Lessons on Urethral Lidocaine in Urodynamics

NCT04038099 | Completed Phase 4 Results FDA Drug

• 1 other identifier: STU-2019-0540
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Urethra Issue; Pelvic Organ Prolapse; Urinary Incontinence; Vaginal Vault Prolapse; Cystocele; Uterine Prolapse; Vaginal Prolapse; Pelvic Floor Disorders

Outcome Measures

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.

  Assess whether use of intraurethral 2% lidocaine jelly meaningfully impacts sensation during filling (especially, strong desire to void).

  Within same visit, approximately 90-120 minutes.

Secondary Outcomes (10)

• 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.

• 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.

• Filling Metrics: Number of Participants With Detrusor Overactivity

  Cystometrogram 2 within same visit, approximately 90-120 minutes.

• Filling Metrics: Number of Participants With Normal Bladder Compliance

  Within same visit, approximately 90-120 minutes.

• Voiding Metrics: Maximum Flow Rate

  Within same visit, approximately 90-120 minutes.

Study Arms (2)

Water Based Lubricating Jelly

PLACEBO COMPARATOR

5ml of Water Based Lubricating Jelly

Drug: Water-Based Vaginal Lubricant

Lidocaine 2% Jelly

ACTIVE COMPARATOR

5ml of Lidocaine 2% Jelly

Drug: lidocaine topical

Interventions

Water-Based Vaginal Lubricant DRUG

5cc water based jelly applied intraurethral

Water Based Lubricating Jelly

lidocaine topical DRUG

5cc 2% lidocaine jelly applied intraurethral

Lidocaine 2% Jelly

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients
• \>18 years of age
• Already scheduled (or being scheduled) for UDS to assess urinary incontinence
• Able to speak and read in English

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (1)

• 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

  RESULT

Related Links

• Research Video

MeSH Terms

Conditions

Pelvic Organ Prolapse; Urinary Incontinence; Cystocele; Uterine Prolapse; Pelvic Floor Disorders

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Urinary Bladder Diseases; Uterine Diseases; Genital Diseases, Female; Genital Diseases; Pregnancy Complications

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Christina Hicks, MS, APRN, WHNP-BC, FAUNA
• Organization: UT Southwestern Medical Center

christy.hicks@utsouthwestern.edu

2146453848

Study Officials

• Christina M Hegan, APRN WHNP-BC

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse practitioner

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: July 30, 2019
• Study Start: August 14, 2019
• Primary Completion: August 18, 2021
• Study Completion: August 18, 2021
• Last Updated: August 1, 2023
• Results First Posted: August 1, 2023

Record last verified: 2023-07

Locations

US (1)