Lidocaine for Pain After Urodynamic Testing

NCT ID: NCT03390790

Last Updated: 2019-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-25
• Study Completion Date: 2019-03-29

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.

Conditions

Voiding Disorders; Overactive Bladder; Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lidocaine gel

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

Group Type: EXPERIMENTAL

Lidocaine gel 2%

Intervention Type: DRUG

If assigned to this intervention via randomization, participants will receive lidocaine (numbing) gel prior to their urodynamics procedure.

Lubricant gel

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

Group Type: PLACEBO_COMPARATOR

Standard lubricant gel

Intervention Type: OTHER

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

Interventions

Lidocaine gel 2%

If assigned to this intervention via randomization, participants will receive lidocaine (numbing) gel prior to their urodynamics procedure.

Intervention Type: DRUG

Standard lubricant gel

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Atlantic Health System

OTHER

Sponsor Role: lead

Responsible Party

charbel salamon

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Atlantic Health System

Morristown, New Jersey, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33208652 (View on PubMed)

Other Identifiers

1112951-1

Identifier Type: -

Identifier Source: org_study_id