AbobotulinumtoxinA is effective in patients with urinary incontinence due to neurogenic detrusor overactivity regardless of spinal cord injury or multiple sclerosis etiology: Pooled analysis of two phase III randomized studies (CONTENT1 and CONTENT2)

Neurourol Urodyn, 2023 · DOI: 10.1002/nau.25062 · Published: January 1, 2023

Urology Neurology Research Methodology & Design

Simple Explanation

This study examines the effectiveness and safety of abobotulinumtoxinA (aboBoNT-A) in treating urinary incontinence caused by neurogenic detrusor overactivity (NDOI). NDOI is a condition where the bladder muscle contracts involuntarily due to nerve damage. The study focused on patients with NDOI resulting from either spinal cord injury (SCI) or multiple sclerosis (MS), all of whom were using clean intermittent catheterization (CIC). The analysis combines data from two large phase III clinical trials. The results showed that aboBoNT-A significantly reduced urinary incontinence episodes and improved quality of life and bladder function in both SCI and MS patients. The treatment was also found to be well-tolerated.

Study Duration

Not specified

Participants

485 patients with spinal cord injury (SCI) or multiple sclerosis (MS)

Evidence Level

Level III, Phase III randomized, double‐blind studies

Key Findings

1
A significant reduction was observed in mean NDOI episodes/week at Week 6 with both aboBoNT‐A doses versus placebo in the SCI (all p < 0.001) and MS (all p < 0.01) groups
2
Statistically significant improvements from baseline in I‐QoL total summary scores at Week 6 were observed for both aboBoNT‐A doses versus placebo in the SCI and MS groups (all p < 0.001)
3
Significant improvements from baseline in all urodynamic parameters at Week 6 with both doses of aboBoNT‐A versus placebo regardless of etiology

Research Summary

This study pooled data from two phase III clinical trials to assess the efficacy and safety of abobotulinumtoxinA (aboBoNT-A) in treating urinary incontinence due to neurogenic detrusor overactivity (NDOI) in patients with spinal cord injury (SCI) or multiple sclerosis (MS) who regularly perform clean intermittent catheterization (CIC). The results demonstrated that aboBoNT-A significantly reduced the number of weekly NDOI episodes and improved incontinence-related quality of life (I-QoL) and urodynamic parameters in both SCI and MS groups compared to placebo. The treatment was well-tolerated, with a similar safety profile observed between SCI and MS etiologies. These findings suggest that aboBoNT-A is an effective and safe treatment option for NDOI in patients with SCI or MS who regularly perform CIC.

Practical Implications

Clinical Practice

AboBoNT-A can be considered as an effective treatment for NDOI in SCI and MS patients performing CIC, improving continence and quality of life.

Treatment Guidelines

The study supports the inclusion of aboBoNT-A in treatment guidelines for NDOI, particularly for patients already using CIC.

Future Research

Further research could explore optimal dosing strategies and long-term outcomes of aboBoNT-A treatment in different NDOI etiologies.

Study Limitations

1
The sample size was not powered for etiology subgroup analyses
2
No imputations to account for missing data were performed, which may limit the conclusions of this analysis.
3
Findings are specific to patients with NDOI due to SCI and MS who perform regular CIC.

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