- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01576900
The Effect of Combined Systematized Behavioural Modification Education Program (SyBeMeP) With DDAVP in Patients With Nocturia
In patients with nocturia, combinational treatment of DDAVP and SyBeMeP might show better outcomes.
Systemic video instruction might prove to be beneficial by helping patients have better understanding on treatment and replacing healthcare personnel.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
One of main reason of nocturia is known as nocturnal polyuria. For the treatment of nocturia caused by overactive bladder, the combined therapy of anticholinergics plus behavioural modification has been established as the first line therapy. However, nocturia mainly comes from polyuria has been treated with desmopressin pharmacotherapy and the effect of behaviour modification education has not yet evaluated. Therefore, in this study, short term synergistic effect of combinational treatment of desmopressin and SyBeMeP (Systemized Behavioral Modification education Program) comparing desmopressin monotherpy will be evaluated in patients with nocturia.
Control group: Desmopressin (Minirin Tablet 0.1-0.4mg/day) + simple instruction Study group: Desmopressin (Minirin Tablet 0.1-0.4mg/day) + SyBeMeP. Patients will be randomized and assigned to each group at the ratio of 1:1. At screening visit, flowmetry and residual urine measurement, Complete Blood Count (CBC), atypical diabetes mellitus (ADM), electrolytes, urinalysis micro, urine concentration, and demographic examination will be done. Voiding diary will be distributed. At 2nd visit, patients will be randomized and each treatment will be initiated. IPSS, ICIQ-nocturia, and PPTB will be completed. Voiding diary will be distributed. At 3rd visit (2 weeks after from 2nd visit): IPSS, ICIQ-nocturia, and PPTB will be completed. Assess the treatment outcome including voiding diary analysis.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Seoul, Korea, Republik von, 110-744
- Seoul National University Hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- A patient with nocturia, who visited department of urology as outpatient
- Have not been treated with desmopressin for at least 6 months before
Exclusion Criteria:
- Sleep disorder,
- history of medication for voiding,
- diabetes insipidus,
- diabetes mellitus,
- cardiovascular disease,
- voiding difficulties (including residual urine of more than 100ml),
- small bladder capacity,
- overactive bladder,
- illiteracy,
- psychiatric disorder and having no intention to be enrolled by written agreement
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
---|---|
Desmopressin monotherapy
Control group: Desmopressin (Minirin Tablet 0.1-0.4mg/day)
+ simple instruction
|
|
Combination group
Study group: Desmopressin (Minirin Tablet 0.1-0.4mg/day) + SyBeMeP * Patients will be randomized and assigned to each group at the ratio of 1:1. |
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Decrease in urinary frequency (No. of nocturia)
Zeitfenster: baseline, 2 week, 1 month, and 3 months
|
baseline, 2 week, 1 month, and 3 months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Voiding diary indices
Zeitfenster: baseline, 2 weeks, 1 month and 3 months
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baseline, 2 weeks, 1 month and 3 months
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IPSS
Zeitfenster: baseline, 2 weeks, 1 month and 3 months
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baseline, 2 weeks, 1 month and 3 months
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ICIQ-nocturia
Zeitfenster: baseline, 2 weeks, 1 month and 3 months
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baseline, 2 weeks, 1 month and 3 months
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patient's perception of bladder condition (PPTB)
Zeitfenster: baseline, 2 weeks, 1 month and 3 months
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baseline, 2 weeks, 1 month and 3 months
|
patient's satisfaction on the education
Zeitfenster: baseline, 2 weeks, 1 month and 3 months
|
baseline, 2 weeks, 1 month and 3 months
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Studienleiter: Sung Yong Cho, M.D.,Ph.D., Seoul National University Hospital
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Nocturia-SBMP
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