NCT05356260

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 175 (actual)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lower Urinary Tract Symptoms

Interventions

Type	Name	Description
DEVICE	URincontrol4men	The intervention is built as an app
OTHER	Care 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.

Timeline

• Start date: 2022-04-08
• Primary completion: 2024-12-05
• Completion: 2024-12-05
• First posted: 2022-05-02
• Last updated: 2024-12-13

Locations

1 site across 1 country: Netherlands