Status:
COMPLETED
The Value of Multiple Urine Flow Rate Measurements in Male Benign Prostatic Hyperplasia (BPH) Subjects
Lead Sponsor:
Wellspect HealthCare
Conditions:
Bladder Outlet Obstruction
Lower Urinary Tract Symptoms
Eligibility:
MALE
45-85 years
Phase:
NA
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 understand...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00710749
Start Date
July 1 2008
End Date
March 1 2009
Last Update
November 11 2021
Active Locations (4)
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1
David Geffen school of Medicine at UCLA, Department of Urology
Los Angeles, California, United States, 90095-1738
2
UMC ST Radboud Nijmegen, Department of Urology
Nijmegen, Netherlands, 6500 HB
3
Klinika Urology, Akademi Medycznej
Warsaw, Poland, 02005
4
Clinical Research Unit, Morriston Hospital, Swansea NHS Trust
Swansea, United Kingdom, SA6 6NL