Non-neurogenic Overactive Bladder (OAB) MedDRA version: 9.1 Level: LLT Classification code 10059617 Term: Overactive bladder
Conditions
Interventions
Trade Name: BOTOX
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Clostridium botulinum serotype A neurotoxin
Concentration unit: U/ml unit(s)/millilitre
Concentration type
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Previous use of botulinum toxin Type A Outpatient, male or female subjects, of any race, between 21 and 75 years of age. Subjects with a non-neurogenic bladder and detrusor overactivity Subjects with urinary incontinence (minimum of one occurrence per day). [NOTE: Bladder emptying may be accomplished with straining, intermittent catheterization (IC), spontaneous micturition or leakage episodes.] Subject has urge urinary incontinence on 3 day bladder diary as defined by urinary leakage associated with common triggers of urge leakage such as “key in the door”, running to the bathroom, standing up, running water, etc. Subject has severe incontinence as defined below: 1) Mean # of daily leakage episodes = 1/day documented on 3 day bladder diary 2) Mean # of voids = 8/day documented on 3 day bladder diary Laboratory findings required 1)Urine dipstick or urine culture negative for urinary tract infection 2)Post void residual volume =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients not previously exposed to botulinum toxin type A Use of botulinum toxin type A within previous 6 months Female subjects who are pregnant (positive urine pregnancy test) or of childbearing age who are not taking suitable contraceptive precautions. Subjects with a history of transurethral sphincterotomy, bladder neck or prostatic resection, previous bladder surgery including myomectomy or augmentation cystoplasty. Subjects with chronic indwelling catheters. Subjects with any medical condition that may increase their risk of exposure to botulinum toxin including diagnosed myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis or any other disease that might interfere with neuromuscular function. Subjects with an allergy or sensitivity to any component of BOTOX® Subjects unable to discontinue any agents that might interfere with neuromuscular function (i.e., aminoglycoside antibiotics, curare-like agents, etc.). Subjects with, in the opinion of the Investigator, unstable multiple sclerosis. Subjects with known, uncontrolled systemic disease. Subjects with evidence of recent alcohol/drug abuse. Subjects who, in the opinion of the Investigator, have a significant condition or situation that may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study. Subjects with a history of poor cooperation, non-compliance, or unreliability. Subjects currently participating in an investigational drug study or who have participated in an investigational drug study within 30 days of the Baseline Visit. History of carcinoma of the bladder Presence of a foreign body in the bladder, cystitis or other correctable aetiology for urgency urinary incontinence. Gross fecal incontinence (due to confounding effects on pad weights and counts) Clear evidence of emptying phase or detrusor dysfunction that may put the subject at risk for urinary retention Known allergy to Ciprofloxacin (used for urinary tract infection prophylaxis) or to lidocaine or related compounds (used for local analgesia) Prior documented resistance to Botox®
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To quantify the action of botulinum toxin serotype-A (BOTOX) on urgency using a novel electronic measurement device.;Secondary Objective: To quantify the action of botulinum toxin serotype-A (BOTOX) on a number of secondary end-points including quality of life, urinary frequency and voided volume and urodynamic parameters measured using ambulatory urodynamics.;Primary end point(s): a)We hypothesise that Botox® will significantly decrease the frequency of urgency and increase the warning time, refractory (urgency free) time and intervoid interval (primary end points). b)We Hypothesise that Botox® will cause statistically significant alterations in urinary frequency, voided volume and quality of life (secondary end points). c)We Hypothesise that Botox® will decrease the duration, amplitude and frequency of overactive detrusor contractions measured on ambulatory urodynamics (secondary end points). | — |
Countries
United Kingdom
Outcome results
None listed