Gynecology & Obstetrics
Open Access
ISSN: 2161-0932
ISSN: 2161-0932
Ashraf TA and Gamal M
Study design: A randomized clinical prospective comparative study. Setting: The study was conducted in the Department of Obstetrics and Gynecology, between May 2010 and August 2012.
Objective: To compare the efficacy and safety of a uterine thermal balloon system with hysteroscopic endometrial resection in the treatment of selected cases of menorrhagia.
Patients and methods: The study comprised seventy premenopausal women with persistent intractable menorrhagia, selected under strict inclusion criteria. Patients were randomized into two equal groups of 35 patients each. Patients of the first group were treated by uterine thermal balloon system (35 patients), while those of the other group were treated by hysteroscopic endometrial resection (35 patients). Quantification of pre-procedural and post-procedural menstrual blood was defined by pad count and self-assessment. Twelve-month follow-up data were presented on all women and compared statistically.
Results: Twelve-month results indicated that both techniques significantly reduced menstrual blood flow with no clinically significant difference between the two groups. Success rates, as reflected by percent of patients who returned to normal bleeding or less, were comparable being 82.8% for the balloon group and 91.4% for the resection group. Procedural time was reduced significantly in the uterine balloon therapy group. Intra-operative complications occurred in three (8.5%) of the hysteroscopic resection patients, whereas no intra-operative complications occurred in the thermal balloon group.
Conclusion: Uterine thermal balloon therapy is as efficacious as hysteroscopic resection in the treatment of selected cases of menorrhagia. Further studies are needed to confirm this conclusion.