An interventional study of Disposable device and Digital device in Bladder Outlet Obstruction and Lower Urinary Tract Symptoms, sponsored by Wellspect HealthCare. Completed at 4 sites in 4 countries. Open to male participants aged 45 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-11-11.
Sponsored by Wellspect HealthCare (part of Dentsply Sirona) · Not applicable, Interventional, and Diagnostic
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.
46 studies on the registry are indexed under Urinary Bladder Neck Obstruction; 10 are open to participants now.
This study's enrollment of 60 is below the median of 88 across 30 interventional studies indexed under Urinary Bladder Neck Obstruction.
Browse Urinary Bladder Neck Obstruction studies →Wellspect HealthCare is the lead sponsor of 23 studies on the registry; 1 is open to participants now.
First submitted before Wellspect HealthCare became part of Dentsply Sirona.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Disposable device · Device: Digital device · Device: Clinic flow measurement
Device: Disposable device · Device: Digital device · Device: Clinic flow measurement
Disposable urine flow meter
Digital urine flowmeter
Clinic gold standard flow measurement
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.
Time frame: At every voiding event during approximately one week.
| Milestone | Disposable Device First, Then Digital Device | Digital Device First, Then Disposable Device |
|---|---|---|
| Started | 30 | 30 |
| Completed | 30 | 30 |
| Not completed | 0 | 0 |
| Milestone | Disposable Device First, Then Digital Device | Digital Device First, Then Disposable Device |
|---|---|---|
| Started | 30 | 30 |
| Completed | 29 | 30 |
| Not completed | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Milestone | Disposable Device First, Then Digital Device | Digital Device First, Then Disposable Device |
|---|---|---|
| Started | 29 | 30 |
| Completed | 29 | 30 |
| Not completed | 0 | 0 |
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.
| ml/s | Disposable Device | Clinic | Digital Device |
|---|---|---|---|
| Mean Urine Flow Rate | 12 ± 4 | 13 ± 7 | 16 ± 8 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Disposable Device | — | 0/60 (0%) | 0/60 (0%) |
| Clinic | — | 0/60 (0%) | 0/60 (0%) |
| Digital Device | — | 0/60 (0%) | 0/60 (0%) |
| Age, Continuous(years) | Entire Study Population |
|---|---|
| Mean | 66 ± 9.8 |
| Sex: Female, Male(Participants) | Entire Study Population |
|---|---|
| Female | 0 |
| Male | 60 |
| Region of Enrollment(participants) | Entire Study Population |
|---|---|
| United States | 2 |
| Poland | 16 |
| Netherlands | 13 |
| United Kingdom | 29 |
The record gives a start of Jul 2008, a primary completion of Mar 2009 and a completion of Mar 2009. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2011, 2 years 3 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Urinary Bladder Neck Obstruction →