The voiding position study (RRSCE)
| ISRCTN | ISRCTN62736854 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62736854 |
| Protocol serial number | NTR146; 17 |
| Sponsor | Care and Public Health Research Institute (CAPHRI) (The Netherlands) |
| Funder | The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 19/12/2008
- 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
Dr Roelf JC Norg
Scientific
Scientific
Maastricht University
Department of General Practice
P.O. Box 616
Maastricht
6200 MD
Netherlands
| Phone | +31 (0)43 388 2802 |
|---|---|
| roelf.norg@hag.unimaas.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised active controlled crossover two-arm trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | The voiding position study - a replicated randomised single case experiment |
| Study acronym | RRSCE |
| Study objectives | The position in which men with lower urinary tract symptoms (LUTS) are voiding may have an influence on the quality of the voiding. The Dutch guidelines for the treatment of LUTS in general practice recommend patients to void in a sitting position. It is unclear whether this advice is correct. The (little) available evidence suggests it may even be wrong. |
| Ethics approval(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Lower urinary tract symptoms (LUTS) |
| Intervention | Two positions in which men can void are compared: 1. Sitting 2. Standing |
| Intervention type | Other |
| Primary outcome measure(s) |
Peak urinary flow rate |
| Key secondary outcome measure(s) |
1. Mean urinary flow rate |
| Completion date | 22/03/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target sample size at registration | 21 |
| Key inclusion criteria | 1. Men 2. Aged greater than or equal to 55 years 3. Moderate LUTS, i.e. total score on the International Prostate Symptom Score 8 - 19 |
| Key exclusion criteria | 1. History of surgery for LUTS, e.g. prostatectomy 2. Current use of medication that may influence voiding, e.g. diuretics, anticholinergic medication, alpha-blockers, 5-alpha-reductase inhibitors |
| Date of first enrolment | 01/08/2004 |
| Date of final enrolment | 22/03/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Maastricht University
Maastricht
6200 MD
Netherlands
6200 MD
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
