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

UMIN ID: UMIN000002119

Registered date:24/06/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Benign prostatic hypertophy associated with overactive bladder
• Date of first enrollment: 2009/07/01
• Target sample size: 90
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

naftopidil 25mg to 75mg daily
tamsulosin 0.2mg daily

Outcome(s)

• Primary Outcome: grade of desire for voiding measured by frequency volume chart
• Secondary Outcome: frequency of voiding, maximum voiding volume, average voiding volume

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male
• Exclude 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

Related Information

• Primary Sponsor: Department of Urology, the University of Tokyo Hospital
• Secondary Sponsor: Nihon University, Bokutoh Hospital, Tokyo Kyosai Hospital, Police Hospital, Fraternity Memorial Hospital, Geriatric Hospital, Japan Red Cross Medical Center, Misato Kenwa Hospital
• Source(s) of Monetary Support: none,None