Study on the treatment of therapy-resistant enuresis with desmopressin and reboxetine; a randomised, placebo-controlled, double-blinded, cross-over study

ppsala University Children´s Hospital0 个研究点开始时间: 2009年2月27日最近更新: 2012年3月19日

试验速览

暂无简介。

•1. Age 6 - 25 years
•2. Severe enuresis (at least six wet nights in two weeks)
•3. Previous unsuccessful treatment attempts with desmopressin in standard dosage
•4. Previous unsuccesful treatment attempts with the enuresis alarm or treatment with the alarm not feasible due to the family situation
•5. Willingness and ability to provide a signed informed consent
•Are the trial subjects under 18? yes
•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) no
•F.1.3.1 Number of subjects for this age range

•1. Presence of more than occasional day-time incontinence
•2. Signs or symptoms indicating
•a urologic disease or malformation
•b neurologic or mental handicap
•c diabetes mellitus or other endocrinologic/metabolic disease
•d any arrythmia or other heart condition
•e urinary tract infection during the six months preceding inclusion
•f kidney disease
•3. Depression or other severe psychiatric disease (excluding ADHD)
•4. Concomitant medication with drugs interfering with bladder function, kidney function, sleep or the autonomic nervous system
•5. Hypersensitivity to reboxetine or desmopressin
•6. Sudden heart death, long QT syndrome or unclear arrythmias in the family (parents, siblings, uncles/aunts, grandparents and cousins)
•7. Pregnancy; planned or suspected. Sexually active young women need to use contraception to be eligible for inclusion in the study
•8. Substance abuse
•9. Inability to give a fully informed consent
•10. Inability to swallow oral capsules
•11. Previous treatment with reboxetine
•12. Reduction of the number of wet nights with more than 50% during pre-study desmopressing treatment, as compared with baseline

发起方

ppsala University Children´s Hospital