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Completed

NCT Number: NCT04038099

Lessons on Urethral Lidocaine in Urodynamics

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.

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Key information

Conditions

Urethra Issue Cystocele Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Floor Disorders Pelvic Organ Prolapse Pregnancy Complications Prolapse Signs and Symptoms Urinary Bladder Diseases Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations Uterine Diseases Uterine Prolapse Vaginal Prolapse Vaginal Vault Prolapse

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Water-Based Vaginal Lubricant

Drug

5cc water based jelly applied intraurethral

Lidocaine topical

Drug

5cc 2% lidocaine jelly applied intraurethral

Primary outcomes

  1. 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.

    Time frame: 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 outcomes

  1. 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).

    Time frame: 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.

  2. 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).

    Time frame: 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.

  3. Filling Metrics: Number of Participants With Detrusor Overactivity

    Time frame: 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.

  4. Filling Metrics: Number of Participants With Normal Bladder Compliance

    Time frame: 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.

  5. Voiding Metrics: Maximum Flow Rate

    Time frame: Within same visit, approximately 90-120 minutes.

    Determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts maximum flow rate (mL/sec).

  6. 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.

    Time frame: 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.

  7. Voiding Metrics: Voided Volume and Post-void Residual

    Time frame: 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.

  8. Voiding Metrics: Percentage of Voiding Efficiency

    Time frame: 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.

  9. Voiding Metrics: Pdet Max

    Time frame: 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.

  10. Voiding Metrics: Pdet Peak Flow

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

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

Acronym: LULU

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 30, 2019
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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