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Reduction in Number of Botox Injections for Urgency Urinary Incontinence

NCT04731961 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-01-28

No results posted yet for this study

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.

Conditions

  • Urgency Urinary Incontinence

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.

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Principal Investigators

  • Monique J Vaughan, MD · University of Virginia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-23
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04731961 on ClinicalTrials.gov