Urinary Bladder, Overactive, Incontinence, Urge, Incontinence, Urinary, Urinary Urge Incontinence, Urinary Frequency More Than Once at Night, Nocturia
Conditions
Keywords
overactive bladder, urgency urinary incontinence, onabotulinumtoxin, bladder, botox
Brief summary
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
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.
Interventions
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.
Sponsors
Medstar Health Research Institute
University of South Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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.
Intervention model description
Single-blinded randomized controlled trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain from procedure: score | Within 5 minutes of procedure completion | Pain score as rated on a 10-point visual analog scale within 5 minutes of procedure completion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of procedure | Procedure time | 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 |
| Positive treatment response | 6 weeks post-procedure | The percentage of patients with a positive treatment response based on answering a Global Response Assessment given 6 weeks after completion of procedure |
| Urinary tract infections | 12 weeks post-procedure | Percentage of patients with culture-proven post-procedure urinary tract infections within 12 weeks of procedure |
| Urinary retention | 12 weeks post-procedure | Percentage of patients with post-procedure urinary retention requiring clean intermittent catheterization within 12 weeks of procedure |
Countries
United States
Contacts
Primary ContactEric S Chang, MD
Backup ContactAllison Wyman, MD
Outcome results
None listed