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The voiding position study - a replicated randomised single case experiment.


- candidate number1239
- NTR NumberNTR146
- ISRCTNISRCTN62736854
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR25-aug-2005
- Secondary IDs17 
- Public TitleThe voiding position study - a replicated randomised single case experiment.
- Scientific TitleThe voiding position study (RRSCE).
- ACRONYMThe voiding position study (RRSCE)
- hypothesisThe 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) studiedLower Urinary Tract Symptoms (LUTS)
- Inclusion criteria1. Men;
2. Age >= 55 years;
3. Moderate LUTS, i.e. total score on the International Prostate Symptom Score 8-19.
- Exclusion criteriaHistory 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 receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-aug-2004
- planned closingdate22-mrt-2005
- Target number of participants21
- InterventionsTwo positions in which men can void are compared:
1. Sitting;
2. Standing.
- Primary outcomePeak Urinary Flow Rate.
- Secondary outcome1. Mean urinary flow rate;
2. Mean micturition time;
3. Experienced differences.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMD. LLM. Roelf J.C. Norg
- CONTACT for SCIENTIFIC QUERIESMD. LLM. Roelf J.C. Norg
- Sponsor/Initiator University Maastricht (UM), CAPHRI Research Institute
- Funding
(Source(s) of Monetary or Material Support)
the Netherlands Organisation for Health Research and Development
- PublicationsN/A
- Brief summaryThe voiding position study (RRSCE)


1. Background:
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.


2. Onderzoeksvragen:
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?


3. Design:
replicated randomized single case experiment.
- Main changes (audit trail)
- RECORD18-aug-2005 - 2-jul-2008


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