Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
G9410491
Study information
Scientific title
Evaluation of the efficacy of oxybutynin and imipramine in the management of detrusor instability
Acronym
Study hypothesis
To investigate the efficacies of oxybutynin and imipramine in the treatment of detrusor instability. A pragmatic trial titrating dose against effect and side effects. All patients continuing with bladder education.
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Incontinence
Intervention
1. Oxybutynin: Oxybutynin titrated to a maximum dose of 5 mg tds and imipramin placebo
2. Imipramine: Imipramine titrated to a maximum dose of 75 mg bd and Oxybutynin placebo
3. Control: matching placebo tablets of Imipramine and Oxybutynin
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
oxybutynin and imipramine
Primary outcome measure
Clinical assessment using urinary diaries and 24 hour home pad tests.
Secondary outcome measures
Not provided at time of registration
Overall study start date
01/06/1997
Overall study end date
01/09/2001
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Failed conservative therapies for urinary dysfunction (nursing interventions)
2. Urodynamicaly proven detrusor instability
Participant type(s)
Patient
Age group
Not Specified
Sex
Not Specified
Target number of participants
345
Participant exclusion criteria
1. Pregnancy
2. Malignancy
3. Fistula
4. Contra-indications to the use of oxybutynin or imipramine
5. Bladder outflow obstruction (measured urodynamically)
Recruitment start date
01/06/1997
Recruitment end date
01/09/2001
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Department of Epidemiology and Public Health
Leicester
LE1 2TP
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
UK Medical Research Council, MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|