OnabotulinumtoxinA 100 UNT [Botox] for Urinary Urge Incontinence

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Urinary Urge Incontinence+6 More
OnabotulinumtoxinA 100 UNT [Botox] - Drug
Eligibility
18+
Female
What conditions do you have?
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Study Summary

This trial will test whether injecting Botox® into the bladder at one site or ten sites is more effective at treating overactive bladder or urgency urinary incontinence. Efficacy and patient satisfaction will be measured by questionnaires.

Eligible Conditions
  • Urinary Urge Incontinence
  • Urinary Urgency
  • Urinary Incontinence, Urge
  • Overactive Bladder Syndrome (OABS)
  • increased frequency of urination

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Other trials for Urinary Urge Incontinence

Study Objectives

0 Primary · 5 Secondary · Reporting Duration: 3 months after botox procedure

Month 3
Patient Global Impression - Improvement (PGI-I)
PVR collected at 3 wk post-procedure
Post-void residual (PVR)
Month 3
Number of participants with urinary tract infection (UTI)
Month 3
Urinary Bladder
immediately after procedure
Visual Analogue Scale (VAS) - Pain

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Urinary Urge Incontinence

Trial Design

2 Treatment Groups

10 Injection Sites
1 of 2
1 Injection Site
1 of 2
Active Control
Experimental Treatment

102 Total Participants · 2 Treatment Groups

Primary Treatment: OnabotulinumtoxinA 100 UNT [Botox] · No Placebo Group · Phase 4

1 Injection Site
Drug
Experimental Group · 1 Intervention: OnabotulinumtoxinA 100 UNT [Botox] · Intervention Types: Drug
10 Injection Sites
Drug
ActiveComparator Group · 1 Intervention: OnabotulinumtoxinA 100 UNT [Botox] · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months after botox procedure

Who is running the clinical trial?

St. Joseph Hospital of OrangeOTHER
9 Previous Clinical Trials
1,200,901 Total Patients Enrolled
University of California, IrvineLead Sponsor
496 Previous Clinical Trials
1,878,211 Total Patients Enrolled
1 Trials studying Urinary Urge Incontinence
32 Patients Enrolled for Urinary Urge Incontinence
Kaiser PermanenteOTHER
505 Previous Clinical Trials
22,194,829 Total Patients Enrolled
1 Trials studying Urinary Urge Incontinence
99 Patients Enrolled for Urinary Urge Incontinence
Felicia Lane, MDStudy ChairUC Irvine
6 Previous Clinical Trials
324 Total Patients Enrolled
Taylor Brueseke, MDStudy DirectorUC Irvine
Carly Crowder, MDPrincipal InvestigatorUC Irvine

Eligibility Criteria

Age 18+ · Female Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You must be at least 18 years old to participate in this study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 18th, 2021

Last Reviewed: October 25th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References