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.…
ID
Source
Brief title
Condition
- Bladder and bladder neck disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
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 non-invasively. 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.
Study objective
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.
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 burden and risks
In a previous study "A longitudinal non-invasive study of changes in urinary
bladdercontractility secondary to prostatic enlargement" (MEC 202.680/2001/148)
the noninvasive study method has been applied to 1073 participants. Thus far,
the following complications have occurred:
1. Urinary retention in one subject. The investigation did not seem to be the
only factor contributing to the occurrence of this condition. Insofar as
the investigation has been a contributing factor, this seems to be
avoidable if subjects adhere to the instructions given during the
investigation.
2. Urinary tract infection in 1 subject. Treated by antibiotics.
3. Slight, self-limiting macroscopic haematuria in 67 subjects (7%). The
subjects were advised to drink water. No additional treatment was
given.
's-Gravendijkwal 230
3015 CE Rotterdam
NL
's-Gravendijkwal 230
3015 CE Rotterdam
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL31230.078.10 |
| OMON | NL-OMON21192 |