Phase 2
Completed N=37
Effect of Botulinum Toxin A on Detrusor Overactivity and Renal Function in Chronic Spinal Cord Injured Patients
Spinal Cord Injuries
Source: ClinicalTrials.gov NCT01682603 ↗
Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcomePrimary: Net Change of the Urinary Distress Inventory (UDI-6) — 10.4; 7.43 units on a scale
Summary
To investigate the clinical effect of detrusor botulinum toxin A (BoNT-A) injection on neurogenic detrusor overactivity (NDO) and renal function and to compare the difference of expressions of sensory receptors and nerve growth factor (NGF) in the bladder wall of patients respond and not respond to BoNT-A injections in chronic spinal cord injured (SCI) patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Net Change of the Urinary Distress Inventory (UDI-6) |
10.4; 7.43 | — |
| PRIMARY Net Change of the Incontinence Impact Questionnaire (IIQ-7) |
11.9; 5.57 | — |
| PRIMARY Net Change of the Quality of Life Index (QoL-I) |
4.00; 2.21 | — |
| SECONDARY Net Change of the Cystometric Bladder Capacity (CBC) |
305.9; 437.6 | — |
| SECONDARY Net Change of the Bladder Compliance |
30.6; 29.0 | — |
| SECONDARY Net Change of the Maximum Flow Rate (Qmax) |
4.56; 3.54 | — |
| SECONDARY Net Change of the Void Volume |
79.6; 59.2 | — |
| SECONDARY Net Change of the Detrusor Pressure (Pdet) |
36.1; 12.9 | — |
| SECONDARY Net Change of the Postvoid Residual Volume (PVR) |
226.3; 378.5 | — |
Eligibility Criteria
Inclusion Criteria
- Adults with age of 19 years old or above
- Patients with chronic suprasacral cord SCI will be enrolled.
- Patients will be proven having NDO by videourodynamic study during the screening period.
- They also receive 99mTc-DTPA renal scanning for GFR at baseline.
- Patients with NDO induced urinary incontinence who have adequate hand function or have a care-giver available for CIC, and the baseline total GFR of less than 80 mL/min are main inclusion criteria
Exclusion Criteria
- Patients with detrusor underactivity and large bladder compliance, patients proven to have intrinsic sphincteric deficiency
- Patients who have hypersensitivity to BTX-A or constituent ingredients of BTX-A.
Data sourced from ClinicalTrials.gov (NCT01682603). 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.