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

Wellspect HealthCare60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Bladder Outlet Obstruction Lower Urinary Tract Symptoms

Interventions

Disposable deviceDEVICE

Disposable urine flow meter

Digital deviceDEVICE

Digital urine flowmeter

Clinic flow measurementDEVICE

Clinic gold standard flow measurement

Eligibility

Sex: MALEMin age: 45 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (4)

David Geffen school of Medicine at UCLA, Department of Urology

Los Angeles, California, United States

UMC ST Radboud Nijmegen, Department of Urology

Nijmegen, Netherlands

Klinika Urology, Akademi Medycznej

Warsaw, Poland

Clinical Research Unit, Morriston Hospital, Swansea NHS Trust

Swansea, United Kingdom

Outcomes

Primary Outcomes

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.

Time frame: At every voiding event during approximately one week.

Data from ClinicalTrials.gov

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