Overactive Detrusor Clinical Trial
Official title:
Efficacy of Peri-trigonal Onabotulinumtoxin Injections in the Treatment of Refractory Idiopathic Detrusor Overactivity (IDO): A Single-blind, Randomised Controlled Trial Comparing Peri-trigonal Injections vs Injection of the Bladder Body.
Overactive Bladder (OAB) is a chronic condition caused by instability of the detrusor or
bladder muscle, which gives rise to symptoms of urinary urgency and often urinary
incontinence. Idiopathic Detrusor Overactivity (IDO) is a subset of OAB where the cause for
the bladder muscle instability is unknown.
OAB is usually treated by conservative measures or with oral medications eg.
anticholinergics. Injection of onabotulinum toxin A (onaBoNT-A) into the bladder wall is
licenced in the treatment of refractory IDO where oral medications fail. The injected toxin
paralyses the bladder by blocking the ability of certain (motor) nerves to communicate with
the bladder muscle. As these nerves are mainly concentrated in what is known as the "body"
of the bladder this is traditionally where the injections are given.
In addition to its action on motor nerves, onaBoNT-A also affects sensory nerve pathways.
Recent studies show that IDO is caused by both motor and sensory nerve dysfunction,
therefore injecting the "trigone", a part of the bladder where sensory nerves are
particularly dense, may be of clinical benefit. Three studies comparing trigone versus
trigone-sparing injection of botulinum toxin in the treatment of IDO have been carried out.
One of these indicated a significant benefit in targeting the trigone and the other two did
not show any difference.
Our study aims to examine if injection of onaBoNT-A into the trigone alone will provide
symptom and functional improvement in patients with IDO by comparing peritrigonal injection
of onaBoNT-A with the traditional method of injection which spares the trigone.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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