- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04305743
Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A
November 3, 2020 updated by: Eric Chang, University of South Florida
Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A for Treatment of Overactive Bladder: a Multi-center Randomized Controlled Trial
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.
Study Overview
Status
Recruiting
Conditions
Intervention / 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.
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Eric S Chang, MD
- Phone Number: 813-259-8500
- Email: ericchang@usf.edu
Study Contact Backup
- Name: Allison Wyman, MD
- Phone Number: 813-259-8500
- Email: awyman@usf.edu
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20010
- Recruiting
- MedStar Washington Hospital Center
-
Contact:
- Nancy Ringel, MD
- Email: nringel@gmail.com
-
Sub-Investigator:
- Amy Park, MD
-
Sub-Investigator:
- Cheryl Iglesia, MD
-
Principal Investigator:
- Nancy Ringel, MD
-
-
Florida
-
Tampa, Florida, United States, 33606
- Recruiting
- University of South Florida Health South Tampa Center for Advanced Healthcare
-
Sub-Investigator:
- Renee Bassaly, DO
-
Contact:
- Eric S Chang, MD
- Phone Number: 813-259-8500
- Email: ericchang@usf.edu
-
Contact:
- Allison Wyman, MD
- Phone Number: 813-259-8500
- Email: awyman@usf.edu
-
Sub-Investigator:
- Isabel Prieto, MD
-
Sub-Investigator:
- Ryan Hidalgo, MD
-
Sub-Investigator:
- Kristie Greene, MD
-
Sub-Investigator:
- Allison Wyman, MD
-
Principal Investigator:
- Eric S Chang, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 5 Injections
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.
|
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.
Other Names:
|
ACTIVE_COMPARATOR: 20 Injections
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain from procedure: score
Time Frame: Within 5 minutes of procedure completion
|
Pain score as rated on a 10-point visual analog scale within 5 minutes of procedure completion
|
Within 5 minutes of procedure completion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of procedure
Time Frame: 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
|
Procedure time
|
Positive treatment response
Time Frame: 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
|
6 weeks post-procedure
|
Urinary tract infections
Time Frame: 12 weeks post-procedure
|
Percentage of patients with culture-proven post-procedure urinary tract infections within 12 weeks of procedure
|
12 weeks post-procedure
|
Urinary retention
Time Frame: 12 weeks post-procedure
|
Percentage of patients with post-procedure urinary retention requiring clean intermittent catheterization within 12 weeks of procedure
|
12 weeks post-procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Eric S Chang, MD, University of South Florida
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 9, 2019
Primary Completion (ANTICIPATED)
January 1, 2021
Study Completion (ANTICIPATED)
June 1, 2021
Study Registration Dates
First Submitted
March 9, 2020
First Submitted That Met QC Criteria
March 11, 2020
First Posted (ACTUAL)
March 12, 2020
Study Record Updates
Last Update Posted (ACTUAL)
November 5, 2020
Last Update Submitted That Met QC Criteria
November 3, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Urologic Diseases
- Urinary Bladder Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Pain
- Neurologic Manifestations
- Urination Disorders
- Elimination Disorders
- Urinary Bladder, Overactive
- Urinary Incontinence
- Enuresis
- Pain, Procedural
- Urinary Incontinence, Urge
- Nocturia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Cholinergic Agents
- Membrane Transport Modulators
- Acetylcholine Release Inhibitors
- Neuromuscular Agents
- Botulinum Toxins, Type A
- abobotulinumtoxinA
Other Study ID Numbers
- PRO00039851
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
All statistical analyses will be performed at the University of South Florida.
The investigators performing review of data and statistical analyses will not require the use of, or have access to any personally identifying patient information from either the primary or secondary site of the study.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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