The use of diagnostic tools for men above 50 years with micturition complaints in general practice
| ISRCTN | ISRCTN12306080 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12306080 |
| Secondary identifying numbers | 2010/098 |
- Submission date
- 22/06/2020
- Registration date
- 30/06/2020
- Last edited
- 14/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
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
Contact information
Scientific
Eiteren 15
Ijsselstein
6525 EZ
Netherlands
| Phone | +31 (0)652378946 |
|---|---|
| hlammers@t-steyn.nl |
Study information
| Study design | Cluster randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Diagnostic |
| Participant information sheet | No participant information sheet available |
| 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 |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/02/2010 |
| Completion date | 15/03/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 362 |
| Total final enrolment | 344 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/11/2010 |
| Date of final enrolment | 11/03/2018 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Geert Grooteplein 21
Nijmegen
6525 EZ
Netherlands
Sponsor information
Other
Dept. of Primary and Community Care
Geert Grooteplein 21
route 118
Nijmegen
6525 EZ
Netherlands
| Phone | +31-24-3618181 |
|---|---|
| Toine.Lagro@radboudumc.nl | |
| Website | https://www.radboudumc.nl/afdelingen/eerstelijnsgeneeskunde |
"ROR" |
https://ror.org/05wg1m734 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/09/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high impact peer-reviewed journal. |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 26/06/2021 | 14/09/2021 | Yes | No |
Editorial Notes
14/09/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
20/04/2021: The intention to publish date was changed from 01/07/2020 to 01/09/2021.
29/06/2020: Trial’s existence confirmed by Radboud University Nijmegen Medical Centre.
