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exploratory randomized clinical traial comparing naftopidil with tamsulosin in cases with benign prostatic hypertrophy assciated with overactive bladder

exploratory randomized clinical traial comparing naftopidil with tamsulosin in cases with benign prostatic hypertrophy assciated with overactive bladder - exploratory randomized clinical traial comparing naftopidil with tamsulosin in cases with benign prostatic hypertrophy assciated with overactive bladder

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002119
Enrollment
90
Registered
2009-06-24
Start date
2009-07-01
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

Benign prostatic hypertophy associated with overactive bladder

Interventions

naftopidil 25mg to 75mg daily tamsulosin 0.2mg daily

Sponsors

Department of Urology, the University of Tokyo Hospital
Lead Sponsor
Nihon University, Bokutoh Hospital, Tokyo Kyosai Hospital, Police Hospital, Fraternity Memorial Hospital, Geriatric Hospital, Japan Red Cross Medical Center, Misato Kenwa Hospital
Collaborator

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. previously untreated cases with benign prostatic hypertrophy 2. prostatic volume>=20ml 3. IPSS total score>=8 and QOL score>=2 4. Question 2 of IPSS>=2 5. Question 4 of IPSS>=2

Exclusion criteria

Exclusion criteria: 1. residual volume>=50ml 2. cases with prostatic cancer, bladder cancer or interstitial cystitis 3. cases with urethral stricture 4. cases with diseases which may affect on the lower urinary tract symptoms such as diabate mellitus, cerebral vascular disease and spinal cord injury 5. cases with past history of allergic reaction to naftopidil or tamsulosin

Design outcomes

Secondary

MeasureTime frame
frequency of voiding, maximum voiding volume, average voiding volume

Primary

MeasureTime frame
grade of desire for voiding measured by frequency volume chart

Countries

Japan

Contacts

Public ContactHaruki Kume

the University of Tokyo Hospital Department of Urology

kumeh-uro@h.u-tokyo.ac.jp+81-3-5800-8662

Outcome results

None listed

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