Status:
COMPLETED
Intradetrusor Botulinum Toxin A for OAB Via 1 Versus 10 Injections: A Randomized Clinical Trial
Lead Sponsor:
University of California, Irvine
Collaborating Sponsors:
Kaiser Permanente
St. Joseph Hospital of Orange
Conditions:
Overactive Bladder
Urinary Urge Incontinence
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
Patients with either overactive bladder (OAB) or urgency urinary incontinence (UUI) with be randomized (like a flip of a coin) to receive 100 units of bladder Botox® at either one injection site or te...
Detailed Description
Intradetrusor (bladder) Botulinum toxin A (BTA or Botox®) is a well-established treatment for urinary urgency incontinence (UUI).\[1,2\] While this treatment's efficacy in comparison to alternative th...
Eligibility Criteria
Inclusion
- Female
- 18 years old or greater
- Diagnosis of overactive bladder (urinary urgency or frequency, OAB) or urinary urgency incontinence (UUI)
Exclusion
- Have a diagnosis of neurogenic bladder
- Received intravesical botox injections within prior 6 months
- Current treatment with either: SNM, PTNS, or OAB medications - need wash out as below
- SNM - turn device off for at least 2 weeks prior to procedure, off during 3-month follow up window
- PTNS - no treatments within 2 weeks of start, none during 3-month post-procedure follow up window
- OAB meds - 2 week wash out period prior to injection, none during 3-month post-procedure follow up window
- Currently pregnant or trying to get pregnant
- Contraindications to Botox® - hypersensitivity to Botox®, inability to self-catheterize/refusal to have indwelling catheter
- Have a UTI (can enroll after treatment)
- Have urinary retention (PVR\>150cc on two occasions)
- Do not speak English or Spanish
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2024
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT05308979
Start Date
May 1 2022
End Date
March 31 2024
Last Update
February 28 2025
Active Locations (1)
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1
University of California Irvine Medical Center
Orange, California, United States, 92868