Clinical trial NCT04038099: Lessons on Urethral Lidocaine in Urodynamics
Official title: Lessons on Urethral Lidocaine in Urodynamics (LULU): Impact of Intraurethral Lidocaine on Cystometric Parameters and Discomfort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urethra Issue
Pelvic Organ Prolapse
Urinary Incontinence
Vaginal Vault Prolapse
Cystocele
Uterine Prolapse
Vaginal Prolapse
Pelvic Floor Disorders
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2019-07-30
Enrollment: 63
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Within same visit, approximately 90-120 minutes.
Secondary outcomes:
measure: 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).
timeFrame: Change from cystometrogram 1 to cystometrogram 2 within same visit, approximately 90-120 minutes.
measure: 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).
timeFrame: Change from cystometrogram 1 to cystometrogram 2 within same visit, approximately 90-120 minutes.
measure: Filling Metrics: Number of Participants With Detrusor Overactivity
timeFrame: Cystometrogram 2 within same visit, approximately 90-120 minutes.
measure: Filling Metrics: Number of Participants With Normal Bladder Compliance
timeFrame: Within same visit, approximately 90-120 minutes.
measure: Voiding Metrics: Maximum Flow Rate
timeFrame: Within same visit, approximately 90-120 minutes.
measure: 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.
timeFrame: within same visit, approximately 90-120 minutes.
measure: Voiding Metrics: Voided Volume and Post-void Residual
timeFrame: Within same visit, approximately 90-120 minutes.
measure: Voiding Metrics: Percentage of Voiding Efficiency
timeFrame: Cystometrogram 2 within same visit, approximately 90-120 minutes.
measure: Voiding Metrics: Pdet Max
timeFrame: Within same visit, approximately 90-120 minutes.
measure: Voiding Metrics: Pdet Peak Flow
timeFrame: Within same visit, approximately 90-120 minutes.
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Christina M Hegan, APRN WHNP-BC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hicks, C., Schaffer, J., Pruzynski, J., & Rahn, D. (2022). Impact of Intraurethral Lidocaine on Cystometric Parameters and Patient Discomfort: A Randomized Controlled Trial. Urologic Nursing, 42(5), 237-257. https://doi.org/10.7257/2168-4626.2022.42.5.237