Benign Prostatic HyperplasiaNCT00111592
Effectiveness of a Treatment Protocol for Lower Urinary Tract Symptoms in General Practice
A study testing treatment protocol with clear indications for therapy in people with Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
- What is being tested?
- treatment protocol with clear indications for therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2000to Dec 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- International Prostate Symptom Score > 7
- Age > 55 years
Who cannot join
- Heart failure
- Diabetes type I
- Psychiatric disorder/cognitive dysfunction
- History of prostate surgery
- Active treatment for lower urinary tract symptoms
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University of Maastricht, Department of General Practice
Maastricht, Limburg
About this study
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.
Read the 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.
- Being tested
- current usual care, treatment protocol with clear indications for therapy
- Keywords
- BPH, benign prostatic hyperplasia
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
current usual careProcedure or surgery
current usual care
treatment protocol with clear indications for therapyProcedure or surgery
treatment protocol with clear indications for therapy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | current usual care Receives: Procedure: current usual care |
| 2 | Experimental | treatment protocol with clear indications for therapy Receives: Procedure: treatment protocol with clear indications for therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2005 (estimated)
- Study startAug 2000
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Yamanouchi
- Investigators
- Roelf Norg, Principal investigator, Department of General Practice, Universiteit Maastricht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00111592
- Sponsor's protocol ID
- MEC 00-007
- Status last verified
- Nov 2007
- First submitted
- 23 May 2005
- Last updated
- 9 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Treatment Protocol for Lower Urinary Tract Symptoms in General Practice
- ClinicalTrials.gov ID
- NCT00111592
- Acronym / sponsor ID
- MEC 00-007
- Keywords
- BPH, benign prostatic hyperplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Yamanouchi
- Study start
- Aug 2000
- Study completion
- Dec 2004 (actual)
- First posted
- 24 May 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: current usual carecurrent usual care |
| 2 | Experimental | Procedure: treatment protocol with clear indications for therapytreatment protocol with clear indications for therapy |
Who may qualify
- Ages
- 55 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- International Prostate Symptom Score > 7
- Age > 55 years
Key exclusion criteria (5 listed)
- Heart failure
- Diabetes type I
- Psychiatric disorder/cognitive dysfunction
- History of prostate surgery
- Active treatment for lower urinary tract symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| current usual carecurrent usual care | Procedure or surgery | 1 |
| treatment protocol with clear indications for therapytreatment protocol with clear indications for therapy | Procedure or surgery | 2 |
Primary outcome
Degree of lower urinary tract symptoms (International Prostate Symptom Score [IPSS])
Maximum urinary flow rate (Qmax)
3 secondary outcomes
Bother due to lower urinary tract symptoms (Danish-Prostatic Symptom Score [Dan-PSS])
incidence of acute urinary retention
incidence of urinary tract infections
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roelf Norg principal investigator
Department of General Practice, Universiteit Maastricht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing treatment protocol with clear indications for therapy in people with Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of lower urinary tract symptoms (International Prostate Symptom Score [IPSS]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2016.