Clinical trial NCT00111592: Effectiveness of a Treatment Protocol for Lower Urinary Tract Symptoms in General Practice
Official title: Effectiveness of a Treatment Protocol for Lower Urinary Tract Symptoms in General Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Keywords: BPH
benign prostatic hyperplasia
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Yamanouchi
First posted: 2005-05-24
Enrollment: 208
Sex: MALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Degree of lower urinary tract symptoms (International Prostate Symptom Score [IPSS])
measure: Maximum urinary flow rate (Qmax)
Secondary outcomes:
measure: Bother due to lower urinary tract symptoms (Danish-Prostatic Symptom Score [Dan-PSS])
measure: incidence of acute urinary retention
measure: incidence of urinary tract infections
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: University of Maastricht, Department of General Practice
state: Limburg
Study officials:
affiliation: Department of General Practice, Universiteit Maastricht
name: Roelf Norg
role: PRINCIPAL_INVESTIGATOR
References: