Effectiveness of a Treatment Protocol for Lower Urinary Tract Symptoms in General Practice
Primary Purpose
Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
current usual care
treatment protocol with clear indications for therapy
Sponsored by
About this trial
This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring BPH, benign prostatic hyperplasia
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
Sites / Locations
- University of Maastricht, Department of General Practice
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
current usual care
treatment protocol with clear indications for therapy
Outcomes
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
Full Information
NCT ID
NCT00111592
First Posted
May 23, 2005
Last Updated
November 8, 2016
Sponsor
Maastricht University Medical Center
Collaborators
Yamanouchi
1. Study Identification
Unique Protocol Identification Number
NCT00111592
Brief Title
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
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
August 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Yamanouchi
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
Keywords
BPH, benign prostatic hyperplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
208 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
current usual care
Arm Title
2
Arm Type
Experimental
Arm Description
treatment protocol with clear indications for therapy
Intervention Type
Procedure
Intervention Name(s)
current usual care
Intervention Description
current usual care
Intervention Type
Procedure
Intervention Name(s)
treatment protocol with clear indications for therapy
Intervention Description
treatment protocol with clear indications for therapy
Primary Outcome Measure Information:
Title
Degree of lower urinary tract symptoms (International Prostate Symptom Score [IPSS])
Title
Maximum urinary flow rate (Qmax)
Secondary Outcome Measure Information:
Title
Bother due to lower urinary tract symptoms (Danish-Prostatic Symptom Score [Dan-PSS])
Title
incidence of acute urinary retention
Title
incidence of urinary tract infections
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roelf Norg
Organizational Affiliation
Department of General Practice, Universiteit Maastricht
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maastricht, Department of General Practice
City
Maastricht
State/Province
Limburg
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of a Treatment Protocol for Lower Urinary Tract Symptoms in General Practice
We'll reach out to this number within 24 hrs