Skip to content

Observational study to assess dose-up efficacy of anticholinergic agent on nocturia in overactive bladder patients

Observational study to assess dose-up efficacy of anticholinergic agent on nocturia in overactive bladder patients - Observational study to assess dose-up efficacy of anticholinergic agent on nocturia in overactive bladder patients(Dose Flex Study)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000012640
Enrollment
100
Registered
2013-12-20
Start date
2013-12-24
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

Overactive bladder

Interventions

None listed

Sponsors

Clinical Research Support Center Kyushu
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Patients who are regarded as overactive bladder at the start of dosing imidafenacin 2)Patients who have the follow criteria even after administering imidafenacin for more than 4 weeks IPSS Q7(nocturia score) >=3 3)Aged >=20 years

Exclusion criteria

Exclusion criteria: 1)Patients with contraindications for imidafenacin 2)Patients who have current condition of severe difficulty of urination 3)Patients who have history of urinary retention 4)Patients with serious kidney dysfunction 5)Residual urine volume > 50 mL 6)Patients with cancer in bladder, cystoliths, urinary tract infection, recurrent urinary tract infection or interstitial cystitis 7)Patients with polyuria 8)Patients who have administered prohibited substances or done prohibited therapy in the 4 weeks prior to the start of study (excepting operations on urinary and sexual organs) 9)Patients who have been operated on the urinary or sexual organs in the 6 months prior to the start of study 10)Patients with unstable lower urinary tract symptoms 11)Any other patients who are regarded as unsuitable for this study by the investigator

Design outcomes

Primary

MeasureTime frame
Change in IPSS Q7 (nocturia score) as change in nocturnal voids

Countries

Japan

Contacts

Public ContactYasuyuki Suzuki

Tokyo Metropolitan Rehabilitation Hospital Department of Medical Care

ysuro@jikei.ac.jp03-3616-8600

Outcome results

None listed

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