Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A

Study Overview
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Brief Summary
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Currently, in clinical practice there has been no standardization in the number of injections a single dose of intradetrusor onabotulinumtoxin A is administered in. Given the increasing use of this treatment modality, the aim of this study is to compare outcomes for patients given a 100 unit dose of onabotulinumtoxin A split into 5 as compared to 20 injections for the treatment of overactive bladder or urgency urinary incontinence refractory to medical treatment.

Detailed Description
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The intradetrusor injection of onabotulinumtoxin A for treatment of idiopathic overactive bladder and urgency urinary incontinence refractory to anticholinergic or β-agonist treatment was approved by the United States Food and Drug Administration (FDA) in 2013. Since then, multiple randomized placebo-controlled trials have demonstrated the effectiveness of the treatment. Currently, Allergan, Inc. and the FDA recommend the intravesical administration of onabotulinumtoxin A with dilution to 100 units/10 mL with preservative-free 0.9% Sodium Chloride Injection, as 20 injections of 0.5 mL each. Currently, in clinical practice there has been no standardization in the number of intravesical injections, with a single dose of onabotulinumtoxin A being administered in as few as 1 injection to as many as 40 injections into the detrusor muscle. Given the increasing use of this treatment modality, the investigators aim to compare patient outcomes for patients given a 100 unit dose of onabotulinumtoxin A split into 5 as compared to the recommended 20 injections for the treatment of idiopathic overactive bladder or urgency urinary incontinence refractory to medical treatment.

Official Title
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Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A for Treatment of Overactive Bladder: a Multi-center Randomized Controlled Trial

Conditions
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Urinary Bladder, Overactive, Incontinence, Urge, Incontinence, Urinary, Urinary Urge Incontinence, Urinary Frequency More Than Once at Night, Nocturia

Intervention / Treatment
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* Drug: OnabotulinumtoxinA 100 UNT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women >=18 years of age with diagnosis of urinary urgency, urinary frequency, urgency urinary incontinence, overactive bladder. Procedure scheduled in either the outpatient clinic or the operating room to be performed without use of sedation, general, or neuraxial anesthesia. Exclusion Criteria: Male gender. Women <18 years of age. Non-English speaking. Pregnancy (patient will self-report pregnancy). Participant has symptoms of overactive bladder due to any known neurological reason (e.g. spinal cord injury, multiple sclerosis, cerebrovascular accident, Alzheimer's disease, Parkinson's disease, etc.) Participant uses clean intermittent catheterization or indwelling catheter to manage urinary incontinence. Participant has a history or current diagnosis of bladder cancer or other urothelial malignancy. Participant has a known allergy or sensitivity to any botulinum toxin preparation. Participant has any medical condition that may put her at increased risk with exposure to onabotulinumtoxin A, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis. Participant is scheduled for administration of onabotulinumtoxin A with use of sedation, general, or neuraxial anesthesia.

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: Single-blinded randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 5 Injections<br>Participant's bladder is backfilled with 50 mL of 1% lidocaine for 15 minutes, then drained prior to procedure start. Dose of 100 units onabotulinumtoxin A with dilution to 100 Units/10 mL with preservative-free 0.9% Sodium Chloride Injection is prepared. Cystoscopy is performed. The 23 gauge Laborie InjeTAK needle is inserted 3 mm into the detrusor. 5 injections of 2 mL each (total volume of 10 mL) in a single procedure is performed 1 cm apart in the bladder body. For the final injection, approximately 1 mL of sterile normal saline should be injected such that the remaining onabotulinumtoxin A in the needle is delivered to the bladder. | Drug: OnabotulinumtoxinA 100 UNT<br>* Intradetrusor onabotulinumtoxin A is administered cystoscopically with 100 unit dose given as either 5 or 20 injections in a single procedure based on the arm the participant is randomized into.<br>* Other names: BOTOX;|
| Active Comparator: 20 Injections<br>Participant's bladder is backfilled with 50 mL of 1% lidocaine for 15 minutes, then drained prior to procedure start. Dose of 100 units onabotulinumtoxin A with dilution to 100 Units/10 mL with preservative-free 0.9% Sodium Chloride Injection is prepared. Cystoscopy is performed. The 23 gauge Laborie InjeTAK needle is inserted 3 mm into the detrusor. 20 injections of 0.5 mL each (total volume of 10 mL) in a single procedure is performed 1 cm apart in the bladder body. For the final injection, approximately 1 mL of sterile normal saline should be injected such that the remaining onabotulinumtoxin A in the needle is delivered to the bladder. | Drug: OnabotulinumtoxinA 100 UNT<br>* Intradetrusor onabotulinumtoxin A is administered cystoscopically with 100 unit dose given as either 5 or 20 injections in a single procedure based on the arm the participant is randomized into.<br>* Other names: BOTOX;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain from procedure: score | Pain score as rated on a 10-point visual analog scale within 5 minutes of procedure completion | Within 5 minutes of procedure completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of procedure | Total time of procedure defined as time cystoscope is introduced into the bladder to the time the cystoscope is removed from the bladder after completion of all injections | Procedure time | 
| Positive treatment response | The percentage of patients with a positive treatment response based on answering a Global Response Assessment given 6 weeks after completion of procedure | 6 weeks post-procedure | 
| Urinary tract infections | Percentage of patients with culture-proven post-procedure urinary tract infections within 12 weeks of procedure | 12 weeks post-procedure | 
| Urinary retention | Percentage of patients with post-procedure urinary retention requiring clean intermittent catheterization within 12 weeks of procedure | 12 weeks post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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overactive bladder, urgency urinary incontinence, onabotulinumtoxin, bladder, botox