Topical Lidocaine for Pessary Removal and Reinsertion Pain Reduction: A Randomized Clinical Trial.

Abstract

BACKGROUND Vaginal pessaries are an inexpensive non-surgical treatment for pelvic organ prolapse and stress urinary incontinence. Pessary maintenance includes periodic removal, cleaning, and reinsertion, which can be painful. Lidocaine-prilocaine cream has been shown to significantly reduce pain during pessary maintenance exams. In some practices, Lidocaine HCl 2% jelly may be more readily available and serve as an alternative to lidocaine-prilocaine cream. However, the effect of Lidocaine HCl 2% jelly use during pessary maintenance exams has not been tested. OBJECTIVE To estimate the effect of Lidocaine HCl 2% jelly versus lubricating jelly on pain at the time of office pessary removal and reinsertion. STUDY DESIGN This study is a single-blind, randomized clinical trial among patients presenting to a urogynecology office at a tertiary care center. Participants were randomized to the application of 5cc of Lidocaine HCl 2% jelly or a water-based lubricating jelly five minutes before pessary removal. Visual analog scale pain scores were collected from the participants at baseline, at pessary removal, and at pessary reinsertion. The primary outcome was the visual analog scale pain score at the time of pessary removal. A sample size of 33 per group (n=66) was planned to estimate an absolute mean difference in visual analog pain scale of 2.05 cm at the time of pessary removal. RESULTS Between September 2022 and June 2023, 192 women were screened, and 66 were enrolled. Thirty-three participants were randomized into the lubricating jelly group and 33 participants were randomized into the Lidocaine HCl 2% jelly group. The two groups were similar in baseline characteristics. Most participants were postmenopausal, using vaginal estrogen, wearing a 70 mm ring pessary with support for pelvic organ prolapse, and reported being very satisfied with the pessary. Other pessaries worn included ring without support, incontinence rings with and without support, Gellhorn, and donut. The pessary sizes ranged from 51 mm to 96 mm. There was no significant difference in pessary type and size between groups. Visual analog scale pain scores at pessary removal were low in both groups: 3.23±3.00 cm in the lubricating group and 2.66±2.77 cm in the lidocaine group. After adjusting for baseline pain, there was no significant difference in pain at pessary removal between the lidocaine jelly and the lubricating jelly groups (mean difference=-0.56 cm, 95% CI: -1.97 to 0.85; p=0.44). Despite no significant difference in visual analog scale pain scores, 71.2% of participants reported a desire for numbing jelly at future pessary examinations. CONCLUSION Pain during pessary removal and reinsertion is low. Compared to lubricating jelly, lidocaine jelly did not further reduce pain during pessary examinations.