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


- candidate number8098
- NTR NumberNTR2346
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-mei-2010
- Secondary IDsNL31230.078.10 / A300919 ; CCMO / Erasmus MC
- Public TitleNon-invasive evaluation of urinary bladder contractility and urethral resistance after ProACT treatment of stress urinary incontinence in men: a pilot study.
- Scientific TitleNon-invasive evaluation of urinary bladder contractility and urethral resistance after ProACT treatment of stress urinary incontinence in men: a pilot study.
- ACRONYM
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedStress urinary incontinence
- Inclusion criteria1. Male ≥ 18 years of age;
2. Subjectively dry after ProACT implantation for post-prostatectomy incontinence;
3. Mentally and physically able to visit the outpatient clinic;
4. Signed informed consent.
- Exclusion criteria1. Unable to urinate in a standing position;
2. Maximum urinary flow rate below 5 ml/s;
3. Previous lower urinary tract surgery, except prostatectomy and ProACT implantation;
4. Congenital disease of the lower urinary tract;
5. Heart failure.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 15-apr-2010
- planned closingdate15-apr-2012
- Target number of participants50
- InterventionsNon-invasive measurement of the urinary bladder pressure.
- Primary outcomeFrom invasive pressure flow study (if applicable):
1. Urethral resistance parameters (BOOI (Bladder Outlet Obstruction Index));
2. Bladder contractility parameters (Wmax (maximum bladder contractility)).

From non-invasive condom catheter measurements:
1. Isovolumetric bladder pressure (Pcond.max);
2. 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.
- Secondary outcomeFrom free flow-rate measurement:
1. Maximum urinary flow-rate;
2. Voided volume.

From invasive pressure flow study (if applicable):
1. Detrusor pressure at maximum flow-rate;
2. Maximum flow-rate;
3. Urethral resistance parameters (URA (Urethral Resistance Factor), Average and slope of lowest part of PURR (Passive Urethral Resistance Relation));
4. Bladder contractility parameters (BCI (Bladder Contractility Index)).

From non-invasive condom catheter measurements:
1. Maximum flow-rate;
2. Residual urine volume measured by transabdominal ultrasound;
3. IPSS (International Prostate Symptom Score) questionnaire;
4. QoL questionnaire.
- TimepointsWhen subjectively dry after ProACT implantation for post-prostatectomy incontinence.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDrs. E. Utomo
- CONTACT for SCIENTIFIC QUERIESDr. B.F.M. Blok
- Sponsor/Initiator Erasmus Medical Center, Department of Urology
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center, Department of Urology
- PublicationsN/A
- Brief summaryProACT (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.
- Main changes (audit trail)
- RECORD28-mei-2010 - 3-jan-2014


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