Neurogenic or idiopathic overactive bladder, not adequately responding to anticholinergic therapy MedDRA version: 9.1 Level: LLT Classification code 10059617 Term: Overactive bladder
Conditions
Interventions
Trade Name: BOTOX ®
Product Name: botulinum toxin A
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Botulinum toxin type A
CAS Number: 93384-43-1
Other descriptive name: Bo
Sponsors
University Medical Center Groningen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with an overactive bladder, planned for Botulinum toxin A injection, will be included in this study. Male and female patients 20 – 70 years of age Symptoms of overactive bladder for more than 6 months Overactive bladder is defined as urgency and frequency with or without incontinence. Micturition frequency > 7 times/day Incontinence episodes > 6/week Detrusor overactivity on urodynamic investigation (consisting of decreased detrusor compliance, early detrusor contractions) Informed consent is obtained Patients are capable of filling out a micturition diary and Quality of Life-questionnaire Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Treatment with Botulinum toxin A in the last 9 months Treatment with anticholinergic drugs during the last 2 weeks Active or repeated urinary tract infection Peripheral neuropathy (i.e. Diabetic neuropathy) Having an indwelling catheter Malignancy in the area of the pelvis Pelvic surgery in the last 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To find out the relation between the change in detrusor contractility and the amount of post void residual urine.;Primary end point(s): The change in detrusor contractility after Botulinum toxin A treatment.;Main Objective: To find out whether injection of Botulinum toxin A into the detrusor muscle has any influence on its contractility, in patients with overactive bladder refractory to anticholinergic therapy. | — |
Countries
Netherlands
Outcome results
None listed