Lower Urinary Tract Symptoms
Conditions
Keywords
Lower urinary tract symptoms, eHealth, Self-management, Primary care
Brief summary
Research question: Does offering an online self-management program lead to more efficient use of care by men with urinary complaints? Hypothesis: Many men with urinary symptoms receive medication from their GP. Advice on how to self-manage complaints is often skipped. This while self-management is effective. By offering self-management instead of visiting a GP the use of care by men with urinary complaints may decrease and treatment may become more efficient. Study design: Men are randomized to receive either care-as-usual by their GP or the online self-management program. Men will be followed for six months and the cost-effectiveness of the online self-management intervention will be compared to the care-as-usual
Detailed description
Rationale: Although self-management can be difficult to implement because it is time consuming to explain, it has proven effective for LUTS. For this reason, we developed an online intervention that can be used at home by men with LUTS, giving tailored advice to each case. Objective: To assess the effectiveness and cost-effectiveness of providing an online personalized self-management program as a first-line intervention to men with lower urinary tract symptoms (LUTS) compared to care as usual (CAU). Study design: A pragmatic non-inferiority randomized controlled trial in the general population. Study population: Men with LUTS (\>18 years of age) who are considering visiting a general practitioner for their complaints. Intervention: Access to an online program offering personalized selfmanagement advice compared to care as usual Main endpoints: Outcomes will be assessed at 6 weeks, 3 months and 6 months.
Interventions
DEVICEURincontrol4men
The intervention is built as an app
OTHERCare as usual
CAU will be that typically provided by GPs. Also patients will be informed about a page on thuisarts.nl regarding male LUTS. The pragmatic trial design means that care can vary depending on the preferences of patients and GPs in this group.
Sponsors
ZonMw: The Netherlands Organisation for Health Research and Development
Bekkenbodem4All
Leiden University Medical Center
University of Twente
Isala
University Medical Center Groningen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Pragmatic non-inferiority randomized controlled trial
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men with lower urinary tract symptoms who are thinking about visiting a GP for their complaints
Exclusion criteria
* Men with complicated LUTS who should seek urgent care, including those with nocturnal incontinence (e.g., chronic urinary retention), the inability to void despite urgency (e.g., acute urinary retention), and with sudden onset or worsening LUTS (e.g., urinary tract infections). * Men receiving treatment from a pelvic physiotherapist, GP, or urologist (including at any point in the previous year). * Men with a history of prostate cancer, bladder cancer, or urinary tract surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Patient Global Impression of Improvement (PGI-I) | 6 months | The PGII is a single-question global index for change of incontinence symptoms that is rated with a 7-point Likert scale ranging from very much worse to very much better. This variable will be dichotomized into improved (scores ≥ better) and not improved. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms Module (ICIQ-MLUTS) | 6 weeks and 6 months | The ICIQ-MLUTS is a questionnaire for evaluating male lower urinary tract symptoms and impact on quality of life. Its has two subscales; voiding symptoms (range 0 -20) and incontinence symptoms (range 0-24) with higher scores indicating more symptoms. |
| International Prostate Symptom Score Quality of Life (IPSS QoL) | 6 weeks and 6 months | International Prostate Symptom Score (single item) quality of life. The score ranges from 0 - 6 with a higher score indicating a lower quality of life. |
| the EuroQol instrument (EQ-5D-5L) | 6 weeks and 6 months | The EQ-5D-5L is s generic quality of life questionnaire. Utilities can be calculated from this questionnaire with a maximum score of 1 indicating a perfect health state. |
| iMTA Medical Consumption Questionnaire (iMCQ) | 6 months | Costs of medical consumption |
| iMTA Productivity Cost Questionnaire (iPCQ) | 6 months | Costs of productivity losses |
Countries
Netherlands
Outcome results
None listed