A randomised, double blind, placebo controlled, crossover trial of the adjuvant properties of imipramine for the overactive bladder
| ISRCTN | ISRCTN31004502 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31004502 |
| Secondary identifying numbers | PB-PG-0107-12198 |
- Submission date
- 13/02/2008
- Registration date
- 20/02/2008
- Last edited
- 06/06/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof James Malone Lee
Scientific
Scientific
Department of Medicine
University College London
Clerkenwell Building
Highgate Hill
Archway
London
N19 5LW
United Kingdom
| Phone | +44 (0)207 2885301 |
|---|---|
| james.malone-lee@ucl.ac.uk |
Study information
| Study design | Randomised double-blind placebo-controlled cross-over trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A randomised, double blind, placebo controlled, crossover trial of the adjuvant properties of imipramine for the overactive bladder |
| Study objectives | 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(s) | An application to the Moorfields and Whittington Research Ethics Committee is in progress as of 13/02/2008 – approval pending |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Imipramine |
| Primary outcome measure | 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 study start date | 01/05/2008 |
| Completion date | 01/05/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | 1. Age >= 18 years 2. Able to consent 3. Suffering from overactive bladder symptoms 4. Taking antimuscarinic treatment for detrusor overactivity |
| Key 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 |
| Date of first enrolment | 01/05/2008 |
| Date of final enrolment | 01/05/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University College London
London
N19 5LW
United Kingdom
N19 5LW
United Kingdom
Sponsor information
The Whittington Hospital NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Magdala Avenue
London
N19 5LW
England
United Kingdom
| Senga.Steel@whittington.nhs.uk | |
| Website | http://www.whittington.nhs.uk |
"ROR" |
https://ror.org/01ckbq028 |
Funders
Funder type
Government
National Institute for Health Research - the Research for Patient Benefit (RfPB) programme (ref: PB-PG-0107-12198)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
06/06/2016: No publications found, verifying study status with principal investigator.
