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	Treatment or Intervention
Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms	Procedure: protocolized treatment

Further Study Details: 

Primary Outcomes: Degree of lower urinary tract symptoms (International Prostate Symptom Score [IPSS]); Maximum urinary flow rate (Qmax)
Secondary Outcomes: Bother due to lower urinary tract symptoms (Danish-Prostatic Symptom Score [Dan-PSS]); incidence of acute urinary retention; incidence of urinary tract infections
Expected Total Enrollment:  240

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.

Ages Eligible for Study:  55 Years and above,  Genders Eligible for Study:  Male

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

Netherlands, Limburg
      University of Maastricht, Department of General Practice, Maastricht,  Limburg,  Netherlands

Study ID Numbers:  MEC 00-007
Record last reviewed:  May 2005
Last Updated:  May 23, 2005
Record first received:  May 23, 2005
ClinicalTrials.gov Identifier:  NCT00111592
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) (Awaiting confirmation)
ClinicalTrials.gov processed this record on 2005-05-24