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Lessons on Urethral Lidocaine in Urodynamics

NCT04038099 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2023-08-01

Study results available
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Summary

This trial will assess whether use of intraurethral 2% lidocaine jelly meaningfully impacts sensation during filling (i.e., a change of more than 25% of first sensation, first desire to void, strong desire to void, or maximum cystometric capacity) and determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts pain/discomfort, filling metrics, and voiding metrics.

Conditions

  • Urethra Issue
  • Pelvic Organ Prolapse
  • Urinary Incontinence
  • Vaginal Vault Prolapse
  • Cystocele
  • Uterine Prolapse
  • Vaginal Prolapse
  • Pelvic Floor Disorders

Interventions

DRUG

Water-Based Vaginal Lubricant

5cc water based jelly applied intraurethral

DRUG

lidocaine topical

5cc 2% lidocaine jelly applied intraurethral

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Christina M Hegan, APRN WHNP-BC · University of Texas Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-14
Primary Completion
2021-08-18
Completion
2021-08-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04038099 on ClinicalTrials.gov