Botulinum Toxin in the Treatment of Idiopathic Detrusor Overactivity
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02009540|
Recruitment Status : Unknown
Verified December 2013 by Mr HD Flood, University Hospital of Limerick.
Recruitment status was: Not yet recruiting
First Posted : December 12, 2013
Last Update Posted : December 12, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Overactive Detrusor||Drug: Botulinum toxin injected to bladder body Drug: Botulinum toxin injected into trigone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|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.|
|Study Start Date :||December 2013|
|Estimated Primary Completion Date :||January 2014|
Placebo Comparator: Botulinum toxin injected to bladder body
arm will receive 100u of onaBoNT-A in 20x1ml aliquots (5u/ml). 20 injections will be given into the bladder wall, sparing the trigone. Injections will be given through all layers of the bladder eg suburothelially and intradetrusor.
Drug: Botulinum toxin injected to bladder body
arm will receive 100u of onaBoNT-A in 20x1ml aliquots (5u/ml). 20 injections will be given into the bladder wall, sparing the trigone. Injections will be given through all layers of the bladder eg suburothelially and intradetrusor. The intervention will be performed under local anaesthetic using a flexible cystoscope.
Active Comparator: Botulinum toxin injected into trigone
Arm B will receive 100u onaBoNT-A injected into 10x1ml suburothelial peri-trigonal sites (aliquot dose 10u/ml).
Drug: Botulinum toxin injected into trigone
Arm B will receive 100u onaBoNT-A injected into 10x1ml suburothelial peri-trigonal sites (aliquot dose 10u/ml). The procedure will be performed under local anaesthetic by flexible cystoscopy.
- Global Response Assessment [ Time Frame: measured at 3 months following intervention ]
- Functional outcomes - 3 day sensation related bladder diary [ Time Frame: measured at 3 months following intervention ]Three day sensation related bladder diary
- IIQ-7 quality of life questionnaire [ Time Frame: measured at 3 months following intervention ]
- Treatment tolerability - numerical rating scale (0-10) [ Time Frame: measured at 2 weeks following intervention ]
- UDI-6 quality of life questionnaire [ Time Frame: measured at 3 months following intervention ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02009540
|Contact: H D Flood, FRCSIfirstname.lastname@example.org|
|University Hospital of Limerick||Not yet recruiting|
|Contact: H D Flood|
|Principal Investigator:||H D Flood, FRCSI||University Hospital of Limerick|