The effect of Botulinum toxin A injections for overactive bladder on detrusor contractility - Botulinum toxin A and detrusor contractility
- Conditions
- eurogenic or idiopathic overactive bladder, not adequately responding to anticholinergic therapyMedDRA version: 9.1Level: LLTClassification code 10059617Term: Overactive bladder
- Registration Number
- EUCTR2007-004650-93-NL
- Lead Sponsor
- niversity Medical Center Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method