Condition category
Urological and Genital Diseases
Date applied
13/02/2008
Date assigned
20/02/2008
Last edited
06/06/2016
Prospective/Retrospective
Prospectively 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

Prof James Malone Lee

ORCID ID

Contact details

Department of Medicine
University College London
Clerkenwell Building
Highgate Hill
Archway
London
N19 5LW
United Kingdom
+44 (0)207 2885301
james.malone-lee@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PB-PG-0107-12198

Study information

Scientific title

A randomised, double blind, placebo controlled, crossover trial of the adjuvant properties of imipramine for the overactive bladder

Acronym

Study hypothesis

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

An application to the Moorfields and Whittington Research Ethics Committee is in progress as of 13/02/2008 – approval pending

Study design

Randomised double-blind placebo-controlled cross-over trial

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

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

Phase

Not Applicable

Drug names

Imipramine

Primary outcome measures

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 trial start date

01/05/2008

Overall trial end date

01/05/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age >= 18 years
2. Able to consent
3. Suffering from overactive bladder symptoms
4. Taking antimuscarinic treatment for detrusor overactivity

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant 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

Recruitment start date

01/05/2008

Recruitment end date

01/05/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University College London
London
N19 5LW
United Kingdom

Sponsor information

Organisation

The Whittington Hospital NHS Trust (UK)

Sponsor details

Magdala Avenue
London
N19 5LW
United Kingdom
-
Senga.Steel@whittington.nhs.uk

Sponsor type

Government

Website

http://www.whittington.nhs.uk

Funders

Funder type

Government

Funder name

National Institute for Health Research - the Research for Patient Benefit (RfPB) programme (ref: PB-PG-0107-12198)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

06/06/2016: No publications found, verifying study status with principal investigator.