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NCT03033355 · ClinicalTrials.gov registry record
Central Nervous System Changes Following OnabotulinumtoxinA Injection in the Bladder
A clinical trial of Multiple Sclerosis and Lower Urinary Tract Symptoms, sponsored by The Methodist Hospital Research Institute.
- Completed
- Registry status
- 12
- Enrollment target
- 1
- Study location
NCT03033355: Completed study of Multiple Sclerosis and Lower Urinary Tract Symptoms, sponsored by The Methodist Hospital Research Institute.
NCT03033355 is a study of Multiple Sclerosis and Lower Urinary Tract Symptoms that has completed, run by The Methodist Hospital Research Institute. The registered enrollment target is 12 participants, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03033355, a study of Multiple Sclerosis and Lower Urinary Tract Symptoms, has completed, sponsored by The Methodist Hospital Research Institute.
- COMPLETED
- Registry status
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this research study is to evaluate higher neural changes following intra-detrusor injection of Onabotulinumtoxin-A (BTX-A) in patients with Multiple Sclerosis (MS). We will use our prospectively collected cohort of patients. Concurrent Urodynamic and Functional Magnetic Resonance (fMRI) data will be recorded pre- and post-intravesical injection of BTX-A in patients with Multiple Sclerosis (MS) and neurogenic detrusor activity (NDO).
Primary Outcome
Brain activation patterns associated with the strong desire to void (Full Urge) were examined using functional magnetic resonance imaging (fMRI), assessing BOLD signal intensity in predefined regions of interest at baseline and 6-10 weeks following OnabotulinumtoxinA (OnabotA) injection. Post-treatment changes in activity (voxel signal) were analyzed based on a statistical threshold, with increased activation defined by a T-value greater than or equal to 2.0 and decreased activation by a T-value
Conditions Studied
Interventions
- DRUG Intra-detrusor injection of Onabotulinumtoxin-A
Study Locations (1)
Texas
- Houston Methodist Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2014-02 |
| Est. Completion | 2019-03 |
What the finished NCT03033355 record still lists
NCT03033355 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (98% lower).
The record links to 5 conditions, with Multiple Sclerosis appearing as the primary indexed condition, and to 1 intervention - of which Intra-detrusor injection of Onabotulinumtoxin-A is the first listed.
NCT03033355 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03033355 about?
NCT03033355 is a clinical study titled "Central Nervous System Changes Following OnabotulinumtoxinA Injection in the Bladder". The purpose of this research study is to evaluate higher neural changes following intra-detrusor injection of Onabotulinumtoxin-A (BTX-A) in patients with Multiple Sclerosis (MS). We will use our prospectively collected cohort of patients. Concurrent Urodynamic and Functional Magnetic Resonance (fM...
What is the current status of trial NCT03033355?
This trial is currently completed. The enrollment target is 12 participants. The study started on 2014-02. Estimated completion is 2019-03.
What conditions does trial NCT03033355 study?
This clinical trial studies the following conditions: Multiple Sclerosis, Lower Urinary Tract Symptoms, Neurogenic Bladder, Urge Incontinence, Detrusor, Overactive.
What interventions are being tested in trial NCT03033355?
The interventions under investigation include: Intra-detrusor injection of Onabotulinumtoxin-A (DRUG).
Who is sponsoring clinical trial NCT03033355?
This trial is sponsored by The Methodist Hospital Research Institute, which has 126 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03033355 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03033355's enrollment target sits among peer trials
12 297th of 315 higher than 15 of 315 other Multiple Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Sclerosis 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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