Lidocaine for Pessary Check Pain Reduction

December 7, 2023 updated by: University of South Florida

Lidocaine for Pessary Removal and Reinsertion Pain Reduction

The primary objective of this study is to estimate the effect of lidocaine jelly on patient pain at the time of office pessary removal.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of the study is to investigate the effects of lidocaine jelly on patient pain at the time of office pessary removal and reinsertion. All patients presenting to the University of South Florida Urogynecology clinic for a pessary maintenance appointment or "pessary check" will be screened as potential study participants. After being informed of risks and benefits of participation, informed consent will be obtained. Patients will be randomized into two groups: the control group or experimental group. The patient will complete a brief questionnaire and pain assessment using a Visual Analog Scale (VAS).

Patients will be blinded. The investigators will be unblinded. The investigators will apply the jelly (lidocaine vs lubricating). The participant will have an equal chance of being in the control arm or experimental arm. After 5 minutes, the investigator will assess the patient's genital hiatus with valsalva and proceed with pessary removal per the investigator's routine. The patient will complete another VAS to indicate pain level after pessary removal. The investigator will perform a speculum exam per routine and then reinsert the pessary. The patient will complete a final VAS to indicate level of pain after pessary reinsertion along with a brief final questionnaire.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33606
        • USF Health Outpatient Urogynecology Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Women aged 18 years or older
  • Presenting for routine pessary management for prolapse, stress urinary incontinence, or both with a pessary in place
  • able to provide written informed consent
  • able to complete the visual analog scale

Exclusion Criteria:

  • Women less than 18 years of age.
  • Patients who speak neither English nor Spanish
  • Pregnancy
  • Medical contraindication to lidocaine
  • Planned change in pessary size or type
  • Patients who remove and reinsert their pessary at home

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Lubricating jelly (placebo) will be placed in the vagina to the level of the pessary, five minutes prior to pessary removal.
Drug: Placebo Jelly
Participants in the control arm will undergo pessary removal and reinsertion after the application of lubricating jelly.
Other Names:
  • Lubricating Gel
  • Vaginal Lubricant
Experimental: Experimental
Lidocaine jelly will be placed in the vagina to the level of the pessary, five minutes prior to the pessary removal.
Drug: Lidocaine Hcl 2% Jelly
Participants in the experimental arm will undergo pessary removal and reinsertion after the application of lidocaine topical gel.
Other Names:
  • Lidocaine Jelly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in patient's pain using the visual analog scale (VAS) after pessary removal
Time Frame: 0 and 5 minutes
Self-reported pain level at time of pessary removal controlling for baseline pain. Scale is from 0 to 10 (0=no pain and 10=worst pain)
0 and 5 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in patient's pain using the visual analog scale (VAS) after pessary reinsertion
Time Frame: 0 and 10 minutes
Self-reported pain level at time of pessary reinsertion controlling for baseline pain. Scale is from 0 to 10 (0=no pain and 10=worst pain)
0 and 10 minutes
Genital Hiatus with Valsalva
Time Frame: 0 minutes
Genital hiatus measurement in centimeters prior to removal of the pessary
0 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Florida

Investigators

  • Principal Investigator: Araba A Jackson, MD, University of South Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2022

Primary Completion (Actual)

June 23, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

July 15, 2022

First Submitted That Met QC Criteria

August 5, 2022

First Posted (Actual)

August 9, 2022

Study Record Updates

Last Update Posted (Actual)

December 14, 2023

Last Update Submitted That Met QC Criteria

December 7, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro004522

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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