EFFICACY OF DULOXETINE IN THE TREATMENT OF URINARY INCONTINENCEAFTER PROSTATECTOMIE DUE TO CANCER - Dulox-1
- Conditions
- We want to evaluate the effect of Duloxetine 40mg BID (80mg daily dose) on the number of urinary incontinence episodes as shown on a 74 days bladder diary, compared to placebo for male which had a prostatectomy due to cancer. We'll also study tolerance and efficacy of duloxetine with Qol questionnaires.MedDRA version: 9.1Level: LLTClassification code 10046543Term: Urinary incontinence
- Registration Number
- EUCTR2008-000968-16-FR
- Lead Sponsor
- CeRePP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- 90
a. Male patients of 18 to 70 years old, having undergone a radical prostatectomy more than 1 year ago and suffering of SUI or mixed urinary incontinence with predominant SUI and without detrusor overactivity on urodynamic assessment, with 7 to 28 incontinence episodes as certified with a 7 days bladder diary. An incontinence episode is defined as a noticeable leakage of urine which would soil or wet a pad or an underwear, a containment garment or a clothing . This implies discrete episodes of incontinence .
b. Controlled prostatic disease (PSA<0,1ng/ml)
c. Patient consenting to participate to the trial and having signed the informed consent document
d. Patients having a positive one hour pad test (?>2gr)
e. Patient able to fill in micturition chart and questionnaires, ambulatory and able to independently use toilet without difficulty, with no language barrier
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
1. Active or recent history (6 months) of urethral stenosis, treated or not
2. Active or recurrent (3 episodes yearly) history of urinary infection
3. Uncontrolled or potentially uncontrolled prostrate cancer as defined by a serum PSA >0,1ng/ml
4. Recent (2 weeks before V0) or actual treatment with alpha-agonists, serotonine-capture inhibitors or anticholinergic-antimuscarinic drugs
5. History of pelvic floor radiotherapy
6. Recent (1 month previous to study) pelvic floor training or patient intending to have pelvic floor training during the following 3 months
7. Maximal urinary flow rate < 15ml/sec
8. Post-voiding residue > 100ml identified with bladder scan.
9. Polyuria as defined by a diuresis more than 2500ml.
10. Detrusor overactivity present during cystometry, with or without any urinary incontinence
11. Impaired bladder capacity and / or impaired bladder compliance
12. Severe urinary stress incontinence as defined as more than 12 leakages mentioned in the 3 days bladder diary
13. History of surgical treatment of stress urinary incontinence (bulking agents, male sling placement, artificial sphincter ...)
14. Significant neurological disease able to interfere with lower urinary tract symptoms ( multiple sclerosis, Parkinson disease...)
15. Medication regimen that includes diuretics where dose and/or frequency have not been stable for at least 12 weeks prior to randomization or is anticipated to change during the course of the study.
16. Have elevated liver function tests meeting the following criteria:
ALT/SGPT (alanine aminotransaminase) = 3 times the upper limit of normal (ULN) of the laboratory performing the evaluation or Total bilirubin = 1.5 times the ULN of the laboratory performing the tests.
17. Patients who are investigator site personnel directly affiliated with the study or are immediate family of investigator site personnel directly affiliated with the study
18. Patient actually participating in another trial or having participated less than 1 month ago.
19. Patient rating a score of 2 or 3 on Item 9 of the BDI-II
20. Use of monoamine oxidase inhibitors (MAOIs), Cymbalta (duloxetine), fluvoxamine, ciprofloxacine, enoxacine or other medications with a potential undesirable interaction with duloxetine within 14 days prior to randomization or at any time during the study or within 5 days of discontinuation of study drug
21. Patient having uncontrolled narrow-angle glaucoma
22. Patient having a hypersensitivity to duloxetine or any of the inactive ingredients
23. Liver disease resulting in hepatic impairment
24. Severe renal impairment (creatinine clearance < 30 ml/min)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method