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

• Conditions: octurnal enuresis (bedwetting); MedDRA version: 9.1Level: LLTClassification code 10014928Term: Enuresis

• Registration Number: EUCTR2008-002636-15-SE
• Lead Sponsor: ppsala University Children´s Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

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