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

Urinary Bladder, Overactive Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04305743
• Other study ID #: PRO00039851
• Status: Recruiting
• Phase: Phase 4
• Start date: October 9, 2019
• Est. completion date: June 1, 2021

Study information

• Verified date: November 2020
• Source: University of South Florida
• Contact: Eric S Chang, MD
• Phone: 813-259-8500
• Email: ericchang[@]usf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Incontinence, Urge
• Incontinence, Urinary
• Nocturia
• Pain, Procedural
• Urinary Bladder, Overactive
• Urinary Frequency More Than Once at Night
• Urinary Incontinence
• Urinary Incontinence, Urge
• Urinary Urge Incontinence

Intervention

Drug:
• OnabotulinumtoxinA 100 UNT
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.

Locations

Country	Name	City	State
United States	University of South Florida Health South Tampa Center for Advanced Healthcare	Tampa	Florida
United States	MedStar Washington Hospital Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of South Florida	Medstar Health Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Urinary tract infections	Percentage of patients with culture-proven post-procedure urinary tract infections within 12 weeks of procedure	12 weeks post-procedure
Secondary	Urinary retention	Percentage of patients with post-procedure urinary retention requiring clean intermittent catheterization within 12 weeks of procedure	12 weeks post-procedure