Does Reduction of Number of Intradetrusor Injection Sites of aboBoNTA (Dysport®) Impact Efﬁcacy and Safety in a Rat Model of Neurogenic Detrusor Overactivity?

Toxins, 2015 · DOI: 10.3390/toxins7124896 · Published: December 17, 2015

Simple Explanation

This study investigates whether reducing the number of injection sites for abobotulinumtoxinA (aboBoNTA, Dysport®) affects its effectiveness and safety in treating neurogenic detrusor overactivity (NDO) in rats with spinal cord injuries. Female rats with spinal cord injuries were given intradetrusor injections of either saline or aboBoNTA, distributed among four or eight sites, to assess the impact on bladder function. The findings suggest that aboBoNTA has similar inhibiting effects on bladder function regardless of whether it is injected in four or eight sites, indicating that reducing the number of injection sites may not impair efficacy.

Study Duration

Not specified

Participants

63 female Sprague–Dawley rats

Evidence Level

Level IV, Preclinical investigation in a rat model

Key Findings

1
AboBoNTA significantly decreased maximal pressure in the bladder, regardless of whether it was injected in four or eight sites.
2
When injected in four sites, aboBoNTA significantly increased bladder capacity and compliance, while only compliance was improved when injected in eight sites.
3
AboBoNTA significantly reduced the frequency and amplitude of nonvoiding contractions (NVC).

Research Summary

This preclinical study investigated the impact of reducing the number of injection sites for aboBoNTA in treating NDO in a rat model, finding similar inhibiting effects regardless of whether four or eight sites were used. The study assessed clinically-relevant urodynamic parameters and demonstrated that aboBoNTA effectively decreased maximal pressure and reduced NVC frequency and amplitude, irrespective of the number of injection sites. While reducing the number of injection sites did not impair efficacy, the authors suggest that further safety data is needed to determine whether this approach improves the benefit-risk ratio.

Practical Implications

Optimizing Dosing Schemes

The study suggests that reducing the number of injection sites for aboBoNTA may be a viable option, potentially leading to faster and less painful injection procedures.

Harmonizing Clinical Procedures

The findings contribute to the standardization of clinical protocols for BoNTA injections, addressing the influence of injection site variation on urodynamic outcomes.

Improving Benefit-Risk Ratio

Additional data on the safety aspects of reducing injection sites are needed to determine whether it allows for an improvement of the benefit-risk ratio of BoNTA-based treatments for NDO.

Study Limitations

1
Urgency and urinary incontinence, main symptomatic clinical features investigated, are not quantiﬁed in animal preclinical studies.
2
BWL might have been the consequence of a decrease in food and water intake due to a BoNTA-induced transient muscular weakness as it was already reported in patients.
3
Harvesting of bladder, followed by histological assessment

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