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RECRUITING
NCT04731961
NA

Reduction in Number of Botox Injections for Urgency Urinary Incontinence

Sponsor: University of Virginia

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

Standard of care (15 Botox injections)

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

PROCEDURE

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