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

niversity College London0 个研究点目标入组 20 人开始时间: 2011年2月7日最近更新: 2015年8月4日

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•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

•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

发起方

niversity College London