Clinical evaluation of long-term safety and effectiveness of a third-generation thermal uterine balloon therapy system for heavy menstrual bleeding
Journal of Minimally Invasive Gynecology, 06/29/2012
Cash C et al. – At extended 36–month follow–up, results were similar to the previously reported results at 1 year using prospectively defined matched–pair analysis, and demonstrated superiority in treating amenorrhea using the third–generation UBT system vs the first–generation UBT system.Methods
- Thirteen hospitals: 12 in the United States and 1 in Mexico.
- Two–hundred fifty premenopausal women aged at least 30 years with heavy menstrual bleeding not responsive to previous medical therapy for at least 3 months.
- After treatment with a third–generation thermal UBT system, patients were randomly assigned to receive post–procedure curettage (PPC) or no PPC.
- Amenorrhea was estimated at 12 months using individual success defined by a pictorial blood loss assessment chart score of 0, and at 24– and 36–month follow–up by patient response of amenorrhea on a 5–point scale (amenorrhea, spotting, and light, normal, or excessive bleeding).
- In the intention–to–treat population, at 36 months after ablation, the amenorrhea rate was 26.8% with the third–generation UBT system, and 13.0% with the first–generation UBT system.
- Results by assigned intervention were 29.8% in the no PPC group vs 23.8% in the PPC group.