|- candidate number||1239|
|- NTR Number||NTR146|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||25-aug-2005|
|- Secondary IDs||17 |
|- Public Title||The voiding position study - a replicated randomised single case experiment.|
|- Scientific Title||The voiding position study (RRSCE).|
|- ACRONYM||The voiding position study (RRSCE)|
|- hypothesis||The position in which men with Lower urinary tract symptoms are voiding may have an influence on the quality of the voiding. |
The Dutch guidelines for the treatment of LUTS in general practice recommend patients to void in a sitting position. It is unclear whether this advise is correct.
The (little) available evidence suggests it may even be wrong.
|- Healt Condition(s) or Problem(s) studied||Lower Urinary Tract Symptoms (LUTS)|
|- Inclusion criteria||1. Men; |
2. Age >= 55 years;
3. Moderate LUTS, i.e. total score on the International Prostate Symptom Score 8-19.
|- Exclusion criteria||History of surgery for LUTS, e.g. prostatectomy; current use of medication that may influence voiding, e.g. diuretics, anticholinergic medication, alpha-blockers, 5-alph-reductase inhibitors.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-aug-2004|
|- planned closingdate||22-mrt-2005|
|- Target number of participants||21|
|- Interventions||Two positions in which men can void are compared:|
|- Primary outcome||Peak Urinary Flow Rate.|
|- Secondary outcome||1. Mean urinary flow rate;|
2. Mean micturition time;
3. Experienced differences.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||MD. LLM. Roelf J.C. Norg|
|- CONTACT for SCIENTIFIC QUERIES||MD. LLM. Roelf J.C. Norg|
|- Sponsor/Initiator ||University Maastricht (UM), CAPHRI Research Institute|
(Source(s) of Monetary or Material Support)
|the Netherlands Organisation for Health Research and Development|
|- Brief summary||The voiding position study (RRSCE)|
The Dutch guidelines for the management of Lower urinary tract symptoms (LUTS) recommend general lifestyle advices. One of these is to void in a sitting position. This advice is not evidence-based. Little research has been done. The results are not conclusive. It seems that the standing position may be most favourable, contrary to the advice in the guideline.
Primary research question:
Does the peak urinary flow rate differ between a sitting or standing voiding position?
Secundary research questions:
Does the mean urinary flow rate differ between a sitting or standing voiding position?
Does the micturition time differ between a sitting or standing voiding position?
Do men with moderate LUTS experience differences in symptoms between a sitting or standing voiding position?
replicated randomized single case experiment.
|- Main changes (audit trail)|
|- RECORD||18-aug-2005 - 2-jul-2008|