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Lidocaine for Pessary Check Pain Reduction

NCT05493735 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2023-12-14

No results posted yet for this study

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.

Conditions

  • Pelvic Organ Prolapse
  • Stress Urinary Incontinence

Interventions

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.

Sponsors & Collaborators

  • University of South Florida

    lead OTHER

Principal Investigators

  • Araba A Jackson, MD · University of South Florida

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-08
Primary Completion
2023-06-23
Completion
2023-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05493735 on ClinicalTrials.gov