Uterine thermal balloon therapy for the treatment of menorrhagia: the first 300 patients from a multi-centre study. International Collaborative Uterine Thermal Balloon Working Group.

OBJECTIVE: To evaluate the safety and efficacy of thermal balloon therapy for menorrhagia. DESIGN: Prospective, observational study. SETTING: Fifteen centres in Canada and Europe. POPULATION: Two hundred and ninety-six eligible women for whom follow up data were available for three months or more. Eligible women included those for whom further fertility was not a concern, were not postmenopausal, suffered from intractable menorrhagia, had a normal uterine cavity, and who were fully informed regarding the investigational nature of uterine thermal balloon therapy. METHODS: Three hundred and twenty-one procedures of balloon endometrial ablation were performed using the same protocol between June 1994 and August 1996. Exclusion criteria included structural uterine abnormality or (pre) malignant lesions. Treatment entailed controlled heating of fluid in an intrauterine balloon. General anaesthesia was employed in the 61% of procedures while local anaesthesia with or without sedation was used in 39% of cases. ANALYSIS: Follow up data at 3 and/or 6, and/or 12 months were required for inclusion in the analysis. A paired t test, Wilcoxon signed-ranks test, and multiple and logistic regression analyses were used to evaluate the changes in bleeding and dysmenorrhoea patterns, and possible confounding variables, respectively. Success was defined as the subjective reduction of menses to eumenorrhoea or less. RESULTS: No intra-operative complications occurred, and post-operative morbidity was minimal. Success of the procedure was constant over the year (range 88%-91%). Treatment led to a significant decrease in the duration of menstrual flow and severity of pain (P < 0.0001). Increasing age, higher balloon pressure, smaller uterine cavity, and a lesser degree of pre-procedure menorrhagia were associated with significantly improved results. Pre-treatment with gonadotrophin releasing hormone agonists increased amenorrhoea and spotting rates (P = 0.03), but was only used in 5% of cases. CONCLUSION: Thermal balloon endometrial ablation appears to be safe, as well as effective in properly selected women with menorrhagia and is potentially an outpatient procedure.

Clinical trial of the uterine thermal balloon for treatment of menorrhagia.

STUDY OBJECTIVES: To evaluate the safety and efficacy of thermal balloon endometrial ablation in women with menorrhagia, and to identify factors influencing outcome. DESIGN: Prospective, observational study (Canadian Task Force classification II-2). SETTING: Three Canadian university-affiliated teaching hospitals. PATIENTS: One hundred twenty-one women suffering from menorrhagia serious enough to make them candidates for endometrial ablation or hysterectomy. Patients without obvious structural or (pre)malignant abnormalities were included if their uterine cavities sounded to less than 12 cm, they were in good health, and had undergone hysteroscopy or pelvic ultrasound and endometrial biopsy within 6 months and had a normal Papanicolaou smear within 1 year. INTERVENTIONS: A balloon catheter was placed through the cervix and after inflation in the endometrial cavity with 5% dextrose in water, was heated to 87 +/- 5 degrees C. Two-thirds of patients avoided general anesthesia and very few required cervical dilatation to admit the 4.5-mm diameter catheter. Balloon pressures were 90 to 140 mm Hg in 13 patients; pressures between 140 and 190 mm Hg were well tolerated by the rest. Nineteen women underwent 12 minutes of therapy, and the rest had 8-minute sessions. MEASUREMENTS AND MAIN RESULTS: No intraoperative complications occurred, and minor postoperative morbidity occurred in 4% of patients. Preoperative and postoperative bleeding was assessed by pad counts and patient self-reports. The degree of dysmenorrhea was recorded similarly. A paired t test was used to compare pretreatment with posttreatment pad counts. A Wilcoxon signed rank test was employed to evaluate the effect of treatment on dysmenorrhea. The effects on outcome of several independent variables were analyzed by multiple and logistic regression. Success of the procedure was constant over the year (range 86-90%). Treatment led to significant decreases in menstrual flow, duration, and pain (p <0.0001). No significant effects of parity, uterine position or cavity depth, timing, or various endometrial-thinning regimens were found. Increasing age was significantly associated with increased odds of success (p < 0.05). Excluding the 19 women who underwent 12 minutes of therapy did not change statistical results, whereas excluding the 13 treated with balloon pressures less than 140 mm Hg improved the results. Conclusion. The facts that bleeding and dysmenorrhea were significantly reduced by thermal balloon endometrial ablation, that no intraoperative complication occurred, and that postoperative morbidity was minimal, lead us to conclude that this is potentially a safe and effective technique. Larger studies and longer follow-up are required to substantiate this impression.

Uterine Balloon Therapy for the Treatment of Menorrhagia

From June 1994 to December 1995, 116 women (mean age 39 yrs, range 27-50 yrs) who met inclusion and exclusion criteria underwent endometrial ablation with a thermal balloon system. Forty-one (35%) were treated under general and 71 (61%) under neuroleptic anesthesia. Four (3%) treatments were performed under paracervical block only. A 16-cm long, 3-mm diameter catheter with a latex balloon at its tip housing a heating element was inserted into the uterus and filled with sterile 5% dextrose in water solution (mean 10.4 ml, range 2-55 ml). The catheter was connected to a control unit that maintained the temperature at 87 ± 5° C, monitored the pressure, and terminated the treatment after 8 minutes. The starting uterine pressure was 80 to 140 mm Hg in the first 13 women and greater than 140 mm Hg in the rest. Nineteen women were treated for 12 minutes and all others for 8 minutes. Complications were endometritis (3), hematometra (2), and cystitis (1). At 6-month follow-up, after 8 minutes of treatment, persistent menorrhagia was reported by 38% and 12% of patients at less than and greater than 140 mm Hg pressure, respectively. At greater than 140 mm Hg pressure, menorrhagia was reported by 13% of women after 8 and 12 minutes of treatment. In 38 women, amenorrhea or spotting occurred in 29%, hypomenorrhea in 45%, eumenorrhea in 21%, and menorrhagia in 5%. Uterine balloon therapy is a safe and effective treatment for menorrhagia at uterine pressures of 150 to 180 mm Hg and of 8 minutes' duration.

Endometrial ablation with a thermal balloon for the treatment of menorrhagia.

STUDY OBJECTIVE: To evaluate the safety and clinical efficacy of a uterine thermal balloon endometrial ablation system for the treatment of menorrhagia. DESIGN: Prospective pilot study. SETTING: University-affiliated teaching hospital. PATIENTS: Thirty women with menorrhagia who met inclusion and exclusion criteria and signed informed consent. INTERVENTIONS: Under general (9 women) or neuroleptic (21) anesthesia and paracervical block, a 16-cm long, 3-mm diameter catheter with a latex balloon at its tip, housing a heating element, was inserted blindly transcervically into the uterus and filled with sterile 5% dextrose in water solution (range 2-21 ml, mean 9.2 ml). The catheter was connected to a control unit that maintained the temperature at 87 degrees C, monitored the pressure, and terminated the treatment after 8 minutes. MEASUREMENTS AND MAIN RESULTS: There were no intraoperative or postoperative complications. At 6 months 25 patients (83%) reported significant improvement in menorrhagia (amenorrhea 1, staining 4, hypomenorrhea 13, moderate improvement 7). By 12 months 23 women (77%) reported significant improvement (amenorrhea 1, staining 4, hypomenorrhea 13, moderate improvement 5). CONCLUSIONS: Uterine balloon thermal therapy is a safe and effective option for women with menorrhagia. The procedure does not require additional training and expertise in operative hysteroscopy and the presently used energy sources. It requires no cervical dilatation (5 mm), is tolerated well under neuroleptic anesthesia, and potentially can be offered as an office procedure under local anesthesia.