Effects of Topical Lidocaine During Urodynamic Testing In Women

NCT03881293 | Completed

• 1 other identifier: IRB#12-09
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

Urodynamic testing is used to help diagnose causes of urinary incontinence and voiding dysfunction. The purpose of the urodynamic test is to gain insight into the patient's urinary symptoms and assist in making a diagnosis. Catheter insertion and manipulation during the test can be uncomfortable for the patient. Lidocaine gel has not been used routinely during urodynamic testing. However, it is used routinely during outpatient cystoscopy and with any urethral catheterization. The investigators proposed that lidocaine numbing gel could be used without compromising test findings. The study included 110 adult women. The purpose was:

1. 1.Determine whether the use of topical lidocaine during urodynamic testing decreases patient discomfort during the procedure.
2. 2.Evaluate whether the use of topical lidocaine affects the urodynamic results.

Conditions

Urinary Stress Incontinence; Pain

Keywords

urodynamics; women; lidocaine gel

Outcome Measures

Primary Outcomes (1)

• Change in pain immediately after urethral pressure profilometry

  Patient rated pain using Likert Scale of 0-10 (0 is no pain and 10 is worst pain)

  Pain was assessed immediately after urethral pressure profilometry was performed

Secondary Outcomes (2)

• Demonstration of stress urinary incontinence during the urodynamic test

  During the urodynamic test

• Perception of bladder filling

  During the urodynamic test

Study Arms (2)

Placebo Lubricant Gel

PLACEBO COMPARATOR

5 ml water-soluble gel instilled transurethrally ten minutes prior to catheter insertion

Drug: water soluble lubricant

Lidocaine 2% Gel

ACTIVE COMPARATOR

5 ml lidocaine 2% gel instilled transurethrally ten minutes prior to catheter insertion

Drug: lidocaine 2% gel

Interventions

lidocaine 2% gel DRUG

Transurethral instillation of 5 ml lidocaine 2% gel

Lidocaine 2% Gel

water soluble lubricant DRUG

Transurethral instillation of 5 ml water soluble lubricant

Placebo Lubricant Gel

Eligibility Criteria

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

You may qualify if:

• Women with complaint of stress urinary incontinence who were scheduled for a urodynamic test Patients with symptomatic pelvic organ prolapse if they also had stress incontinence symptoms.
• Community dwelling elderly patients who were able to provide their own history and were able to sign for themselves

You may not qualify if:

• Patients who were unable to provide their own consent Patients who are allergic to lidocaine Children and pregnant patients

Sponsors & Collaborators

• Kristine Zinkgraf: lead
• Medical College of Wisconsin: collaborator
• WomenConnected: collaborator

MeSH Terms

Conditions

Urinary Incontinence, Stress; Pain

Interventions

Lidocaine; Gels

Condition Hierarchy (Ancestors)

Urinary Incontinence; 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; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Katherine Stevenson, MD

  ProHealth Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Advanced Practice Nurse

Model Details: Double Blinded Randomized Control Trial

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: March 19, 2019
• Study Start: December 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 19, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share