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| Sponsors and Collaborators: |
Maastricht University Medical Center Yamanouchi |
|---|---|
| Information provided by: | Maastricht University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00111592 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms |
Procedure: current usual care Procedure: treatment protocol with clear indications for therapy |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Effectiveness of a Treatment Protocol for Lower Urinary Tract Symptoms in General Practice |
| Enrollment: | 208 |
| Study Start Date: | August 2000 |
| Study Completion Date: | December 2004 |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
current usual care
|
Procedure: current usual care
current usual care
|
|
2: Experimental
treatment protocol with clear indications for therapy
|
Procedure: treatment protocol with clear indications for therapy
treatment protocol with clear indications for therapy
|
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.
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Netherlands, Limburg | |
| University of Maastricht, Department of General Practice | |
| Maastricht, Limburg, Netherlands | |
| Principal Investigator: | Roelf Norg | Department of General Practice, Universiteit Maastricht |
More Information
| Study ID Numbers: | MEC 00-007 |
| Study First Received: | May 23, 2005 |
| Last Updated: | November 21, 2007 |
| ClinicalTrials.gov Identifier: | NCT00111592 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
|
BPH benign prostatic hyperplasia |
|
Hyperplasia Prostatic Diseases Prostatic Hyperplasia Genital Diseases, Male |
|
Pathologic Processes |
