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

Not Applicable

Completed

• Conditions: Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia
• Interventions: Procedure: current usual care; Procedure: treatment protocol with clear indications for therapy

• Registration Number: NCT00111592
• Lead Sponsor: Maastricht University Medical Center

Brief 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.

Study Timeline

• Study Start: 2000-08
• Study Completion: 2004-12
• Study First Submitted: 2005-05-23
• Study First Submitted QC: 2005-05-23
• Study First Posted: 2005-05-24
• Status Verified: 2007-11
• Last Update Submitted: 2016-11-08
• Last Update Posted: 2016-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 208

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	current usual care	current usual care
2	treatment protocol with clear indications for therapy	treatment protocol with clear indications for therapy

Primary Outcome Measures

Name	Time	Method
Maximum urinary flow rate (Qmax)
Degree of lower urinary tract symptoms (International Prostate Symptom Score [IPSS])

Secondary Outcome Measures

Name	Time	Method
incidence of urinary tract infections
incidence of acute urinary retention
Bother due to lower urinary tract symptoms (Danish-Prostatic Symptom Score [Dan-PSS])

Trial Locations

Locations (1)

University of Maastricht, Department of General Practice; 🇳🇱 Maastricht, Limburg, Netherlands