Vaginoscopy Against Standard Treatment: a randomised controlled trial.
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.