Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A
- Conditions
- Urinary Bladder, OveractiveIncontinence, UrgeIncontinence, UrinaryUrinary Urge IncontinenceUrinary Frequency More Than Once at NightNocturia
- Interventions
- Registration Number
- NCT04305743
- Lead Sponsor
- University of South Florida
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 60
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 5 Injections OnabotulinumtoxinA 100 UNT 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. 20 Injections OnabotulinumtoxinA 100 UNT 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Urinary tract infections 12 weeks post-procedure Percentage of patients with culture-proven post-procedure urinary tract infections within 12 weeks of procedure
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 retention 12 weeks post-procedure Percentage of patients with post-procedure urinary retention requiring clean intermittent catheterization within 12 weeks of procedure
Trial Locations
- Locations (2)
University of South Florida Health South Tampa Center for Advanced Healthcare
🇺🇸Tampa, Florida, United States
MedStar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States