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

Completed · Not applicable

Conditions studied: Bladder Outlet Obstruction, Lower Urinary Tract Symptoms

In brief

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.

Key facts

Study ID

NCT00710749

Run by

Wellspect HealthCare

People needed

60

Starts

2008-07-01

Expected to finish

2009-03-01

Last updated by the study team

2021-11-11

Who can join

Age: 45 and older, up to 85. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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