Clinical trial NCT04305743: Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A
Official title: Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A for Treatment of Overactive Bladder: a Multi-center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Urinary Bladder, Overactive
Incontinence, Urge
Incontinence, Urinary
Urinary Urge Incontinence
Urinary Frequency More Than Once at Night
Nocturia
Keywords: overactive bladder
urgency urinary incontinence
onabotulinumtoxin
bladder
botox
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: Medstar Health Research Institute
First posted: 2020-03-12
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blinded randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain from procedure: score
timeFrame: Within 5 minutes of procedure completion
Secondary outcomes:
measure: Duration of procedure
timeFrame: Procedure time
measure: Positive treatment response
timeFrame: 6 weeks post-procedure
measure: Urinary tract infections
timeFrame: 12 weeks post-procedure
measure: Urinary retention
timeFrame: 12 weeks post-procedure
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Tampa
country: United States
facility: University of South Florida Health South Tampa Center for Advanced Healthcare
state: Florida
Study officials:
affiliation: University of South Florida
name: Eric S Chang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chang ES, Ringel N, Woodburn KL, Tanner JP, Bassaly R, Greene K, Wyman A, Iglesia C. Postprocedural Pain Associated With 5 Versus 20 Intradetrusor Injections of onabotulinumtoxinA for Treatment of Overactive Bladder: A Multicenter Randomized Clinical Trial. Urogynecology (Phila). 2022 Aug 1;28(8):518-525. doi: 10.1097/SPV.0000000000001199. Epub 2022 May 12.