Warning Time and Patient Centred Goals with Transdermal Oxybutynin

• Register: ISRCTN
• Last refreshed on: 13 January 2015
• Main ID: ISRCTN87161129
• Date of registration: 24/11/2005
• Prospective Registration: Yes
• Primary sponsor: King's College London (UK)
• Public title: Warning Time and Patient Centred Goals with Transdermal Oxybutynin
• Date of first enrolment: 01/12/2005
• Target sample size: 96
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN87161129
• Study type: Interventional
• Study design: Double blind randomised controlled trial (RCT) (Treatment)

Countries of recruitment

United Kingdom

Contacts

• Name: Linda Cardozo

Key inclusion & exclusion criteria

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
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), 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

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Overactive bladder
Urological and Genital Diseases
Other disorders of urinary system

Intervention(s)

Transdermal Oxybutynin or Placebo Patch

Primary Outcome(s)

Achievement of goals score

Secondary Outcome(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)

Secondary ID(s)

EUDRACT 2005-005009-41

2005-005009-41

Source(s) of Monetary Support

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.