Uterine Balloon Treatment for Heavy Period Bleeding.

This study was also designed to determine the effect of a post procedure curettage on bleeding patterns and post-operative discharge and pain.

Inclusion criteria

• Female at least 30 years of age who is premenopausal and for whom childbearing is complete.
• Excessive menstrual bleeding documented by a diary score of at least 150.
• Have documented 3 months failed medical therapy or either a) contraindicated for or b) refused medical therapy.
• Have an anatomically normal uterine cavity sounding at least 4cm, but not greater than 12cm.
• Have a normal pap smear and no unexplained abnormal pap smears within 1 year of the procedure.
• Agree not to switch from hormonal to non-hormonal contraception or vice versa during or just prior to the study.
• Agree to use reliable contraception throughout the study.
• Freely agree to participate in the study, including all study related procedures and evaluations, and document this agreement by signing informed consent documentation.

Exclusion criteria

• Active pelvic inflammatory disease (PID) or recurrent chronic PID.
• Active genital or urinary tract infection at the time of the procedure.
• History of malignancy of the reproductive system within 5 years of the procedure or have ever had malignancy of the endometrium.
• Endometrial neoplasia, determined by endometrial biopsy taken within 6 months of procedure.
• Cavity distorting submucous myoma(s) determined by preoperative hysterogram, hysteroscopy, or transvaginal sonography within 6 months of the procedure.
• Previous endometrial ablation procedure.
• Previous uterine surgeries (such as full thickness myomectomy, subserosal myomectomy, uterine reconstruction, or any surgery in which thinning of the uterine musculature could occur) except for low transverse caesarean section.
• Pregnant or desirous of future pregnancy.
• Taken endometrial suppression medication, except for oral contraceptives, within 3 months of the procedure.
• Concurrent open or laparoscopic surgery.