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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine gel | Experimental | If assigned to this arm, participants have lidocaine gel 2% applied to their external urethra and vagina one time prior to the urodynamics procedure. |
|
| Lubricant gel | Placebo Comparator | If assigned to this arm, participants will have a standard lubricant gel applied to their external urethra and vagina prior to the urodynamics procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine gel 2% | Drug | If assigned to this intervention via randomization, participants will receive lidocaine (numbing) gel prior to their urodynamics procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| 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. |
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Inclusion Criteria:
• All female patients between the ages of 40-80 undergoing urodynamic testing.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlantic Health System | Morristown | New Jersey | 07960 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33208652 | Derived | 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. |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Standard lubricant gel | Other | If assigned to this intervention via randomization, participants will receive standard lubricant gel prior to their urodynamics 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. |
| 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. |
| Urodynamic findings | Standard urodynamics findings will be analyzed. | At time of procedure. |
| Procedure time | Procedure time will be recorded for all subjects. | At time of procedure. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014555 | Urination Disorders |