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Lessons on Urethral Lidocaine in Urodynamics (LULU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04038099
Recruitment Status : Recruiting
First Posted : July 30, 2019
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Urethra Issue Pelvic Organ Prolapse Urinary Incontinence Vaginal Vault Prolapse Cystocele Uterine Prolapse Vaginal Prolapse Pelvic Floor Disorders Drug: Water-Based Vaginal Lubricant Drug: lidocaine topical Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Diagnostic
Official Title: Lessons on Urethral Lidocaine in Urodynamics (LULU): Impact of Intraurethral Lidocaine on Cystometric Parameters and Discomfort
Actual Study Start Date : August 14, 2019
Estimated Primary Completion Date : October 22, 2021
Estimated Study Completion Date : October 22, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arm Intervention/treatment
Placebo Comparator: Water Based Lubricating Jelly
5ml of Water Based Lubricating Jelly
Drug: Water-Based Vaginal Lubricant
5cc water based jelly applied intraurethral

Active Comparator: Lidocaine 2% Jelly
5ml of Lidocaine 2% Jelly
Drug: lidocaine topical
5cc 2% lidocaine jelly applied intraurethral




Primary Outcome Measures :
  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: Change from cystometrogram 1 to cystometrogram 2 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 :
  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: Detrusor Overactivity [ 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 the presence/absence of detrusor overactivity

  4. Filling Metrics: Compliance [ 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 compliance (change in volume/ change in Pdet).

  5. Voiding Metrics: Maximum Flow Rate [ 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 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: 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 voiding pattern.

  7. Voiding Metrics: Detrusor vs. Valsalva vs. Mixed Void Type based on presence of detrusor activity (increase in pdet) or Valsalva activity (increase in pabd) or both during voiding. [ 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 detrusor vs. Valsalva vs mixed void type.

  8. Voiding Metrics: Voided Volume and Post-void Residual [ 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 voided volume and post-void residual (mL).

  9. Voiding Metrics: Voiding Efficiency [ 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 voiding efficiency. [voided volume/(voided volume + PVR)]

  10. Voiding Metrics: Pdet Max [ 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 Pdet Max (cm/H2O).

  11. Voiding Metrics: Pdet Peak Flow [ 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 Pdet Peak Flow (cm/H2O).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04038099


Contacts
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Contact: Christina M Hegan, APRN WHNP-BC 214-645-3815 christy.hicks@utsouthwestern.edu
Contact: Agnes Burris, RN 214-645-3833 agnes.burris@utsouthwestern.edu

Locations
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United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Christina M Hegan, APRN WHNP-BC    214-645-3815    christy.hicks@utsouthwestern.edu   
Contact: Agnes Burris, RN    214-645-3833    agnes.burris@utsouthwestern.edu   
Principal Investigator: Christina M Hegan, APRN WHNP-BC         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Christina M Hegan, APRN WHNP-BC University of Texas Southwestern Medical Center
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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT04038099    
Other Study ID Numbers: STU-2019-0540
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Urinary Incontinence
Pelvic Floor Disorders
Cystocele
Uterine Prolapse
Prolapse
Pelvic Organ Prolapse
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Pathological Conditions, Anatomical
Pregnancy Complications
Urinary Bladder Diseases
Uterine Diseases
Genital Diseases, Female
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action