A Study of Minirin Melt in 24 Months Treatment in Patients With Nocturia

A Prospective Safety Study in 24 Months Treatment of Nocturia With Minirin Melt in Clinical Practice in the Czech Republic

A Confirmation of the Safety Profile for Minirin Melt in Clinical Practice

Study Overview

• Status: Completed
• Conditions: Nocturia

• Study Type: Observational
• Enrollment (Actual): 4136

Contacts and Locations

Study Locations

• Czech Republic
  • Benešov, Czech Republic
    • Nemocnice Rudolfa a Stefanie (there may be other sites in this country)
  • Benešov, Czech Republic
    • Soukromá ambulance, Benešov
  • Beroun, Czech Republic
    • Soukromá ambulance Beroun
  • Bohunín, Czech Republic
    • Slezská urologie
  • Brno, Czech Republic
    • Urocentrum Brno
  • Brno, Czech Republic
    • URIONTEGRITAS soukromá ambulance
  • Brno, Czech Republic
    • Uro - clinic
  • Brno, Czech Republic
    • Úrazová nemocnice Brno
  • Citonice, Czech Republic
    • Soukromá ambalance
  • Domažlice, Czech Republic
    • Domažlická Nemocnice
  • Dvůr Králové nad Labem, Czech Republic
    • Městská nemocnice Dvůr Králové nad Labem a.s.
  • Havlíčkův Brod, Czech Republic
    • Nemocnice Havlíčkův Brod
  • Havířov, Czech Republic
    • Nemocnice s poliklinkou Havířov
  • Hluk, Czech Republic
    • Gynekologická ambulance Hluk
  • Hradec Králové, Czech Republic
    • Fakultni Nemocnice Hradec Kralove
  • Hradec Králové, Czech Republic
    • PPCHC Sanus Hradec Králové
  • Hustopeče u Brna, Czech Republic
    • Městská nemocnice Hustopeče
  • Jaroměř, Czech Republic
    • Urologická ambulance UROLA
  • Jilemnice, Czech Republic
    • Soukromá ambulance, Jilemnice
  • Kladno, Czech Republic
    • Oblastni nemocnice Kladno a.s.
  • Klatovy, Czech Republic
    • Urologie s.r.o.
  • Krnov, Czech Republic
    • Soukromá ambulance Krnov
  • Kromeriz, Czech Republic
    • Kromerizska nemocnice a.s.
  • Lanškroun, Czech Republic
    • Soukromá ambulance, Lanškroun
  • Mohelnice, Czech Republic
    • Soukromá ambulance Mohelnice
  • Nový Jičín, Czech Republic
    • Sourkomá ambulance, Nový Jičín
  • Nový Jíčín, Czech Republic
    • Nemocnice Nový Jičín
  • Náchod, Czech Republic
    • Oblastni nemocnice Nachod
  • Olomouc, Czech Republic
    • FN Olomouc
  • Olomouc, Czech Republic
    • Centrum MEDIOL s.r.o.
  • Ostrava, Czech Republic
    • Mestska nemocnice Ostrava
  • Ostrava Ploskovice, Czech Republic
    • Gynekologická ambulance
  • Ostrava-Vítkovice, Czech Republic
    • Vitkovicka nemocnice a.s.
  • Pelhřimov, Czech Republic
    • Nemocnice Pelhrimov
  • Plzeň, Czech Republic
    • FN Plzen
  • Plzeň, Czech Republic
    • Poliklinika Denisovo nábřeží
  • Prachatice, Czech Republic
    • Urologická ambulance
  • Praha 1, Czech Republic
    • Urologická klinika Praha 1
  • Praha 10, Czech Republic
    • Urologie Zahradní Město s.r.o.
  • Praha 10 - Uhříněves, Czech Republic
    • Urologie - NZZ Lékařský dům
  • Praha 2, Czech Republic
    • Nemocnice s poliklinikou Praha Italská
  • Praha 2, Czech Republic
    • VFN
  • Praha 4, Czech Republic
    • MEDICON
  • Praha 4, Czech Republic
    • Urologické oddělení
  • Praha 5, Czech Republic
    • Soukromá ambulance, Praha 5
  • Praha 6, Czech Republic
    • Urocare
  • Praha 6, Czech Republic
    • Ustredni vojenska nemocnice
  • Praha 7, Czech Republic
    • Soukromá ambulance Praha 7
  • Praha 8, Czech Republic
    • FN Bulovka
  • Praha 8, Czech Republic
    • Urosanté s.r.o
  • Písek, Czech Republic
    • Nemocnice Písek
  • Přerov, Czech Republic
    • JR Urocentrum Přerov s.r.o.
  • Přeštice, Czech Republic
    • Soukromá ambulance, Přeštice
  • Teplice, Czech Republic
    • Krajská Zdravotní - Nemocnice Teplice
  • Trutnov, Czech Republic
    • Urologická ambulance
  • Turnov, Czech Republic
    • Městská nemocnice Turnov
  • Tábor, Czech Republic
    • Nemocnice Tábor
  • Třebíč, Czech Republic
    • Nemocnice Třebíč
  • Třinec, Czech Republic
    • Nemocnice Podlesí a.s.
  • Uherské Hradiště, Czech Republic
    • Nemocnice Uherské Hradiště
  • Valašské Meziříčí, Czech Republic
    • Nemocnice Valašské Meziříčí
  • Zlín, Czech Republic
    • DUAM s.r.o. Lékařský dům
  • Zlín, Czech Republic
    • Krajská nemocnice T.Bati a.s.
  • Zlín, Czech Republic
    • Soukromá ambulance, Zlín
  • Znojmo, Czech Republic
    • UROKAN s.r.o.
  • Ústí nad Labem, Czech Republic
    • Masarykova Nemocnice V Usti Nad Labem
  • Říčany, Czech Republic
    • Urocare s.r.o.
  • Štemberk, Czech Republic
    • Soukromá ambulance Štemberk

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Adult Patients Suffering From Nocturia 1x or More Times a Night

Description

Inclusion Criteria:

• nocturia

Exclusion Criteria:

• habitual or psychogenic polydipsia,
• known or suspected cardiac insufficiency
• other conditions requiring treatment with diuretics
• moderate and severe renal insufficiency
• known hyponatremia
• syndrome of inappropriate ADH secretion

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients with adverse events	24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of changes in dosage regime	24 months

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: March 7, 2012
• First Submitted That Met QC Criteria: March 9, 2012
• First Posted (Estimate): March 13, 2012

Study Record Updates

• Last Update Posted (Estimate): May 24, 2016
• Last Update Submitted That Met QC Criteria: May 23, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lower Urinary Tract Symptoms; Urological Manifestations; Nocturia
• Other Study ID Numbers: 000056