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

NCT ID: NCT00111592

Last Updated: 2016-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-08-31

Study Completion Date

2004-12-31

Brief Summary

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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

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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

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Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms

Keywords

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BPH benign prostatic hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

current usual care

Group Type ACTIVE_COMPARATOR

current usual care

Intervention Type PROCEDURE

current usual care

2

treatment protocol with clear indications for therapy

Group Type EXPERIMENTAL

treatment protocol with clear indications for therapy

Intervention Type PROCEDURE

treatment protocol with clear indications for therapy

Interventions

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current usual care

current usual care

Intervention Type PROCEDURE

treatment protocol with clear indications for therapy

treatment protocol with clear indications for therapy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Yamanouchi

UNKNOWN

Sponsor Role collaborator

Maastricht University Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Roelf Norg

Role: PRINCIPAL_INVESTIGATOR

Department of General Practice, Universiteit Maastricht

Locations

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University of Maastricht, Department of General Practice

Maastricht, Limburg, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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MEC 00-007

Identifier Type: -

Identifier Source: org_study_id