A randomised trial of Medgyn Endosampler® vs Endocurette® in an outpatient hysteroscopy clinic setting

Abstract

Outpatient hysteroscopy and endometrial biopsy are increasingly being used in the investigation of abnormal uterine bleeding. In our unit, both Endocurette® and Endosampler® endometrial biopsy devices are available in the outpatient hysteroscopy clinic. Literature comparing these devices is lacking. This was a prospective, randomised trial involving women attending the outpatient hysteroscopy clinic at Cork University Maternity Hospital. Women were randomised to endometrial sampling with either Endosampler® or Endocurette® devices. A number of device insertions, pain scores, ease of handling and histological reporting of sample adequacy and tissue histology were recorded. One hundred and six women were recruited comprising 55 pre-menopausal and 51 post-menopausal women. A substantially higher rate of multiple device insertions to obtain a visually adequate sample was recorded using Endocurette® compared with Endosampler®. In the Endosampler® group, 10.7 and 12.5 % of women in pre- and post-menopausal categories had ≥2 device insertions compared to 88.8 and 58.3 %, respectively, with Endocurette® (p = 0.002 and p = 0.0001). There was no difference in the rate of histologically inadequate samples or difficulty with device handling between matched groups. Mean pain scores in the pre- and post-menopausal groups were 5.83 and 4.58 for Endosampler®, and 4.69 and 4.88 for Endocurette® (p = 0.02). The rate of histologically inadequate samples was higher in post-menopausal compared to pre-menopausal women (27.4 vs 3.7 %, p = 0.0025). A significantly lower rate of multiple device insertions for adequate histological sample was recorded with Endosampler®. No significant differences in operational difficulties, patient acceptability and sample adequacy were shown. Higher overall pain scores were reported with Endosampler® with no difference in the rate of severe pain between groups’ satisfaction with the procedure or willingness to undergo the procedure again.