Endometrial Biopsy Versus No Endometrial Biopsy with a Normal-Appearing Cavity During In-office Hysteroscopy for Postmenopausal Bleeding: A Randomized Controlled Trial

Abstract

Study Objective

The objective of this study was to evaluate pain scores in patients with postmenopausal bleeding (PMB) and an atrophic cavity who underwent an endometrial biopsy compared to those who did not at office hysteroscopy.

Design

Single-center, single-blinded randomized control trial. The trial was registered prospectively (ClinicalTrials.gov ID NCT05378152).

Setting

The office hysteroscopy service in an academic and tertiary referral hospital in Dublin, Ireland.

Patients

Women with PMB who attended an office hysteroscopy and had an atrophic cavity on a hysteroscopic evaluation were included. A sample size of 76 was determined to show a 2-point difference in pain scores (Visual Analog Scale [VAS]), assuming 90% statistical power and a 5% level of significance.

Interventions

Women were randomized to either endometrial biopsy (group 1) or a sham procedure (group 2). The primary outcome was to compare pain scores after the intervention using a 100 mm VAS. Secondary outcomes included differences in follow-up patterns between groups.

Measurements and Main Results

A total of 169 women with PMB were recruited over an 18-month period; 87 were excluded on the basis of hysteroscopic findings during the procedure. There were 44 patients in group 1 (biopsy) and 38 patients in group 2 (sham). A significant difference in pain scores after the intervention was noted with a mean VAS score of 54 mm (±3 mm) in group 1 and 30 mm (±5 mm) in group 2 (p <.0001). There was no significant difference noted in follow-up patterns between either group.

Conclusions

The performance of routine endometrial biopsy after a normal hysteroscopy with atrophic findings, in women referred with PMB, has been shown to result in higher pain scores. Further studies are needed to consider the role of endometrial biopsy in this context.