Desmopressin Melt Therapy in Patients With Nocturnal Polyuria: a Pharmacokinetic/Dynamic Study
- Registration Number
- NCT01435083
- Lead Sponsor
- University Hospital, Ghent
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description nocturnal polyuria patient with desmopressin MELT Desmopressin -
- Primary Outcome Measures
Name Time Method Pharmacokinetic and dynamic evaluation of desmopressin melt for treatment of nocturnal polyuria in adults hospitalisation of 3 days of which 15h specific for primary outcome measurements * 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
- Secondary Outcome Measures
Name Time Method 24h miction-incontinence-residue registration: urine collections every 3 hours 2x 24h: day 1 19h - day 2 19h ; day 2 20h - day 3 20h 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 creatininMeasurement of blood pressure during 24h 2x 24h: day 1 19h - day 2 19h ; day 2 20h - day 3 20h
Trial Locations
- Locations (1)
University Hospital Ghent
🇧🇪Ghent, Belgium