Abstract | OBJECTIVE: DESIGN: Double-blind, randomised, controlled trial. SETTING: A large teaching hospital with 500 beds in The Netherlands. POPULATION: Women suffering from menorrhagia referred by their general practitioner. METHODS: Women suffering from menorrhagia, without intracavitary abnormalities, were randomly allocated to bipolar radio-frequency ablation (bipolar group) and balloon ablation (balloon group) in a 2:1 ratio. At follow up, both women and observers were unaware of the type of treatment that had been performed. MAIN OUTCOME MEASURES: The main outcome measure was amenorrhea at 3, 6 and 12 months after randomisation. RESULTS: One hundred and twenty-six women were included in the study, of which 83 were allocated to the bipolar group, and 43 to the balloon group. No complications occurred in either of the treatment groups. At the one-year follow up stage, amenorrhea rates were 43% (34/83) in the bipolar group and 8% (3/43) in the balloon group (treatment effect in time P < 0.001). At this stage, 90% of the patients in the bipolar group were satisfied with the result of the treatment against 79% in the balloon group (treatment effect in time P= 0.003). CONCLUSION:
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Authors | Marlies Y Bongers, Petra Bourdrez, Ben W J Mol, A Peter M Heintz, Hans A M Brölmann |
Journal | BJOG : an international journal of obstetrics and gynaecology
(BJOG)
Vol. 111
Issue 10
Pg. 1095-102
(Oct 2004)
ISSN: 1470-0328 [Print] England |
PMID | 15383112
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial)
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Topics |
- Adult
- Catheter Ablation
(methods)
- Catheterization
(methods)
- Double-Blind Method
- Female
- Humans
- Hysterectomy
(methods)
- Menorrhagia
(therapy)
- Patient Satisfaction
- Treatment Outcome
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