Overactive Bladder
Conditions
Keywords
Overactive bladder, Urgency, Urge incontinence, Botulinum toxin A, Quality of life
Brief summary
Overactive bladder induce urgency, urge incontinence, nocturia and pollakiuria. This condition is often resistant to anticholinergic drugs used as a first line treatment for this purpose. Moreover muscarinic side effects (constipation, mouth dryness) often limits the use of those treatments. This study is designed to evaluate the efficacy and safety of botulinum toxin A injected into the detrusor muscle to control symptoms and improve quality of life for patients resistant or intolerant to anticholinergic drugs.
Detailed description
This study is designed to evaluate the efficacy and safety of botulinum toxin A injected into the detrusor muscle to control symptoms and improve quality of life for patients resistant or intolerant to anticholinergic drugs.
Interventions
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Overactive bladder with more than 3 episodes of urgency of urge incontinence per day
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of urgency and urge incontinence episodes at 3 months after injection | at 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Mean value of volume of urine per micturition | — |
| Mean delay between urgency and leakage Quality of life improvement by Iqol and EuroQol (EQ-5D) | — |
| Urodynamic parameters : Volume at first contraction, volume at first desire to void, volume at urgency, maximal bladder capacity, maximal detrusor pressure | — |
| Number of pads used per day | — |
| Number of patients with less than 3 episodes per day of leakages by urge incontinence or urgency per day | — |
| Number of micturition episodes on micturition chart per day | per day |
| Maximal flow | — |
| Visual analogic scale for pain for procedure | — |
| Biologic modifications | — |
| Ultrasound of kidneys | — |
| Toxin A antibodies | — |
| Residual volume of urine after flowmetry | — |
Countries
France
Outcome results
None listed