EUCTR2008-000968-16-FR进行中（未招募）不适用
EFFICACY OF DULOXETINE IN THE TREATMENT OF URINARY INCONTINENCEAFTER PROSTATECTOMIE DUE TO CANCER - Dulox-1
CeRePP0 个研究点目标入组 90 人开始时间: 2008年10月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •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
排除标准
- •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)
研究者
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