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Topical lidocaine for pessary removal and reinsertion pain reduction: a randomized clinical trial - 08/10/24

Doi : 10.1016/j.ajog.2024.09.004 
Araba Amonu Jackson, MD a, , Sara Caitlin Frisco, APRN a, Catherine Marie Lynch, MD a, Jean Paul Tanner, PhD, MPH b, Katie Propst, MD a
a Urogynecology & Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, Morsani College of Medicine, University of South Florida, Tampa, FL 
b College of Public Health, University of South Florida, Tampa, Florida 

Corresponding author: Araba Amonu Jackson, MD.
Sous presse. Épreuves corrigées par l'auteur. Disponible en ligne depuis le Tuesday 08 October 2024

Abstract

Background

Vaginal pessaries are an inexpensive nonsurgical 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 hydrochloride (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 5 cc of lidocaine HCl 2% jelly or a water-based lubricating jelly 5 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 hydrochloride (HCl) 2% jelly group. The 2 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% confidence interval: −1.97–0.85; P=.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.

Le texte complet de cet article est disponible en PDF.

Key words : lidocaine jelly, pelvic exam, pelvic organ prolapse, pelvic pain, stress urinary incontinence


Plan


 The authors report no conflict of interest.
 No financial support was received for this study.
 Cite this article as: Jackson AA, Frisco SC, Lynch CM, et al. Topical lidocaine for pessary removal and reinsertion pain reduction: a randomized clinical trial. Am J Obstet Gynecol 2024;XXX:XX–XX.
 Present address for Araba Amonu Jackson: Division of Urogynecology, Department of Obstetrics and Gynecology, Inova Health System, Falls Church, Virginia.
 Date of clinical trial registration: September 08, 2022.
 Date of initial participant enrollment: August 09, 2022.
 Clinical trial identification number: NCT05493735 (URL of the registration site: NCT05493735?cond=Prolapse&intr=Lidocaine&rank=2).


© 2024  Publié par Elsevier Masson SAS.
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