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The Effect of Combined Systematized Behavioural Modification Education Program (SyBeMeP) With DDAVP in Patients With Nocturia

19. november 2014 opdateret af: Seung-June Oh, Seoul National University Hospital

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

124

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Korea, Republikken
      • Seoul, Korea, Republikken, 110-744
        • Seoul National University Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Korean patients with nocturia regardless of age and gender

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Adfærdsmæssigt: SyBeMeP (Systemized Behavioural Modification education Program)
  • Standard video material will be developed to minimize variation of outcomes caused by differences in contents at each trial site.
  • Video material will be self-study program for PC with running time around 20 minutes. Contents will cover pathophysiology, diagnosis and treatment process, and be easy to understand for everyone with variety of examples. In treatment part, it will describe general principles of behavioural therapy (Adjustment of timing of fluid intake, Reducing alcohol and caffeine, Improving sleep hygiene including moderate exercise, room temperature, noise and lighting. if necessary, compressive stocking, late afternoon nap and leg elevation would be added)
  • During trial, patients will watch SYBeMeP at a specially prepared separate room with computer.
  • After watching the video, check-list on take-home message will be recorded by patients at the site to confirm patients' awareness after education.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Decrease in urinary frequency (No. of nocturia)
Tidsramme: baseline, 2 week, 1 month, and 3 months
baseline, 2 week, 1 month, and 3 months

Sekundære resultatmål

Resultatmål
Tidsramme
Voiding diary indices
Tidsramme: baseline, 2 weeks, 1 month and 3 months
baseline, 2 weeks, 1 month and 3 months
IPSS
Tidsramme: baseline, 2 weeks, 1 month and 3 months
baseline, 2 weeks, 1 month and 3 months
ICIQ-nocturia
Tidsramme: baseline, 2 weeks, 1 month and 3 months
baseline, 2 weeks, 1 month and 3 months
patient's perception of bladder condition (PPTB)
Tidsramme: baseline, 2 weeks, 1 month and 3 months
baseline, 2 weeks, 1 month and 3 months
patient's satisfaction on the education
Tidsramme: baseline, 2 weeks, 1 month and 3 months
baseline, 2 weeks, 1 month and 3 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Seoul National University Hospital

Samarbejdspartnere

Ferring Pharmaceuticals

Efterforskere

  • Studieleder: Sung Yong Cho, M.D.,Ph.D., Seoul National University Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2012

Primær færdiggørelse (Faktiske)

1. oktober 2014

Studieafslutning (Faktiske)

1. oktober 2014

Datoer for studieregistrering

Først indsendt

13. februar 2012

Først indsendt, der opfyldte QC-kriterier

11. april 2012

Først opslået (Skøn)

13. april 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

20. november 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. november 2014

Sidst verificeret

1. november 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Nocturia-SBMP

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Nocturia

Kliniske forsøg med SyBeMeP (Systemized Behavioural Modification education Program)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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