Lessons on Urethral Lidocaine in Urodynamics (LULU)

The University of Texas System (UT)

Status and phase: Completed; Phase 4

Conditions: Pelvic Floor Disorders; Uterine Prolapse; Cystocele; Vaginal Prolapse; Pelvic Organ Prolapse; Vaginal Vault Prolapse; Urinary Incontinence; Urethra Issue

Treatments: Drug: lidocaine topical; Drug: Water-Based Vaginal Lubricant

Study type: Interventional

Funder types: Other

Identifiers

NCT04038099

STU-2019-0540

Details and patient eligibility

About

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.

Full 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.

Enrollment: 63 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female patients
• >18 years of age
• Already scheduled (or being scheduled) for UDS to assess urinary incontinence
• Able to speak and read in English

Exclusion criteria

• Diagnosis of pelvic pain, interstitial cystitis, or bladder pain syndrome
• Known neurogenic disease impacting voiding/ continence (e.g., Parkinson disease, multiple sclerosis, myasthenia gravis, recent stroke)
• Active UTI
• Pelvic organ prolapse that is unable to be easily reduced
• Pregnancy or breastfeeding
• Allergy or hypersensitivity to lidocaine or local anesthetics

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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63 participants in 2 patient groups, including a placebo group

Water Based Lubricating Jelly

Placebo Comparator group

Description:

5ml of Water Based Lubricating Jelly

Treatment:

Drug: Water-Based Vaginal Lubricant

Lidocaine 2% Jelly

Active Comparator group

Description:

5ml of Lidocaine 2% Jelly

Treatment:

Drug: lidocaine topical