Uterine thermal balloon therapy for the treatment of menorrhagia: the first 300 patients from a multi‐centre study

Abstract

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.

Thermal Balloon Endometrial Ablation: A Safe and Effective Modality for Treatment of Dysfunctional Menorrhagia

“…Similar high success rates were recorded by other investigators (10,11,12,13,14,15). However, long-term follow-up showed a slightly lower success rates (16).…”

“…In 1994, Neuwirth et al introduced the concept of thermal balloon ablation (9). Since then, the procedure is gaining popularity day after day being with minimal learning curve, minimum complications, and the short and medium term cure-rate appears very promising (10).…”

Uterine Balloon Therapy : An Alternative Therapy for Menorrhagia

“…A large multi centre observational study [3] and others comparing UBT with established first generation ablation treatments such as rollerball [4] and TCRE [5,6] reported success in reducing menstrual blood loss and outcomes comparable with first generation ablation techniques. This intervention fulfilled a largely unmet women's health need of permanent treatment of menorrhagia with avoidance of hysterectomy.The technique of UBT is technically uncomplicated and serious side effects are rare.…”

Thermal endometrial ablation in dysfunctional uterine bleeding: an economic comparison of bipolar ablation and balloon ablation

“…A thermistor in the balloon is used to raise the temperature of the fluid to 87°C (170°F) for a period of 8 min, while maintaining the pressure of the balloon at 170 mmHg or higher. Endometrial thinning was performed by aspiration curettage prior to the balloon treatment procedure [6].…”