Lidocaine for Pessary Check Pain Reduction

Phase 3

Completed

• Conditions: Pelvic Organ Prolapse; Stress Urinary Incontinence
• Interventions: Drug: Placebo Jelly; Drug: Lidocaine Hcl 2% Jelly

• Registration Number: NCT05493735
• Lead Sponsor: University of South Florida

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-07-15
• Study First Submitted QC: 2022-08-05
• Study First Posted: 2022-08-09
• Study Start: 2022-09-08
• Primary Completion: 2023-06-23
• Study Completion: 2023-06-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-07
• Last Update Posted: 2023-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo Jelly	Lubricating jelly (placebo) will be placed in the vagina to the level of the pessary, five minutes prior to pessary removal.
Experimental	Lidocaine Hcl 2% Jelly	Lidocaine jelly will be placed in the vagina to the level of the pessary, five minutes prior to the pessary removal.

Primary Outcome Measures

Name	Time	Method
Change in patient's pain using the visual analog scale (VAS) after pessary removal	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 Outcome Measures

Name	Time	Method
Change in patient's pain using the visual analog scale (VAS) after pessary reinsertion	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)
Genital Hiatus with Valsalva	0 minutes	Genital hiatus measurement in centimeters prior to removal of the pessary

Trial Locations

Locations (1)

USF Health Outpatient Urogynecology Clinics; 🇺🇸 Tampa, Florida, United States