: To test the hypothesis that treating dysfunctional uterine bleeding by automated application of electrothermal energy to the uterine cavity, with precise regional control, might yield results equivalent to those reported for hysteroscopically directed laser and electrosurgical endometrial ablations. MATERIALS AND METHODS: Patients with life style compromising menorrhagia, referred to six gynecologic surgical centers for hysterectomy or endometrial ablation, were admitted to the study if they had normal cervical cytology, a benign endometrial biopsy, no defined cause for their bleeding, and consented to participate in the evaluation of a newly developed Vesta DUB Treatment System. The device consists of a silicone-inflatable electrode carrier to be inserted into the uterine cavity and a controller to monitor and distribute current from a matched electrosurgical generator. Treatment involved a 3-minute or shorter warm-up period and a 4-minute treatment phase. RESULTS: Three- to 24-month follow-up data were available for 187 patients, with a mean follow-up of 14.8 months. The amenorrhea rate was 38%. Bleeding was reduced in 95% of patients. Actuarially, 88 +/- 3% of patients should expect to be free of menorrhagia, dissatisfaction, or need for a second procedure out to 24 months. CONCLUSIONS: The unique regional feed-back control offered by this system causes thorough, evenly distributed, thermal destruction 4-5 mm into the myometrium that reduces bleeding with durability equivalent to published reports of hysteroscopic endometrial ablation.
OBJECTIVE: To test the hypothesis that treating dysfunctional uterine bleeding by automated application of electrothermal energy to the uterine cavity, with precise regional control, might yield results equivalent to those reported for hysteroscopically directed laser and electrosurgical endometrial ablations. MATERIALS AND METHODS:Patients with life style compromising menorrhagia, referred to six gynecologic surgical centers for hysterectomy or endometrial ablation, were admitted to the study if they had normal cervical cytology, a benign endometrial biopsy, no defined cause for their bleeding, and consented to participate in the evaluation of a newly developed Vesta DUB Treatment System. The device consists of a silicone-inflatable electrode carrier to be inserted into the uterine cavity and a controller to monitor and distribute current from a matched electrosurgical generator. Treatment involved a 3-minute or shorter warm-up period and a 4-minute treatment phase. RESULTS: Three- to 24-month follow-up data were available for 187 patients, with a mean follow-up of 14.8 months. The amenorrhea rate was 38%. Bleeding was reduced in 95% of patients. Actuarially, 88 +/- 3% of patients should expect to be free of menorrhagia, dissatisfaction, or need for a second procedure out to 24 months. CONCLUSIONS: The unique regional feed-back control offered by this system causes thorough, evenly distributed, thermal destruction 4-5 mm into the myometrium that reduces bleeding with durability equivalent to published reports of hysteroscopic endometrial ablation.