involuntary urine loss due to increased abdominal pressure. stress urinary incontinence
Conditions
Interventions
None listed
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Male >= 18 years of age • Subjectively dry after ProACT implantation for post-prostatectomy incontinence • Mentally and physically able to visit the outpatient clinic • Signed informed consent
Exclusion criteria
Exclusion criteria: • Unable to urinate in a standing position • Maximum urinary flow rate below 5 ml/s • Previous lower urinary tract surgery, except ProACT* implantation • Congenital disease of the lower urinary tract • Heart failure • Use of anticoagulants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| From invasive pressure flow study (if applicable): • Urethral resistance parameters (BOOI (Bladder Outlet Obstruction Index)) • Bladder contractility parameters (Wmax (maximum bladder contractility)) From non-invasive condom catheter measurements: • Isovolumetric bladder pressure (Pcond.max) • URR (urethral resistance); an experimental non-invasive measure for bladder outlet obstruction, calculated from the maximum condom pressure (Pcond.max) and the maximum free flow rate. [9] | — |
Secondary
| Measure | Time frame |
|---|---|
| From free flow-rate measurement: • Maximum urinary flow-rate • Voided volume From invasive pressure flow study (if applicable): • Detrusor pressure at maximum flow-rate • Maximum flow-rate • Urethral resistance parameters (URA (Urethral Resistance Factor), Average and slope of lowest part of PURR (Passive Urethral Resistance Relation)) • Bladder contractility parameters (BCI (Bladder Contractility Index)) From non-invasive condom catheter measurements: • Maximum flow-rate • Residual urine volume measured by transabdominal ultrasound • IPSS (International Prostate Symptom Score) questionnaire • QoL questionnaire | — |
Countries
Netherlands
Outcome results
None listed