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

ISRCTN	ISRCTN31004502
DOI	https://doi.org/10.1186/ISRCTN31004502
Protocol serial number	PB-PG-0107-12198
Sponsor	The Whittington Hospital NHS Trust (UK)
Funder	National Institute for Health Research - the Research for Patient Benefit (RfPB) programme (ref: PB-PG-0107-12198)

Submission date: 13/02/2008
Registration date: 20/02/2008
Last edited: 06/06/2016

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

Prof James Malone Lee
Scientific

Department of Medicine
University College London
Clerkenwell Building
Highgate Hill
Archway
London
N19 5LW
United Kingdom

Phone	+44 (0)207 2885301
Email	james.malone-lee@ucl.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised double-blind placebo-controlled cross-over trial
Secondary study design	Randomised cross over trial
Study type	Participant information sheet
Scientific title	A randomised, double blind, placebo controlled, crossover trial of the adjuvant properties of imipramine for the overactive bladder
Study objectives	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(s)	An application to the Moorfields and Whittington Research Ethics Committee is in progress as of 13/02/2008 – approval pending
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Imipramine
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	01/05/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	40
Key inclusion criteria	1. Age >= 18 years 2. Able to consent 3. Suffering from overactive bladder symptoms 4. Taking antimuscarinic treatment for detrusor overactivity
Key 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
Date of first enrolment	01/05/2008
Date of final enrolment	01/05/2010

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University College London

London
N19 5LW
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

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