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Lidocaine for Pain After Urodynamic Testing

Primary Purpose

Voiding Disorders, Overactive Bladder, Urinary Incontinence

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lidocaine gel 2%
Standard lubricant gel
Sponsored by
Atlantic Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Voiding Disorders

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Atlantic Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lidocaine gel

Lubricant gel

Arm Description

If assigned to this arm, participants have lidocaine gel 2% applied to their external urethra and vagina one time prior to the urodynamics procedure.

If assigned to this arm, participants will have a standard lubricant gel applied to their external urethra and vagina prior to the urodynamics procedure.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).
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.
Urodynamic findings
Standard urodynamics findings will be analyzed.
Procedure time
Procedure time will be recorded for all subjects.

Full Information

First Posted
October 20, 2017
Last Updated
July 18, 2019
Sponsor
Atlantic Health System
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1. Study Identification

Unique Protocol Identification Number
NCT03390790
Brief Title
Lidocaine for Pain After Urodynamic Testing
Official Title
The Impact of Pre-procedure Periurethral Topical Lidocaine Application on Pain Scores After Complex Urodynamic Testing in Women
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 25, 2018 (Actual)
Primary Completion Date
March 29, 2019 (Actual)
Study Completion Date
March 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Atlantic Health System

4. Oversight

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.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Voiding Disorders, Overactive Bladder, Urinary Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine gel
Arm Type
Experimental
Arm Description
If assigned to this arm, participants have lidocaine gel 2% applied to their external urethra and vagina one time prior to the urodynamics procedure.
Arm Title
Lubricant gel
Arm Type
Placebo Comparator
Arm Description
If assigned to this arm, participants will have a standard lubricant gel applied to their external urethra and vagina prior to the urodynamics procedure.
Intervention Type
Drug
Intervention Name(s)
Lidocaine gel 2%
Intervention Description
If assigned to this intervention via randomization, participants will receive lidocaine (numbing) gel prior to their urodynamics procedure.
Intervention Type
Other
Intervention Name(s)
Standard lubricant gel
Intervention Description
If assigned to this intervention via randomization, participants will receive standard lubricant gel prior to their urodynamics procedure.
Primary Outcome Measure Information:
Title
The change in patient visual analog pain score (vaginal area only) from before procedure to 4-6 hours after urodynamic testing
Description
Participants will rate their pain according to a visual analog pain scale from 0 (no pain) to 100 (worst pain imaginable).
Time Frame
Baseline and 4-6 hours post procedure.
Secondary Outcome Measure Information:
Title
Change in patient visual analog pain score (vaginal area only) from before procedure to 24 hours after urodynamic testing.
Description
Participants will rate their pain according to a visual analog pain scale from 0 (no pain) to 100 (worst pain imaginable).
Time Frame
Baseline and 24 hours post procedure.
Title
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.
Description
Participants will rate their pain according to a visual analog pain scale from 0 (no pain) to 100 (worst pain imaginable).
Time Frame
Baseline and 24 hours post procedure.
Title
To assess voiding difficulties and other adverse events immediately after urodynamic testing, at 4-6 hours, 24 hours, and two weeks after urodynamic testing.
Description
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.
Time Frame
Baseline and 2 weeks post-procedure.
Title
Urodynamic findings
Description
Standard urodynamics findings will be analyzed.
Time Frame
At time of procedure.
Title
Procedure time
Description
Procedure time will be recorded for all subjects.
Time Frame
At time of procedure.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Atlantic Health System
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33208652
Citation
Avondstondt AM, Chiu S, Salamon C. Periurethral Lidocaine Does Not Decrease Pain After Urodynamic Testing in Women: A Double-Blinded Randomized Control Trial. Female Pelvic Med Reconstr Surg. 2021 May 1;27(5):e528-e532. doi: 10.1097/SPV.0000000000000983.
Results Reference
derived

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Lidocaine for Pain After Urodynamic Testing

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