Idiopathic overactive bladder (symptoms of frequency and urgency) with urinary incontinence. MedDRA version: 7.1 Level: LLT Classification code 10059617
Conditions
Interventions
Trade Name: BOTOX®
Product Name: BOTOX®
Product Code: 9060X
Pharmaceutical Form: Powder for solution for injection
Current Sponsor code:
Sponsors
ALLERGAN LTD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All inclusion criteria are listed since they are all equally important. • Patient is male or female, aged 18 to 85 years old • Patient weighs = 50 kg (110 lbs) • Patient has symptoms of idiopathic overactive bladder (frequency and urgency) with urinary urge incontinence for a period of at least 6 months immediately prior to screening day -15, determined by documented patient history • Patient is able to complete study requirements including electronic bladder diary completion, using the toilet without assistance (patient’s incontinence is not due to inability to reach the toilet) and attend all study visits, in the opinion of the investigator • Written informed consent has been obtained • Patient has negative pregnancy test result if female and of child-bearing potential • Written Data Protection consent has been obtained • Patient experiences =8 episodes of urinary urge incontinence, with no more than one incontinence-free day, determined by completion of patient bladder diary collected over seven consecutive days during the screening period (screening day -14 to randomization day 0) • Patient experiences urinary frequency, defined as an average of =8 micturitions per day (normal voids only), with no more than one micturition-free day, determined by completion of patient bladder diary collected over seven consecutive days during the screening period (screening day -14 through randomization day 0) • Patient has not been adequately managed with one or more anticholinergic drugs for their overactive bladder symptoms, in the opinion of the investigator. Not adequately managed is defined as an inadequate response to or intolerable side effects after at least one month of anticholinergic therapy on an optimized dose • Patient is willing to use clean intermittent catheterization (CIC) to empty the bladder or is willing to have an indwelling catheter, if necessary following study treatment 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: All exclusion criteria are listed since they are all equally important. • Patient has symptoms of overactive bladder due to any known neurological reason e.g. spinal cord injury, multiple sclerosis, cerebral vascular accident, Alzheimer’s disease, Parkinson’s disease, etc. • Patient has received anticholinergic or sympathomimetic medication for the treatment of overactive bladder within 21 days of randomization day 0 • Patient uses clean intermittent catheterization (CIC) to manage their urinary incontinence • Patient has history or evidence of any pelvic or urological abnormalities, bladder surgery or disease, other than “overactive bladder”, that may impact bladder function. Note: Patient is currently using or has not removed a previously implanted electrostimulation/neuromodulation device for treatment of urinary incontinence (the latest time the device should have been removed is 6 weeks prior to randomization); use of other non-implantable electrostimulatory devices is also exclusionary. • Patient has history or current diagnosis of bladder cancer or has urine cytology results which may indicate bladder cancer (e.g., suspicious results or diagnostic of malignancy) at screening day -15 • Patient has a post void residual urine volume >200mL at screening day -15 • 24 hour total volume voided > 3000 mL of urine determined by completion of patient bladder diary collected during the seven consecutive days during the screening period (day -14 to day 0) • Patient has a predominance of stress incontinence, determined by patient history, in the opinion of the investigator • Patient is male with previous or current diagnosis of prostate cancer. Patients with a PSA level greater than 4.0 ng/mL will require a biopsy to rule out prostate cancer, unless a prostatic biopsy has been performed within the past 12 months • Patient is male, >40 years of age and has a urine flow rate 2 times the upper limit of normal at screening day -15 • Patient has a history of two or more treated urinary tract infections within 6 months of screening day -15 • Patient has urinary infection defined as a bacteriuria count of >105/mL conjoint with leukocyturia >5/hpf at screening day -15 • Patient has asymptomatic urinary infection, defined as positive nitrites, blood and/or leukocyte esterase on urine dipstick reagent strip test at randomization day 0 • Patient has history of unexplained hematuria or unexplained hematuria if >5 RBCs/hpf are present at screening day -15 or randomization day 0) • Patient has active genital infection, other than genital warts, either concurrently or within 4 weeks prior to screening day -15 • Patient has a history of interstitial cystitis, in the opinion of the investigator • Patient has evidence of urethral obstruction, in the opinion of the investigator at screening day -15 or randomization day 0 • Patient has a detrusor compliance on urodynamic evaluation of = 20 mL/cmH20 at randomization day 0 • Patient uses anti-platelet or anti-coagulant therapy within 3 days prior to randomization day 0. Note: Some medications can be withheld
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the study is to evaluate the safety and efficacy of a single treatment of each of 5 doses of BOTOX® compared to BOTOX® Placebo in patients with idiopathic overactive bladder with urinary urge incontinence who have not been adequately managed with anticholinergic therapy. The primary measure is the reduction of weekly frequency of urinary urge incontinence episodes. ; Secondary Objective: The study will also evaluate the following secondary measures in the study: • Number of episodes of micturition • Number of episodes of nocturia • Number of episodes of urgency • 24 hour total volume voided • Post void residual urine volume • Urodynamic parameters (which include post void residual volume, volume at first involuntary detrusor contraction, maximum cystometric capacity, peak (amplitude) detrusor pressure following first involuntary detrusor contraction, end fill pressure and detrusor compliance) • Health outcome measures (which include SF-36, King’s Health Questionnaire (symptoms component only), Incontinence Quality of Life Instrument, EQ-5D, Patient Satisfaction Questionnaire, Patient Global Assessment) ; Primary end point(s): The primary measure is number of episodes of urinary urge incontinence (episodes to be indicated as urge or stress incontinence episodes as applicable), as recorded by patient bladder diary during 7 consecutive days prior to study visit day 0, and during seven consecutive days immediately prior to weeks 2, 6, 12, 18, 24, 30 and 36 (primary endpoint at week 12). The primary endpoint for this study is at 12 weeks. | — |
Countries
Belgium, Germany, United Kingdom
Outcome results
None listed