Evaluation of the efficacy of oxybutynin and imipramine in the management of detrusor instability
| ISRCTN | ISRCTN58226681 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58226681 |
| Secondary identifying numbers | G9410491 |
- Submission date
- 25/10/2000
- Registration date
- 25/10/2000
- Last edited
- 17/11/2015
- 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
Dr C McGrother
Scientific
Scientific
Department of Epidemiology and Public Health
University of Leicester
22-28 Princess Road West
Leicester
LE1 2TP
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Evaluation of the efficacy of oxybutynin and imipramine in the management of detrusor instability |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 01/09/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 345 |
| Key inclusion criteria | 1. Failed conservative therapies for urinary dysfunction (nursing interventions) 2. Urodynamicaly proven detrusor instability |
| Key exclusion criteria | 1. Pregnancy 2. Malignancy 3. Fistula 4. Contra-indications to the use of oxybutynin or imipramine 5. Bladder outflow obstruction (measured urodynamically) |
| Date of first enrolment | 01/06/1997 |
| Date of final enrolment | 01/09/2001 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Epidemiology and Public Health
Leicester
LE1 2TP
United Kingdom
LE1 2TP
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
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
17/11/2015: No publications found on PubMed.
