Nocturia and noctural polyuria
Conditions
Interventions
Trade Name: Minirin Melt 120 µg
Product Name: Desmopressine
Pharmaceutical Form: Oral lyophilisate
INN or Proposed INN: DESMOPRESSIN ACETATE
CAS Number: 62357862
Concentration unit: µg microgram(s)
C
Sponsors
Ghent University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Written informed consent prior to the performance of any study-related activity - Patients 18 years and older with an average of = 2 nocturnal voids per night 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
Exclusion criteria
Exclusion criteria: - hypersensitivity/anaphylactic reaction on desmopressin or one of the other substances - pregnancy - genito-urinary tract pathology (infection, tumor,...) - urolithiasis - suspicion or evidence of cardiac failure - moderate to severe renal insufficiency (creatinin clearance < 50 ml/min) - psychogenic or habitual polydipsia - hyponatriemia or predisposition for hyponatriemia - diabetes insipidus - syndrome of inadequate ADH production
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To see what the influence is of desmopressine melt 120µg on the complaint of nocturia (getting up at night, urine production, sleep);Secondary Objective: To register side effects, and see if these side effects can be correlated to blood levels and urine results ;Primary end point(s): Urine production, concentrating capacity of desmopressin Melt, side effects | — |
Countries
Belgium
Outcome results
None listed