ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ISRCTN
Last refreshed on:	17 October 2016
Main ID:	ISRCTN58226681
Date of registration:	25/10/2000
Prospective Registration:	No
Primary sponsor:	Medical Research Council (MRC) (UK)
Public title:	Evaluation of the efficacy of oxybutynin and imipramine in the management of detrusor instability
Scientific title:	Evaluation of the efficacy of oxybutynin and imipramine in the management of detrusor instability
Date of first enrolment:	01/06/1997
Target sample size:	345
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN58226681
Study type:	Interventional
Study design:	Randomised controlled trial (Not Specified)
Phase:	Not Specified

Countries of recruitment
United Kingdom

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	C McGrother
Address:	Department of Epidemiology and Public Health University of Leicester 22-28 Princess Road West LE1 2TP Leicester United Kingdom
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria: 1. Failed conservative therapies for urinary dysfunction (nursing interventions)
2. Urodynamicaly proven detrusor instability
Exclusion criteria: 1. Pregnancy
2. Malignancy
3. Fistula
4. Contra-indications to the use of oxybutynin or imipramine
5. Bladder outflow obstruction (measured urodynamically)

Age minimum:
Age maximum:
Gender: Not Specified

Health Condition(s) or Problem(s) studied

Incontinence
Urological and Genital Diseases
Incontinence

Intervention(s)

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

Primary Outcome(s)

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

Secondary Outcome(s)

Not provided at time of registration

Secondary ID(s)

G9410491

Source(s) of Monetary Support

Medical Research Council (MRC) (UK)

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.