Skip to main content
OpenTrials
Completed

NCT Number: NCT02380742

Topical Anesthetic Use In Pessary Management

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lidocaine-prilocaine cream

Drug

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

Other names: 5% EMLA cream

placebo cream

Drug

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

Primary outcomes

  1. VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain

    Time frame: 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 outcomes

  1. VAS Score at the Time of Pessary Removal Adjusting for Pessary Type and Investigator Training

    Time frame: 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)

  2. VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain and Patient Age

    Time frame: 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)

  3. VAS Score at the Time of Pessary Insertion Adjusting for Baseline Pain

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Loyola University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 5, 2015
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.