Intradetrusor Botulinum Toxin A: Are Less Injections Better?

• Status: Not yet recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: Female

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 ten injection sites. Efficacy and patient satisfaction will be measured by questionnaires.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, Irvine
• Collaborators: Kaiser Permanente; St. Joseph Hospital of Orange
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A

Criteria

Inclusion Criteria:

• Female

• 18 years old or greater

• Diagnosis of overactive bladder (urinary urgency or frequency, OAB) or urinary urgency incontinence (UUI)

Exclusion Criteria:

• 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