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

  • STATUS
    Recruiting
  • End date
    Apr 1, 2023
  • participants needed
    698
  • sponsor
    University Medical Center Groningen
Updated on 12 May 2022

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

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.

Details
Condition Lower Urinary Tract Symptoms
Treatment Care as Usual, URincontrol4men
Clinical Study IdentifierNCT05356260
SponsorUniversity Medical Center Groningen
Last Modified on12 May 2022

Eligibility

Yes No Not Sure

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
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