LULU: Lessons on Urethral Lidocaine in Urodynamics

Sponsor

University of Texas Southwestern Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04038099

Collaborator

(none)

Enrollment

Location

Arms

38.3

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Aug 14, 2019

Anticipated Primary Completion Date :

Oct 22, 2022

Anticipated Study Completion Date :

Oct 22, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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. [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

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.
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: Detrusor Overactivity [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
Filling Metrics: Compliance [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).
Voiding Metrics: Maximum Flow Rate [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).
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. [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.
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. [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.
Voiding Metrics: Voided Volume and Post-void Residual [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).
Voiding Metrics: Voiding Efficiency [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)]
Voiding Metrics: Pdet Max [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).
Voiding Metrics: Pdet Peak Flow [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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