Trials / Completed
CompletedNCT04038099
Lessons on Urethral Lidocaine in Urodynamics
Lessons on Urethral Lidocaine in Urodynamics (LULU): Impact of Intraurethral Lidocaine on Cystometric Parameters and Discomfort
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 63 (actual)
- Sponsor
- University of Texas Southwestern Medical Center · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This trial is a randomized, double blind, controlled trial for patients undergoing complex cystometric evaluation. Patients will undergo routine complex cystometric evaluation for acquisition of baseline data using a small amount of intraurethral aqueous jelly for catheter lubrication. Then, they will be randomized to instillation of either placebo (additional intraurethral aqueous jelly, 5ml) or intraurethral 2% lidocaine jelly. Participants then undergo complex cystometry a second time. Normal variations in studies with placebo will be compared to variations within the 2% lidocaine jelly group to determine if cystometric parameters are altered in any clinically important ways. Patient discomfort will also be evaluated by both the patient and the urodynamics advanced practice nurse.
Conditions
- Urethra Issue
- Pelvic Organ Prolapse
- Urinary Incontinence
- Vaginal Vault Prolapse
- Cystocele
- Uterine Prolapse
- Vaginal Prolapse
- Pelvic Floor Disorders
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Water-Based Vaginal Lubricant | 5cc water based jelly applied intraurethral |
| DRUG | lidocaine topical | 5cc 2% lidocaine jelly applied intraurethral |
Timeline
- Start date
- 2019-08-14
- Primary completion
- 2021-08-18
- Completion
- 2021-08-18
- First posted
- 2019-07-30
- Last updated
- 2023-08-01
- Results posted
- 2023-08-01
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04038099. Inclusion in this directory is not an endorsement.