Clinical trial NCT05356260: Self-management Compared to Care-as-usual for Men With Lower Urinary Tract Symptoms
Official title: URincontrol4men: Self-management Through an App, Compared to the Consultation of a General Practitioner for Men With Lower Urinary Tract Symptoms
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lower Urinary Tract Symptoms
Keywords: Lower urinary tract symptoms
eHealth
Self-management
Primary care
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
name: Bekkenbodem4All
name: Leiden University Medical Center
name: University of Twente
name: Isala
First posted: 2022-05-02
Enrollment: 175
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic non-inferiority randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Patient Global Impression of Improvement (PGI-I)
timeFrame: 6 months
Secondary outcomes:
measure: International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms Module (ICIQ-MLUTS)
timeFrame: 6 weeks and 6 months
measure: International Prostate Symptom Score Quality of Life (IPSS QoL)
timeFrame: 6 weeks and 6 months
measure: the EuroQol instrument (EQ-5D-5L)
timeFrame: 6 weeks and 6 months
measure: iMTA Medical Consumption Questionnaire (iMCQ)
timeFrame: 6 months
measure: iMTA Productivity Cost Questionnaire (iPCQ)
timeFrame: 6 months
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Marco Blanker
role: PRINCIPAL_INVESTIGATOR
References: