Benign Prostatic Hypertrophy, Prostatic Hyperplasia, Urinary Retention
Conditions
Keywords
Acute Urinary Retention, AUR, Benign Prostatic Hyperplasia, Benign Prostatic Hypertrophy, BPH, Enlarged Prostate
Brief summary
A study to determine the effect on prevention of Acute Urinary Retention (inability to urinate) in males with an enlarged prostate, also known as BPH. * Free study-related medical care provided.
Interventions
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has been suffering for at least 6 months with any of the following symptoms: * daytime or nighttime urinary frequency * urgent feeling to urinate * difficulty starting urinary stream * interruption of urinary stream * feeling of incomplete urination * Has not had a previous episode of acute urinary retention * Has not been diagnosed with prostate cancer * Has not had previous prostate surgery * Is not an insulin-dependent diabetic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| occurrence of first episode of acute urinary retention (AUR) | — |
Secondary
| Measure | Time frame |
|---|---|
| need for benign prostatic hyperplasia (BPH)-related surgery, international prostate symptoms score (IPSS) | — |
Countries
Australia, Bulgaria, Canada, Denmark, Finland, Greece, Hungary, Israel, Netherlands, Norway, Poland, Portugal, Romania, South Africa, Spain, Sweden, United States
Outcome results
None listed