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OpenTrials
Completed

NCT Number: NCT00111592

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.

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Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Signs and Symptoms Urogenital Diseases Urological Manifestations

Age range

55 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Maastricht, Department of General Practice

Maastricht, Limburg, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

current usual care

Procedure

current usual care

treatment protocol with clear indications for therapy

Procedure

treatment protocol with clear indications for therapy

Primary outcomes

  1. Degree of lower urinary tract symptoms (International Prostate Symptom Score [IPSS])

  2. Maximum urinary flow rate (Qmax)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Yamanouchi

Registry information

Important dates

Study start
2000
Study completion
2004
First posted
May 24, 2005
Registry last updated
Nov 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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