Treatment outcomes | N (%), median [range] |
---|---|
NPV% directly after treatment | 66.5% [0–120.6] |
First 25 treatments: 21 fibroids | 44.6% [0–99.7]* |
Remaining treatments: 81 fibroids | 74.7% [0–120.6]** |
Adverse events per woman | |
Grade 1 adverse event on treatment day | 17/70 (24.2%) pain/nausea |
Grade 3b adverse event on treatment day | 1/70 (1.4%) 3th degree skin burn |
Grade 1 adverse event follow-up | 22/70 (31.4%) pain/ bleeding |
Grade 2 adverse event follow-up | 2/70 (2.9%) urinary tract infection |
Adverse events needing treatment | 3/70 (4.3%) antibiotics/operation |
Volume decrease in fibroids with an available MRI scan at 6-month follow-up | 42.4% [− 173.2 to 100] |
First 25 treatments: 14 fibroids | 31.7% [7.1–62.2] |
Remaining treatments: 70 fibroids | 48.3% [− 173.2 to 100] |
Reintervention rate per woman | 19/70 (27.1%) |
Hysterectomy | 10/19 (52.6%) |
Myosure | 2/19 (10.5%) |
UAE | 4/19 (21.1%) |
MR-HIFU | 4/19 (21.1%) |
First 22 women | 10/22 (45.5%) |
Remaining 48 women | 9/48 (18.8%) |
Moment of reintervention | 8 months [1–27] |
Follow-up duration | 24 months [14–44] |
Failure of treatment | 19/76 (25.0%) |
First 25 treatments | 12/25 (48.0%) |
Remaining 48 treatments | 7/51 (13.7%) |
Kind of failures | |
Treatment | 13/19 (68.4%) |
Heating | 6/19 (31.6%) |