Desmopressin Melt Therapy in Nocturnal Polyuria Patients: Pharmacodynamic Study

The objective of this study is to find out what the pharmacodynamic (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?

The patient will be given a prescription to buy Minirin Melt 60µg at the local pharmacy. During 30 days, the patient has to take Minirin Melt 60µg in the evening before going to bed.

There are two groups of patients:

Group A:

Patients that still have to undergo an evaluation phase, according to standard procedures (e.g. osmolality test, blood sample). This procedure is not a part of this study. The study starts when the 1st Minirin Melt tablet has been taken (= day 1).

Group B:

This group already went through the evaluation phase (by participation to study 1 or study 3 as mentioned above) and they have been prescribed Minirin Melt 60 µg ambulatory.

The study starts when the patients takes his first prescribed Minirin Melt tablet:

• On day 3 and day 7 a blood sample will be taken at the UZ Ghent for safety control (Na+, K+, creatinin, osmolality = good clinical practice guideline). These first 2 visits (day 3 and day 7) are standard procedure. If the patient is at high risk for side effects, blood has to be taken during the first 7 days.
• On day 3 the patient has to give a urine sample.
• Patients have to fill out a frequency/volume chart during the first 14 days.
• On day 30, a 3rd blood sample will be taken

Study Overview

• Status: Completed
• Conditions: Nocturia
• Intervention / Treatment: Drug: Desmopressin

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 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 women, 18 years and older, with an average of ≥ 2 nocturnal voids per night
• evidence for nocturnal polyuria (nocturnal urine volume >33% of total volume over 24h), determined on frequency/volume chart
• Diuresis <2.5L

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 < 60 ml/min)
• psychogenic or habitual polydipsia
• hyponatraemia or predisposition for hyponatraemia
• diabetes insipidus
• syndrome of inadequate ADH production
• suspicion or evidence of liver failure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Desmopressin Melt Therapy in Nocturnal Polyuria Patients	Drug: Desmopressin; Administration of minirin melt 60 µg: desmopressin (acetate) 60 µg oral lyophilisate.; Other Names: Minirin Melt 60 µg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood samples for plasma concentration of Na+, K+, creatinin, osmolality (safety profile)at day 3.		At day 3 after first desmopressin intake.
Urine sample for urine concentration of Na+, K+, creatinin and osmolality		At day 3
Area Under Curve (AUC) frequency/volume chart during the first 14 days		Every day during the first 14 days.
The decrease of number of nocturnal micturition episodes.	Questionnaires at day 0 to evaluate the decrease of number of nocturnal micturition episodes.	At day 0
The decrease of the number of nocturnal micturition episodes.	Questionnaires at day 30 to evaluate the number of nocturnal micturition episodes	At day 30
Registration of number of side effects at day 3.		At day 3
Blood samples for plasma concentration of Na+, K+, creatinin, osmolality (safety profile)at day 7.		At day 7 after first desmopressin intake
Blood samples for plasma concentration of Na+, K+, creatinin, osmolality (safety profile)at day 30.		At day 30 after first desmopressin intake
Registration of number of side effects at day 7		At day 7
Registration of number of side effects at day 30.		At day 30

Collaborators and Investigators

• Sponsor: University Hospital, Ghent

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2012
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: September 14, 2011
• First Submitted That Met QC Criteria: September 22, 2011
• First Posted (Estimate): September 23, 2011

Study Record Updates

• Last Update Posted (Actual): December 15, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Nocturnal polyuria
• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Nocturia; Polyuria; Physiological Effects of Drugs; Natriuretic Agents; Hemostatics; Coagulants; Antidiuretic Agents; Deamino Arginine Vasopressin
• Other Study ID Numbers: 2011/567