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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Bladder Outlet Obstruction, Lower Urinary Tract Symptoms

Intervention / Treatment
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* Device: Disposable device
* Device: Digital device
* Device: Clinic flow measurement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Disposable device first, then Digital device<br> | Device: Disposable device<br>* Disposable urine flow meter<br>Device: Digital device<br>* Digital urine flowmeter<br>Device: Clinic flow measurement<br>* Clinic gold standard flow measurement<br>|
| Experimental: Digital device first, then Disposable device<br> | Device: Disposable device<br>* Disposable urine flow meter<br>Device: Digital device<br>* Digital urine flowmeter<br>Device: Clinic flow measurement<br>* Clinic gold standard flow measurement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Urine Flow Rate | Measurements with a disposable device and the current clinic gold standard measurement were compared to test the hypothesis that three repeated measurements with the disposable device was as accurate as one clinic flow measurement. A digital device was used as a reference of the most exact way to evaluate each patient's individual flow. | At every voiding event during approximately one week. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lower urinary tract symptoms leading to lower flow rates