To assess the effectiveness and cost-effectiveness of providing an online personalized self-management program as a first-lineintervention to men with lower urinary tract symptoms (LUTS) compared to care as usual (CAU).
ID
Source
Brief title
Condition
- Urinary tract signs and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Outcomes will be assessed at 6 weeks and 3 and 6 months. The primary outcome
measure will be the Patient Global Impression of
Improvement after 6 months.
Secondary outcome
The secondary outcome measures will be the differences in cost-effectiveness,
ICIQ-MLUTS score, quality of life, medical consumption, and productivity
losses.
Background summary
The prevalence of moderate-to-severe lower urinary tract symptoms (LUTS) in men
is 20%-25% and increases with age.
Most guidelines on male LUTS recommend promoting self-management and lifestyle
changes as the first-line option,
especially for patients with mild complaints. In the Netherlands, many of these
patients will first visit a general practitioner (GP).
However, the lack of clinic time to explain self-management means that GPs are
more likely to prescribe medication, with
around half of all men who visit their GP being prescribed an alpha-blocker. In
2018, over 300,000 Dutch men were
prescribed alpha-blockers for LUTS; unfortunately, despite being the first-line
drug treatments, their effects are small and
may not even reach the level of minimal important difference . It may therefore
be preferable to provide patients with a valid
alternative that can be trialed before attending the GP and receiving
unnecessary medical care.
LUTS are highly amenable to self-management thanks to their mixed etiology,
uncertain and generally favorable clinical course,
lack of cure, and status as a social and professional challenge. Although
self-management can be difficult to implement
because it is time-consuming to explain, it has proven effective when a pathway
to implementation can be found. For this
reason, our study group developed an online intervention that can be used at
home by men with LUTS, giving tailored advice to
each case. For this, men complete questions about symptom severity, lifestyle
(e.g., coffee and alcohol consumption),
height, and weight, plus a frequency-volume chart, and appropriate advice is
presented. This tool was
developed based on available literature and the opinions and experiences of
Dutch GPs and urologists, and it has been
piloted among men with uncomplicated LUTS in secondary care. Feasibility
testing has also continued in primary care
[data to be published]. The intervention is also suitable for people with low
literacy levels because all information is presented in
video and audio formats.
Self-management is ideally given in primary care or before people seek help,
indicating that the intervention could be made
available to men in the community. However, we must first study the
cost-effectiveness of the online self-management program
in terms of the healthcare-seeking behaviors of men with LUTS in primary care,
specifically targeting those who are considering
visiting a GP.
Study 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.
Intervention
Six weeks of access to an online program offering personalized self-management
advice compared to care as usual
Study burden and risks
Participants in both intervention arms can directly benefit from the treatment
they receive. Risk of both treatments are negligible. Results of the study can
have long term benefits for men with LUTS as in the case of non-inferiority of
the eHealth intervention they can benefit from a treatment that is easy
accessible.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
Men with LUTS
Exclusion criteria
Nocturnal incontinence
Inability to void despite urgency
Sudden onset or worsening LUTS
Treatment from a pelvic physiotherapist, GP, or urologist at any point in the
previous year for LUTS
A history of prostate cancer, bladder cancer, or urinary tract surgery.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL79018.042.21 |