RecruitingNot ApplicableNCT04731961

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


Sponsor

University of Virginia

Enrollment

56 participants

Start Date

Feb 23, 2021

Study Type

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

Sex: FEMALEMin Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Experimental Arm (5 Botox injections) and a procedure called Standard of care (15 Botox injections) for people with urgency urinary incontinence. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 21 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREStandard of care (15 Botox injections)

The controls will be given the standard of care of 15 Botox injections.

PROCEDUREExperimental 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

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NCT04731961


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