Reduction in Number of Botox Injections for Urgency Urinary Incontinence

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT04731961
Status
Recruiting
Apply to this trial

Conditions

  • Urgency Urinary Incontinence

Eligibility Criteria

Sex
FEMALE
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Standard of care (15 Botox injections) — PROCEDURE
    The controls will be given the standard of care of 15 Botox injections.
  • Experimental Arm (5 Botox injections) — PROCEDURE
    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.

Study Details

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.

Key Dates

Start date
Feb 23, 2021
Status verified
Jan 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Controls
    Subjects in this arm will be administered the standard injection site protocol (15 sites).
  • Experimental: Experimental
    Subjects in this arm will be administered the same amount of Botox in 5 injection sites.

Primary Outcome Measure

Reducton of Urgency Urinary Incontinence episodes in standard of care versus modified treatment group [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of VirginiaCharlottesvilleVirginia22903
Monique Vaughan, MD
[email protected]
4349242103

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By research site
University of Virginia· Charlottesville, VA

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