Improve postoperative urine continence after prostatectomy for prostate cancer.
ID
Source
Brief title
Condition
- Urinary tract signs and symptoms
- Renal and urinary tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Urine continence at 3 and 6 months postoperatively assesed using questionnaires
and the urine pad test.
Secondary outcome
Urine retention and bladder/urethra anastomosis stricture formation and urine
leakage at cystogram and erectile function recovery.
Background summary
Urine incontinence is a relatively frequent problem after prostatectomy. Most
men have problems retaining urine in the first months after surgery. In the
first 6 to 12 months the majority of men experience urine loss to some degree.
Possible explanations are mentioned neuropraxia of pelvic floor muscles,
denervation of the proximal urethra, local damage to the musculature of the
pelvic floor, and the loss of the urethral closure mechanism by the prostate.
Although urine continence recovers in most men after several months. Several
methods have been applied to prevent early urine incontinence. Moreover,
secondary (suspension) procedures of the urethra have been suggested to treat
postprostatectomy urine incontinence. The current study evaluates the use of
urethra support by a suburethrale placed vas deferens to prevent early
postprostatectomy urine incontinence.
Study objective
Improve postoperative urine continence after prostatectomy for prostate cancer.
Study design
A randomized prospective analysis with single-blind design (the surgeon can not
be blinded). Patients will not be informed on the selected treatment.
Intervention
After the prostatectomy procedure men will be intraoperatively randomized
between the vas deferens urethral support (VDUS) procedure or standard
anastomosis. VDUS will be performed by isolation of 15cm of vas deferens
isolated from the right or left parailiac region. The vas section will be used
as a sling underneath the proximal membranous urethra and fixed to the pubic
bone on both sides. A 60cm H2O tension will be applied prior to fixation of the
vas deferens to the pubic bone.
Study burden and risks
The prostatectomy procedure will be prolonged by an estimated 10 minutes for
the VDUS procedure. After a prostatectomy the vas deferens is no longer
functional and can be used for suspension. Early results from perineal
suspension methods showed risk of urine retention after suspension over 60cm of
H2O pressure. For this reason suspension will be limited to this level of
urethral pressure as described above. In the case of postoperative retention
requiring recatheterisation it can be expected that with time the vas
difference will dissolve considering the fact that it is fully disconnected
from its blood supply. This will probably occur within several months. If no
sufficient urine passage is acquired by that time, a bladder neck incision is
feasible without extra risk for urethral sphincter damage considering the fact
that the suspension will be positioned at the bladder neck rather than the
urethral sphincter.
plesmanlaan 121
1066 CX Amsterdam
NL
plesmanlaan 121
1066 CX Amsterdam
NL
Listed location countries
Age
Inclusion criteria
= localized prostate cancer treated with prostatectomy
= normal preoperative urine continence
Exclusion criteria
= earlier prostatic surgery such as TURP
= non-dutch speaking men
= inability to understand informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL26125.031.09 |