Bladder Outlet ObstructionNCT00710749
The Value of Multiple Urine Flow Rate Measurements in Male Benign Prostatic Hyperplasia (BPH) Subjects
A study testing Disposable device, Digital device and Clinic flow measurement in people with Bladder Outlet Obstruction and Lower Urinary Tract Symptoms, run by Wellspect HealthCare at 4 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 45 to 85 years, men only
- Conditions the study is for
- Bladder Outlet Obstruction, Lower Urinary Tract Symptoms
- What is being tested?
- Disposable device, Digital device and Clinic flow measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Jul 2008to Mar 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 10Show fewer
- 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
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
United States1 site
David Geffen school of Medicine at UCLA, Department of Urology
Los Angeles, California, 90095-1738
Netherlands1 site
UMC ST Radboud Nijmegen, Department of Urology
Nijmegen, 6500 HB
United Kingdom1 site
Clinical Research Unit, Morriston Hospital, Swansea NHS Trust
Swansea, SA6 6NL
About this study
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
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.
- Being tested
- Disposable device, Digital device, Clinic flow measurement
- Keywords
- Lower urinary tract symptoms leading to lower flow rates
- Medical subject headings
- Urinary Bladder Neck Obstruction, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disposable deviceDevice
Disposable urine flow meter
Digital deviceDevice
Digital urine flowmeter
Clinic flow measurementDevice
Clinic gold standard flow measurement
| Study group | Role | What they receive |
|---|---|---|
| Disposable device first, then Digital device | Experimental | Not described Receives: Device: Disposable device; Device: Digital device; Device: Clinic flow measurement |
| Digital device first, then Disposable device | Experimental | Not described Receives: Device: Disposable device; Device: Digital device; Device: Clinic flow measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At every voiding event during approximately one week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bladder Outlet ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wellspect HealthCare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Magnus Jacobsson, Prof., Study chair, Dentsply Sirona Implants and Consumables
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00710749
- Sponsor's protocol ID
- YA-FLO-0001
- Status last verified
- Nov 2021
- First submitted
- 3 Jul 2008
- Last updated
- 11 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00710749
- Acronym / sponsor ID
- YA-FLO-0001
- Keywords
- Lower urinary tract symptoms leading to lower flow rates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Wellspect HealthCareIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 4 Jul 2008 (estimated)
- Results
- Posted 23 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Disposable device first, then Digital device | Experimental | Device: Disposable device, Device: Digital device, Device: Clinic flow measurement |
| Digital device first, then Disposable device | Experimental | Device: Disposable device, Device: Digital device, Device: Clinic flow measurement |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Disposable deviceDisposable urine flow meter | Device | Digital device first, then Disposable device, Disposable device first, then Digital device |
| Digital deviceDigital urine flowmeter | Device | Digital device first, then Disposable device, Disposable device first, then Digital device |
| Clinic flow measurementClinic gold standard flow measurement | Device | Digital device first, then Disposable device, Disposable device first, then Digital device |
Primary outcome
Mean Urine Flow Rate
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magnus Jacobsson, Prof. study chair
Dentsply Sirona Implants and Consumables
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Disposable device, Digital device and Clinic flow measurement in people with Bladder Outlet Obstruction and Lower Urinary Tract Symptoms, run by Wellspect HealthCare at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Netherlands, Poland, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Urine Flow Rate (time frame: At every voiding event during approximately one week.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2021.