Warning Time and Patient Centred Goals with Transdermal Oxybutynin
| ISRCTN | ISRCTN87161129 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87161129 |
| EudraCT/CTIS number | 2005-005009-41 |
| Secondary identifying numbers | EUDRACT 2005-005009-41 |
- 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
Scientific
8 Devonshire Place
London
W1G 6HP
United Kingdom
Study information
| 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 |
| 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 |
| 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 |
| Completion date | 01/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
8 Devonshire Place
London
W1G 6HP
United Kingdom
W1G 6HP
United Kingdom
Sponsor information
King's College London (UK)
University/education
University/education
Prof Linda Cardozo
8 Devonshire Place
London
W1G 6HP
England
United Kingdom
"ROR" |
https://ror.org/0220mzb33 |
|---|
Funders
Funder type
Industry
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.
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
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 |
