Lidocaine for Pain After Urodynamic Testing

Urinary Incontinence Clinical Trial

Official title:

The Impact of Pre-procedure Periurethral Topical Lidocaine Application on Pain Scores After Complex Urodynamic Testing in Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03390790
• Other study ID #: 1112951-1
• Status: Completed
• Phase: Phase 4
• Start date: January 25, 2018
• Est. completion date: March 29, 2019

Study information

• Verified date: July 2019
• Source: Atlantic Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Urodynamic testing can be associated with mild discomfort, particularly at the time of insertion, repositioning, and removal of the bladder catheter (a tube inserted into the bladder via the urethra). Few studies have investigated ways to improve patient comfort during this procedure. In this study, the investigators want to see if applying external lidocaine (a numbing gel) prior to the procedure can help to minimize patient discomfort.

Description:

Urodynamic testing can be associated with mild discomfort, particularly at the time of insertion, repositioning, and removal of the bladder catheter (a tube inserted into the bladder via the urethra). Few studies have investigated ways to improve patient comfort during this procedure. In this study, the investigators want to see if applying lidocaine (a numbing gel) prior to the procedure can help to minimize patient discomfort.

Participation in this study will involve only 1 clinic visit (for urodynamic testing), plus 2 phone calls to ask participants about pain (1 at 4-6 hours after testing; and 1 at 24 hours after testing). Additionally, the investigators will record any adverse effects (such as an allergic reaction to the gel or new irritation/pain) that happen within 2 weeks after testing.

Participants will be randomly assigned to receive either lidocaine gel or placebo gel for their urodynamic testing. The placebo gel will be a standard lubricant gel, meaning that it contains no active drug. The assigned study regimen will be chosen by chance, like flipping a coin. Participants will have an equal (50/50) chance of being given either study regimen. Neither the participant nor the study doctor or nurse practitioner will know which study regimen the participant is getting. Additionally, a member of the study team will ask participants about their pain level before and after the testing. The rest of the urodynamic testing procedure will take place exactly as it would if the participant was not in this research study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: March 29, 2019
• Est. primary completion date: March 29, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• All female patients between the ages of 40-80 undergoing urodynamic testing.

Exclusion Criteria:

• Urinary tract infection or symptoms of infection at time of procedure or within past 2 weeks

• History of urinary retention

• Known or suggested history of urethral syndrome or painful bladder syndrome

• Prior anti-incontinence surgery

• Prior pelvic surgery with placement of transvaginal mesh

• Known urethral or bladder anomaly including urethral diverticulum or congenital anomalies of the bladder or urethra

• History of genital herpes outbreak within the past 3 months

• Defects in mucosal surfaces including periurethral or vaginal abrasions, ulcerations, or lacerations

• Neurologic disease affecting urethral sensation

• Chronic pelvic pain

• Contraindication or allergy to topical anesthetic

• Pregnancy

• Syncopal episode during preparation for or execution of uroflowometry

Related Conditions & MeSH terms

• Enuresis
• Overactive Bladder
• Urinary Bladder, Overactive
• Urinary Incontinence
• Voiding Disorders

Intervention

Drug:
• Lidocaine gel 2%
If assigned to this intervention via randomization, participants will receive lidocaine (numbing) gel prior to their urodynamics procedure.

Other:
• Standard lubricant gel
If assigned to this intervention via randomization, participants will receive standard lubricant gel prior to their urodynamics procedure.

Locations

Country	Name	City	State
United States	Atlantic Health System	Morristown	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Atlantic Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in patient visual analog pain score (vaginal area only) from before procedure to 4-6 hours after urodynamic testing	Participants will rate their pain according to a visual analog pain scale from 0 (no pain) to 100 (worst pain imaginable).	Baseline and 4-6 hours post procedure.
Secondary	Change in patient visual analog pain score (vaginal area only) from before procedure to 24 hours after urodynamic testing.	Participants will rate their pain according to a visual analog pain scale from 0 (no pain) to 100 (worst pain imaginable).	Baseline and 24 hours post procedure.
Secondary	Patient visual analog pain score (vaginal area only) before procedure, at conclusion of all procedure-related activities, 4-6 hours after procedure, and 24 hours after procedure.	Participants will rate their pain according to a visual analog pain scale from 0 (no pain) to 100 (worst pain imaginable).	Baseline and 24 hours post procedure.
Secondary	To assess voiding difficulties and other adverse events immediately after urodynamic testing, at 4-6 hours, 24 hours, and two weeks after urodynamic testing.	Participants will receive a phone call at 4-6 hours and 24 hours after urodynamic testing. Any study participant-initiated complaints of voiding difficulties within two weeks of the procedure will be documented and addressed.	Baseline and 2 weeks post-procedure.
Secondary	Urodynamic findings	Standard urodynamics findings will be analyzed.	At time of procedure.
Secondary	Procedure time	Procedure time will be recorded for all subjects.	At time of procedure.