Condition category
Urological and Genital Diseases
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
19/12/2008
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

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 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

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

Trial setting

Other

Trial 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

Phase

Not Specified

Drug names

Primary outcome measures

Peak urinary flow rate

Secondary outcome measures

1. Mean urinary flow rate
2. Mean micturition time
3. Experienced differences

Overall trial start date

01/08/2004

Overall trial end date

22/03/2005

Reason abandoned

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

Patient

Age group

Adult

Gender

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

Trial 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

http://www.caphri.nl/

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes