Skip to content

Global Assessment Study of Anti-cholinergics on Efficacy and Tolerability for Patients with OAB

Global Assessment Study of Anti-cholinergics on Efficacy and Tolerability for Patients with OAB - GAP Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003033
Enrollment
300
Registered
2010-04-14
Start date
2009-11-01
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 0.1mg is orally administered to the patients with overactive bladder twice a day, after the breakfast and supper. Solifenacin Succinate 5mg is orally administered to the patients with ove

Sponsors

GAP Study Group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients with Q3 score of Overactive Bladder Symptom Score (OABSS) >=2 and the total score >=3. (2) 20 years old or more outpatient (3) Written consent with participation in this examination will be enrolled.

Exclusion criteria

Exclusion criteria: (1) Genuine stress incontinence. (2) Prostate cancer, bladder cancer, urinary tract stones, symptomatic urinary tract infection, recurrent urinary tract infection and interstitial cystitis. (3) Indwelling or intermittent urethral catheterization. (4) Polyuria. (5) Lower urinary tract symptom is unstable. (6) Serious heart failure, serious liver failure and serious kidney failure. (7) Contraindications to antimusucarinic agents. (8) Sjogren's syndrome or hyposalivation by RT. (9) Treatment with banned medicine within 2 weeks before the run-in period. (10) Electric stimulation therapy or bladder training within 3 months before the run-in period. (11) Genitourinary surgery within 6 months before the run-in period. (12) Any other cases who are regarded as inadequate for study enrollment by the investigator.

Design outcomes

Primary

MeasureTime frame
After 4 weeks, 8 weeks, 12 weeks of treatment, the efficacy ( Overactive Bladder Symptom Score (OABSS)) will be evaluated.

Secondary

MeasureTime frame
After 4 weeks, 8 weeks, 12 weeks of treatment, Dry Mouth symptom and Constipation symptom will be evaluated.

Countries

Japan

Outcome results

None listed

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