Skip to content

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00111592
Enrollment
208
Registered
2005-05-24
Start date
2000-08-31
Completion date
2004-12-31
Last updated
2016-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms

Keywords

BPH, benign prostatic hyperplasia

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.

Interventions

PROCEDUREcurrent usual care

current usual care

PROCEDUREtreatment protocol with clear indications for therapy

treatment protocol with clear indications for therapy

Sponsors

Yamanouchi
CollaboratorUNKNOWN
Maastricht University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
55 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Degree of lower urinary tract symptoms (International Prostate Symptom Score [IPSS])
Maximum urinary flow rate (Qmax)

Secondary

MeasureTime frame
Bother due to lower urinary tract symptoms (Danish-Prostatic Symptom Score [Dan-PSS])
incidence of acute urinary retention
incidence of urinary tract infections

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026