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NCT04020510 · ClinicalTrials.gov registry record · Phase 4
Standard Injections Versus Reduced Injections for Intravesical onabotulinumtoxinA Treatment of Overactive Bladder
A Phase 4 study of Overactive Bladder, sponsored by Walter Reed National Military Medical Center.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 184
- Enrollment target
- 1
- Study location
NCT04020510 is a Phase 4 study of Overactive Bladder that is actively recruiting participants, run by Walter Reed National Military Medical Center. The registered enrollment target is 184 participants, below the 208-participant average among 45 other Overactive Bladder trials with a reported enrollment target (12% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04020510, a Phase 4 study of Overactive Bladder, is actively recruiting participants, sponsored by Walter Reed National Military Medical Center.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 184 participants
- Enrollment target
- 1
- Study location
Study Summary
OnabotulinumtoxinA is an effective treatment for both idiopathic and neurogenic overactive bladder and was FDA approved for this indication in 2013. The standard technique for injecting onabotulinumtoxinA into the detrusor is mixing 100 units of onabotulinumtoxinA into 10mL of injectable normal saline and injecting 20 sites with 0.5mL in the posterior wall of hte bladder for idiopathic overactive bladder and mixing 200 units into 30mL and injecting 30 sites with 1mL for neurogenic overactive bladder. The purpose of this study is to compare the efficacy of a technique using a reduced number of injections with the same dosage of onabotulinumtoxinA to the standard technique. The hypothesis is that the reduced technique will not be inferior in terms of efficacy as the standard technique and that there will be a lower incidence of urinary tract infections and urinary retention requiring catheterization post-procedure.
Conditions Studied
Interventions
- DRUG onaBoNT-A
Study Locations (1)
Maryland
- Walter Reed National Military Medical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 184 participants |
| Start Date | 2019-07-01 |
| Est. Completion | 2021-12-31 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04020510
The ClinicalTrials.gov registry entry for NCT04020510 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 184 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 208-participant average among 45 other Overactive Bladder trials with a reported enrollment target (12% lower). The listed sponsor is Walter Reed National Military Medical Center, which has 48 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Overactive Bladder appearing as the primary indexed condition, and to 1 intervention - of which onaBoNT-A is the first listed.
NCT04020510 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT04020510 about?
NCT04020510 is a clinical study titled "Standard Injections Versus Reduced Injections for Intravesical onabotulinumtoxinA Treatment of Overactive Bladder". OnabotulinumtoxinA is an effective treatment for both idiopathic and neurogenic overactive bladder and was FDA approved for this indication in 2013. The standard technique for injecting onabotulinumtoxinA into the detrusor is mixing 100 units of onabotulinumtoxinA into 10mL of injectable normal sali...
What is the current status of trial NCT04020510?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 184 participants. The study started on 2019-07-01. Estimated completion is 2021-12-31.
What conditions does trial NCT04020510 study?
This clinical trial studies the following conditions: Overactive Bladder.
What interventions are being tested in trial NCT04020510?
The interventions under investigation include: onaBoNT-A (DRUG).
Who is sponsoring clinical trial NCT04020510?
This trial is sponsored by Walter Reed National Military Medical Center, which has 48 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04020510 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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