Desmopressin Melt Therapy in Patients With Nocturnal Polyuria: a Pharmacokinetic/Dynamic Study

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 Overview

• Status: Completed
• Conditions: Nocturnal Polyuria
• Intervention / Treatment: Drug: Desmopressin

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • University Hospital Ghent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: nocturnal polyuria patient with desmopressin MELT	Drug: Desmopressin; 120 µg, oral lyophilisate, sublingual use; Other Names: Minirin Melt 120 µg, H01BA02

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 intakeafter water load with 15ml/kg body weight (morning day 3): 1h, 2h, 3h after water load	hospitalisation of 3 days of which 15h specific for primary outcome measurements

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2x 24h: day 1 19h - day 2 19h ; day 2 20h - day 3 20h
Measurement of blood pressure during 24h		2x 24h: day 1 19h - day 2 19h ; day 2 20h - day 3 20h

Collaborators and Investigators

• Sponsor: University Hospital, Ghent

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: September 13, 2011
• First Submitted That Met QC Criteria: September 14, 2011
• First Posted (Estimate): September 15, 2011

Study Record Updates

• Last Update Posted (Estimate): December 5, 2014
• Last Update Submitted That Met QC Criteria: December 4, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Nocturia
• Additional Relevant MeSH Terms: Urologic Diseases; Urological Manifestations; Urination Disorders; Polyuria; Physiological Effects of Drugs; Natriuretic Agents; Hemostatics; Coagulants; Antidiuretic Agents; Deamino Arginine Vasopressin
• Other Study ID Numbers: 2011/566