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Neurotoxin

onaBoNT-A for Overactive Bladder

Phase 4
Waitlist Available
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
Males or Females ≥ 18 years of age
Predominant complaint of urinary urgency, urinary frequency or urge incontinence
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-9 months post-procedure
Awards & highlights

Study 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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-9 months post-procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-9 months post-procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

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
136 Previous Clinical Trials
37,151 Total Patients Enrolled
Angela DiCarlo-Meacham, MDPrincipal Investigator - Walter Reed National Military Medical Center
Walter Reed National Military Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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~32 spots leftby Mar 2025