Condition category
Urological and Genital Diseases
Date applied
08/11/2005
Date assigned
24/11/2005
Last edited
21/12/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Linda Cardozo

ORCID ID

Contact details

8 Devonshire Place
London
W1G 6HP
United Kingdom

Additional identifiers

EudraCT number

2005-005009-41

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

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

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Overactive bladder

Intervention

Transdermal Oxybutynin or Placebo Patch

Intervention type

Drug

Phase

Not Specified

Drug names

Oxybutynin

Primary outcome measures

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 trial start date

01/12/2005

Overall trial end date

01/12/2007

Reason abandoned

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

Patient

Age group

Adult

Gender

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), 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

Recruitment start date

01/12/2005

Recruitment end date

01/12/2007

Locations

Countries of recruitment

United Kingdom

Trial 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
United Kingdom

Sponsor type

University/education

Website

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20626389
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21070569
3. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21279328

Publication citations

  1. Results

    Cartwright R, Srikrishna S, Cardozo L, Robinson D, Patient-selected goals in overactive bladder: a placebo controlled randomized double-blind trial of transdermal oxybutynin for the treatment of urgency and urge incontinence., BJU Int., 2011, 107, 1, 70-76, doi: 10.1111/j.1464-410X.2010.09508.x.

  2. Results

    Cartwright R, Srikrishna S, Cardozo L, Robinson D, Validity and reliability of the patient's perception of intensity of urgency scale in overactive bladder., BJU Int., 2011, 107, 10, 1612-1617, doi: 10.1111/j.1464-410X.2010.09684.x.

  3. Results

    Cartwright R, Srikrishna S, Cardozo L, Robinson D, Validity and reliability of patient selected goals as an outcome measure in overactive bladder., Int Urogynecol J, 2011, 22, 7, 841-847, doi: 10.1007/s00192-011-1360-0.

Additional files

Editorial Notes