Contact information
Type
Scientific
Contact name
Dr Roelf JC Norg
ORCID ID
Contact details
Maastricht University
Department of General Practice
P.O. Box 616
Maastricht
6200 MD
Netherlands
+31 (0)43 388 2802
roelf.norg@hag.unimaas.nl
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
NTR146; 17
Study information
Scientific title
The voiding position study - a replicated randomised single case experiment
Acronym
RRSCE
Study hypothesis
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
Study design
Randomised active controlled crossover two-arm trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Other
Study type
Quality of life
Patient information sheet
Condition
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
Peak urinary flow rate
Secondary outcome measures
1. Mean urinary flow rate
2. Mean micturition time
3. Experienced differences
Overall study start date
01/08/2004
Overall study end date
22/03/2005
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Sex
Male
Target number of participants
21
Participant 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
Recruitment start date
01/08/2004
Recruitment end date
22/03/2005
Locations
Countries of recruitment
Netherlands
Study participating centre
Maastricht University
Maastricht
6200 MD
Netherlands
Sponsor information
Organisation
Care and Public Health Research Institute (CAPHRI) (The Netherlands)
Sponsor details
University Maastricht
P.O. Box 616
Maastricht
6200 MD
Netherlands
+31 (0)43 388 2446
e.habets@caphri.unimaas.nl
Sponsor type
Research organisation
Website
ROR
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (The 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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|