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

Phase 1

• Conditions: Overactive bladder symptoms; MedDRA version: 1 Level: LLT Classification code 10059617 Term: <Manually entered code. Term in E.1.1>

• Registration Number: EUCTR2008-000893-19-GB
• Lead Sponsor: Whittington NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-06-17
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

1. Adults aged 18 years or older
2. Both males and females
3. Symptoms of frequency more than or equal to 8 per day; urgency with or without urge incontinence
4 On antimuscarinic montherapy for overactive bladder symptoms
4. Able to give informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1)<18 years
2)Inability to provide consent.
3)Current urinary infection as determined by >10 wbcs per ml onmicroscopy or 10^5 colony forming organisms on MSU.
4) History of mania.
5) Has taken monoamine oxidase inhibitors in the last 3 months.
6) Myocardial infraction in the previous 6 months.
7) Cadiovascular disease
8) History of cardiac arrythmias.
9) History of active liver disease
10) Deranged liver function tests.
11) Pregnant or breast feeding
12) Heart Block
13) Porphyria
14) Open angle glaucoma
15) Baldder cancer
16) Prostate cancer
17) Patients currently taking antidepressants with the exception of serotonin reuptake inhibitors or serotonin/noradrenaline reuptake inhibitors.
18) Hyperthyroidism

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: To ascertain unequivocally the benefit of imipramine at 25mg once a day in addition to an antimuscarinic agent for the treatment of overactive baldder symptoms.<br> The primary outcomes of the study are the measurements of, urgency score using a validated urgency questionnaire<br> ;<br> Secondary Objective: The secondery outcomes are<br> 1) daily incontinence episodes<br> 2) daily urinary frequency<br> 3) patient preference for treatment.<br> 4) Quality of life assessment (I-Quol)<br> 5) Record of side effects.<br> ;Primary end point(s): Trial participation ends once a patient has completed 12 weeks of treatment within the trial and has completed their final assessment.