Demographic survey in patients with overactive bladder and investigation on efficacy and safety of antimuscarinic agents.

Demographic survey in patients with overactive bladder and investigation on efficacy and safety of antimuscarinic agents. - TOPICS (Tokyo OAB Patients Imidafenacin-Control Study)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001878

Enrollment

400

Registered

2009-04-16

Start date

2009-04-01

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

Overactive bladder

Interventions

Imidafenacin 0.1 mg is orally administered to the patients with overactive bladder twice a day, after the breakfast and supper, for one year as possible, at least for three months. Propiverine Hydroc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with Q3 score of Overactive Bladder Symptom Score(OABSS) >=2 and the total score >=3 and agree with participation in this examination will be enrolled.

Exclusion criteria

Exclusion criteria: 1) Prostate Specific Antigen (PSA) >=1.5 ng/ml. 2) stress urinary incontinence (CLSS:Q5 >=2 point). 3) bladder pain (CLSS:Q9 >=2 point). 4) voiding difficulty (CLSS:Q7 >=2 point). 5) a significant residual urine.(Significance is by physicians judged) 6) hematuria or pyuria. 7) positive urinary cytology. 8) contraindications to antimusucarinic agents. a. urinary retention. b. obstruction in pylorus, duodenum or intestinum and paralytic ileus. c. decreased gastrointestinal motility. d. closed-angle glaucoma. e. myasthenia gravis. f. serious heart failure. g. serious hepatic dysfunction (Child-Pugh classification C). h. hypersensitivity to the drug substance or other components of each products.

Design outcomes

Secondary

Measure	Time frame
Core Lower Urinary Tract Symptom Score (CLSS), International Prostate Symptom Score (IPSS), Athens insomnia standard (AIS), prevalence and severity of side effect , time to dry mouth , Japanese version CAS, QT elongation, urinary retention, treatment discontinuation, SF-12, time to efficacy, and the treatment satisfaction rating will be evaluated in 3 months, 6 months, 12 months after the beginning of administration .	—

Measure

Time frame

Core Lower Urinary Tract Symptom Score (CLSS), International Prostate Symptom Score (IPSS), Athens insomnia standard (AIS), prevalence and severity of side effect , time to dry mouth , Japanese version CAS, QT elongation, urinary retention, treatment discontinuation, SF-12, time to efficacy, and the treatment satisfaction rating will be evaluated in 3 months, 6 months, 12 months after the beginning of administration .

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Primary

Measure	Time frame
After 3 months, 6 months, 12 months of treatment, the efficacy ( Overactive Bladder Sympton Score (OABSS)) and the safety (Ministry of Health, Labour and Welfare science of long life synthesis research business "Interview sheet to the subjective symptom of the intraoral dryness. ") of antimuscarinic agents will be evaluated .	—

Countries

Japan

Outcome results

None listed

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