N/A
Completed N=12
Central Nervous System Changes Following OnabotulinumtoxinA Injection in the Bladder
Source: ClinicalTrials.gov NCT03033355 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcomePrimary: Change in Blood Oxygen Level Dependent (BOLD) Signals in the Brain After Treatment — 2.6; 2.6; 3.5; 2.6 BOLD Signal Change Derived T-Value — p=0.0012
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Blood Oxygen Level Dependent (BOLD) Signals in the Brain After Treatment |
2.6; 2.6; 3.5; 2.6; 2.6; 2.4 | 0.0012 sig |
| SECONDARY Changes in Urodynamic (UDS) Parameters Following OnabotA Treatment |
261.4; 377.9; 134.5; 195.5 | — |
| SECONDARY Number of Participants Presenting With Neurogenic Detrusor Overactivity (NDO) Events During Urodynamic Studies (UDS) Before and After OnabotA Treatment |
6; 1 | — |
| SECONDARY Changes in Subjective Clinical Outcomes Following Treatment - Urogenital Distress Inventory, Short Form (UDI-6) |
12.09; 6.27; 3.27; 1.55; 2.64; 1.1 | — |
| SECONDARY Changes in Subjective Clinical Outcomes Following Treatment - Incontinence Impact Questionnaire Short Form (IIQ-7) |
9.64; 4.36 | — |
| SECONDARY Changes in Voiding Diary Metrics - Urge Urinary Incontinence (UUI) Events Per Day |
1.64; 0.42 | — |
| SECONDARY Changes in Voiding Diary Metrics - Number of Participants Requiring Clean Intermittent Catheterization(CIC) |
8; 11 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with clinical diagnosis of neurogenic bladder.
- History of any neurologic illness or injury (including but not limited to spinal cord injury, Multiple Sclerosis, spina bifida, Parkinson's, major spine surgery).
- 18 years or older.
- Female patients.
Exclusion Criteria
- Male
- History of any incontinence surgery (sling, Marshall-Marchetti-Krantz Procedure, Burch).
- History of any lower urinary tract surgery or manipulation (urethral dilation).
- Positive urine pregnancy test at enrollment .
Data sourced from ClinicalTrials.gov (NCT03033355). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.