Contact information
Type
Scientific
Primary contact
Prof James Malone Lee
ORCID ID
Contact details
Department of Medicine
University College London
Clerkenwell Building
Highgate Hill
Archway
London
N19 5LW
United Kingdom
+44 (0)207 2885301
james.malone-lee@ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PB-PG-0107-12198
Study information
Scientific title
A randomised, double blind, placebo controlled, crossover trial of the adjuvant properties of imipramine for the overactive bladder
Acronym
Study hypothesis
We hypothesise that 25 mg imipramine in addition to antimuscarinic drugs is superior to placebo in addition to an antimuscarinic drug for the treatment of overactive bladder symptoms.
Ethics approval
An application to the Moorfields and Whittington Research Ethics Committee is in progress as of 13/02/2008 – approval pending
Study design
Randomised double-blind placebo-controlled cross-over trial
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Overactive bladder symptoms
Intervention
Imipramine 25 mg once a day given orally vs placebo.
Imipramine will be given for 6 weeks followed by placebo for 6 weeks and vice versa in the other arm of this cross-over trial.
Intervention type
Drug
Phase
Not Applicable
Drug names
Imipramine
Primary outcome measures
Urgency score questionnaire (Al Buheissi S, et al., 2008), carried out after 1 week of run-in period and at 2, 4, 6, 8, 10 and 12 weeks.
Secondary outcome measures
The following will be assessed after 1 week of run-in period and at 6 and 12 weeks:
1. 24 hour urinary frequency
2. Daily urinary Incontinence records
3. Patient preference for treatment
4. Incontinence Quality of Life questionnaire (I-QOL) score
5. Record of side effects
Overall trial start date
01/05/2008
Overall trial end date
01/05/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age >= 18 years
2. Able to consent
3. Suffering from overactive bladder symptoms
4. Taking antimuscarinic treatment for detrusor overactivity
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
1. Unable to consent
2. Pregnant
3. Breast feeding
4. Recent myocardial infarction
5. History of psychiatric illness
6. Taking monoamine oxidase inhibitors
7. <18 years
Recruitment start date
01/05/2008
Recruitment end date
01/05/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University College London
London
N19 5LW
United Kingdom
Sponsor information
Organisation
The Whittington Hospital NHS Trust (UK)
Sponsor details
Magdala Avenue
London
N19 5LW
United Kingdom
-
Senga.Steel@whittington.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research - the Research for Patient Benefit (RfPB) programme (ref: PB-PG-0107-12198)
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