Loyola University Medical Center

Gottlieb Memorial Hospital

MacNeal Hospital

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NCT02380742

Topical Anesthetic Use In Pessary Management

Official Title:

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

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.

Eligibility

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

Disease(s) and\or Condition(s)

Pain

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: DRUG
    • Name: lidocaine-prilocaine cream
    • Description: 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
    • Arm Group Labels: lidocaine-prilocaine
    • Type: DRUG
    • Name: Placebo cream
    • Description: 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
    • Arm Group Labels: Placebo
Sponsor
  • Loyola University