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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00710749
Recruitment Status : Completed
First Posted : July 4, 2008
Results First Posted : June 23, 2011
Last Update Posted : November 11, 2021
Sponsor:
Information provided by (Responsible Party):
Wellspect HealthCare

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Bladder Outlet Obstruction Lower Urinary Tract Symptoms Device: Disposable device Device: Digital device Device: Clinic flow measurement Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official 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
Study Start Date : July 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00710749


Locations
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United States, California
David Geffen school of Medicine at UCLA, Department of Urology
Los Angeles, California, United States, 90095-1738
Netherlands
UMC ST Radboud Nijmegen, Department of Urology
Nijmegen, Netherlands, 6500 HB
Poland
Klinika Urology, Akademi Medycznej
Warsaw, Poland, 02005
United Kingdom
Clinical Research Unit, Morriston Hospital, Swansea NHS Trust
Swansea, United Kingdom, SA6 6NL
Sponsors and Collaborators
Wellspect HealthCare
Investigators
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Study Chair: Magnus Jacobsson, Prof. Dentsply Sirona Implants
More Information
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Responsible Party: Wellspect HealthCare
ClinicalTrials.gov Identifier: NCT00710749    
Other Study ID Numbers: YA-FLO-0001
First Posted: July 4, 2008    Key Record Dates
Results First Posted: June 23, 2011
Last Update Posted: November 11, 2021
Last Verified: November 2021
Keywords provided by Wellspect HealthCare:
Lower urinary tract symptoms leading to lower flow rates
Additional relevant MeSH terms:
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Urinary Bladder Neck Obstruction
Lower Urinary Tract Symptoms
Urological Manifestations
Urethral Obstruction
 Urethral Diseases
Urologic Diseases
Urinary Bladder Diseases