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

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.

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Key information

Conditions

Bladder Outlet Obstruction Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urethral Diseases Urethral Obstruction Urinary Bladder Diseases Urinary Bladder Neck Obstruction Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

45 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

UMC ST Radboud Nijmegen, Department of Urology, Nijmegen, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Disposable device

Device

Disposable urine flow meter

Digital device

Device

Digital urine flowmeter

Clinic flow measurement

Device

Clinic gold standard flow measurement

Primary outcomes

Mean Urine Flow Rate

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

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.

Sponsors and collaborators

Lead sponsor

Wellspect HealthCare

Industry

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Jul 4, 2008
Registry last updated: Nov 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed