|- candidate number||1211|
|- NTR Number||NTR301|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||9-sep-2005|
|- Secondary IDs||A300112 |
|- Public Title||A longitudinal non-invasive study of changes in urinary bladder contractility secondary to benign prostatic hyperplasia.|
|- Scientific Title||A longitudinal non-invasive study of changes in urinary bladder contractility secondary to benign prostatic hyperplasia.|
|- Healt Condition(s) or Problem(s) studied||Benign prostatic hyperplasia (BPH)|
|- Inclusion criteria||1. Men aged 38-77;|
2. Mentally and physically able to complete a voiding diary and to visit the outpatient clinic;
3. Written informed consent to participate in the trial.
|- Exclusion criteria||1. Unable to urinate in a standing position;|
2. Previous lower urinary tract surgery;
3. Congenital disease of the lower urinary tract;
4. Use of medication or other interventions for lower urinary tract symptoms;
5. Other diseases that could alter urinary function (e.g. Parkinson, CVA, DM, kidney failure, bladder/prostate cancer, current urinary tract infection);
6. Heart failure;
7. Voiding pattern at first visit incompatible with measurement technique, e.g. flow rate too low (<6 ml/s), interrupted voiding, straining;
8. Mentally or physically unable to complete a voiding diary and to visit the outpatient clinic;
9. Use anticoagulants.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-nov-2001|
|- planned closingdate||1-okt-2009|
|- Target number of participants||1020|
|- Interventions||Non-invasive measurement of the urinary bladder pressure.|
|- Primary outcome||The study is observational, there is no endpoint.|
|- Secondary outcome||N/A|
|- Trial web site||http://www.erasmusmc.nl/urologie/furore|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Dr. R. Mastrigt, van|
|- CONTACT for SCIENTIFIC QUERIES||Dr. R. Mastrigt, van|
|- Sponsor/Initiator ||Erasmus Medical Center, Department of Urology|
(Source(s) of Monetary or Material Support)
|Dutch Kidney Foundation (Nierstichting Nederland), Vereniging Trustfonds Erasmus University Rotterdam|
|- Publications||1. JWNC Huang Foen Chung, R.van Mastrigt. Correlation of non-invasive urodynamics with IPSS and prostate volume. Neurourol. Urodyn. 22 : 453 - 454 (2003).|
2. JWNC Huang Foen Chung, A. Bohnen, J.J.M.Pel, J.L.H.R.Bosch, R.Niesing, R.van Mastrigt. Application of non-invasive urodynamics to longitudinally study changes in the urinary bladder contractility. Neurourol.Urodyn. 21-4 : 351-352 (2002).
|- Brief summary||With increasing age the prostate enlarges. In response to the increasing resistance to urinary flow, the urinary bladder changes (compensation). At a later stage the bladder may decompensate which eventually makes emptying the bladder impossible (urinary retention). |
During the compensation phase, pressures in the bladder may become excessive, leading to reflux of urine and kidney damage.
Compensation and decompensation of the urinary bladder muscle are important issues in the decision to operate. These changes in function of the bladder muscle can be assessed by calculating its contractility from urodynamic measurements of pressure and flow-rate during voiding. Presently, such pressure measurements are invasive.
For this reason these measurements are not done as often as desirable and have also rarely been done in an epidemiological study.
Therefore no reference data on the development of the contractility of the bladder muscle in response to prostatic enlargement is available and it is unknown if and when a certain degree of obstruction of the outflow tract will cause irreversible damage to the bladder wall muscle.
The sector Furore (Physics, function and reconstruction of the urinary tract) of the department Urology of the EMCR has developed a method to measure the urinary bladder pressure non-invasively.
This method now makes it possible to acquire the necessary reference data in a non-invasive epidemiological study.
|- Main changes (audit trail)|
|- RECORD||16-aug-2005 - 13-nov-2008|