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Evaluation of the clinical efficacy and safety of the combined administration of Imidafenacin and alfa1-blocker in BPH patients with OAB.

Evaluation of the clinical efficacy and safety of the combined administration of Imidafenacin and alfa1-blocker in BPH patients with OAB. - FUN Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000007973
Enrollment
100
Registered
2012-05-17
Start date
2012-06-01
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

None listed

Sponsors

FUN(Fukuoka Urology Network)
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) Benign prostatic hyperplasia 2) Patients who have overactive bladder even after administering alfa1-blocker (Silodosin or Naftopidil) for more than 4 weeks 3) Age more than 50 years 4) Prostate volume is more than 20mL or less than 50ml 5) Patients from whom we have received consent

Exclusion criteria

Exclusion criteria: 1) Patients who have administered prohibited substances or done prohibited therapy within the 4 weeks before enrollment. (Sex hormone drug and 5-alpha reductase inhibitor within the 52 weeks before enrollment.) 2) Patients who changed the dosage or usage of a restricted medicine within the 4 weeks before enrollment 3) Patients with prostate cancer, neurogenic bladder, urethra stricture, chronic prostatitis, symptomatic urinary tract infection, urinary tract stones and interstitial cystitis 4) Patients with anuresis 5) Patients with pyloristenosis, constriction of dodecadactylon, construction of enteron and adynamic ileus 6) Patients with deterioration of enterokinesis 7) Patients with angle-closure glaucoma 8) Patients with myasthenia gravis 9) Patients with serious cardiac disorder, serious liver dysfunction and serious kidney dysfunction 10) Patients with history of hypersensitive reaction to anticholinergic agents 11) Residual urine volume is more than 50mL 12) Patients in which it has been confirmed that Qmax is less than 5mL/s 13) Patients with Polyuria 14) Any other patients who are regarded as unsuitable for this study by the investigator

Design outcomes

Primary

MeasureTime frame
Change of total OABSS score

Countries

Japan

Contacts

Public ContactNarihito Seki

Kyushu Central Hospital Urology

narihito@kyushu-ctr-hsp.com092-541-4936

Outcome results

None listed

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