Evaluation of the efficacy of oxybutynin and imipramine in the management of detrusor instability
| ISRCTN | ISRCTN58226681 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58226681 |
| Protocol serial number | G9410491 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | Medical Research Council (MRC) (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | oxybutynin and imipramine |
| Primary outcome measure(s) |
Clinical assessment using urinary diaries and 24 hour home pad tests. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/09/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Department of Epidemiology and Public Health
Leicester
LE1 2TP
United Kingdom
LE1 2TP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
17/11/2015: No publications found on PubMed.
