The Value of Multiple Urine Flow Rate Measurements in Male Benign Prostatic Hyperplasia (BPH) Subjects

An Open Prospective Multicenter Study Comparing the Urine Flow Measurements of Standard Clinic Flow Measurements vs Comercially Available Portable Digital Flow Meters and a Disposable Flow Meter in a Crossover and Randomized Order on Male BPH Subjects

Crossover comparison of different flow meters with a digital home flow meter as a reference. Main hypothesis: Reapeated home flow measurements with a disposable device will provide a better understanding of the patients urinary flow than a single measurement performed in the clinic.

Inclusion Criteria:

• Provision of informed consent
• Males aged 45-85 years
• >60% of the voiding volume is above 100 ml per voiding verified by a urinary diary
• Able to read write and understand given instructions

Exclusion Criteria:

• Patients practicing CIC
• Ongoing symptomatic UTI
• Known Neurological Disease that is affecting the bladder function
• Known past or present alcohol or drug abuse
• Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study site)
• Previous enrolment or randomisation of treatment in the present study.
• Suspected poor compliance based on less than 80 % compliance to voiding diary
• Severe non-compliance to protocol as judged by the investigator and/or Astra Tech
• On alpha-blocker or 5-alpha reductase inhibitor treatment, treatment started less than 2 months prior to enrolment
• Clinic flow below 100 ml