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

Lower Urinary Tract Symptoms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00710749
• Other study ID #: YA-FLO-0001
• Status: Completed
• Phase: N/A
• Start date: July 2008
• Est. completion date: March 2009

Study information

• Verified date: November 2021
• Source: Wellspect HealthCare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Bladder Outlet Obstruction
• Lower Urinary Tract Symptoms
• Urinary Bladder Neck Obstruction

Intervention

Device:
• Disposable device
Disposable urine flow meter
• Digital device
Digital urine flowmeter
• Clinic flow measurement
Clinic gold standard flow measurement

Locations

Country	Name	City	State
Netherlands	UMC ST Radboud Nijmegen, Department of Urology	Nijmegen
Poland	Klinika Urology, Akademi Medycznej	Warsaw
United Kingdom	Clinical Research Unit, Morriston Hospital, Swansea NHS Trust	Swansea
United States	David Geffen school of Medicine at UCLA, Department of Urology	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Wellspect HealthCare

Countries where clinical trial is conducted

United States,  Netherlands,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At every voiding event during approximately one week.