Atlantic Health System
Morristown, New Jersey, 07960, United States
NCT Number: NCT03390790
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.
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Notify Me40 year–80 year
Female
Interventional
Phase 4
Morristown, New Jersey, 07960, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
If assigned to this intervention via randomization, participants will receive lidocaine (numbing) gel prior to their urodynamics procedure.
If assigned to this intervention via randomization, participants will receive standard lubricant gel prior to their urodynamics procedure.
Time frame: Baseline and 4-6 hours post procedure.
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.
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.
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 2 weeks post-procedure.
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: At time of procedure.
Standard urodynamics findings will be analyzed.
Time frame: At time of procedure.
Procedure time will be recorded for all subjects.
Atlantic Health System
Other
The Impact of Pre-procedure Periurethral Topical Lidocaine Application on Pain Scores After Complex Urodynamic Testing in Women
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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