Back to resultsThe Value of Multiple Urine Flow Rate Measurements in Male Benign Prostatic Hyperplasia (BPH) Subjects
Primary Purpose
Bladder Outlet Obstruction, Lower Urinary Tract Symptoms
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Disposable device
Digital device
Clinic flow measurement
Sponsored by
About this trial
This is an interventional diagnostic trial for Bladder Outlet Obstruction focused on measuring Lower urinary tract symptoms leading to lower flow rates
Eligibility 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
Sites / Locations
- David Geffen school of Medicine at UCLA, Department of Urology
- UMC ST Radboud Nijmegen, Department of Urology
- Klinika Urology, Akademi Medycznej
- Clinical Research Unit, Morriston Hospital, Swansea NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Disposable device first, then Digital device
Digital device first, then Disposable device
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00710749
Brief Title
The Value of Multiple Urine Flow Rate Measurements in Male Benign Prostatic Hyperplasia (BPH) Subjects
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wellspect HealthCare
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Outlet Obstruction, Lower Urinary Tract Symptoms
Keywords
Lower urinary tract symptoms leading to lower flow rates
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Disposable device first, then Digital device
Arm Type
Experimental
Arm Title
Digital device first, then Disposable device
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Disposable device
Intervention Description
Disposable urine flow meter
Intervention Type
Device
Intervention Name(s)
Digital device
Intervention Description
Digital urine flowmeter
Intervention Type
Device
Intervention Name(s)
Clinic flow measurement
Intervention Description
Clinic gold standard flow measurement
Primary Outcome Measure Information:
Title
Mean Urine Flow Rate
Description
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.
Time Frame
At every voiding event during approximately one week.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magnus Jacobsson, Prof.
Organizational Affiliation
Dentsply Sirona Implants and Consumables
Official's Role
Study Chair
Facility Information:
Facility Name
David Geffen school of Medicine at UCLA, Department of Urology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1738
Country
United States
Facility Name
UMC ST Radboud Nijmegen, Department of Urology
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands
Facility Name
Klinika Urology, Akademi Medycznej
City
Warsaw
ZIP/Postal Code
02005
Country
Poland
Facility Name
Clinical Research Unit, Morriston Hospital, Swansea NHS Trust
City
Swansea
ZIP/Postal Code
SA6 6NL
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
The Value of Multiple Urine Flow Rate Measurements in Male Benign Prostatic Hyperplasia (BPH) Subjects
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