The epidemiological investigation on the effect of nocturia on sleep and the evaluation of the interventional efficacy of Imidafenacin.

The epidemiological investigation on the effect of nocturia on sleep and the evaluation of the interventional efficacy of Imidafenacin. - The investigation on the effect of nocturia on sleep and the evaluation of efficacy of Imidafenacin.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004341

Enrollment

500

Registered

2010-11-01

Start date

2009-03-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nocturia, Overactive bladder, Sleep disorder

Interventions

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. Sc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ( Intervention study ) The patients of overactive bladder with nocturia more than once per night.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public Contacthigetaka Suekane

Kurume University School of Medicine Department of Urology

suekane@med.kurume-u.ac.jp0942-31-7572

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026