desmopressin melt therapy in patients with nocturnal polyuria: a pharmacokinetic/dynamic study

Conditions: Nocturnal Polyuria

Summary: 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


Eligibility criteria:
inclusion criteria: * written informed consent prior to the performance of any study-related activity * patients, men and woman, 18 years and older, with nocturnal polyuria, resulting in nocturia (2 voids or more at night) and/or nocturnal incontinence. exclusion criteria: * hypersensitivity/anaphylactic reaction on desmopressin or one of the other substances * pregnancy * genitourinary 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 * hyponatraemia or predisposition for hyponatraemia * diabetes insipidus * syndrome of inadequate adh production

Keywords: nocturia