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Non-invasive ultrasonic diagnosis of urinary Bladder Outlet Obstruction (BOO)

Non-invasive ultrasonic diagnosis of urinary Bladder Outlet Obstruction (BOO) - Ultrasonic BOO diagnosis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON40568
Enrollment
125
Registered
2014-04-16
Start date
2014-07-21
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bladder obstruction Urethral obstruction

Interventions

None listed

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) Male 18 years or older 2) Healthy volunteers: student or staff member at Erasmus MC 3) Patients: eligible for TURP based on clinical criteria who will be urodynamically investigated at Erasmus MC 4) Mentally and physically able to visit the Erasmus MC 5) Signed informed consent

Exclusion criteria

Exclusion criteria: 1) Unable to urinate in a standing position 2) Previous lower urinary tract surgery 3) Congenital disease of the lower urinary tract

Design outcomes

Primary

MeasureTime frame
The raw ultrasound data will be processed using Matlab procedures developed in an earlier study resulting in decorrelation curves.

Secondary

MeasureTime frame
In healthy volunteers from free flow-rate measurement: Maximum urinary flow-rate and voided volume are quantitative parameters that will be derived using earlier developed Matlab procedures in the flowmeter setup. They will be used to verify/support the stratification of patients according to the degree of obstruction. In patients from free flow-rate measurement: Maximum urinary flow-rate and voided volume are quantitative parameters that are automatically calculated by Audact software used in the clinical urodynamic setups. The parameters are stored in Ms-Access databases in Erasmus MC servers. They will be to verify/support the stratification of patients according to the degree of obstruction. In patients from invasive pressure flow study: Detrusor pressure at maximum flow-rate Maximum flow-rate Urethral resistance parameters URA (Urethral Resistance Factor) BOOI (Bladder Outlet Obstruction Index) Slope of lowest part of PURR (Passive Urethral Resistance Relation) Bladder contractility parameters Wmax (maximum bladder contractility) BCI (Bladder Contractility Index) These parameters will be used to relate the (de)correlation of the ultrasound images to the degree of obstruction and/or bladder contractility of the patients.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)