|- candidate number||13474|
|- NTR Number||NTR3678|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-okt-2012|
|- Secondary IDs||080678 IWT|
|- Public Title||Dynamics of male pelvic floor contractions through transperineal ultrasound imaging in continent and incontinent patients after radical prostatectomy.|
|- Scientific Title||Dynamics of male pelvic floor contractions through transperineal ultrasound imaging in continent and incontinent patients after radical prostatectomy.|
|- hypothesis||1. To investigate the intra- and interreliability of transperineal ultrasound measurements of the displacement of multiple points along the urethra in men after radical prostatectomy;|
2. To compare the relative displacement of urethrovesical junction, anorectal junction and distal urethra during voluntary pelvic floor muscle contractions from preoperative to 3 months postoperative after radical prostatectomy;
3. To compare the relative displacement of urethrovesical junction, anorectal junction and distal urethra during voluntary pelvic floor muscle contractions between continent and incontinent men after radical prostatectomy.
|- Healt Condition(s) or Problem(s) studied||Urinary incontinence, Transperineal ultrasound, Radical prostatectomy|
|- Inclusion criteria||Continent patients:|
1. Patients who will have a radical prostatectomy for localised or locally advanced prostate cancer in the University Hospital Gasthuisberg in Leuven;
2. Patients who can participate in one pre- and one postoperative transperineal ultrasound measurement in the University Hospital Gasthuisberg.
1. Patients who had a radical prostatectomy in the University Hospital Gasthuiberg, minimally 1 year before and are still urinary incontinent;
2. Patients willing to participate in one transperineal ultrasound measurement.
|- Exclusion criteria||Patients who don't want to participate to the study.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-dec-2012|
|- planned closingdate||1-mei-2013|
|- Target number of participants||16|
|- Interventions||Both groups will have transperineal ultrasound.|
Group 1: Patients who are planned for a radical prostatectomy will have a transperineal ultrasound of the displacement of multiple points along the urethra pre- and postoperatively.
Group 2: Patients who had a radical prostatectomy minimum one year before and are still incontinent will have a transperineal ultrasound of the displacement of the same multiple points along the urethra.
|- Primary outcome||To investigate if the displacement of the anorectal junction, ventral and dorsal urethrovesical junction, dorsal point of the bulbus and dorsal point of the striated urethral sphincter have a good intra- and interrater reliability.|
|- Secondary outcome||To compare the displacement of the different structures of urinary continent and incontinent men after radical prostatectomy.|
|- Timepoints||Group 1 (continent men): Preoperatively and 3 months postoperatively;|
Group 2 (incontinent men): Minimum 1 year postoperatively.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| Inge Geraerts|
|- CONTACT for SCIENTIFIC QUERIES|| Inge Geraerts|
|- Sponsor/Initiator ||Kath. Universiteit Leuven, Faculteit Bewegings- en Revalidatiewetenschappen|
(Source(s) of Monetary or Material Support)
|Institute for the Promotion of Innovation by Science and Technology in Flanders (IWT), Toegepast Biomedisch onderzoek met een primaire Maatschappelijke finaliteit (TBM)|
|- Brief summary||Prostate cancer is the most common cancer in men on this moment. Radical prostatectomy is since many years the gold standard for eradication of localized prostate cancer. Urinary incontinence however remains one of the most embarrassing complications after prostatectomy. This project aims to investigate the underlying causes of urinary incontinence by visualising the displacement of several points along the urethra, while contracting the pelvic floor, with transperineal ultrasound. |
|- Main changes (audit trail)|
|- RECORD||24-okt-2012 - 12-nov-2012|