CompletedNot Applicable

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

United States, Netherlands, Poland60 participantsStarted 2008-07

Plain-language summary

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.

Who can participate

Age range45 Years – 85 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Mean Urine Flow Rate

Timeframe: At every voiding event during approximately one week.

Trial details

NCT IDNCT00710749

SponsorWellspect HealthCare

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-03

Results submitted2011-03-18

View on ClinicalTrials.gov More Bladder Outlet Obstruction trials