Heavy Menstrual Bleeding Clinical Trial
Official title:
Evaluation of Feasibility and Effectiveness of 4th Generation Bipolar Radiofrequency Endometrial Ablation Device: a Cohort Study
All women presenting to the gynaecology outpatient clinic with heavy menstrual bleeding
(HMB) in the absence of recognizable pelvic pathology, as determined by one or all of a
normal pelvic ultrasound, hysteroscopy and / or endometrial biopsy, refractory to medical
therapy that persists despite treatment with recommended pharmacological agents(1,2), who
have no desire to preserve their fertility and are willing to have an endometrial ablation
will be invited to participate. Eligible women with HMB will undergo radiofrequency G4
endometrial ablation in either an inpatient or outpatient setting according to their
preference.
Outcomes will be assessed by administering postal questionnaires to measure menstrual
bleeding symptoms including rates of amenorrhoea, dysmenorrhoea and life quality at baseline
and at 6, and 12 months after ablative treatment. After the main study, there will be an
additional evaluation of the long-term effects of outpatient ablative treatments of the
endometrium by postal survey at 5 years.
n/a
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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