Prevention of lower urinary tract symptoms in elderly males: the effects of an increased urine output on symptoms and bladder functioning
| ISRCTN | ISRCTN91699014 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91699014 |
| Secondary identifying numbers | NCT100; ZonMw: 2100.0070 |
- Submission date
- 20/02/2007
- Registration date
- 20/02/2007
- Last edited
- 03/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr M G Spigt
Scientific
Scientific
University Maastricht (UM)
CAPHRI Research Institute
PO Box 616
Maastricht
6200 MD
Netherlands
| Phone | +31 (0)43 388 2309 |
|---|---|
| m.spigt@hag.unimaas.nl |
Study information
| Study design | Randomised active controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Scientific title | |
| Study objectives | Increasing the urine output will lead to improved bladder function and to a decrease in symptom severity. |
| Ethics approval(s) | Approval received by the ethical review board of the Maastricht University/University Hospital Maastricht on the 8th December 2002 (ref: MEC-00-155). |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 15/06/2000 |
| Completion date | 15/06/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Male |
| Target number of participants | 141 |
| Key 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) |
| Key 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. |
| Date of first enrolment | 15/06/2000 |
| Date of final enrolment | 15/06/2003 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Maastricht (UM)
Maastricht
6200 MD
Netherlands
6200 MD
Netherlands
Sponsor information
University Maastricht (UM) (The Netherlands)
University/education
University/education
Department General Practitioner Medicine
PO Box 616
Maastricht
6200 MD
Netherlands
| Phone | +31 (0)43 388 2309 |
|---|---|
| m.spigt@hag.unimaas.nl | |
| Website | http://www.unimaas.nl/default.asp?taal=en |
"ROR" |
https://ror.org/02jz4aj89 |
Funders
Funder type
Research organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
