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Neurotoxin

onaBoNT-A for 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 baseline, 4-12 weeks post-procedure and 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 ~ baseline, 4-12 weeks post-procedure and 6-9 months post-procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 4-12 weeks post-procedure and 6-9 months post-procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4-12 weeks post-procedure and 6-9 months post-procedure for reporting.

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 more

Secondary 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.

Do I qualify?Apply below to find out