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Neurotoxin
Is 10 Injections of Bladder Botox Less Painful Than 20 Injections?
Phase 4
Waitlist Available
Led By Catherine Matthews, MD
Research Sponsored by Wake Forest University Health Sciences
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 12 weeks post procedure
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing whether 10 injections of Botox is less painful and just as effective as 20 injections for treating urge incontinence.
Eligible Conditions
- Overactive Bladder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks post procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks post procedure
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pain
Secondary study objectives
Difference in Mean Urge Incontinence Episodes
Over Active Bladder (OAB) Questionnaire Short Form - Health Related Quality of Life
Over Active Bladder (OAB) Questionnaire Short Form Scores - Health Related Quality of Life
+2 moreAwards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Active Control
Group I: 20 Botox InjectionsActive Control1 Intervention
100 units of Botox® (onabotulinumtoxinA) will be combined with 20 cc of sterile saline for the purpose of 20 injections. The bladder will be instilled with 2% lidocaine solution through a catheter for at least 5 minutes prior to the procedure. Cystoscopy with either a rigid or flexible cystoscope (per surgeon preference) will be performed using sterile technique. The Botox® will be injected in a grid like pattern avoiding the trigone.
Group II: 10 Botox InjectionsActive Control1 Intervention
100 units of Botox® (onabotulinumtoxinA) will be combined with 10 cc of sterile saline for the purpose of 10 injections. The bladder will be instilled with 2% lidocaine solution through a catheter for at least 5 minutes prior to the procedure. Cystoscopy with either a rigid or flexible cystoscope (per surgeon preference) will be performed using sterile technique. The Botox® will be injected in a grid like pattern avoiding the trigone.
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,403 Previous Clinical Trials
2,478,294 Total Patients Enrolled
Catherine Matthews, MDPrincipal InvestigatorWake Forest University Health Sciences
6 Previous Clinical Trials
615 Total Patients Enrolled