Topical Anesthetic Use In Pessary Management
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
54 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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