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NCT04731961 · ClinicalTrials.gov registry record · NA
Reduction in Number of Botox Injections for Urgency Urinary Incontinence
A NA study of Urgency Urinary Incontinence, sponsored by University of Virginia.
- Recruiting
- Registry status
- NA
- Development phase
- 56
- Enrollment target
- 1
- Study location
NCT04731961: Recruiting NA study of Urgency Urinary Incontinence, sponsored by University of Virginia.
NCT04731961 is a NA study of Urgency Urinary Incontinence that is actively recruiting participants, run by University of Virginia. The registered enrollment target is 56 participants, below the 284-participant average among 4 other Urgency Urinary Incontinence trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04731961, a NA study of Urgency Urinary Incontinence, is actively recruiting participants, sponsored by University of Virginia.
- RECRUITING
- Registry status
- NA
- Development phase
- 56 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
To determine if a reduced injection site protocol (5 injection sites) of intra-detrusor Onabotulinumtoxin-A is non-inferior in the treatment of refractory urgency urinary incontinence as compared to the standard injection site protocol (15 injection sites). This endpoint will be measured by reduction in the number of UUI episodes per day.
Conditions Studied
Interventions
- PROCEDURE Standard of care (15 Botox injections)
- PROCEDURE Experimental Arm (5 Botox injections)
Study Locations (1)
Virginia
- University of Virginia - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2021-02-23 |
| Est. Completion | 2026-12-31 |
| Phase | NA |
What NCT04731961 shows while recruiting
NCT04731961 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 284-participant average among 4 other Urgency Urinary Incontinence trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Urgency Urinary Incontinence appearing as the primary indexed condition, and to 2 interventions - of which Standard of care (15 Botox injections) is the first listed.
NCT04731961 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT04731961 about?
NCT04731961 is a clinical study titled "Reduction in Number of Botox Injections for Urgency Urinary Incontinence". 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 cen...
What is the current status of trial NCT04731961?
This trial is currently recruiting. It is a NA study. The enrollment target is 56 participants. The study started on 2021-02-23. Estimated completion is 2026-12-31.
What conditions does trial NCT04731961 study?
This clinical trial studies the following conditions: Urgency Urinary Incontinence.
What interventions are being tested in trial NCT04731961?
The interventions under investigation include: Standard of care (15 Botox injections) (PROCEDURE), Experimental Arm (5 Botox injections) (PROCEDURE).
Who is sponsoring clinical trial NCT04731961?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04731961 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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