Topical Anesthetic Use In Pessary Management

Phase 2

Completed

• Conditions: Pain
• Interventions: Drug: lidocaine-prilocaine cream; Drug: Placebo cream

• Registration Number: NCT02380742
• Lead Sponsor: Loyola University

Brief Summary

The purpose of this study is to evaluate if lidocaine-prilocaine (EMLA 5%) cream can reduce pain and discomfort at the time of vaginal pessary removal and insertion. Half of the participants will receive lidocaine-prilocaine (EMLA 5%) cream and the other half will receive a placebo cream.

Detailed Description

Lidocaine-prilocaine (EMLA 5%) cream has been shown to be effective in reducing pain during minor gynecologic procedures. The primary objective of this trial is to determine if the use of 5% EMLA cream at the time of pessary removal and insertion reduces pain when compared to the use of placebo cream.

Participants will be randomized to receive either 10 grams of 5% EMLA cream (4 mL) or 4 mL of placebo cream (aqueous cream BP). Cream will be applied in office at the time of pessary removal and insertion.

Study Timeline

• Study First Submitted: 2015-02-26
• Study First Submitted QC: 2015-03-02
• Study First Posted: 2015-03-05
• Study Start: 2015-07
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Results First Submitted: 2016-10-05
• Status Verified: 2017-01
• Results First Submitted QC: 2017-01-03
• Last Update Submitted: 2017-01-03
• Results First Posted: 2017-02-23
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 54

Inclusion Criteria

• Women in the Loyola Urogynecology clinic who use a pessary for management of pelvic organ prolapse (POP) or urinary incontinence (UI)
• Read and speak the English language

Exclusion Criteria

• Non-English speaking
• Allergy or contraindication to topical anesthetic
• Participation/randomization in the study at a previous visit
• Currently pregnant or lactating or planning a pregnancy within the next 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lidocaine-prilocaine	lidocaine-prilocaine cream	4 mL of lidocaine-prilocaine cream
Placebo	Placebo cream	4 mL of placebo cream

Primary Outcome Measures

Name	Time	Method
VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain	Removal of Pessary	Self-reported pain intensity at time of pessary removal controlling for baseline pain. Scale is from 0 to 10 (0=no pain and 10=worst pain)

Secondary Outcome Measures

Name	Time	Method
VAS Score at the Time of Pessary Removal Adjusting for Pessary Type and Investigator Training	Removal of Pessary	Self-reported pain intensity at time of pessary removal after controlling for pessary type and investigator training level. Scale is from 0 to 10 centimeters (0=no pain and 10=worst pain)
VAS Score at the Time of Pessary Insertion Adjusting for Baseline Pain	Insertion of Pessary	Practitioner's perception of patient's pain score at time of pessary insertion adjusting for baseline pain. Scale is from 0 to 10 centimeters (0=no pain and 10=worst pain)
VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain and Patient Age	Removal of Pessary	Self-reported pain intensity at time of pessary removal after controlling for patient age and baseline pain score. Scale is from 0 to 10 centimeters (0=no pain and 10=worst pain)

Trial Locations

Locations (1)

Loyola University Medical Center; 🇺🇸 Maywood, Illinois, United States