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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04305743
Other study ID # PRO00039851
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


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
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