Warning Time and Patient Centred Goals with Transdermal Oxybutynin

ISRCTN	ISRCTN87161129
DOI	https://doi.org/10.1186/ISRCTN87161129
Clinical Trials Information System (CTIS)	2005-005009-41
Protocol serial number	EUDRACT 2005-005009-41
Sponsor	King's College London (UK)
Funder	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.

Submission date: 08/11/2005
Registration date: 24/11/2005
Last edited: 21/12/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Linda Cardozo
Scientific

8 Devonshire Place
London
W1G 6HP
United Kingdom

Study information

Primary study design	Interventional
Study design	Double blind randomised controlled trial (RCT)
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	WTPCGTO
Study objectives	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
Health condition(s) or problem(s) studied	Overactive bladder
Intervention	Transdermal Oxybutynin or Placebo Patch
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Oxybutynin
Primary outcome measure(s)	Achievement of goals score
Key secondary outcome measure(s)	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)
Completion date	01/12/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	96
Key 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
Key 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
Date of first enrolment	01/12/2005
Date of final enrolment	01/12/2007

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

8 Devonshire Place

London
W1G 6HP
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	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