UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004341 |
|---|---|
| Receipt number | R000005197 |
| Scientific Title | The epidemiological investigation on the effect of nocturia on sleep and the evaluation of the interventional efficacy of Imidafenacin. |
| Date of disclosure of the study information | 2010/11/01 |
| Last modified on | 2013/11/06 15:25:52 |
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Basic information
Public title
The epidemiological investigation on the effect of nocturia on sleep and the evaluation of the interventional efficacy of Imidafenacin.
Acronym
The investigation on the effect of nocturia on sleep and the evaluation of efficacy of Imidafenacin.
Scientific Title
The epidemiological investigation on the effect of nocturia on sleep and the evaluation of the interventional efficacy of Imidafenacin.
Scientific Title:Acronym
The investigation on the effect of nocturia on sleep and the evaluation of efficacy of Imidafenacin.
Region
| Japan |
Condition
Condition
Nocturia, Overactive bladder, Sleep disorder
Classification by specialty
| Psychiatry | Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We investigate the effect of nocturia and sleep disorder on QOLs, using the questionnaire to patients. In addition, we evaluate the efficacy of an anti- cholinergic drug, Imidafenacin, on nocturia, sleep disorder, daytime sleepiness and QOLs for OAB patients with nocturia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The effect of nocturia and sleep disorder on QOLs
-Nocturia micturitions in the item of the overactive bladder symptom score ( OABSS )
-Pittsburgh sleep quality index ( PSQI )
-Epworth sleepiness scale ( ESS )
-8-Item short-form health survey
( SF-8 )
Key secondary outcomes
1.The frequency of OAB with nocturia and its effect on QOLs
-OABSS
-International prostate symptom score (IPSS)
-ESS
-SF-8
2.The interventinal efficacy of
Imidafenacin to patients with OAB
-The time course of global score, nocturia micturitions, sub-scores in OABSS.
-The time course of scores in PSQI, ESS and SF-8
3.The frequency of SAS with sleep disorder and its effect on QOLs
-The time course of nocturia micturitions in OABSS.
-ESS
-PSQI(Q10a and Q10b)
-SF-8
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Screening patients with nocturia more than once per night using overactive bladder symptom score ( OABSS ), the questionnaire to patients, consist of PSQI, ESS, SF-8 and IPSS, will be carried out.
Screening patients with overactive bladder using OABSS, eligible patients will receive 0.2-0.4 mg/day Imidafenacin for 12 weeks.
After 4 weeks of treatment with Imidafenacin, the efficacy of the treatment regimen will be assessed. If the effect of Imidafenacin is inadequate ( at least to sleep disturbance ), start internal use of sleeping pills ( 5 mg of Myslee ) with Imidafenacin. Patients administered already sleeping pills or resistant to new sleeping pills consider psychiatric consultation.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
( Intervention study )
The patients of overactive bladder with nocturia more than once per night.
Key exclusion criteria
( Intervention study )
The following patients must be excluded:
1) Patients with polyuria
2) Patients with post-void residual volume >100 cc.
3) Patients who are judged inappropriate for the clinical trial by doctors.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigetaka Suekane |
Organization
Kurume University School of Medicine
Division name
Department of Urology
Zip code
Address
Asahi-machi 67, Kurume,
TEL
0942-31-7572
suekane@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | higetaka Suekane |
Organization
Kurume University School of Medicine
Division name
Department of Urology
Zip code
Address
Asahi-machi 67, Kurume,
TEL
0942-31-7572
Homepage URL
suekane@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kurume University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
久留米大学病院（福岡県）、社会保険久留米第一病院（福岡県）、筑後市立病院（福岡県）、大牟田市立総合病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2009 | Year | 02 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 06 | Day |
Last modified on
| 2013 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005197
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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