Overactive bladder.
Conditions
Interventions
Trade Name: Kentera Oxybutynin Transdermal Patch
Product Name: Kentera Oxybutynin Transdermal Patch
Product Code: Kentera
Pharmaceutical Form: Transderm
Sponsors
King's College Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: At study entry: 1. Female patient aged ©ø18 2. Written informed consent obtained 3. Patient is willing and able to complete the FVC and questionnaires correctly. 4. Symptoms of overactive bladder (frequency and/or urgency and/or urge incontinence) for at least 3 months and/or previously demonstrated DO at urodynamics. At randomization: 1. At least three episodes of urgency or urge incontinence on FVC over 3 days. 2. Frequency greater than 8/day on FVC averaged over 3 days. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: At study entry: 1. History of hypersensitivity 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 rate50mls) 6. Patient with indwelling catheter or practicing CISC. 7. Evidence of current UTI or bladder stone or malignancy. 8. Uncontrolled narrow angle glaucoma, myasthenia gravis, gastric or urinary retention, moderate or severe 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: 1. Failure to complete FVC according to instructions. .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The main secondary outcome measure is "warning time". This is defined as the interval between first noticing strong desire to pass urine, and the moment when the patient does pass urine, or leak. This measure is important to patients because an increased warning time gives an increased time to find a toilet, reducing social inconvenience, and the possibility of leaking. Previous trials have shown that successful treatment with anticholnergic medicines can prolong warning time. ;Primary end point(s): 6 or 14 weeks, depending on patient choice.; Main Objective: The trial investigates the benefits of Kentera, a new transdermal preparation of oxybutynin for overactive bladder syndrome. The principal outcome measure is achievement of patient-selected goals, and compares this to more conventional quality of life and urinary frequency outcome measures. Patient-selected goals are an outcome measure designed to capture elements of the patient experience that would ordinarily be overlooked by clinicians. Allowing the patient to choose her own goals and then rate their achievement, reflects the improvements that actually matter to patients. | — |
Countries
United Kingdom
Outcome results
None listed