Milton H Goldrath1. 1. Department of Obstetrics and Gynecology, Wayne State University, Detroit, Michigan, USA.
Abstract
STUDY OBJECTIVE: To compare the safety and efficacy of endometrial ablation using HydroThermAblator (HTA) and rollerball (RB) for treatment of menorrhagia. DESIGN: Prospective, randomized, multicenter study (Canadian Task Force classification I). SETTING:Nine private practice and university centers in the United States. PATIENTS: Two hundred seventy-six women. INTERVENTION: Hysteroscopic endometrial ablation with the HTA (187 women) and RB (89). MEASUREMENTS AND MAIN RESULTS:Bleeding was assessed by pictorial diaries for 12 months, with patient interviews at 24 and 36 month. Amenorrhea rates, reduction of bleeding to normal levels or less, and patient satisfaction were tracked for 36 months, with rates in the HTA group of 53%, 94%, and 98% and in the RB group of 46%, 91%, and 97%, respectively. CONCLUSION: Endometrial ablation with the HTA is a safe, effective, and durable treatment of menorrhagia in a broad patient population. It offers advantages over RB by reducing anesthesia requirements, reducing operating time, and eliminating risks of excessive fluid absorption, and is more easily learned.
RCT Entities:
STUDY OBJECTIVE: To compare the safety and efficacy of endometrial ablation using HydroThermAblator (HTA) and rollerball (RB) for treatment of menorrhagia. DESIGN: Prospective, randomized, multicenter study (Canadian Task Force classification I). SETTING: Nine private practice and university centers in the United States. PATIENTS: Two hundred seventy-six women. INTERVENTION: Hysteroscopic endometrial ablation with the HTA (187 women) and RB (89). MEASUREMENTS AND MAIN RESULTS: Bleeding was assessed by pictorial diaries for 12 months, with patient interviews at 24 and 36 month. Amenorrhea rates, reduction of bleeding to normal levels or less, and patient satisfaction were tracked for 36 months, with rates in the HTA group of 53%, 94%, and 98% and in the RB group of 46%, 91%, and 97%, respectively. CONCLUSION: Endometrial ablation with the HTA is a safe, effective, and durable treatment of menorrhagia in a broad patient population. It offers advantages over RB by reducing anesthesia requirements, reducing operating time, and eliminating risks of excessive fluid absorption, and is more easily learned.
Authors: Radoslaw Wasiak; Anna Filonenko; David J Vanness; Kim U Wittrup-Jensen; Donald E Stull; Steven Siak; Ian Fraser Journal: Int J Womens Health Date: 2012-07-12