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Neurotoxin
Standard Injections Versus Reduced Injections for Intravesical onabotulinumtoxinA Treatment of Overactive Bladder
Phase 4
Recruiting
Led By Angela DiCarlo-Meacham, MD
Research Sponsored by Walter Reed National Military Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-9 months post-procedure
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Pivotal Trial
Drug Has Already Been Approved
Summary
This trial is testing a new way to give a already-FDA-approved med for overactive bladder. The new way uses fewer injections of the med, & doctors hope it will be just as effective as the old way with fewer side effects.
Eligible Conditions
- Overactive Bladder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-9 months post-procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-9 months post-procedure
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean change from baseline in overactive bladder symptom severity and health related quality of life scores on the overactive bladder questionnaire short form
Mean change from baseline in overactive bladder symptoms and incontinence episodes using patient reported pad counts and episodes of nocturia
Urinary Bladder
+1 moreSecondary study objectives
Incidence of urinary retention requiring intermittent catheterization
Incidence of urinary tract infection
Mean change in pain from baseline following intradetrusor onabotulinumtoxinA injection using visual analog scale
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Reduced InjectionsExperimental Treatment1 Intervention
For idiopathic overactive bladder, 100 units of onabotulinumtoxinA mixed in 10mL of injectable saline injected in 5 sites with 2mL per injection in an "X" configuration on posterior wall of the bladder above the trigone. For neurogenic overactive bladder, 200 units of onabotulinumtoxinA mixed in 10mL of injectable saline injected in 5 sites with 2mL per injection in an "X" configuration on posterior wall of the bladder above the trigone.
Group II: Standard InjectionsActive Control1 Intervention
For idiopathic overactive bladder, 100 units of onabotulinumtoxinA mixed in 10mL of injectable saline injected in 20 sites with 0.5mL per injection along the posterior wall of the bladder above the trigone. For neurogenic overactive bladder, 200 units of onabotulinumtoxinA mixed in 30mL of injectable saline injected in 30 sites with 1mL per injection along the posterior wall of the bladder above the trigone.
Find a Location
Who is running the clinical trial?
Walter Reed National Military Medical CenterLead Sponsor
143 Previous Clinical Trials
33,220 Total Patients Enrolled
Angela DiCarlo-Meacham, MDPrincipal Investigator - Walter Reed National Military Medical Center
Walter Reed National Military Medical Center