Overactive bladder syndrome is characterized by a combination of urinary frequency, urgency and urge incontinence.
Conditions
Interventions
Trade Name: Dysport
Product Name: Dysport
Product Code: botulinum toxin
Pharmaceutical Form: Powder for solution for injection
INN or Pr
Sponsors
Gwent Healthcare NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria. Patients with urodynamically proven detrusor overactivity. This must be on conventional CMG or VCMG - not ambulatory monitoring This may be of congenital, neuropathic or idiopathic aetiology. Previous failed treatment with conservative and standard medical therapy. Patients who might otherwise be considered for neuromodulation, augmentation or diversion surgery. A subgroup of patients with known neurogenic detrusor overactivity who already have indwelling suprapubic catheters may also be studied. 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: Exclusions. Patients < 18 years of age. Patients with proven bladder outflow obstruction on urodynamics. Any patients with generalised disorder of muscle activity eg; Myaesthenia Gravis. Serious concomitant illness. Patients with bleeding disorders. Pregnant or breast feeding patients. Patients who would not tolerate intermittent self catheterisation (this excludes the subgroup who already have indwelling suprapubic catheters). Patients in whom stress incontinence is the primary symptom. Previous failure of Botulinum toxin therapy. Acute urinary infection. Any other bladder pathology demonstrated at the time of cystoscopy (includes trauma, stones, tumour).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Aim of proposed investigation. The aim is to measure the efficacy and tolerability of Botulinum A Toxin in the treatment of detrusor overactivity, and examine whether there is a relationship between the severity and aetiology of pre-treatment detrusor overactivity and the response obtained. ;Secondary Objective: ; Primary end point(s): Efficacy parameters of the study. Primary efficacy measures will be changes from: Baseline median daily frequency. Baseline median leakage episodes. Baseline median number of daily catheterizations. Baseline global Kings HQ score. Baseline domain scores for Kings HQ. Baseline ICIQ-SF and Quality of Life and Symptoms Distress Inventory scores. Success for an individual is defined as an improvement of 20% in any of these parameters. Secondary efficacy parameters will be changes in: Volume at first overactive contraction. Maximum detrusor pressure whilst voiding. Detrusor compliance. Maximum cystometric capacity. Post-void residual urine. For patients who have initially improved but then fail, further treatment will be offered, and the cycle of assessment and follow-up repeated. | — |
Countries
United Kingdom
Outcome results
None listed