Topical Anesthetic Use In Pessary Management

Study Overview
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Brief Summary
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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
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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.

Official Title
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Topical Anesthetic Use In Pessary Management: A Randomized Double Blinded Placebo Controlled Trial

Conditions
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Pain

Intervention / Treatment
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* Drug: lidocaine-prilocaine cream
* Drug: Placebo cream


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lidocaine-prilocaine<br>4 mL of lidocaine-prilocaine cream | Drug: lidocaine-prilocaine cream<br>* The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point<br>* Other names: 5% EMLA cream;|
| Placebo Comparator: Placebo<br>4 mL of placebo cream | Drug: Placebo cream<br>* The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain | 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) | Removal of Pessary | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS Score at the Time of Pessary Removal Adjusting for Pessary Type and Investigator Training | 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) | Removal of Pessary | 
| VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain and Patient Age | 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) | Removal of Pessary | 
| VAS Score at the Time of Pessary Insertion Adjusting for Baseline Pain | 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) | Insertion of Pessary | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pessary, Pain, EMLA, lidocaine, prilocaine