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Reduction in Number of Botox Injections for Urgency Urinary Incontinence
Sponsor: University of Virginia
Summary
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.
Official title: Reduced Site Injection Protocol of Intra-detrusor Onabotulinumtoxin-A for Treatment of Idiopathic Refractory Urgency Urinary Incontinence
Key Details
Gender
FEMALE
Age Range
21 Years - Any
Study Type
INTERVENTIONAL
Enrollment
56
Start Date
2021-02-23
Completion Date
2026-12-31
Last Updated
2025-01-28
Healthy Volunteers
No
Conditions
Interventions
Standard of care (15 Botox injections)
The controls will be given the standard of care of 15 Botox injections.
Experimental Arm (5 Botox injections)
5 Botox injections will be given, with each injection containing three times the amount of Botox than each of the 15 injections given in the standard of care arm.
Locations (1)
University of Virginia
Charlottesville, Virginia, United States