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Comparison of the Therapeutic Effects of Different Injection Number of the Same Dose of Botulinum Toxin A on Overactive Bladder Syndrome
In Brief
A Phase 2 clinical trial evaluating BoNT-A (10 injection), BoNT-A (20 injection), and 1 other intervention for Overactive Bladder. Completed, enrolled 90 participants across 1 site.
Detailed Summary
Overactive bladder (OAB) is a symptom syndrome characterized by urgency frequency with or without urge urinary incontinence (UUI) that may affect the patients' quality of life. Current medical treatments are usually unsuccessful in completely eradicating urgency sensation. Intra-detrusor injection of botulinum toxin A (BoNT-A) modulates the release of neurotransmitters from sensory nerve endings and effectively modulates the inflammatory process mediated by nociceptive afferent nerve dysfunction. Satisfactory clinical results were achieved with intravesical BoNT-A injection, which increased bladder capacity and decreased urgency sensation in patients with neurogenic or idiopathic detrusor overactivity (NDO, IDO). Excellent results were achieved with injection of either 100 U or 200 U of BoNT-A. Episodes of frequency, urgency, and UUI were reduced, maximal cystometric capacity increased, maximal detrusor pressure (Pdet) decreased, and the quality of life index also improved significantly. However, post void residual (PVR) volume increased significantly and some patients required clean intermittent catheterization (CIC) to evacuate the PVR. Dose-related adverse events (AE) increased with increasing dose of BoNT-A. Therefore, adjustments of the BoNT-A dose and sites of injection might minimize the de novo AE and help to maintain success rates.
Study Details
Timeline
Interventions
BoNT-A 100 U 10 injections
BoNT-A 100 U 20 injections
BoNT-A 100 U 40 injections