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
  Purpose

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 Intervention
Benign Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Procedure: current usual care
Procedure: treatment protocol with clear indications for therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of a Treatment Protocol for Lower Urinary Tract Symptoms in General Practice

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Degree of lower urinary tract symptoms (International Prostate Symptom Score [IPSS])
  • Maximum urinary flow rate (Qmax)

Secondary Outcome Measures:
  • Bother due to lower urinary tract symptoms (Danish-Prostatic Symptom Score [Dan-PSS])
  • incidence of acute urinary retention
  • incidence of urinary tract infections

Enrollment: 208
Study Start Date: August 2000
Study Completion Date: December 2004
Arms Assigned Interventions
Active Comparator: 1
current usual care
Procedure: current usual care
current usual care
Experimental: 2
treatment protocol with clear indications for therapy
Procedure: treatment protocol with clear indications for therapy
treatment protocol with clear indications for therapy

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

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00111592

Locations
Netherlands
University of Maastricht, Department of General Practice
Maastricht, Limburg, Netherlands
Sponsors and Collaborators
Maastricht University
Yamanouchi
Investigators
Principal Investigator: Roelf Norg Department of General Practice, Universiteit Maastricht
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00111592     History of Changes
Other Study ID Numbers: MEC 00-007
Study First Received: May 23, 2005
Last Updated: November 21, 2007
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
BPH
benign prostatic hyperplasia

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes

ClinicalTrials.gov processed this record on April 15, 2014