Effectiveness of a Treatment Protocol for Lower Urinary Tract Symptoms in General Practice
|ClinicalTrials.gov Identifier: NCT00111592|
Recruitment Status : Completed
First Posted : May 24, 2005
Last Update Posted : November 9, 2016
|First Submitted Date ICMJE||May 23, 2005|
|First Posted Date ICMJE||May 24, 2005|
|Last Update Posted Date||November 9, 2016|
|Study Start Date ICMJE||August 2000|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00111592 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Effectiveness of a Treatment Protocol for Lower Urinary Tract Symptoms in General Practice|
|Official Title ICMJE||Effectiveness of a Treatment Protocol for Lower Urinary Tract Symptoms in General Practice|
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.
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 Type ICMJE||Interventional|
|Study Phase||Not Applicable|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Actual Enrollment ICMJE
|Original Enrollment ICMJE
|Actual Study Completion Date||December 2004|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||55 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Netherlands|
|Removed Location Countries|
|NCT Number ICMJE||NCT00111592|
|Other Study ID Numbers ICMJE||MEC 00-007|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Maastricht University Medical Center|
|PRS Account||Maastricht University Medical Center|
|Verification Date||November 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP