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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wellspect HealthCare
ClinicalTrials.gov Identifier:
NCT00710749
First received: July 3, 2008
Last updated: September 27, 2012
Last verified: September 2012
History of Changes
  Purpose

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 Intervention
Bladder Outlet Obstruction
Lower Urinary Tract Symptoms
 Device: Disposable device
Device: Digital device
Device: Clinic flow measurement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wellspect HealthCare:

Primary Outcome Measures:
  • Mean Urine Flow Rate [ Time Frame: At every voiding event during approximately one week. ] [ Designated as safety issue: No ]
    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.


Enrollment: 60
Study Start Date: July 2008
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   45 Years to 85 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00710749

Locations
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
Study Chair: Magnus Jacobsson, Prof. Dentsply Implants
  More Information

No publications provided

Responsible Party: Wellspect HealthCare
ClinicalTrials.gov Identifier: NCT00710749     History of Changes
Other Study ID Numbers: YA-FLO-0001
Study First Received: July 3, 2008
Results First Received: March 18, 2011
Last Updated: September 27, 2012
Health Authority: United Kingdom: Research Ethics Committee
Poland: Ethics Committee
Netherlands: Independent Ethics Committee
United States: Institutional Review Board

Keywords provided by Wellspect HealthCare:
Lower urinary tract symptoms leading to lower flow rates

Additional relevant MeSH terms:
Prostatic Hyperplasia
Urinary Bladder Neck Obstruction
Prostatic Diseases
Genital Diseases, Male
 Urethral Obstruction
Urethral Diseases
Urologic Diseases
Urinary Bladder Diseases

ClinicalTrials.gov processed this record on May 21, 2013