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

Not Applicable

Completed

• Conditions: Lower Urinary Tract Symptoms; Bladder Outlet Obstruction
• Interventions: Device: Disposable device; Device: Digital device; Device: Clinic flow measurement

• Registration Number: NCT00710749
• Lead Sponsor: Wellspect HealthCare

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-03
• Study First Submitted QC: 2008-07-03
• Study First Posted: 2008-07-04
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Results First Submitted: 2011-03-18
• Results First Submitted QC: 2011-05-30
• Results First Posted: 2011-06-23
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-10
• Last Update Posted: 2021-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Disposable device first, then Digital device	Disposable device	-
Disposable device first, then Digital device	Clinic flow measurement	-
Disposable device first, then Digital device	Digital device	-
Digital device first, then Disposable device	Disposable device	-
Digital device first, then Disposable device	Digital device	-
Digital device first, then Disposable device	Clinic flow measurement	-

Primary Outcome Measures

Name	Time	Method
Mean Urine Flow Rate	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.

Trial Locations

Locations (4)

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