Medical therapy versus radiofrequency endometrial ablation in the initial treatment of heavy menstrual bleeding (iTOM Trial): A clinical and economic analysis.

BACKGROUND: Radiofrequency endometrial ablation (REA) is currently a second line treatment in women with heavy menstrual bleeding (MHB) if medical therapy (MTP) is contraindicated or unsatisfactory. Our objective is to compare the effectiveness and cost burden of MTP and REA in the initial treatment of HMB. METHODS: We performed a randomized trial at Mayo Clinic Rochester, Minnesota. The planned sample size was 60 patients per arm. A total of 67 women with HMB were randomly allocated to receive oral contraceptive pills (Nordette ®) or Naproxen (Naprosyn®) (n = 33) or REA (n = 34). Primary 12-month outcome measures included menstrual blood loss using pictorial blood loss assessment chart (PBLAC), patients' satisfaction, and Menorrhagia Multi-Attribute Scale (MMAS). Secondary outcomes were total costs including direct medical and indirect costs associated with healthcare use, patient out-of-pocket costs, and lost work days and activity limitations over 12 months. RESULTS: Compared to MTP arm, women who received REA had a significantly lower PBLAC score (median [Interquartile range, IQR]: 0 [0-4] vs. 15 [0-131], p = 0.003), higher satisfaction rates (96.8%vs.63.2%, p = 0.003) and higher MMAS (median [IQR]: 100 [100-100] vs. 100 [87-100], p = 0.12) at 12 months. Direct medical costs were higher for REA ($5,331vs.$2,901, 95% confidence interval (CI) of mean difference:$727,$4,852), however, when indirect costs are included, the difference did not reach statistical significance ($5,469 vs. $3,869, 95% CI of mean difference:-$339, $4,089). CONCLUSION: For women with heavy menstrual bleeding, initial radiofrequency endometrial ablation compared to medical therapy offered superior reduction in menstrual blood loss and improvement in quality of life without significant differences in total costs of care. CLINICAL TRIAL REGISTRATION: NCT01165307.

Economic and clinical benefits of radiofrequency ablation versus hysterectomy in patients suffering from menorrhagia: a retrospective analysis with German health claims data.

OBJECTIVE: To assess clinical and economic benefits of radiofrequency ablation (RFA) compared to hysterectomy when treating patients suffering from menorrhagia. METHODS: Based on German health claims data, a retrospective, longitudinal, observational analysis was performed. Patients having continuously statutory health insurance coverage during the study and being coded for menorrhagia and a relevant treatment option were included in the analysis. The control group was created using propensity score matching. RESULTS: We discovered that using RFA generates cost savings of €1844 during the quarter of performance. As direct costs during a 2-year follow-up show similar levels in both groups, these initial savings can be preserved. This is partly because even if more patients in the RFA group were re-coded for menorrhagia after initial therapy, just a small proportion of these patients required another surgical intervention. CONCLUSION: RFA should more often be considered a relevant treatment option both from an economic and a medical point of view.

Outpatient microwave endometrial ablation: 5-year follow-up of a randomised controlled trial without endometrial preparation versus standard day surgery with endometrial preparation.

The objective was to compare long-term outcomes following outpatient microwave endometrial ablation in the postmenstrual phase with those following day surgery microwave endometrial ablation after standard drug-based endometrial preparation. Of the women originally recruited, 154/197 (78%) returned questionnaires. The primary outcome of satisfaction was high in both groups (71% postmenses versus 65% preparation) as were the amenorrhoea rates (84% versus 87%). There was no significant difference in the hysterectomy rates between the two arms. It can be concluded that microwave endometrial ablation outcomes are not affected in the long term by undertaking the procedure in the postmenstrual phase in an outpatient setting.

Hysteroscopic appearance of endometrial cavity after microwave endometrial ablation.

STUDY OBJECTIVE: To assess the appearance of the endometrial cavity after microwave endometrial ablation. DESIGN: Prospective observational study. SETTING: GuangDong Women's and Children's Hospital, GuangDong, China. PATIENTS: A total of 349 patients who underwent microwave endometrial ablation from January 2000 through August 2008 were followed up for 1 month to 8 years. At follow-up in 2007 and 2008, patients were advised of this clinical study and were randomly selected for participation if they agreed to undergo outpatient hysteroscopy to assess the uterine cavity during follow-up visits. Fifty three patients (median [range] age, 43.1 [33-53] years) were recruited into the study at the time of endometrial ablation. INTERVENTION: Outpatient hysteroscopy. MAIN RESULTS: Within the first 3 months after ablation, outpatient hysteroscopy revealed varying amounts of necrotic tissue from the endometrium and superficial myometrium of the uterus. Six months postablation, a granulomatous reaction and fibrosis were present. A fibrotic cavity was also evident, and menstrual flow was reduced or had ceased. One year after ablation, hysteroscopy demonstrated a fibrotic cavity with myofibrous scars. Most patients developed amenorrhea at this time. Two years or more postablation, a second hysteroscopy demonstrated various types of intrauterine adhesions in 28 of the 53 women (52.8%). A cervical adhesion was observed in 1 patient (1.9%), focal adhesions in the fundal area in 12 (22.6%), a narrowed and scarred uterine cavity with bilateral stenotic tubal ostia in 11 (20.7%), and complete obliteration of the cavity in 4 (7.5%). Of these 28 women, 22 had amenorrhea, 3 had vaginal spotting during menstruation, and 2 had hypomenorrhea. Of those without intrauterine adhesions, only 5 had amenorrhea, 10 had vaginal spotting, and 8 had hypomenorrhea. CONCLUSION: The hysteroscopic appearance of the uterine cavity after microwave endometrial ablation varies considerably. In this study, the menstrual outcome was correlated with postablation uterine cavity appearance.

A randomised comparison of microwave endometrial ablation with transcervical resection of the endometrium; follow up at a minimum of five years.

OBJECTIVE: To compare long term outcomes following microwave endometrial ablation (MEA) or transcervical resection of the endometrium (TCRE). DESIGN: Follow up of a randomised controlled trial. SETTING: Gynaecology department of a large UK teaching hospital. POPULATION/SAMPLE: Two hundred and thirty-nine participants in a randomised comparison of MEA with TCRE. METHODS: Collection of patient completed postal questionnaires and operative databank review. MAIN OUTCOME MEASURES: Women's satisfaction with and acceptability of treatment, menstrual symptoms, changes in health-related quality of life and additional treatments received. RESULTS: Two hundred and thirty-six of the original 263 women returned questionnaires (90%) after a minimum of five years post-treatment. Women allocated to MEA were significantly more likely to be totally or generally satisfied with treatment (86% vs 74%; difference 12%, 95% CI 2% to 23%), to find it acceptable (97% vs 91%; difference 6%, 95% CI 1% to 13%) and would recommend it (97% vs 89%; difference 8%, 95% CI 1% to 14%). Bleeding and pain scores were highly significantly reduced following both MEA and TCRE, achieving amenorrhoea rates of 65% and 69%, respectively. The hysterectomy rate after a minimum of five years was 16% in the MEA and 25% in the TCRE arm. CONCLUSIONS: Both techniques achieve significant and comparable improvements in menstrual symptoms, and health-related quality of life. While high rates of satisfaction with treatment and acceptability of treatment are achieved by TCRE, these are significantly lower than levels following MEA. These long term data, when combined with the trials' operative findings and known costs of both procedures, now inform us that MEA is a more effective and efficient treatment for heavy menstrual loss than TCRE.

A retrospective cohort study comparing microwave endometrial ablation with levonorgestrel-releasing intrauterine device in the management of heavy menstrual bleeding.

OBJECTIVE: To compare microwave endometrial ablation (MEA) with a levonorgestrel-releasing intrauterine device (Mirena) in the management of heavy menstrual bleeding. DESIGN: A retrospective cohort study SAMPLE: Thirty-nine women were treated with MEA and 23 women with Mirena, in the South East Regional Health Service of South Australia during 1998 to 2001; the mean duration of follow-up was 14.6 months. MAIN OUTCOME MEASURES: Primary measures included acceptability of the treatment process, effectiveness of the treatment, and satisfaction with outcomes. Secondary measures included side effects, complications and quality of life (using the SF-36). RESULTS: Acceptability of the treatment process and satisfaction with outcomes was very high for both procedures. Each treatment led to a statistically significant reduction in menstrual bleeding (p < 0.0001) and dysmenorrhoea scores (p < 0.002). CONCLUSIONS: There were no statistical differences between the two treatments for any of the primary or secondary outcome measures assessed. The treatments seem equally effective in the management of heavy menstrual loss.

Fatal hemorrhagic cystitis induced by pelvic irradiation and cyclophosphamide therapy. Case reports and review.

The potent cytotoxic drug cyclophosphamide has been used extensively for neoplastic and non-neoplastic diseases. Patients taking this drug may have received or may be receiving pelvic irradiation concurrently. This report describes two patients who developed fatal hemorrhagic cystitis induced by pelvic irradiation and cyclophosphamide therapy. Etiology, incidence, pathologic descriptions, and diagnostic and therapeutic aspects of this entity are described. The incidence and risk of serious, life-threatening bladder hemorrhage from cyclophosphamide therapy is increased by prior or concurrent pelvic irradiation. Alternative cytotoxic, non-urotoxic chemotherapy should be used in these high-risk patients.

Treatment of functional menorrhagia by radiofrequency-induced thermal endometrial ablation.

42 patients were enrolled in a trial of radiofrequency-induced thermal endometrial ablation for the treatment of functional menorrhagia. The radiofrequency electromagnetic energy was delivered via a probe placed within the endometrial cavity. 10 patients received 330 kJ of energy, 10 received 445 kJ, and the other 22 received 660 kJ. 19 (87%) of those receiving the highest dose became amenorrheic or had a considerable reduction in menstrual flow. The procedure is simple and the heat induced in the endometrium does not penetrate much beyond the inner layers of the myometrium. There is no need for distension of the uterine cavity with flushing media.

Bladder cancer following low or high dose pelvic irradiation.

Eleven women presenting to this department since 1971 with bladder cancer have had previous pelvic irradiation. The tumours were generally of high grade and advanced T-category. Prognosis was poor and only 32% survived for one year. The interval observed between low dose pelvic irradiation and subsequent bladder cancer was longer than after high dose pelvic irradiation (mean interval of 30 years compared with 16.5 years).