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

UMIN ID: UMIN000001878

Registered date:16/04/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Overactive bladder
• Date of first enrollment: 2009/04/01
• Target sample size: 400
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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 Hydrochloride 20 mg is orally administered to the patients with overactive bladder once a day after a meal for one year as possible, at least for three months.
Solifenacin Succinate 5 mg is orally administered to the patients with overactive bladder once a day for one year as possible, at least for three months.
Tolterodine Tartrate 4 mg is orally administered to the patients with overactive bladder once a day for one year as possible, at least for three months.

Outcome(s)

• Primary Outcome: 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 .
• Secondary Outcome: 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 .

Key inclusion & exclusion criteria

• Age minimum: 50years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: TOPICS society (Tokyo OAB Patients Imidafenacin-Control Study society)
• Source(s) of Monetary Support: None