Clinical trial NCT03390790: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Voiding Disorders
Overactive Bladder
Urinary Incontinence
Lead sponsor: Atlantic Health System
Sponsor class: OTHER
First posted: 2018-01-04
Enrollment: 134
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The change in patient visual analog pain score (vaginal area only) from before procedure to 4-6 hours after urodynamic testing
timeFrame: Baseline and 4-6 hours post procedure.
Secondary outcomes:
measure: Change in patient visual analog pain score (vaginal area only) from before procedure to 24 hours after urodynamic testing.
timeFrame: Baseline and 24 hours post procedure.
measure: 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.
timeFrame: Baseline and 24 hours post procedure.
measure: To assess voiding difficulties and other adverse events immediately after urodynamic testing, at 4-6 hours, 24 hours, and two weeks after urodynamic testing.
timeFrame: Baseline and 2 weeks post-procedure.
measure: Urodynamic findings
timeFrame: At time of procedure.
measure: Procedure time
timeFrame: At time of procedure.
Other outcomes:
Locations:
city: Morristown
country: United States
facility: Atlantic Health System
state: New Jersey
Study officials:
References:
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.