Additional identifiers
EudraCT/CTIS number
2005-005009-41
IRAS number
ClinicalTrials.gov number
Protocol/serial number
EUDRACT 2005-005009-41
Study information
Scientific title
Acronym
WTPCGTO
Study hypothesis
Transdermal oxybutynin reduces urinary warning time, and helps patients achieve their goals for treatment.
Ethics approval(s)
Pending from King's College Hospital Research Ethics Committee
Study design
Double blind randomised controlled trial (RCT)
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Treatment
Patient information sheet
Condition
Overactive bladder
Intervention
Transdermal Oxybutynin or Placebo Patch
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
Oxybutynin
Primary outcome measure
Achievement of goals score
Secondary outcome measures
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)
Overall study start date
01/12/2005
Overall study end date
01/12/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Female
Target number of participants
96
Participant exclusion criteria
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), Parkinsons 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
Recruitment start date
01/12/2005
Recruitment end date
01/12/2007
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
8 Devonshire Place
London
W1G 6HP
United Kingdom
Sponsor information
Organisation
King's College London (UK)
Sponsor details
Prof Linda Cardozo
8 Devonshire Place
London
W1G 6HP
England
United Kingdom
Sponsor type
University/education
Website
ROR
Funders
Funder type
Industry
Funder name
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.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2011 | Yes | No | |
| Results article | results | 01/05/2011 | Yes | No | |
| Results article | results | 01/07/2011 | Yes | No |