Comparing Number of Injection Sites of In-office Intravesical Onabotulinumtoxin A Treatments for Overactive Bladder: A Randomized Controlled Trial

Study Overview
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Brief Summary
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Overactive bladder (OAB) is a syndrome characterized by urinary urgency, with or without urinary incontinence, nocturia, and urinary frequency. Intravesical injection of onabotulinumtoxinA is approved by the US Food and Drug Administration for treatment of neurogenic and idiopathic OAB. Current standard of practice involves 100 U of onabotulinumtoxinA diluted in 10 ml saline cystoscopically injected into approximately 20 different detrusor muscle sites equally distributed along the posterior bladder wall and dome. This treatment was classically done in the operating room under general anesthesia, but now is typically performed in an office setting using local anesthesia (lidocaine) as this is more feasible and tolerable. Patients can experience discomfort and pain with each injection. Evidence has also shown that administering the same dose of onabotulinumtoxinA into fewer injection sites in the detrusor muscle (ranging from 3 to 10) results in equivalent efficacy compared to the current standard. However, it has yet to be determined if there is a significant difference in patient satisfaction and tolerability when the procedure is administered in an office setting using the same dosage with fewer injections. Our study aims to assess whether patient tolerance and satisfaction of intravesicular onabotulinumtoxinA increases with the use of 4 detrusor injections as opposed to 20 injections when performed in an office setting on women with OAB.

Official Title
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Comparing Number of Injection Sites of In-office Intravesical Onabotulinumtoxin A Treatments for Overactive Bladder: A Randomized Controlled Trial

Conditions
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Overactive Bladder Syndrome, Overactive Bladder

Intervention / Treatment
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* Drug: OnabotulinumtoxinA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: females, adults 18 years of age and older, diagnosed with OAB Exclusion Criteria: bladder pathology including nephrolithiasis, active urinary tract infection, bladder trauma, neurogenic bladder, patients who have previously received intravesical onabotulinumtoxin A injections, pregnant patients, minor patients, male patients

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One group of participants will receive the experimental treatment, which is 4 injections, and the other group of participants will receive the standard treatment, which is 20 injections.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>100 U of onabotulinumtoxinA toxin diluted in 10 mL of saline cystoscopically injected into approximately 4 different detrusor muscle sites along the posterior bladder wall and dome. | Drug: OnabotulinumtoxinA<br>* 100 U of Onabotulinumtoxin A diluted in 10 mL of saline injected into the wall of the detrusor muscle at various sites<br>|
| Active Comparator: Control Group<br>100 U of onabotulinumtoxinA toxin diluted in 10 mL of saline cystoscopically injected into approximately 20 different detrusor muscle sites along the posterior bladder wall and dome. | Drug: OnabotulinumtoxinA<br>* 100 U of Onabotulinumtoxin A diluted in 10 mL of saline injected into the wall of the detrusor muscle at various sites<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived pain of each participant before, during, and after the procedure on a scale of 0-10 | The Pain Survey is a self-reported instrument used to assess pain before, during, and after a procedure. Possible scores range from 0 (no pain) to 10 (worst pain possible). | within the hour prior to initiating the intervention, and immediately at the conclusion of the 30-minute intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Benefit, Satisfaction, and Willingness to Continue of each participant after the procedure | The Benefit, Satisfaction, and Willingness to Continue (BSW) questionnaire is a validated instrument administered by the physician. It asks participants if they had benefit, satisfaction, and a willingness to continue from a specific treatment. If yes, responses range from 1(little benefit, little, satisfaction, a little bit willing) to 2(much benefit, very satisfied, very willing). | 2 weeks +/- 7 days after procedure and 3 +/- 7 days months after procedure | 
| Change in extent of Overactive Bladder Symptoms before and after receiving the procedure | The Overactive Bladder questionnaire (OAB-q) short form is a validated instrument that measures the extent to which participants have various symptoms of OAB over the past 4 weeks. The responses range from 1(not at all) to 6(a very great deal). | Pre procedure, 2 weeks +/- 7 days after procedure, and 3 +/- 7 days months after procedure | 
| The Prevalence of complications with botox after receiving the procedure | The Complications with Botox survey is an instrument used to measure if and how many times participants experienced UTIs, difficulty urinating, or hematuria after the Botox procedure. Participants self-report the number of times if they have experienced the side effect. | 2 weeks +/- 7 days after procedure, and 3 +/- 7 days months after procedure |