Condition category
Urological and Genital Diseases
Date applied
25/10/2000
Date assigned
25/10/2000
Last edited
17/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr C McGrother

ORCID ID

Contact details

Department of Epidemiology and Public Health
University of Leicester
22-28 Princess Road West
Leicester
LE1 2TP
United Kingdom

Additional identifiers

EudraCT 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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial 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

Phase

Not Specified

Drug names

oxybutynin and imipramine

Primary outcome measures

Clinical assessment using urinary diaries and 24 hour home pad tests.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/1997

Overall trial end date

01/09/2001

Reason abandoned

Eligibility

Participant inclusion criteria

1. Failed conservative therapies for urinary dysfunction (nursing interventions)
2. Urodynamicaly proven detrusor instability

Participant type

Patient

Age group

Not Specified

Gender

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

United Kingdom

Trial 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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

17/11/2015: No publications found on PubMed.