EUCTR2009-014049-10-FR进行中（未招募）1 期
Exploratory study of besipirdine efficacy and safety in male patients with persistent stress urinary incontinence after radical prostatectomy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 25
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
- •- Male out patients,
- •- Aged =40 and = 80 years,
- •- Stress urinary incontinence following radical prostatectomy (for prostate cancer) persistent for at least 12 months and stable for at least 6 months prior to selection visit,
- •- Using pads for Stress Urinary Incontinence,
- •- Pad weight between 10 and 75 g at 24-hour home Pad Test (average weight of the 24-hour home pad test performed for 3 consecutive days within the 7 days prior to the inclusion visit),
- •- Life expectancy of at least 6 months
- •- Having signed his informed consent form,
- •- Patient able to fill in self-questionnaires,
- •- Affiliated to a social security system, or is a beneficiary
- •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
- •- Mixed incontinence with predominant Overactive Bladder
- •- Urinary incontinence prior to prostatectomy,
- •- Neurological pathology that affects the lower urinary tract (Spinal cord lesions, multiple sclerosis, Parkinson’s disease, Diabetes Mellitus ….),
- •- Adult nocturnal enuresis,
- •- Recent urethral pathology (<6 months) such as fistula, diverticulosis, stenosis,
- •- Recent radiotherapy (<6 months)
- •- Absence of voluntary micturition (permanent leakage),
- •- Polyuria (urinary volume > 3 l/day),
- •- Recurrent urinary infection (every 6 months or less),
- •- Perineal reeducation on-going or stopped less than 3 months prior to selection,
- •- Bad compliance in patient diary completion during the run-in period (i.e. data reported less than 3 consecutive days),
- •- Bradycardia (resting HR<50 bpm),
- •- Arterial Hypertension (defined as SBP>140 mmHg and/or DBP>90 mmHg or uncontrolled and not stable),
- •- Any clinically significant cardiac arrhythmia or conduction disturbance,
- •- Evidence of active liver disease (levels of AST or ALT> 2 times the upper normal laboratory value and/or alkaline phosphatase > 1,5 times the upper normal laboratory value)
- •- Intake of any treatment known to have an activity on urethral sphincter or detrusor (e.g. anticholinergic, antidepressants, a-stimulants…)
- •- Recent start or dosage modification of anti-androgen treatment (< 6 months)
- •- Patient known to be non responder to NSRI,
- •- Bad compliance to study drug intake during the run-in period (i.e. less than 70%),
- •- Alcohol or drug abuse or dependence,
- •- Is a family member or work associate (secretary, nurse, technician,…) of the Investigator,
- •- Has participated in another clinical trial within the last 3 month(s), has received treatment with known remnant effects or undergone investigation liable to interfere with the present clinical trial,
- •- Mentally unable to understand the nature, objectives and possible consequences of the trial; or refusing to subject himself to its constraints,
- •- Has forfeited his freedom by administrative or legal award or is under guardianship.
- •- Known lactose intolerance,
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