Condition category
Urological and Genital Diseases
Date applied
20/02/2007
Date assigned
20/02/2007
Last edited
03/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr M G Spigt

ORCID ID

Contact details

University Maastricht (UM)
CAPHRI Research Institute
PO Box 616
Maastricht
6200 MD
Netherlands
+31 (0)43 388 2309
m.spigt@hag.unimaas.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NCT100; ZonMw: 2100.0070

Study information

Scientific title

Acronym

Study hypothesis

Increasing the urine output will lead to improved bladder function and to a decrease in symptom severity.

Ethics approval

Approval received by the ethical review board of the Maastricht University/University Hospital Maastricht on the 8th December 2002 (ref: MEC-00-155).

Study design

Randomised active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Condition

Prostate Cancer, Lower Urinary Tract Symptoms (LUTS)

Intervention

The study population was recruited via 21 general practices.
The General Practitioners (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 zero to 35), questions on co-morbidity, and a 24-hours drink diary, together with the informed consent documents, were enclosed with the doctor's invitation.

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 [8 ml] each day during dinner), also for a period of six months.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

15/06/2000

Overall trial end date

15/06/2003

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Senior

Gender

Male

Target number of participants

141

Participant 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.

Recruitment start date

15/06/2000

Recruitment end date

15/06/2003

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Maastricht (UM)
Maastricht
6200 MD
Netherlands

Sponsor information

Organisation

University Maastricht (UM) (The Netherlands)

Sponsor details

Department General Practitioner Medicine
PO Box 616
Maastricht
6200 MD
Netherlands
+31 (0)43 388 2309
m.spigt@hag.unimaas.nl

Sponsor type

University/education

Website

http://www.unimaas.nl/default.asp?taal=en

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes