A Study of Minirin Melt in Patients With Nocturia

Retrospective Safety Study in 12 Months Treatment Nocturia With Minirin Melt in Clinical Practice in Czech Republic

This is a confirmation of safety profile for Minirin Melt in clinical practice.

Study Overview

• Status: Completed
• Conditions: Nocturia

• Study Type: Observational
• Enrollment (Actual): 2187

Contacts and Locations

Study Locations

• Czech Republic
  • Benešov, Czech Republic
    • Nemocnice Rudolfa a Stefanie
  • Benešov, Czech Republic
    • Private ambulance Benešov
  • Beroun, Czech Republic
    • Private ambulance Beroun
  • Bohumín, Czech Republic
    • Private ambulance - Slezská urologie, s.r.o.
  • Brno, Czech Republic
    • Health centre Brno
  • Brno, Czech Republic
    • Hospital Accident
  • Brno, Czech Republic
    • Hospital Delta - private ambulance
  • Brno, Czech Republic
    • Private ambulance Uro-Clinic, s.r.o.
  • Brno, Czech Republic
    • Urocentrum
  • Brno - Zábrdovice, Czech Republic
    • Private Ambulance
  • Domažlice, Czech Republic
    • Domažlická nemocnice a.s.
  • Dvůr Králové, Czech Republic
    • Soukromá ambulance Dvůr Králové
  • Děčín, Czech Republic
    • Hospital Dečín
  • Hanušovice, Czech Republic
    • Private Ambulance
  • Havlíčkův Brod, Czech Republic
    • Hospital Havlíčkův Brod
  • Havířov, Czech Republic
    • Hospital with health centre
  • Hluk, Czech Republic
    • Gynekologická ambulance Hluk
  • Horšovský Týn, Czech Republic
    • Private ambulance Urologie, s.r.o.
  • Hradec Králové, Czech Republic
    • Hospital Hradec Kralove
  • Hustopeč u Brna, Czech Republic
    • Městská nemocnice Hustopeče
  • Jablonec nad Nisou, Czech Republic
    • Private Ambulance
  • Jablonec nad Nisou, Czech Republic
    • Soukromá ambulance Jablonec nad Nisou
  • Jilemnice, Czech Republic
    • Private Ambulance
  • Karlovy Vary, Czech Republic
    • Hospital ambulance
  • Kladno, Czech Republic
    • Oblastní nemocnice Kladno
  • Krnov, Czech Republic
    • Hospital Krnov
  • Kromeriz, Czech Republic
    • Hospital Kroměříž
  • Kuřim, Czech Republic
    • Soukromá ambulance Kuřim
  • Lanškroun, Czech Republic
    • Private Ambulance
  • Mohelnice, Czech Republic
    • Soukromá ambulance Mohelnice
  • Nový Jičín, Czech Republic
    • Private Ambulance
  • Náchod, Czech Republic
    • Hospital Náchod
  • Olomouc, Czech Republic
    • Hospital Olomouc
  • Olomouc, Czech Republic
    • Private ambulance - Mediol, s.r.o.
  • Ostrava, Czech Republic
    • City Hospital
  • Ostrava - Poruba, Czech Republic
    • Private Ambulance
  • Ostrava - Vítkovice, Czech Republic
    • Vítkovická Hospital
  • Pelhřimov, Czech Republic
    • Hospital Pelhřimov
  • Plzeň, Czech Republic
    • Hospital Plzeň
  • Plzeň, Czech Republic
    • Private ambulance Plzeň
  • Prachatice, Czech Republic
    • Private ambulance Prachatice
  • Praha 10, Czech Republic
    • Private Ambulance
  • Praha 2, Czech Republic
    • Hospital Želeniční nemocnice
  • Praha 2, Czech Republic
    • Urocentrum Praha 2
  • Praha 2, Czech Republic
    • Urology clinic Hospital Praha
  • Praha 2, Czech Republic
    • Všeobecná fakultní nemocnice
  • Praha 4, Czech Republic
    • MEDICON
  • Praha 4, Czech Republic
    • Private ambulance - Urosante s.r.o.
  • Praha 4, Czech Republic
    • Private ambulance Praha 4
  • Praha 4, Czech Republic
    • Thomayer Hospital
  • Praha 5, Czech Republic
    • Private ambulance Praha 5
  • Praha 5, Czech Republic
    • Private Ambulance
  • Praha 6, Czech Republic
    • Urocare
  • Praha 7, Czech Republic
    • Private Ambulance
  • Praha 7, Czech Republic
    • Private gyn. ambulance
  • Praha 8, Czech Republic
    • Hospital Bulovka
  • Praha 8, Czech Republic
    • Privátní ambulance Dr. A. Antončík
  • Písek, Czech Republic
    • Hospital Písek
  • Přerov, Czech Republic
    • Hospital Přerov
  • Přeštice, Czech Republic
    • Private ambulance - Preštice
  • Rakovník, Czech Republic
    • Private Ambulance
  • Roudnice nad Labem, Czech Republic
    • Soukromá ambulance Roudnice nad Labem
  • Rožnov pod Radhoštěm, Czech Republic
    • Private Ambulance
  • Teplice, Czech Republic
    • Hospital ambulance
  • Turnov, Czech Republic
    • Panoch Hospital
  • Tábor, Czech Republic
    • Hospital Tábor
  • Třebíč, Czech Republic
    • Hospital Třebíč
  • Třinec, Czech Republic
    • Hospital Podlesí,s.r.o.
  • Uherské Hradiště, Czech Republic
    • Hospital with health centre
  • Valašské Meziřící, Czech Republic
    • Nemocnice Valašské Meziříčí
  • Zlin, Czech Republic
    • Private Ambulance
  • Zlín, Czech Republic
    • Krajska nemocnice T. Bati
  • Zlín, Czech Republic
    • Medel, s.r.o.
  • Zlín, Czech Republic
    • Private ambulance Lékařský dům
  • Znojmo, Czech Republic
    • UROKAN, s.r.o.
  • Ústí nad Labem, Czech Republic
    • Masaryk Hospital
  • Ústí nad Orlicí, Czech Republic
    • Hospital Ústí nad Orlicí
  • Černošice, Czech Republic
    • Soukromá ambulanc Černošice
  • Česká Lípa, Czech Republic
    • Hospital Česká Lípa
  • Říčany, Czech Republic
    • Hospital Řičany - private ambulance
  • Štenberk, Czech Republic
    • Soukromá ambulance Štenberk
  • Šumperk, Czech Republic
    • Private Ambulance
  • Šumperk, Czech Republic
    • Šumperská nemocnice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

primary care clinic

Description

Inclusion Criteria:

• nocturia

Exclusion Criteria:

• habitual or psychogenic polydipsia
• known or suspected cardiac insufficiency and other conditions requiring treatment with diuretics
• moderate and severe renal insufficiency
• know 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
Verify the safety profile	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety aspect of dosage	12 months

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: September 21, 2010
• First Submitted That Met QC Criteria: September 29, 2010
• First Posted (Estimate): September 30, 2010

Study Record Updates

• Last Update Posted (Estimate): January 6, 2014
• Last Update Submitted That Met QC Criteria: January 3, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lower Urinary Tract Symptoms; Urological Manifestations; Nocturia
• Other Study ID Numbers: FE992026 CS37