NCT00111592

Effectiveness of a Treatment Protocol for Lower Urinary Tract Symptoms in General Practice

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 208 (actual)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: Male
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Benign Prostatic Hyperplasia
• Lower Urinary Tract Symptoms

Interventions

Type	Name	Description
PROCEDURE	current usual care	current usual care
PROCEDURE	treatment protocol with clear indications for therapy	treatment protocol with clear indications for therapy

Timeline

• Start date: 2000-08-01
• Completion: 2004-12-01
• First posted: 2005-05-24
• Last updated: 2016-11-09

Locations

1 site across 1 country: Netherlands