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Completed

NCT Number: NCT05493735

Lidocaine for Pessary Check 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Lidocaine Hcl 2% Jelly

Drug

Participants in the experimental arm will undergo pessary removal and reinsertion after the application of lidocaine topical gel.

Other names: Lidocaine Jelly

Placebo Jelly

Drug

Participants in the control arm will undergo pessary removal and reinsertion after the application of lubricating jelly.

Other names: Lubricating Gel, Vaginal Lubricant

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. Genital Hiatus with Valsalva

    Time frame: 0 minutes

    Genital hiatus measurement in centimeters prior to removal of the pessary

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Registry information

Official study title

Lidocaine for Pessary Removal and Reinsertion Pain Reduction

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 9, 2022
Registry last updated
Dec 14, 2023

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.

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