Long term F/U study of BOTOX in Neurogenic Detrusor Overactivity

• Research type

  Research Study

• Full title

  A Multicentre, Long-term Follow-up Study of the Safety and Efficacy of BOTOX (Botulinum Toxin Type A) Purified Neurotoxin Complex in Patients with Urinary Incontinence Due to Neurogenic Detrusor Overactivity

• Sponsor organisation

  Urology, EU R&D, Allergan Ltd

• Eudract number

  2009-009216-53

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Neurogenic detrusor overactivity (NDO) is a condition that occurs in patients with a neurological disorder such as multiple sclerosis (MS) or a spinal cord injury. The neurological disorder causes the control of the bladder to be affected and the bladder (detrusor) muscle contracts uncontrollably; this is called detrusor overactivity and can lead to severe symptoms such as urinary incontinence, frequent voiding and the uncontrollable desire to void (urgency). In addition, the condition can lead to dangerously high pressures to develop within the bladder and this can lead to bladder or kidney damage. NDO is currently treated by anticholinergic medications but some patients find these ineffective or can not continue with the medications due to the side effects. Other treatments are invasive surgical procedures which do not always work and carry a significant risk of harm. BOTOX© is known to relax muscles and is therefore being studied as a treatment for NDO. The bladder muscle can be easily injected using a telescope (cystoscope) inserted into the bladder. It is expected that the treatment will stop the uncontrollable contractions leading to improvements in symptoms (particularly incontinence) and to improvements in bladder pressures so that damage to the bladder/kidneys does not occur. The BOTOX© effect decreases after a few months therefore to maintain a benefit patients will need to have further injections once symptoms start to return. Allergan (manufacturer of BOTOX©) are already performing studies to determine if BOTOX© is safe and effective for this condition, with the aim of obtaining a license to market BOTOX© for NDO. The purpose of this study is to investigate the long term safety and effectiveness of BOTOX© and of repeat treatments with BOTOX©. To be eligible for this study patients must have received treatment in a previous Allergan study assessing initial treatment with BOTOX© for NDO.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  09/H0505/40

• Date of REC Opinion

  28 Apr 2009

• REC opinion

  Further Information Favourable Opinion