Reduction in Number of Botox Injections for Urgency Urinary Incontinence
Reduced Site Injection Protocol of Intra-detrusor Onabotulinumtoxin-A for Treatment of Idiopathic Refractory Urgency Urinary Incontinence
University of Virginia
56 participants
Feb 23, 2021
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
The controls will be given the standard of care of 15 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)
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NCT04731961