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ISRCTN
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ISRCTN87161129
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ClinicalTrials.gov identifier
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Public title
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Warning Time and Patient Centred Goals with Transdermal Oxybutynin
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Scientific title
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Acronym
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WTPCGTO
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Serial number at source
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EUDRACT 2005-005009-41
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Study hypothesis
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Transdermal oxybutynin reduces urinary warning time, and helps patients achieve their goals for treatment.
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Ethics approval
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Pending from King's College Hospital Research Ethics Committee
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Study design
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Double blind randomised controlled trial (RCT)
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Overactive bladder
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Participants - inclusion criteria
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At study entry:
1. Female patient aged ≥18
2. Written informed consent obtained
3. Patient is willing and able to complete the frequency volume chart (FVC) and questionnaires correctly
4. Symptoms of overactive bladder (frequency/urge/urge incontinence) for ≥3 months AND/OR previously demonstrated detrusor overactivity (DO) at urodynamics
At randomisation:
1. At least three episodes of urgency or urge incontinence on FVC over 3 days
2. At least frequency ≥8 on FVC over 3 days
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Participants - exclusion criteria
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At study entry:
1. History of allergy to oxybutynin or any of the ingredients of Kentera
2. History of allergy from medical tape or transdermal skin patch
3. Pregnancy, intention to become pregnant during study period, unreliable contraception despite being sexually active, breast feeding
4. Urodynamic proven mixed incontinence
5. Voiding difficulties (flow rate <15 ml/s, or post void residual >50 ml)
6. Patient with indwelling catheter or practicing clean intermittent self-catheterisation (CISC)
7. Evidence of current urinary tract infection (UTI) or bladder stone or malignancy
8. Uncontrolled narrow angle glaucoma, myasthenia gravis, gastric or urinary retention, renal impairment or dialysis, moderate or severe hepatic impairment, chronic intestinal disease (including ulcerative colitis and gastrointestinal obstruction), megacolon, diabetic neuropathy, oesophageal inflammation (hiatus hernia, gastrooesophageal reflux), Parkinson’s disease, or other significant clinical condition (at the discretion of the investigator)
9. Other specific medications: anticholinergics, antispasmodics, anti-parkinsonian, tricyclics, tetracyclics, duloxetine, antihistamines, antiemetics, diuretics, neuroleptics, type I antiarrythmics, opioids, alpha-antagonists, CYP3A4 inhibitors or inducers, any other bladder medication
At randomisation:
Failure to complete FVC according to instructions
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Anticipated start date
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01/12/2005
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Anticipated end date
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01/12/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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96
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Interventions
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Transdermal Oxybutynin or Placebo Patch
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Primary outcome measure(s)
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Achievement of goals score
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Secondary outcome measure(s)
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1. Change in King's Health Questionnaire (KHQ) scores (by domain and total)
2. Change in mean, median and minimum warning time
3. Compliance with medication
4. Change in episodes of urgency/urge incontinence
5. Change in frequency/nocturia
Outcomes assessed by 3 day bladder diaries incorporating Patients Perception of Intensity of Urgency Scale (PPIUS)
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Sources of funding
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UCB Pharma (UK) - an investigator initiated study, meaning that investigators will 'own' the data, but UCB Pharma are funding on the assumption that the publication of the results will be of commercial benefit to them.
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Trial website
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Publications
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2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20626389
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Contact name
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Prof
Linda
Cardozo
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Address
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8 Devonshire Place
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City/town
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London
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Zip/Postcode
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W1G 6HP
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Country
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United Kingdom
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Sponsor
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King's College London (UK)
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Address
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Prof Linda Cardozo
8 Devonshire Place
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City/town
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London
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Zip/Postcode
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W1G 6HP
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Country
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United Kingdom
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Date applied
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08/11/2005
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Last edited
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19/07/2010
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Date ISRCTN assigned
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24/11/2005
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