on-invasive evaluation of urinary bladder contractility and urethral resistance after ProACT treatment of stress urinary incontinence in men: a pilot study.

Completed

Conditions: involuntary urine loss due to increased abdominal pressure.
stress urinary incontinence
10004994

Registration Number: NL-OMON34897

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

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

• 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

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>From invasive pressure flow study (if applicable):<br /><br>• Urethral resistance parameters (BOOI (Bladder Outlet Obstruction Index))<br /><br>• Bladder contractility parameters (Wmax (maximum bladder contractility))<br /><br><br /><br>From non-invasive condom catheter measurements:<br /><br>• Isovolumetric bladder pressure (Pcond.max)<br /><br>• URR (urethral resistance); an experimental non-invasive measure for bladder<br /><br>outlet obstruction, calculated from the maximum condom pressure (Pcond.max) and<br /><br>the maximum free flow rate. [9]</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>From free flow-rate measurement:<br /><br>• Maximum urinary flow-rate<br /><br>• Voided volume<br /><br><br /><br>From invasive pressure flow study (if applicable):<br /><br>• Detrusor pressure at maximum flow-rate<br /><br>• Maximum flow-rate<br /><br>• Urethral resistance parameters (URA (Urethral Resistance Factor), Average and<br /><br>slope of lowest part of PURR (Passive Urethral Resistance Relation))<br /><br>• Bladder contractility parameters (BCI (Bladder Contractility Index))<br /><br><br /><br>From non-invasive condom catheter measurements:<br /><br>• Maximum flow-rate<br /><br>• Residual urine volume measured by transabdominal ultrasound<br /><br>• IPSS (International Prostate Symptom Score) questionnaire<br /><br>• QoL questionnaire</p><br>