At a glance
ClinicalIndex Comparison RecordN/ACompleted· 60 enrolled
Drug / intervention
Disposable device +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating Disposable device, Digital device, and 1 other intervention for Bladder Outlet Obstruction and Lower Urinary Tract Symptoms. Completed, enrolled 60 participants across 4 sites in 4 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesNetherlands, Poland, United Kingdom, United States
Collaborators--
Timeline
N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2008
First PostedJul 2008
Primary CompletionMar 2009
TodayJul 2026
First PostedJul 4, 2008
Enrollment StartJul 1, 2008
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 18.0 years ago
Interventions
Disposable devicedevice
Disposable urine flow meter
Digital devicedevice
Digital urine flowmeter
Clinic flow measurementdevice
Clinic gold standard flow measurement