Objective: To compare factors influencing adequacy of endometrial samples obtained using two outpatient sampling devices--Pipelle and Tao Brush.
Design: Pragmatic unblinded trial with investigation schedule randomised separately within two groups according to endometrial cancer risk.
Setting: Gynaecology outpatient clinic of a large city hospital in Edinburgh, Scotland.
Population: All women referred to a gynaecology outpatient clinic during a 28-month period complaining of abnormal vaginal bleeding.
Methods: Women were assigned to two 'risk groups' for endometrial cancer ('high risk' for postmenopausal women and 'moderate risk' for premenopausal women aged over 40 years or with other risk factors). Women in each risk group had both types of biopsy and were randomised to two outpatient visualisations: hysteroscopy and/or transvaginal ultrasound scan.
Main outcome measures: Completion of the investigation, adequacy of sample and acceptability of investigation to women.
Results: In 200 high-risk women, adequate samples were significantly more likely to be obtained by Tao Brush than Pipelle (P < 0.001). Nulliparity was strongly associated with failed insertion for both devices (P < 0.001). Inadequate samples were strongly associated with postmenopausal status only for Pipelle (P < 0.001), and among premenopausal women, for both samplers, with nulliparity (P < 0.001). A significantly greater proportion of women preferred the Tao Brush to the Pipelle endometrial sampler (P < 0.001).
Conclusions: In postmenopausal women, Tao Brush sampling offers advantages over use of Pipelle, and the former should be considered as an alternative or additional sampling device in this group of women.