OBJECTIVE: To compare two second-generation endometrial ablation systems in women with dysfunctional uterine bleeding (DUB) who want conservative surgical treatment. DESIGN: A double-blind, randomized trial. SETTING: A minimal access gynecological surgery unit in northeast England. PATIENT(S): Fifty-seven women diagnosed with DUB were recruited, with 55 undergoing surgery and completing 12-month follow-up. INTERVENTION(S): Thirty-seven women underwent a NovaSure endometrial ablation, and 18 had a Cavaterm endometrial ablation. Clinical and quality of life data were collected 6 and 12 months after treatment. MAIN OUTCOME MEASURE(S): Amenorrhea, menstrual change, quality of life, sexual activity, patient satisfaction, and procedure acceptability. RESULT(S): Amenorrhea, hypomenorrhea, eumenorrhea, and menorrhagia rates for the Cavaterm and Novasure groups at 12 months were 2/18 (11%) vs. 16/37 (43%); 11/18 (61%) vs. 10/37 (27%); 5/18 (27%) vs. 6/37 (16%); and 0/18 vs. 5/37 (13%), respectively. At 12 months, 83% and 92% of women were either satisfied or very satisfied in the Cavaterm or Novasure groups, respectively. There were no major complications in either group. CONCLUSION(S): Both the Cavaterm and the Novasure endometrial ablation systems are effective in reducing menstrual loss in women with DUB and achieve high rates of patient satisfaction. The Novasure system achieved a statistically significantly higher rate of amenorrhea in this study.
RCT Entities:
OBJECTIVE: To compare two second-generation endometrial ablation systems in women with dysfunctional uterine bleeding (DUB) who want conservative surgical treatment. DESIGN: A double-blind, randomized trial. SETTING: A minimal access gynecological surgery unit in northeast England. PATIENT(S): Fifty-seven women diagnosed with DUB were recruited, with 55 undergoing surgery and completing 12-month follow-up. INTERVENTION(S): Thirty-seven women underwent a NovaSure endometrial ablation, and 18 had a Cavaterm endometrial ablation. Clinical and quality of life data were collected 6 and 12 months after treatment. MAIN OUTCOME MEASURE(S): Amenorrhea, menstrual change, quality of life, sexual activity, patient satisfaction, and procedure acceptability. RESULT(S): Amenorrhea, hypomenorrhea, eumenorrhea, and menorrhagia rates for the Cavaterm and Novasure groups at 12 months were 2/18 (11%) vs. 16/37 (43%); 11/18 (61%) vs. 10/37 (27%); 5/18 (27%) vs. 6/37 (16%); and 0/18 vs. 5/37 (13%), respectively. At 12 months, 83% and 92% of women were either satisfied or very satisfied in the Cavaterm or Novasure groups, respectively. There were no major complications in either group. CONCLUSION(S): Both the Cavaterm and the Novasure endometrial ablation systems are effective in reducing menstrual loss in women with DUB and achieve high rates of patient satisfaction. The Novasure system achieved a statistically significantly higher rate of amenorrhea in this study.
Authors: Magdalena Bofill Rodriguez; Sofia Dias; Vanessa Jordan; Anne Lethaby; Sarah F Lensen; Michelle R Wise; Jack Wilkinson; Julie Brown; Cindy Farquhar Journal: Cochrane Database Syst Rev Date: 2022-05-31
Authors: L J Middleton; R Champaneria; J P Daniels; S Bhattacharya; K G Cooper; N H Hilken; P O'Donovan; M Gannon; R Gray; K S Khan; J Abbott; J Barrington; S Bhattacharya; M Y Bongers; J-L Brun; R Busfield; M Sowter; T J Clark; J Cooper; K G Cooper; S L Corson; K Dickersin; N Dwyer; M Gannon; J Hawe; R Hurskainen; W R Meyer; H O'Connor; S Pinion; A M Sambrook; W H Tam; I A A van Zon-Rabelink; E Zupi Journal: BMJ Date: 2010-08-16
Authors: Sherif A El-Nashar; Matthew R Hopkins; Douglas J Creedon; William A Cliby; Abimbola O Famuyide Journal: J Minim Invasive Gynecol Date: 2009 Nov-Dec Impact factor: 4.137
Authors: Sherif A El-Nashar; Matthew R Hopkins; Douglas J Creedon; Jennifer L St Sauver; Amy L Weaver; Michaela E McGree; William A Cliby; Abimbola O Famuyide Journal: Obstet Gynecol Date: 2009-01 Impact factor: 7.661
Authors: Jeffrey D Miller; Gregory M Lenhart; Machaon M Bonafede; Cindy M Basinski; Andrea S Lukes; Kathleen A Troeger Journal: Int J Womens Health Date: 2015-01-06
Authors: Abimbola O Famuyide; Shannon K Laughlin-Tommaso; Sherif A Shazly; Kirsten Hall Long; Daniel M Breitkopf; Amy L Weaver; Michaela E McGree; Sherif A El-Nashar; Maureen A Lemens; Matthew R Hopkins Journal: PLoS One Date: 2017-11-15 Impact factor: 3.240