Randomized clinical study of silodosin vs propiverine for men aged 50 or older with overactivebladder and 20 to 30ml of prostate volume

UMIN ID: UMIN000001423

Registered date:14/10/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Overactive bladder
• Date of first enrollment: 2008/10/01
• Target sample size: 120
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Silodosin (4mg) 1 Capsule or Silodosin (2mg) 2 Capsules 2x1 after breakfast and dinner daily, orally
Propiverine (10mg) 1x1 after breakfast daily, orally

Outcome(s)

• Primary Outcome: Proportion of patients who need treatment change or discontinuation within 8 weeks
• Secondary Outcome: OABSS, I-PSS total score, QoL index, voiding/storage subscore, maximal flow rate, postvoid residual urine volume (PVR), the ratio of patients with increasing PVR and adverse effect

Key inclusion & exclusion criteria

• Age minimum: 50years-old
• Age maximum: Not applicable
• Gender: Male
• Exclude criteria: 1) Primary angle-closure glaucoma 2) Obstructive intestinal disease, paralytic ileus, gastrointerstinal atony, myastania gravis, severe heart disease 3) Cognitive disturbance 4) Active urinary tract infection 5) Past history of bladder and/or prostate surgery 6) Past history of bladder and/or prostate cancer 7) Treatment for benign prostate hyperplasia and/or overactive bladder within 3 months 8) Apparent neurological disease 9) judged as being unsuitable for the trial by the researcher

Related Information

• Primary Sponsor: National Center for Geriatrics & Gerontology
• Source(s) of Monetary Support: National Center for Geriatrics & Gerontology