Vaginoscopy Against Standard Treatment: a randomised controlled trial

Abstract

Objective: To evaluate whether vaginoscopy or standard hysteroscopy was more successful in the outpatient setting.

Design: Randomised controlled multicentre trial.

Setting: Outpatient hysteroscopy clinics at two UK hospitals.

Population: 1597 women aged 16 or older undergoing an outpatient hysteroscopy.

Methods: Women were allocated to vaginoscopy or standard hysteroscopy using third party randomisation stratified by menopausal status with no blinding of participants or clinicians.

Main outcome measures: The primary outcome was 'success', a composite endpoint defined as: a complete procedure, no complications, a level of pain acceptable to the patient, and no sign of genitourinary tract infection 2 weeks after the procedure.

Results: Vaginoscopy was significantly more successful than standard hysteroscopy [647/726 (89%) versus 621/734 (85%), respectively; relative risk (RR) 1.05, 95% CI 1.01-1.10; P = 0.01]. The median time taken to complete vaginoscopy was 2 minutes compared with 3 minutes for standard hysteroscopy (P < 0.001). The mean pain score was 42.7 for vaginoscopy, which was significantly less than standard hysteroscopy 46.4 (P = 0.02). Operative complications occurred in five women receiving vaginoscopy and 19 women receiving standard hysteroscopy (RR 0.26, 95% CI 0.10-0.69).

Conclusions: Vaginoscopy is quicker to perform, less painful, and more successful than standard hysteroscopy and therefore should be considered the technique of choice for outpatient hysteroscopy.

Tweetable abstract: Vaginoscopy is quicker to perform, less painful, and more successful than standard hysteroscopy.

Keywords: Ambulatory hysteroscopy; hysteroscopy; office hysteroscopy; outpatient hysteroscopy; vaginoscopy.