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OnabotulinumtoxinA (Botox®) bladder injections are a highly effective treatment for overactive bladder and urgency urinary incontinence. The procedure is typically performed in the office setting with one of two medications to control comfort. However, the effectiveness of these medications has never been compared. The goal of this study is to determine which medication is better at providing comfort during bladder Botox® injections.
The primary aim of this randomized clinical trial is to compare the analgesic effect of oral phenazopyridine to that of intravesical lidocaine during intradetrusor injections of onabotulinumtoxinA performed for idiopathic overactive bladder. The investigators will achieve this by measuring the mean visual-analog pain scores (VAS) in women who are randomized to receive either oral phenazopyridine or intravesical lidocaine.
Secondary aims include assessment of:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Phenazopyridine | Active Comparator | Patients randomized to the oral phenzopyridine arm will receive 200mg phenazopyridine to take by mouth 1-2 hours before their scheduled procedure. |
|
| Intravesical Lidocaine | Active Comparator | Patients randomized to the intravesical lidocaine arm will have the bladder back-filled with 30mL 2% lidocaine for the 20 minutes immediately preceding their procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phenazopyridine | Drug | 200mg PO Phenazopyridine taken 1-2 hours prior to the Botox® injection procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Analgesic Effect Measured with 100mm Visual Analog Scale | The visual analog scale is a visual representation of pain severity rated from 0 (no pain) to 10 (worst pain imaginable). Therefore higher numbers represent more pain.The scale is represented visually using a 100 millimeter line and patients indicate their level of pain by pointing to a location on the line. | Immediately post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Patient Satisfaction | Overall patient satisfaction with the onabotulinumtoxinA injection procedure in women randomized to pre-procedure oral phenazopyridine versus those randomized to intravesical lidocaine instillation. Overall satisfaction will be measured with a single-item question utilizing a Likert scale with options ranging from very satisfied to very unsatisfied. | Immediately post-procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lauren E Stewart, MD | Contact | 401-453-7560 | 48762 | lstewart@wihri.org |
| Name | Affiliation | Role |
|---|---|---|
| Lauren E Stewart, MD | Women and Infants Hospital of Rhode Island | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women & Infants Hospital of Rhode Island | Recruiting | Providence | Rhode Island | 02903 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35580634 | Derived | Stewart LE, Siddique M, Jacobs KM, Raker CA, Sung VW. Oral phenazopyridine vs intravesical lidocaine for bladder onabotulinumtoxinA analgesia: a randomized controlled trial. Am J Obstet Gynecol. 2022 Aug;227(2):308.e1-308.e8. doi: 10.1016/j.ajog.2022.05.025. Epub 2022 May 14. |
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| ID | Term |
|---|---|
| D053202 | Urinary Incontinence, Urge |
| D014549 | Urinary Incontinence |
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D010621 | Phenazopyridine |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000631 | Aminopyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Lidocaine 2% Injectable Solution | Drug | 30mL 2% lidocaine instilled into the bladder lumen 20 via a urinary catheter 20 minutes prior to the Botox® injection procedure |
|
| Ease of Procedure | Physician's perception of ease of onabotulinumtoxinA injection procedure in women randomized to pre-procedure oral phenazopyridine versus those randomized to intravesical lidocaine instillation. This will be measured with a single item, five point Likert scale with options ranging from no difficulty to great difficulty. | Immediately post-procedure |
| Office Efficiency/Total Appointment Duration | Total appointment time or total time spent in an office exam/procedure room in women randomized to pre-procedure oral phenazopyridine versus those randomized to intravesical lidocaine instillation. This will be measured by subtracting the appointment start time (time the patient was placed in the exam room) from the appointment end time (time of patient check-out). | Immediately post-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 |
| D001745 | Urinary Bladder Diseases |
| D000083 |
| Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |