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

Wellspect HealthCare

Status

Completed

Conditions

Lower Urinary Tract Symptoms

Bladder Outlet Obstruction

Treatments

Device: Disposable device

Device: Digital device

Device: Clinic flow measurement

Study type

Interventional

Funder types

Industry

Identifiers

NCT00710749

YA-FLO-0001

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

Male

Ages

45 to 85 years old

Volunteers

No Healthy Volunteers

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