Lidocaine for Pessary Check Pain Reduction

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

Detailed Description
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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.

Official Title
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Lidocaine for Pessary Removal and Reinsertion Pain Reduction

Conditions
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Pelvic Organ Prolapse, Stress Urinary Incontinence

Intervention / Treatment
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* Drug: Lidocaine Hcl 2% Jelly
* Drug: Placebo Jelly


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Lubricating jelly (placebo) will be placed in the vagina to the level of the pessary, five minutes prior to pessary removal. | Drug: Placebo Jelly<br>* Participants in the control arm will undergo pessary removal and reinsertion after the application of lubricating jelly.<br>* Other names: Vaginal Lubricant;|
| Experimental: Experimental<br>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<br>* Participants in the experimental arm will undergo pessary removal and reinsertion after the application of lidocaine topical gel.<br>* Other names: Lidocaine Jelly;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 | 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 | Genital hiatus measurement in centimeters prior to removal of the pessary | 0 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pessary, Lidocaine, Pain Reduction, Pessary Check, Pessary Removal, Pessary Reinsertion, Lubricating Jelly