Reduced Site Injection Protocol of Intra-detrusor Onabotulinumtoxin-A for Treatment of Idiopathic Refractory Urgency Urinary Incontinence
The overall objective of this study is to determine if a reduced injection site protocol (5 injection sites) using an equivalent amount of Botox provides comparable relief of Urgency Urinary Incontinence (UUI) symptoms compared to the standard injection site protocol (15-20 injection sites). Our central hypothesis is that the 5-site injection protocol is non-inferior in terms of relief of UUI symptoms compared to the standard injection site protocol, measured by a non-inferior reduction in the number of UUI episodes per day.
• Females at least 21 years of age
• English speaking
• Five or more urge urinary incontinence episodes on a three-day voiding diary. Urge incontinence episodes will be determined based on voiding diary and subject indication of coincident urge symptoms, allowing for self-characterization of incontinence type
• Urge predominant (urge \>50% of total incontinent episodes) urinary incontinence based on self-reported characterization of incontinent episodes on diary
• Patient or caregiver willing to perform clean intermittent catheterization, or patient willing to have indwelling Foley catheter in the event this would be required
• Request for treatment for urgency urinary incontinence. The patient may have tried other pharmacologic treatments for urge incontinence, such as antispasmodic agents or non-pharmacologic treatments, such as supervised behavioral therapy, supervised physical therapy, unsupervised physical therapy, supervised biofeedback, and transvaginal electrical stimulation.
• Subject has undergone 3-week washout period if subject were on anticholinergic therapy prior to enrollment
• Subject is able to complete all study related items and interviews
• Willingness and ability to comply with scheduled visits and study procedures.