Lidocaine for Pessary Check Pain Reduction

University of South Florida66 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Pelvic Organ Prolapse Stress Urinary Incontinence

Interventions

Lidocaine Hcl 2% JellyDRUG

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

Placebo JellyDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

USF Health Outpatient Urogynecology Clinics

Tampa, Florida, United States

Outcomes

Primary Outcomes

Change in patient's pain using the visual analog scale (VAS) after pessary removal

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)

Time frame: 0 and 5 minutes

Secondary Outcomes

Change in patient's pain using the visual analog scale (VAS) after pessary reinsertion

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)

Time frame: 0 and 10 minutes

Genital Hiatus with Valsalva

Genital hiatus measurement in centimeters prior to removal of the pessary

Time frame: 0 minutes

Data from ClinicalTrials.gov

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