Prevention of lower urinary tract symptoms in elderly males: the effects of an increased urine output on symptoms and bladder functioning

Completed

Conditions: Prostate Cancer, Lower Urinary Tract Symptoms (LUTS)
Urological and Genital Diseases
Other symptoms and signs involving the urinary system

Registration Number: ISRCTN91699014

Lead Sponsor: niversity Maastricht (UM) (The Netherlands)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Male

Target Recruitment: 141

Inclusion Criteria

1. Males, aged between 55 and 75 years of age
2. Gave informed consent
3. Screened for moderate Lower Urinary Tract Symptoms (LUTS) (International Prostate Symptom Score [IPSS] : eight to 19)

Exclusion Criteria

The main exclusion criteria were:
1. The presence of mild (IPSS-score: zero to seven) or severe (IPSS-score: 20 to 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
1. 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 (Prostate Specific Antigen [PSA] more than 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximum Uroflow, measured in ml/s Symptoms, measured with the International Prostate Symptom Score (IPSS).

Secondary Outcome Measures

Name	Time	Method
1. Perceived benefit of the intervention, seven-point scale (ranging from much worse to much better)<br>2. Isovolumetric maximum bladder pressure, measured with non-invasive extrenal condom catheter method<br>3. Bladder wall thickness, measured ultrasonografically by measuring the thickness of the anterior bladder wall