NCT05493735

Lidocaine for Pessary Check Pain Reduction

Lidocaine for Pessary Removal and Reinsertion Pain Reduction

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: University of South Florida · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pelvic Organ Prolapse
• Stress Urinary Incontinence

Interventions

Type	Name	Description
DRUG	Lidocaine Hcl 2% Jelly	Participants in the experimental arm will undergo pessary removal and reinsertion after the application of lidocaine topical gel.
DRUG	Placebo Jelly	Participants in the control arm will undergo pessary removal and reinsertion after the application of lubricating jelly.

Timeline

• Start date: 2022-09-08
• Primary completion: 2023-06-23
• Completion: 2023-06-30
• First posted: 2022-08-09
• Last updated: 2023-12-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study