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

November 10, 2021 updated by: Wellspect HealthCare

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Nijmegen, Netherlands, 6500 HB
        • UMC ST Radboud Nijmegen, Department of Urology
  • Poland
      • Warsaw, Poland, 02005
        • Klinika Urology, Akademi Medycznej
  • United Kingdom
      • Swansea, United Kingdom, SA6 6NL
        • Clinical Research Unit, Morriston Hospital, Swansea NHS Trust
  • United States
    • California
      • Los Angeles, California, United States, 90095-1738
        • David Geffen school of Medicine at UCLA, Department of Urology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Disposable device first, then Digital device
Device: Disposable device
Disposable urine flow meter
Device: Digital device
Digital urine flowmeter
Device: Clinic flow measurement
Clinic gold standard flow measurement
Experimental: Digital device first, then Disposable device
Device: Disposable device
Disposable urine flow meter
Device: Digital device
Digital urine flowmeter
Device: Clinic flow measurement
Clinic gold standard flow measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At every voiding event during approximately one week.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wellspect HealthCare

Investigators

  • Study Chair: Magnus Jacobsson, Prof., Dentsply Sirona Implants

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

July 3, 2008

First Submitted That Met QC Criteria

July 3, 2008

First Posted (Estimate)

July 4, 2008

Study Record Updates

Last Update Posted (Actual)

November 11, 2021

Last Update Submitted That Met QC Criteria

November 10, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YA-FLO-0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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