Lessons on Urethral Lidocaine in Urodynamics

Study Overview
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Brief Summary
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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
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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.

Official Title
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Lessons on Urethral Lidocaine in Urodynamics (LULU): Impact of Intraurethral Lidocaine on Cystometric Parameters and Discomfort

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

Intervention / Treatment
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* Drug: Water-Based Vaginal Lubricant
* Drug: lidocaine topical


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Water Based Lubricating Jelly<br>5ml of Water Based Lubricating Jelly | Drug: Water-Based Vaginal Lubricant<br>* 5cc water based jelly applied intraurethral<br>|
| Active Comparator: Lidocaine 2% Jelly<br>5ml of Lidocaine 2% Jelly | Drug: lidocaine topical<br>* 5cc 2% lidocaine jelly applied intraurethral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensation as Indicated by the Volume of Water Filled (ml) at the Time of Patient Perception of First Sensation, First Urge to Void, Strong Urge to Void, and Full Bladder Capacity During Bladder Filling. | Assess whether use of intraurethral 2% lidocaine jelly meaningfully impacts sensation during filling (especially, strong desire to void). | Within same visit, approximately 90-120 minutes. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Perception of Pain/Discomfort as Indicated by Visual Analog Scale (Scale of 0-100 With 0 Being no Pain and 100 Being the Worst the Pain Imaginable). | Determine whether the use of intraurethral lidocaine 2% jelly meaningfully impacts pain/discomfort measured by a visual analog scale during cystometry (catheter insertion and at maximum cystometric capacity), during pressure flow study (PFS), and post-procedure. | Change from cystometrogram 1 to cystometrogram 2 within same visit, approximately 90-120 minutes. | 
| Provider Perception of Patient Pain/Discomfort as Indicated by Visual Analog Scale (Scale of 0-100 With 0 Being no Pain and 100 Being the Worst Pain Imaginable). | Determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts provider perception of patient discomfort. | Change from cystometrogram 1 to cystometrogram 2 within same visit, approximately 90-120 minutes. | 
| Filling Metrics: Number of Participants With Detrusor Overactivity | Determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts the presence/absence of detrusor overactivity (bladder spasm) during urodynamic bladder testing. Detrusor overactivity was noted and compared between placebo and lidocaine jelly on UDS #2. | Cystometrogram 2 within same visit, approximately 90-120 minutes. | 
| Filling Metrics: Number of Participants With Normal Bladder Compliance | Determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts bladder compliance (change in volume/ change in detrusor pressure (Pdet)). Compliance in UDS #2 was noted and compared in both groups: water-based lubricant and intraurethral 2% lidocaine jelly. Results indicate how many participants in which normal compliance was observed. *There were 3 missing data values in our data. | Within same visit, approximately 90-120 minutes. | 
| Voiding Metrics: Maximum Flow Rate | Determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts maximum flow rate (mL/sec). | Within same visit, approximately 90-120 minutes. | 
| Voiding Metrics: Voiding Pattern (Normal vs. Intermittent/Interrupted vs Prolonged) as Perceived by Provider Interpretation of Pressure Flow Study During Voiding Based on Seconds to Void and Whether Urine Stream is Constant or Intermittent/Interrupted. | Determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts voiding pattern. Voiding pattern was assessed in UDS #2 and identified as either normal, prolonged, intermittent, interrupted or a combination of those identifiers and compared between the two groups. | within same visit, approximately 90-120 minutes. | 
| Voiding Metrics: Voided Volume and Post-void Residual | Determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts voided volume and post-void residual (mL) as recorded during UDS #2. | Within same visit, approximately 90-120 minutes. | 
| Voiding Metrics: Percentage of Voiding Efficiency | Determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts voiding efficiency, which is calculated as the voided volume (mL) divided by the sum of the voided volume (mL) and the post-void residual volume (mL). Voiding efficiency was compared by treatment arm in UDS #2. | Cystometrogram 2 within same visit, approximately 90-120 minutes. | 
| Voiding Metrics: Pdet Max | Determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts Pdet Max (cm/H2O) on UDS #2. | Within same visit, approximately 90-120 minutes. | 
| Voiding Metrics: Pdet Peak Flow | Determine whether the use of intraurethral 2& lidocaine jelly meaningfully impacts Pdet Peak Flow (cm/H2O) on UDS #2. | Within same visit, approximately 90-120 minutes. |