Self-management Compared to Care-as-usual for Men With Lower Urinary Tract Symptoms

Study Overview
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Brief Summary
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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
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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.

Official Title
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URincontrol4men: Self-management Through an App, Compared to the Consultation of a General Practitioner for Men With Lower Urinary Tract Symptoms

Conditions
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Lower Urinary Tract Symptoms

Intervention / Treatment
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* Device: URincontrol4men
* Other: Care as usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pragmatic non-inferiority randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Care as usual<br>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. | Other: Care as usual<br>* 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.<br>|
| Experimental: Online self-management intervention<br>Participants in the intervention group will be given access to an online self-management program that will be personalized. This program was developed based on the results of a literature search, the opinions of expert Dutch GPs and urologists, and a pilot study in secondary care, with further preliminary testing in primary care. The program consists of nine components: information, pelvic floor exercises, bladder training, sitting voiding position, urethral milking, fluid management, caffeine avoidance, alcohol avoidance, and physical activity increase. Information is presented as text with supportive figures, plus audio (a read aloud function for all text) and video fragments to facilitate engagement by men with low literacy levels. | Device: URincontrol4men<br>* The intervention is built as an app<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Patient Global Impression of Improvement (PGI-I) | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms Module (ICIQ-MLUTS) | 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. | 6 weeks and 6 months | 
| International Prostate Symptom Score Quality of Life (IPSS QoL) | 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. | 6 weeks and 6 months | 
| the EuroQol instrument (EQ-5D-5L) | 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. | 6 weeks and 6 months | 
| iMTA Medical Consumption Questionnaire (iMCQ) | Costs of medical consumption | 6 months | 
| iMTA Productivity Cost Questionnaire (iPCQ) | Costs of productivity losses | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lower urinary tract symptoms, eHealth, Self-management, Primary care