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| A randomised, double blind, placebo controlled, crossover trial of the adjuvant properties of imipramine for the overactive bladder |
| Source of record | UK Trials |
| ISRCTN | ISRCTN31004502 |
| Date ISRCTN assigned | 20/02/2008 |
| Local reference number(s) | PB-PG-0107-12198 |
| Public title | A randomised, double blind, placebo controlled, crossover trial of the adjuvant properties of imipramine for the overactive bladder |
| Scientific title | |
| Acronym | N/A |
| Disease/condition/study domain | Overactive bladder symptoms |
| 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. |
| Design/methodology | Randomised, double-blind, placebo-controlled, cross-over trial. |
| Research ethics review | An application to the Moorfiields and Whittington Research Ethics Committee is in progress, as of 13/02/2008. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Age >= 18 years 2. Able to consent 3. Suffering from overactive bladder symptoms 4. Taking antimuscarinic treatment for detrusor overactivity |
| Participants - 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 |
| Patient information material | |
| Anticipated start date | 01/05/2008 |
| Anticipated end date | 01/05/2010 |
| Status of trial | Ongoing |
| Target number of participants | 40 |
| Interventions | 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. |
| Primary outcome measure(s) | 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 measure(s) | 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 |
| Sources of funding | National Institute for Health Research - the Research for Patient Benefit (RfPB) programme (ref: PB-PG-0107-12198) |
| Sponsor name | The Whittington Hospital NHS Trust (UK) |
| Sponsor details | Magdala Avenue London United Kingdom N19 5LW |
| Sponsor email | Senga.Steel@whittington.nhs.uk |
| Sponsor website | http://www.whittington.nhs.uk |
| Contact name | Prof James Malone Lee |
| Contact details | Department of Medicine University College London Clerkenwell Building Highgate Hill Archway London United Kingdom N19 5LW |
| Contact telephone | +44 (0)207 2885301 |
| Contact fax | +44 (0)207 2885302 |
| Contact email | james.malone-lee@ucl.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN31004502 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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