NGF and TRPV1 after intra-detrusor BoNT/A injections in DO

• Research type

  Research Study

• Full title

  Pilot study to establish laboratory methods for urine Nerve Growth Factor (NGF) and immunohistochemical staining of the vanilloid receptor (TRPV1) in bladder biopsies, following open label treatment with botulinum neurotoxin type A in patients with neurogenic detrusor overactivity (NDO) and idiopathic detrusor overactivity (IDO).

• IRAS ID

  51076

• Contact name

  Clare Fowler

• Sponsor organisation

  University College London

• Eudract number

  2010-020944-37

• ISRCTN Number

  n/a

• Research summary

  This is a pilot study to establish laboratory methods for detecting changes in bladder innervation following treatment with detrusor injection of botulinum neurotoxin type A in patients with neurogenic detrusor overactivity (NDO) and idiopathic detrusor overactivity (IDO). The primary focus will be to study the changes in TRPV1 in the suburothelium and levels of NGF in the urothelium and urine of patients with NDO and IDO undergoing treatment with intradetrusor BoNT/A injections for treatment of intractable OAB symptoms. The rationale for this project is that previous work suggests that symptomatic reduction in urinary urgency and frequency will correlate with a decrease in bladder TRPV1 levels post-treatment and this will correlate with a decrease in bladder and urine NGF levels. Bladder biopsy specimens will be examined at baseline (pre-treatment) 10 days and 1 month after treatment, as well as at the time of clinical relapse, which is known to be a variable time between 6 and 10 months following treatment. Previous studies which examined suburothelial and urothelial levels of TRPV1 used an ABC-peroxidase Nickel-enhanced, glucose oxidase immunohistochemical technique of overnight incubation with the primary antibody. A recently established collaboration with Neuropathology at the Institute of Neurology plans to use their Leica Microsystems Bond Max automated immunostainer to estimate receptor and neuropeptide levels in the biopsy specimens. It is the aim of this preliminary pilot study to establish both the laboratory methods and the quantifiable results required for the design of a subsequent research project investigating the changes in human bladder NGF and TRPV1 at given time-points following treatment with intradetrusor Botox© in a larger scale study.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  11/LO/1163

• Date of REC Opinion

  31 Oct 2011

• REC opinion

  Further Information Favourable Opinion