Benign Prostatic Hyperplasia Clinical Trial
Official title:
Effectiveness of a Treatment Protocol for Lower Urinary Tract Symptoms in General Practice
Ageing and the availability of medication has led to an increase of elderly male patients
being treated for lower urinary tract symptoms (LUTS), or voiding problems ("prostate
problems"). However, guidelines are vague as to which patients should and which should not
be treated, and how.
Although several treatment modalities have proven efficacy in selected populations, it is
unclear how effective these treatments are in daily practice.
This study investigates the hypothesis that a treatment protocol in which clear indications
are formulated for all treatment modalities is more effective, as compared to current usual
primary care, in reducing both symptoms as related to the quality of voiding in elderly
males.
Guidelines fail to provide specific diagnostic criteria and clear indications for therapy in
elderly male patients with lower urinary tract symptoms. Consequently, the group of patients
diagnosed with LUTS in primary care is very heterogeneous, and daily care varies widely.
Consequently, efficacy trials of alpha-blockers, 5-alpha-reductase inhibitors and surgery
performed in selected, well defined homogeneous populations cannot easily be generalised to
the heterogeneous primary care situation.
A practical randomised trial enrolling patients on the basis of symptoms have the advantage
of being of immediate practical value.
We compare a treatment protocol with clear indications for therapy with current usual care
in a population selected on symptoms rather than well defined diseases or definite test
results.
Two hundred eight subjects were randomised into intervention (N=104) and control (N=104)
conditions.
After two years of follow-up, IPSS scores, bother scores, maximum urinary flow rates and the
incidence of acute urinary retention and urinary tract infections have been compared.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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