Effectiveness of a Treatment Protocol for Lower Urinary Tract Symptoms in General Practice

NCT00111592 | Completed

• 1 other identifier: MEC 00-007
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Keywords

BPH; benign prostatic hyperplasia

Outcome Measures

Primary Outcomes (2)

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

• Maximum urinary flow rate (Qmax)

Secondary Outcomes (3)

• Bother due to lower urinary tract symptoms (Danish-Prostatic Symptom Score [Dan-PSS])

• incidence of acute urinary retention

• incidence of urinary tract infections

Study Arms (2)

1

ACTIVE COMPARATOR

current usual care

Procedure: current usual care

2

EXPERIMENTAL

treatment protocol with clear indications for therapy

Procedure: treatment protocol with clear indications for therapy

Interventions

current usual care PROCEDURE

current usual care

1

treatment protocol with clear indications for therapy PROCEDURE

treatment protocol with clear indications for therapy

2

Eligibility Criteria

• Age: 55 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• International Prostate Symptom Score \> 7
• Age \> 55 years

You may not qualify if:

• Heart failure
• Diabetes type I
• Psychiatric disorder/cognitive dysfunction
• History of prostate surgery
• Active treatment for lower urinary tract symptoms

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Yamanouchi: collaborator

Study Sites (1)

University of Maastricht, Department of General Practice

Maastricht, Limburg, Netherlands

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Interventions

Clinical Protocols; Therapeutics

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Roelf Norg

  Department of General Practice, Universiteit Maastricht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 23, 2005
• First Posted: May 24, 2005
• Study Start: August 1, 2000
• Study Completion: December 1, 2004
• Last Updated: November 9, 2016

Record last verified: 2007-11

Locations

NL (1)