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). - Bladder biopsies from pts receiving BoNT/A injections for NDO and IDO

• Conditions: MedDRA version: 14.1Level: LLTClassification code 10005046Term: Bladder incontinenceSystem Organ Class: 100000004857; eurogenic & Idiopathic detrusor overactivity in the bladder

• Registration Number: EUCTR2010-020944-37-GB
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-07
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Men and women aged between 18 and 75. The group with NDO will be comprised exclusively of patients with multiple sclerosis who are attending the Uro-Neurology clinics. The group of patients with IDO will be comprised of patients without neurological disease but with urodynamically proven DO who are attending the Uro-Neurology clinics.
In both groups, patients who have failed to respond adequately to two different oral anti-cholinergic medications and remain in need of further measures to treat urgency incontinence.
Willing and able to perform self-catheterisations if required post treatment, if not already doing so
Willing to give written informed consent
Willing to attend the necessary follow up visits
On effective contraception if sexually active - oral contraceptive pill (>3 months use), condoms, intrauterine contraceptive device, depot injection

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Patients with non-neurogenic DO and bladder outlet obstruction upon urodynamic investigation
Presence of a low compliance bladder in the absence of DO
Previous intra-detrusor BoNT/A injections within the last one year.
Patients with known hypersensitivity to Botulinium toxin A or any of its exipients
Pregnant or lactating women and those planning pregnancy
Anticoagulant therapy (On Aspirin, Clopidogrel, Warfarin or other anti-coagulants) at the time of inclusion.
On drugs that might interfere with neuromuscular transmission (e.g. Aminoglycosides)
Pain thought to originate from the urinary tract
Unsuitable past medical history e.g. frequent epilepsy, uncontrolled hypertension, severe coronary artery disease.
Participation in a clinical trial involving an investigational product in the last 3 months

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To establish laboratory methods for detecting changes degrees of bladder stimulation via nerves following treatment with BOTOX in patients with urinary urgency incontinence due either to: <br>neurological disease <br>or of unknown origin. ;Secondary Objective: To obtain initial results on the changes of urine and bladder markers role at <br>14 days after<br>and <br>at the time of clinical relapse (between 6-9 months) post treatment. <br>The information obtained may be used in a future large-scale research study.<br>;Primary end point(s): Changes in urine/bladder NGF levels and urothelial TRPV1 levels at 14 days after treatment, and at the time of documented clinical relapse (a variable time between 6-9 months post treatment