Bladder Outlet Obstruction, Lower Urinary Tract Symptoms
Conditions
Keywords
Lower urinary tract symptoms leading to lower flow rates
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.
Interventions
DEVICEDisposable device
Disposable urine flow meter
DEVICEDigital device
Digital urine flowmeter
DEVICEClinic flow measurement
Clinic gold standard flow measurement
Sponsors
Wellspect HealthCare
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Netherlands, Poland, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population Includes groups randomized to use the Disposable device first and the Digital device first. | 60 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Continuous | 66 years STANDARD_DEVIATION 9.8 |
| Region of Enrollment Netherlands | 13 participants |
| Region of Enrollment Poland | 16 participants |
| Region of Enrollment United Kingdom | 29 participants |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 60 | 0 / 60 | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 | 0 / 60 |
Outcome results
Primary
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.
Population: Intention to treat analysis. Number of participants analyzed differs between groups since data was missing mainly due to technical problems.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Disposable Device | Mean Urine Flow Rate | 12 ml/s | Standard Deviation 4 |
| Clinic | Mean Urine Flow Rate | 13 ml/s | Standard Deviation 7 |
| Digital Device | Mean Urine Flow Rate | 16 ml/s | Standard Deviation 8 |
p-value: 0.44Wilcoxon signed rank test
p-value: 0.0001Wilcoxon signed rank test
p-value: <0.0001Wilcoxon signed rank test