Condition category
Urological and Genital Diseases
Date applied
22/06/2020
Date assigned
30/06/2020
Last edited
29/06/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Lower Urinary Tract Symptoms (LUTS) as hesitating, frequency and nocturia are common problems under men above 50 years. LUTS is not caused by the dysfunction the prostate only, but as the disruption of different processes in the bladder, prostate pelvic floor and urethra. Patients are now treated by the guidelines of the Dutch GP's. In general practice, there is a lack of diagnostic tools. Uroflowmetry and ultrasound bladder scanning are important diagnostic tools in LUTS management assessed by the urologist

Who can participate?
Male patients aged 50 and older, who were consulting their GP with lower urinary tract symptoms for the first time.

What does the study involve?
In our study we made two groups; both groups received primary-care treatment involving with or without uroflowmetry and post-void ultrasound bladder scanning. A year after inclusion we counted the referrals to the urologists in both groups. Thereby we asked the participants if they had more or fewer complaints after a year, if they were satisfied with the treatment and if they used medication.

What are the possible benefits and risks of participating?
There were no short time benefits or possibly harms for the participants.

Where is the study run from?
Radboud University Nijmegen Medical Centre (Netherlands)

When is the study starting and how long is it expected to run for?
October 2010 to March 2018

Who is funding the study?
Agis Health insurance, (now Zilveren Kruis Achmea)

Who is the main contact?
H.A. Lammers, hlammers@t-steyn.nl

Trial website

Contact information

Type

Scientific

Primary contact

Mr H.A. Lammers

ORCID ID

Contact details

Eiteren 15
Ijsselstein
6525 EZ
Netherlands
+31 (0)652378946
hlammers@t-steyn.nl

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

2010/098

Study information

Scientific title

The usefulness of uroflowmetry and ultrasound bladder scanning as diagnostic tools in primary care for new male patients with lower urinary tract symptoms; a cluster randomized controlled trial

Acronym

Study hypothesis

Implementing uroflowmetry and post void ultrasound bladder scanning in primary care for men with LUTS will reduce the number of referrals to urologists.

Ethics approval

Approved 26/10/2010, Medical ethics review committee Arnhem-Nijmegen (Huispost 578, Postbus, 9101, UMC St Radboud Centraal, route 578, Geert Grooteplein 10; +31 24 3613154; cmo@iwkv,ucmn.nl), ref: 2010/098

Study design

Cluster randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Diagnostic

Patient information sheet

No participant information sheet available

Condition

Lower urinary tract symptoms

Intervention

A cluster randomized controlled trial (RCT) was conducted in general practices in the Netherlands with a total patient population of 24,000. Randomization took place at GP level instead of at patient level to minimize the effects of contamination. A total of 11 GPs were included. Randomization took place in a manual way by the head investigator under control of an independent colleague.

After informed consent, the patients in the intervention group received the usual general practice care with two additional diagnostics tests, namely uroflowmetry and post-void ultrasound bladder scanning, conducted by a trained research assistant under standardized conditions, to assess peak flow and post-void residual volume. The control group received the same care without the two investigations.

The number of referrals to a urologist within 3 and 12 months was assessed with a patient questionnaire.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Number of patients referred to urologists within 3 and within 12 months after first consultation measured using patient records

Secondary outcome measures

1. Severity of the symptoms measured using IPSS and IPSS-QOL at baseline and one year of follow up
2. Patient satisfaction measured using a Likert scale of 1 to 5 (very dissatisfied to very satisfied) after one year of follow up
3. Urologic medication use (alpha-blocker or 5ARI) measured using patient questionnaire after one year of follow up

Overall trial start date

01/02/2010

Overall trial end date

15/03/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Patients aged 50 and older, who were consulting their GP with LUTS for the first time. LUTS were defined as ‘micturition problems not evidently explained by a specific condition’, in accordance with the definition found in the practice guideline of the Dutch College of General Practitioners

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

362

Participant exclusion criteria

1. Medication usage (alpha-blockers, 5-alpha-reductase inhibitors or anticholinergics)
2. Previous visits to a urologist because of LUTS
3. Diagnosed or suspected prostate cancer; and a diagnosed urinary tract infection, haematuria or other urologic pathology

Recruitment start date

01/11/2010

Recruitment end date

11/03/2018

Locations

Countries of recruitment

Netherlands

Trial participating centre

Radboud university medical center
Dept. of Primary and Community Care Geert Grooteplein 21
Nijmegen
6525 EZ
Netherlands

Sponsor information

Organisation

Radboud University Nijmegen Medical Centre

Sponsor details

Dept. of Primary and Community Care
Geert Grooteplein 21
route 118
Nijmegen
6525 EZ
Netherlands
+31-24-3618181
Toine.Lagro@radboudumc.nl

Sponsor type

Other

Website

https://www.radboudumc.nl/afdelingen/eerstelijnsgeneeskunde

Funders

Funder type

Industry

Funder name

Agis Health insurance, (now Zilveren Kruis Achmea)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high impact peer-reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from H.A. Lammers, email: hlammers@t-steyn.nl. The data includes measurements of all baseline characteristics of the participant: age, results of uroflowmetry and bladder scan, IPSS questionnaire at baseline and after 12 months, satisfaction and medication questionnaires after 12 years of follow up. The data are available from 01/01/2020 until 01/01/2025. Also available are the informed consent and statistical analyses on every reasonable request. ). This study was conducted in accordance with the Declaration of Helsinki.

Intention to publish date

01/07/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

29/06/2020: Trial’s existence confirmed by Radboud University Nijmegen Medical Centre.