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

This study has been completed.
Sponsor:
Collaborator:
Yamanouchi
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00111592
First received: May 23, 2005
Last updated: November 21, 2007
Last verified: November 2007

May 23, 2005
November 21, 2007
August 2000
Not Provided
  • Degree of lower urinary tract symptoms (International Prostate Symptom Score [IPSS])
  • Maximum urinary flow rate (Qmax)
Same as current
Complete list of historical versions of study NCT00111592 on ClinicalTrials.gov Archive Site
  • Bother due to lower urinary tract symptoms (Danish-Prostatic Symptom Score [Dan-PSS])
  • incidence of acute urinary retention
  • incidence of urinary tract infections
Same as current
Not Provided
Not Provided
 
Effectiveness of a Treatment Protocol for Lower Urinary Tract Symptoms in General Practice
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Benign Prostatic Hyperplasia
  • Lower Urinary Tract Symptoms
  • Procedure: current usual care
    current usual care
  • Procedure: treatment protocol with clear indications for therapy
    treatment protocol with clear indications for therapy
  • Active Comparator: 1
    current usual care
    Intervention: Procedure: current usual care
  • Experimental: 2
    treatment protocol with clear indications for therapy
    Intervention: Procedure: treatment protocol with clear indications for therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
208
December 2004
Not Provided

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
Male
55 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00111592
MEC 00-007
No
Not Provided
Maastricht University
Yamanouchi
Principal Investigator: Roelf Norg Department of General Practice, Universiteit Maastricht
Maastricht University Medical Center
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP