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

ProACT (Prostate Adjustable Continence Therapy) is a therapy used to treat male stress urinary incontinence after
prostatectomy. Too high urethral resistance caused by the balloons can result in a thickened bladder wall with urge
symptoms. In order to diagnose this condition, patients undergo a urodynamic investigation after they are subjectively dry.

This invasive measurement can cause several complications, like lower urinary tract infections and haematuria. The Condom Catheter Method is a newly developed and validated method to assess urinary bladder contractility noninvasively.

In combination with a free-flow rate, it can also be used for diagnosing bladder outlet obstruction. This study
compares the invasive urodynamic method with the non-invasive method to evaluate the effect of ProACT implantation in men with incontinence after radical prostatectomy.



The aim of the study is to investigate the possibility of the use of non-invasive methods for the evaluation of
bladder outlet obstruction after ProACT device implantation by comparing non-invasive measurements with invasive
measurements. The ultimate aim is to use non-invasive urodynamics in stead of invasive urodynamics for the follow up of patients implanted with ProACT.



Study design:

Patients will be invited to undergo the non-invasive condom catheter measurement. A free flow measurement is followed
by two measurements with the condom catheter. During voiding flow is interrupted mechanically. De maximal condom pressure reflects the isovolumetric bladder pressure. The non-invasive measurement will be compared with the invasive measurement patients already receive.



Study population:

Fifty men implanted with Pro-ACT for stress incontinence after radical prostatectomy will be invited to participate in the study.

The aim of the present study is to investigate the possibility of the use of non-invasive methods for the evaluation of
bladder outlet obstruction after ProACT device implantation by comparing non-invasive measurements with invasive
measurements. The ultimate aim is to use non-invasive urodynamics in stead of invasive urodynamics for the follow up of patients implanted with ProACT.

When subjectively dry after ProACT implantation for post-prostatectomy incontinence.

Non-invasive measurement of the urinary bladder pressure.