Lessons on Urethral Lidocaine in Urodynamics

Phase 4

Completed

• Conditions: Cystocele; Uterine Prolapse; Pelvic Organ Prolapse; Vaginal Vault Prolapse; Urinary Incontinence; Urethra Issue; Vaginal Prolapse; Pelvic Floor Disorders
• Interventions: Drug: Water-Based Vaginal Lubricant; Drug: lidocaine topical

• Registration Number: NCT04038099
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief 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.

Study Timeline

• Study First Submitted: 2019-07-24
• Study First Submitted QC: 2019-07-26
• Study First Posted: 2019-07-30
• Study Start: 2019-08-14
• Primary Completion: 2021-08-18
• Study Completion: 2021-08-18
• Results First Submitted: 2023-03-01
• Status Verified: 2023-07
• Results First Submitted QC: 2023-07-18
• Last Update Submitted: 2023-07-18
• Results First Posted: 2023-08-01
• Last Update Posted: 2023-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 63

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Water Based Lubricating Jelly	Water-Based Vaginal Lubricant	5ml of Water Based Lubricating Jelly
Lidocaine 2% Jelly	lidocaine topical	5ml of Lidocaine 2% Jelly

Primary Outcome Measures

Name	Time	Method
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.	Within same visit, approximately 90-120 minutes.	Assess whether use of intraurethral 2% lidocaine jelly meaningfully impacts sensation during filling (especially, strong desire to void).

Secondary Outcome Measures

Name	Time	Method
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).	Change from cystometrogram 1 to cystometrogram 2 within same visit, approximately 90-120 minutes.	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.
Voiding Metrics: Percentage of Voiding Efficiency	Cystometrogram 2 within same visit, approximately 90-120 minutes.	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.
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.	within same visit, approximately 90-120 minutes.	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.
Voiding Metrics: Voided Volume and Post-void Residual	Within same visit, approximately 90-120 minutes.	Determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts voided volume and post-void residual (mL) as recorded during UDS #2.
Voiding Metrics: Pdet Peak Flow	Within same visit, approximately 90-120 minutes.	Determine whether the use of intraurethral 2\& lidocaine jelly meaningfully impacts Pdet Peak Flow (cm/H2O) on UDS #2.
Voiding Metrics: Pdet Max	Within same visit, approximately 90-120 minutes.	Determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts Pdet Max (cm/H2O) on UDS #2.
Filling Metrics: Number of Participants With Detrusor Overactivity	Cystometrogram 2 within same visit, approximately 90-120 minutes.	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.
Voiding Metrics: Maximum Flow Rate	Within same visit, approximately 90-120 minutes.	Determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts maximum flow rate (mL/sec).
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).	Change from cystometrogram 1 to cystometrogram 2 within same visit, approximately 90-120 minutes.	Determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts provider perception of patient discomfort.
Filling Metrics: Number of Participants With Normal Bladder Compliance	Within same visit, approximately 90-120 minutes.	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.

Trial Locations

Locations (1)

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States