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

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ClinicalTrials.gov Identifier: NCT00111592
Recruitment Status : Completed
First Posted : May 24, 2005
Last Update Posted : November 9, 2016
Sponsor:
Collaborator:
Yamanouchi
Information provided by:
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.


Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms Procedure: current usual care Procedure: treatment protocol with clear indications for therapy Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of a Treatment Protocol for Lower Urinary Tract Symptoms in General Practice
Study Start Date : August 2000
Actual Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
current usual care
Procedure: current usual care
current usual care
Experimental: 2
treatment protocol with clear indications for therapy
Procedure: treatment protocol with clear indications for therapy
treatment protocol with clear indications for therapy



Primary Outcome Measures :
  1. Degree of lower urinary tract symptoms (International Prostate Symptom Score [IPSS])
  2. Maximum urinary flow rate (Qmax)

Secondary Outcome Measures :
  1. Bother due to lower urinary tract symptoms (Danish-Prostatic Symptom Score [Dan-PSS])
  2. incidence of acute urinary retention
  3. incidence of urinary tract infections


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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00111592


Locations
Netherlands
University of Maastricht, Department of General Practice
Maastricht, Limburg, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
Yamanouchi
Investigators
Principal Investigator: Roelf Norg Department of General Practice, Universiteit Maastricht

ClinicalTrials.gov Identifier: NCT00111592     History of Changes
Other Study ID Numbers: MEC 00-007
First Posted: May 24, 2005    Key Record Dates
Last Update Posted: November 9, 2016
Last Verified: November 2007

Keywords provided by Maastricht University Medical Center:
BPH
benign prostatic hyperplasia

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Urological Manifestations
Signs and Symptoms