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Reduction in Number of Botox Injections for Urgency Urinary Incontinence

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 2 months later Dec 31, 2025 → Feb 28, 2027
See other at-risk trials from University of Virginia

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Dec 31, 2025 to Feb 28, 2027 Show 6 more changesShow less
    • Enrollment closed, study ongoing
    • Study completion pushed from Dec 31, 2026 to Feb 28, 2027
    • Eligibility criteria expanded, about 29 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study description revised
    • Site details revised
  2. Primary completion date: Dec 31, 2024 to Dec 31, 2025
    • Study completion date: Dec 31, 2025 to Dec 31, 2026
    • Site contact updated
    v3
  3. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Dec 31, 2021 to Dec 31, 2024
    • Study sites: 0 to 1
    • Study completion date: Dec 31, 2022 to Dec 31, 2025
    • Start date changed from estimate of Jan 20, 2021 to Feb 23, 2021
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04731961
Lead Sponsor University of Virginia
Conditions
(from sponsor)		 Urgency Urinary Incontinence
Enrollment 56 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov