|- candidate number||0|
|- NTR Number||NTR100|
|- Date ISRCTN created||20-feb-2007|
|- date ISRCTN requested||18-aug-2005|
|- Date Registered NTR||19-jul-2005|
|- Secondary IDs||ZonMw 2100.0070 |
|- Public Title||Prevention of Lower Urinary Tract Symptoms (LUTS) in elderly males; the effects of an increased urine output on symptoms and bladder functioning.|
|- Scientific Title||Prevention of Lower Urinary Tract Symptoms (LUTS) in elderly males; the effects of an increased urine output on symptoms and bladder functioning.|
|- hypothesis||Increasing the urine output will lead to improved bladder function and to a decrease in symptom severity.|
|- Healt Condition(s) or Problem(s) studied||Prostate cancer, Lower Urinary Tract Symptoms (LUTS)|
|- Inclusion criteria||The 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 criteria||The 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 received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||15-jun-2000|
|- planned closingdate||15-jun-2003|
|- Target number of participants||141|
|- Interventions||People 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 outcome||Maximum Uroflow, measured in ml/s
Symptoms, measured with the International Prostate Symptom Score (IPSS).
|- Secondary outcome||Perceived 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.|
|- Trial web site||N/A|
|- status||stopped: 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|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Publications||J Am Geriatr Soc. 2006 Mar;54(3):438-43.|
|- Brief summary||N/A|
|- Main changes (audit trail)|
|- RECORD||17-aug-2005 - 4-jun-2008|