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Prevention of Lower Urinary Tract Symptoms (LUTS) in elderly males; the effects of an increased urine output on symptoms and bladder functioning.


- candidate number0
- NTR NumberNTR100
- ISRCTNISRCTN91699014
- Date ISRCTN created20-feb-2007
- date ISRCTN requested18-aug-2005
- Date Registered NTR19-jul-2005
- Secondary IDsZonMw 2100.0070 
- Public TitlePrevention of Lower Urinary Tract Symptoms (LUTS) in elderly males; the effects of an increased urine output on symptoms and bladder functioning.
- Scientific TitlePrevention of Lower Urinary Tract Symptoms (LUTS) in elderly males; the effects of an increased urine output on symptoms and bladder functioning.
- ACRONYMN/A
- hypothesisIncreasing the urine output will lead to improved bladder function and to a decrease in symptom severity.
- Healt Condition(s) or Problem(s) studiedProstate cancer, Lower Urinary Tract Symptoms (LUTS)
- Inclusion criteriaThe study population was recruited via 21 general practices.
The GPs invited their total male population between 55 and 75 years of age to participate.
A screening questionnaire, containing the International Prostate Symptom Score (IPSS; range 0-35) (17, 18), questions on co-morbidity, and a 24-hours drink diary, together with the informed consent documents, were enclosed with the doctor's invitation.
1911 men gave informed consent and were screened for moderate LUTS (IPSS-score: 8-19).
- Exclusion criteriaThe main exclusion criteria were:
1. The presence of mild (IPSS-score: 0-7) or severe (IPSS-score: 20-35) LUTS;
2. A self reported fluid intake above 2 litres per day.


Other exclusion criteria were:
1. The presence of diabetes;
2. Parkinson's disease;
3. Renal diseases;
4. Past surgery of the lower urinary tract;
5. A history of prostatic or bladder carcinoma;
6. The use of diuretics, medication for LUTS, or tricyclic antidepressive agents.


We excluded 1673 men on the basis of these criteria. The remaining 238 men were invited for an intake visit and for a baseline assessment. At this point participants were excluded if no baseline assessment was possible (e.g., inability to urinate in the presence of the assessor), if prostate cancer was diagnosed (PSA > 4.0 ėg/l followed by biopsy that confirmed the presence of a carcinoma), or if they had a serum sodium level below 130 mmol/l.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-jun-2000
- planned closingdate15-jun-2003
- Target number of participants141
- InterventionsPeople in the intervention group were advised to drink 1.5 litres of water per day, additional to their normally consumed beverages, for a period of six months. They were advised to divide this amount into three portions of 0.5 litre spread over the day. To improve the adherence to the intervention they were supplied with 0.5 litre glasses. The control group received a placebo intervention in the form of syrup (one tablespoon (8ml) each day during dinner), also for a period of six months.
- Primary outcomeMaximum Uroflow, measured in ml/s Symptoms, measured with the International Prostate Symptom Score (IPSS).
- Secondary outcomePerceived benefit of the intervention, 7-point scale (ranging from "much worse" to "much better"). Isovolumetric maximum bladder pressure, measured with non-invasive extrenal condom catheter method. Bladder wall thickness, measured ultrasonografically by measuring the thickness of the anterior bladder wall.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES M.G. Spigt
- CONTACT for SCIENTIFIC QUERIES M.G. Spigt
- Sponsor/Initiator University Maastricht (UM), Department General Practitioner Medicine
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsJ Am Geriatr Soc. 2006 Mar;54(3):438-43.
- Brief summaryN/A
- Main changes (audit trail)
- RECORD17-aug-2005 - 4-jun-2008


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