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

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia

Treatments: Procedure: treatment protocol with clear indications for therapy; Procedure: current usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT00111592

MEC 00-007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 208 patients

Sex: Male

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• International Prostate Symptom Score > 7
• Age > 55 years

Exclusion criteria

• Heart failure
• Diabetes type I
• Psychiatric disorder/cognitive dysfunction
• History of prostate surgery
• Active treatment for lower urinary tract symptoms

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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208 participants in 2 patient groups

1

Active Comparator group

Description:

current usual care

Treatment:

Procedure: current usual care

2

Experimental group

Description:

treatment protocol with clear indications for therapy

Treatment:

Procedure: treatment protocol with clear indications for therapy