The objective of this study is to find out what the pharmacokinetic/dynamic (PK/PD) characteristics of desmopressin melt are in nocturia patients (compared to healthy volunteers and children). The main questions the investigators want to answer are: * Are differences related to the pathophysiological factors involved in nocturia? * Are there age/gender/size differences? * Can the investigators identify patients who are likely to develop hyponatraemia? * Can the investigators individualize treatment and reduce risk for hyponatraemia? Day 1: * Patient is being hospitalized in the morning * General anamnesis and clinical examination * Uroflow and residue measurements (3x) * Sober blood sample, to determine plasma concentrations of Na+, Cl-, osmolality and creatinin Day 1-2: \- In the evening at 20h: * start (with empty bladder!) 24h miction-incontinence-residue registration: urine collections every 3 hours (every portion of urine within a period of 3 hours must be collected in the same collection device), with: registration of volumes and measurement urinary concentrations of Na+, Cl-, osmolality and creatinin * Measurement of blood pressure during 24h Day 2-3: * In the evening at 19h (day 2): drink 15mL/kg water * At 20h: take desmopressin melt 120µg + start: * 24h miction-incontinence-residue registration: registration of volumes and measurement urinary concentrations of Na+, Cl-, osmolality and creatinin (U1-U7) * Measurement of blood pressure during 24h * Collection of urine:U1 at 19h, U2 at 20h, together with intake of first desmopressin melt, U3 at 21h = 1h after desmopressin melt intake, U4 at 22h = 2 after desmopressin melt intake,U5 at 23h = 3h after desmopressin melt intake, U6 at 2h (day 3) = 6h after desmopressin melt intake, U7 at 8h = 12h after desmopressin melt intake * Blood samples for blood levels of desmopressin: 1h, 2h, 3h, 6h after desmopressin melt intake, 12h after desmopressin melt intake + plasma concentrations of Na+, Cl-, osmolality and creatinin (safety profile) * At 8h in the morning (day 3): drink 15mL/kg water + collection of urine per hour during 3h with measurement of urinary concentrations of Na+, Cl-, osmolality and creatinin: U8 at 9h, U9 at 10h, U10 at 11h * Patient can go home on day 3, unless he is at high risk for side effects, high-risk patients are hospitalized for 7 days
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
120 µg, oral lyophilisate, sublingual use
University Hospital Ghent
Ghent, Belgium
Pharmacokinetic and dynamic evaluation of desmopressin melt for treatment of nocturnal polyuria in adults
* blood analysis for plasma concentration of desmopressin: 1h, 2h, 3h, 6h and 12h after drug intake * urine analysis for urinary concentration of sodium, potassium, creatinin and osmolality: * after water load with 15ml/kg body weight (evening day 2): the moment of drug intake, 1h, 2h, 3h, 6h and 12h after drug intake * after water load with 15ml/kg body weight (morning day 3): 1h, 2h, 3h after water load
Time frame: hospitalisation of 3 days of which 15h specific for primary outcome measurements
24h miction-incontinence-residue registration: urine collections every 3 hours
24h miction-incontinence-residu registration: urine collections every 3 hours (every portion of urine within a period of 3 hours must be collected in the same collection device), with: * Registration of volumes * Measurement urinary concentrations of Na+, Cl-, osmolality and creatinin
Time frame: 2x 24h: day 1 19h - day 2 19h ; day 2 20h - day 3 20h
Measurement of blood pressure during 24h
Time frame: 2x 24h: day 1 19h - day 2 19h ; day 2 20h - day 3 20h
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