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NCT04305743 · ClinicalTrials.gov registry record · Phase 4
Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A
A Phase 4 study of Urinary Bladder, Overactive and Nocturia, sponsored by University of South Florida.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
- 2
- Study locations
NCT04305743: Recruiting Phase 4 study of Urinary Bladder, Overactive and Nocturia, sponsored by University of South Florida.
NCT04305743 is a Phase 4 study of Urinary Bladder, Overactive and Nocturia that is actively recruiting participants, run by University of South Florida. The registered enrollment target is 60 participants, below the 358-participant average among 9 other Urinary Bladder, Overactive trials with a reported enrollment target (83% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04305743, a Phase 4 study of Urinary Bladder, Overactive and Nocturia, is actively recruiting participants, sponsored by University of South Florida.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
- 2
- Study locations
Study Summary
Currently, in clinical practice there has been no standardization in the number of injections a single dose of intradetrusor onabotulinumtoxin A is administered in. Given the increasing use of this treatment modality, the aim of this study is to compare outcomes for patients given a 100 unit dose of onabotulinumtoxin A split into 5 as compared to 20 injections for the treatment of overactive bladder or urgency urinary incontinence refractory to medical treatment.
Primary Outcome
Pain score as rated on a 10-point visual analog scale within 5 minutes of procedure completion
Conditions Studied
Interventions
- DRUG OnabotulinumtoxinA 100 UNT
Study Locations (2)
District of Columbia
- MedStar Washington Hospital Center - Washington D.C.
Florida
- University of South Florida Health South Tampa Center for Advanced Healthcare - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2019-10-09 |
| Est. Completion | 2021-06-01 |
| Phase | Phase 4 |
What NCT04305743 shows while recruiting
NCT04305743 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 358-participant average among 9 other Urinary Bladder, Overactive trials with a reported enrollment target (83% lower).
The record links to 6 conditions, with Urinary Bladder, Overactive appearing as the primary indexed condition, and to 1 intervention - of which OnabotulinumtoxinA 100 UNT is the first listed.
NCT04305743 reports a single indexed study location in District of Columbia, Florida.
Frequently Asked Questions
What is clinical trial NCT04305743 about?
NCT04305743 is a clinical study titled "Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A". Currently, in clinical practice there has been no standardization in the number of injections a single dose of intradetrusor onabotulinumtoxin A is administered in. Given the increasing use of this treatment modality, the aim of this study is to compare outcomes for patients given a 100 unit dose of...
What is the current status of trial NCT04305743?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2019-10-09. Estimated completion is 2021-06-01.
What conditions does trial NCT04305743 study?
This clinical trial studies the following conditions: Urinary Bladder, Overactive, Nocturia, Urinary Urge Incontinence, Incontinence, Urinary, Incontinence, Urge.
What interventions are being tested in trial NCT04305743?
The interventions under investigation include: OnabotulinumtoxinA 100 UNT (DRUG).
Who is sponsoring clinical trial NCT04305743?
This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04305743 being conducted?
This trial has 2 study locations across District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04305743's enrollment target sits among peer trials
60 7th of 9 higher than 3 of 9 other Urinary Bladder, Overactive trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Urinary Bladder, Overactive trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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