None listed
Conditions
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
Sponsors
None listed
Eligibility
Inclusion criteria
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
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 ìg/l followed by biopsy that confirmed the presence of a carcinoma), or if they had a serum sodium level below 130 mmol/l.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Primary
| Measure | Time frame |
|---|---|
| Maximum Uroflow, measured in ml/s Symptoms, measured with the International Prostate Symptom Score (IPSS). | — |
Contacts
Public ContactM.G. Spigt
University Maastricht (UM), CAPHRI Research Institute, P.O.Box 616
Outcome results
None listed