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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-002636-15-SE

Enrollment

Registered

2009-02-27

Start date

2009-04-29

Completion date

Unknown

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nocturnal enuresis (bedwetting) MedDRA version: 9.1 Level: LLT Classification code 10014928 Term: Enuresis

Interventions

Trade Name: Edronax Pharmaceutical Form: Tablet CAS Number: 98769-81-4 Other descriptive name: Reboxetine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 4- Pharmac

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Does reboxetine, or combination therapy with desmopressin and reboxetine, help children with therapy-resistant enuresis? Are there side effects or risks involved when using reboxetine in enuretic children?;Secondary Objective: Is there any way to predict therapy response from the case history or basal bladder and kidney function parameters?;Primary end point(s): The reduction of the number of wet nights during the last two weeks of active treatment, as compared with baseline.	—

Measure

Time frame

Main Objective: Does reboxetine, or combination therapy with desmopressin and reboxetine, help children with therapy-resistant enuresis? Are there side effects or risks involved when using reboxetine in enuretic children?;Secondary Objective: Is there any way to predict therapy response from the case history or basal bladder and kidney function parameters?;Primary end point(s): The reduction of the number of wet nights during the last two weeks of active treatment, as compared with baseline.

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Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026