188: Novasure Impedance Controlled Endometrial Ablation System. Long-Term Follow-Up Results

Abstract

Study ObjectiveAssess the efficacy and safety of the NovaSure system in women with severe menorrhagia secondary to DUB.DesignA prospective, single-arm, pilot study.SettingSt. Imre Teaching Hospital, Budapest, Hungary.PatientsSeventy-five pre-menopausal women with menorrhagia secondary to DUB.InterventionEndometrial ablation using NovaSure Impedance Controlled Endometrial Ablation System.Measurements and Main ResultsNo intra-operative or post-operative complications were observed. Treatment time averaged 90 seconds. The results over the course of follow-up are as follows: at 12 (n=75), 24 (n=74), 36 (n=69), 48 (n=68), 60 (n=57), 72 (n=41) and 84 (n=21) months of follow-up amenorrhea was reported by 72%, 73%, 75%, 75%, 82%, 90% and 95% of patients, with reduction in bleeding to normal or less observed in 96%, 98%, 100%, 100%, 98%, 100% and 100% respectively. Six patients (all treatment successes) underwent hysterectomy due to pelvic pain. Five were diagnosed with adenomyosis and/or endometriosis and one with fibroids. One patient underwent a repeat (rollerball) ablation.ConclusionLong-term follow-up results demonstrate that the NovaSure procedure is very effective and allows for sound data durability. Hysterectomy due to menorrhagia was avoided in 100% of cases and in 92% of cases for all other reasons. Additional long term follow-up data will be available and presented at the time of the meeting. Study ObjectiveAssess the efficacy and safety of the NovaSure system in women with severe menorrhagia secondary to DUB. Assess the efficacy and safety of the NovaSure system in women with severe menorrhagia secondary to DUB. DesignA prospective, single-arm, pilot study. A prospective, single-arm, pilot study. SettingSt. Imre Teaching Hospital, Budapest, Hungary. St. Imre Teaching Hospital, Budapest, Hungary. PatientsSeventy-five pre-menopausal women with menorrhagia secondary to DUB. Seventy-five pre-menopausal women with menorrhagia secondary to DUB. InterventionEndometrial ablation using NovaSure Impedance Controlled Endometrial Ablation System. Endometrial ablation using NovaSure Impedance Controlled Endometrial Ablation System. Measurements and Main ResultsNo intra-operative or post-operative complications were observed. Treatment time averaged 90 seconds. The results over the course of follow-up are as follows: at 12 (n=75), 24 (n=74), 36 (n=69), 48 (n=68), 60 (n=57), 72 (n=41) and 84 (n=21) months of follow-up amenorrhea was reported by 72%, 73%, 75%, 75%, 82%, 90% and 95% of patients, with reduction in bleeding to normal or less observed in 96%, 98%, 100%, 100%, 98%, 100% and 100% respectively. Six patients (all treatment successes) underwent hysterectomy due to pelvic pain. Five were diagnosed with adenomyosis and/or endometriosis and one with fibroids. One patient underwent a repeat (rollerball) ablation. No intra-operative or post-operative complications were observed. Treatment time averaged 90 seconds. The results over the course of follow-up are as follows: at 12 (n=75), 24 (n=74), 36 (n=69), 48 (n=68), 60 (n=57), 72 (n=41) and 84 (n=21) months of follow-up amenorrhea was reported by 72%, 73%, 75%, 75%, 82%, 90% and 95% of patients, with reduction in bleeding to normal or less observed in 96%, 98%, 100%, 100%, 98%, 100% and 100% respectively. Six patients (all treatment successes) underwent hysterectomy due to pelvic pain. Five were diagnosed with adenomyosis and/or endometriosis and one with fibroids. One patient underwent a repeat (rollerball) ablation. ConclusionLong-term follow-up results demonstrate that the NovaSure procedure is very effective and allows for sound data durability. Hysterectomy due to menorrhagia was avoided in 100% of cases and in 92% of cases for all other reasons. Additional long term follow-up data will be available and presented at the time of the meeting. Long-term follow-up results demonstrate that the NovaSure procedure is very effective and allows for sound data durability. Hysterectomy due to menorrhagia was avoided in 100% of cases and in 92% of cases for all other reasons. Additional long term follow-up data will be available and presented at the time of the meeting.