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

Benign Prostatic Hyperplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00111592
• Other study ID #: MEC 00-007
• Status: Completed
• Phase: N/A
• First received: May 23, 2005
• Last updated: November 8, 2016
• Start date: August 2000
• Est. completion date: December 2004

Study information

• Verified date: November 2007
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 55 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Lower Urinary Tract Symptoms
• Prostatic Hyperplasia

Intervention

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

Locations

Country	Name	City	State
Netherlands	University of Maastricht, Department of General Practice	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Yamanouchi

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of lower urinary tract symptoms (International Prostate Symptom Score [IPSS])
Primary	Maximum urinary flow rate (Qmax)
Secondary	Bother due to lower urinary tract symptoms (Danish-Prostatic Symptom Score [Dan-PSS])
Secondary	incidence of acute urinary retention
Secondary	incidence of urinary tract infections