A new approach to office hysteroscopy compared with traditional hysteroscopy: a randomized controlled trial.

OBJECTIVE: To compare a "no touch" approach to diagnostic hysteroscopy without anesthesia with traditional diagnostic hysteroscopy after intracervical injection of mepivacaine hydrochloride 3%.
METHODS: A total of 130 women undergoing diagnostic hysteroscopy were included in the study and were randomized, using a computer-generated randomization list to one of two treatment groups in a ratio of 2:1. Eighty-three women underwent hysteroscopy without speculum, tenaculum, or anesthesia. Forty-seven women received intracervical anesthesia with 10 mL of 3% mepivacaine hydrochloride solution injected at two sites (3:00 and 9:00 positions) and underwent traditional hysteroscopy. Hysteroscopy was performed using a rigid 3.7-mm hysteroscope and a medium of 0.9% saline, and the image was transmitted to a screen visible to the patient. A visual analog scale (VAS) consisting of a 10-cm line was used to assess the intensity of pain experienced during and after the procedure. Overall patient satisfaction was assessed during, immediately after, 15 minutes later, and 3 days after hysteroscopy.
RESULTS: The mean pain score was significantly lower in the group without the use of speculum, tenaculum, or anesthesia (VAS1: 3.8+/-2.7 versus 5.34+/-3.23, P=.01; VAS2: 3.02+/-2.50 versus 4.57+/-3.30, P=.008). Patient satisfaction rate was similar in both groups.
CONCLUSION: Patients reported significantly less pain with the altered approach to diagnostic hysteroscopy compared with patients undergoing the traditional procedure with anesthesia. This new approach can therefore be considered as a useful hysteroscopic technique. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00319410

RCT Entities:   Population Interventions Outcomes