The epidemiological investigation on the effect of nocturia on sleep and the evaluation of the interventional efficacy of Imidafenacin.
Not Applicable
- Conditions
- octuria, Overactive bladder, Sleep disorder
- Registration Number
- JPRN-UMIN000004341
- Lead Sponsor
- Kurume University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 500
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 )
- Secondary Outcome Measures
Name Time Method 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