Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A
Purpose
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.
Conditions
- Urinary Bladder, Overactive
- Incontinence, Urge
- Incontinence, Urinary
- Urinary Urge Incontinence
- Urinary Frequency More Than Once at Night
- Nocturia
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Single-blinded randomized controlled trial
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
- Masking Description
- Participants are randomized into one of two treatment arms (receiving 5 versus 20 injections per treatment with intradetrusor onabotulinumtoxin A) and are not notified of which arm they are participating in.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 5 Injections |
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. |
|
|
Active Comparator 20 Injections |
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. |
|
Recruiting Locations
Washington, District of Columbia 20010
More Details
- Status
- Recruiting
- Sponsor
- University of South Florida
Detailed Description
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.