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

Study Overview
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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.

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

Conditions
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Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms

Intervention / Treatment
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* Procedure: current usual care
* Procedure: treatment protocol with clear indications for therapy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>current usual care | Procedure: current usual care<br>* current usual care<br>|
| Experimental: 2<br>treatment protocol with clear indications for therapy | Procedure: treatment protocol with clear indications for therapy<br>* treatment protocol with clear indications for therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of lower urinary tract symptoms (International Prostate Symptom Score [IPSS]) |  |  | 
| Maximum urinary flow rate (Qmax) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bother due to lower urinary tract symptoms (Danish-Prostatic Symptom Score [Dan-PSS]) |  |  | 
| incidence of acute urinary retention |  |  | 
| incidence of urinary tract infections |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BPH, benign prostatic hyperplasia