Neurogenic & Idiopathic detrusor overactivity in the bladder MedDRA version: 14.1 Level: LLT Classification code 10005046 Term: Bladder incontinence System Organ Class: 100000004857
Conditions
Interventions
Trade Name: Botox
Product Name: Botulinum neurotoxin type A
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: Botulinium toxin type A
Concentration unit: U unit(s)
Conce
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: neurological disease or of unknown origin. ;Secondary Objective: To obtain initial results on the changes of urine and bladder markers role at 14 days after and at the time of clinical relapse (between 6-9 months) post treatment. The information obtained may be used in a future large-scale research study. ;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 | — |
Countries
United Kingdom
Outcome results
None listed