Prostatic HyperplasiaPhase 4NCT02757963
Benign Prostatic Hyperplasia (BPH) Screening Tool Case Finding Study in Subjects >=50 Years
A Phase 4 study testing Benign prostatic enlargement (BPE)/Benign prostatic obstruction (BPO) screening tool and International Prostate Symptom Score (IPSS) screening tool in people with Prostatic Hyperplasia, run by GlaxoSmithKline at 45 sites in 5 countries.
Trial summary
This non-randomized, interventional study will be conducted in a general practice setting to assess the utility of a benign prostatic enlargement (BPE)/benign prostatic obstruction (BPO) screening tool in conjunction with prostate specific antigen (PSA) in finding men confirmed to have BPH on full urologist assessment… Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Prostatic Hyperplasia
- What is being tested?
- Benign prostatic enlargement (BPE)/Benign prostatic obstruction (BPO) screening tool and International Prostate Symptom Score (IPSS) screening tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,679 participants
- Where
- 45 sitesin 5 countries
- Study dates
- 12 May 2016to 27 Feb 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Greater than or equal to (>=) 50 years of age at the time of signing the informed consent form.
- Male.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and protocol.
- Present in a General Practice setting for a reason unrelated to this study.
- Positive IPSS score >=8 and/or positive BPE/BPO screening tool score >=3.
Who cannot join
- History of BPH for which they have received test procedures, medical intervention and/or medicine.
- History of prostate-related LUTS for which they have received test procedures, medical intervention and/or medicine.
- History of prostatic surgery (including transurethral resection of the prostate (TURP), balloon dilatation, thermotherapy, and/or stent replacement) or other invasive or minimally invasive procedures to treat BPH.
- Has other conditions that may cause urinary symptoms (e.g., neurogenic bladder, bladder neck contracture, urethral stricture, bladder malignancy, acute or chronic prostatitis, or acute or chronic urinary tract infections, etc.).
- History or evidence of prostate cancer (e.g., positive biopsy or ultrasound, suspicious DRE and/or rising PSA).
- Current or prior use of the following: 5alpha-reductase inhibitors (finasteride or dutasteride); anti-cholinergics (e.g. oxybutynin, propantheline, tolterodine, solifenacin, darifenacin, mirabegron) alpha-adrenoreceptor blockers (i.e., indoramin, prazosin, terazosin, tamsulosin, alfuzosin, doxazosin and silodosin), herbal products for urinary symptoms; Use of any investigational study drug within 30 days or 5 half-lives of the drug in question, (whichever is longer), preceding the first study visit.
- Use within previous 30 days at Visit 1 of: phosphodiesterase type 5 inhibitor (PDE-5) inhibitors for erectile dysfunction; anabolic steroids
Trial locations and contacts
45 sites in 5 countries.
45 sites in 5 countries
Russia16 sites
GSK Investigational Site
Arkhangelsk, 163020
GSK Investigational Site
Ivanovo, 153005
GSK Investigational Site
Izhevsk, 426063
GSK Investigational Site
Moscow, 123098
GSK Investigational Site
Naro-Fominsk, 143300
GSK Investigational Site
Novosibirsk, 630099
GSK Investigational Site
Odintsovo, 143005
GSK Investigational Site
Saint Petersburg, 195067
GSK Investigational Site
Saint Petersburg, 195271
GSK Investigational Site
Saint Petersburg, 198328
GSK Investigational Site
Saint Petesburg, 195030
GSK Investigational Site
Smolensk, 214031
GSK Investigational Site
St'Petersburg, 197706
GSK Investigational Site
Tomsk, 634 050
GSK Investigational Site
Ulyanovsk, 432063
GSK Investigational Site
Yaroslavl, 150000
Germany9 sites
GSK Investigational Site
Berlin, 10117
GSK Investigational Site
Buchholz, Lower Saxony, 21244
GSK Investigational Site
Dippoldiswalde, Saxony, 01744
GSK Investigational Site
Flörsheim, Hesse, 65439
GSK Investigational Site
Freital, Saxony, 01705
GSK Investigational Site
Leipzig, Saxony, 04329
GSK Investigational Site
Magdeburg, 39120
GSK Investigational Site
Munich, Bavaria, 80339
GSK Investigational Site
Weinheim, Baden-Wurttemberg, 69469
France8 sites
GSK Investigational Site
Aigrefeuille-sur-Maine, 44140
GSK Investigational Site
Grenay, 62160
GSK Investigational Site
Haute-Goulaine, 44115
GSK Investigational Site
La Montagne, 44620
GSK Investigational Site
Nantes, 44277
GSK Investigational Site
Rosiers-d'Égletons, 19300
GSK Investigational Site
Rouen, 76000
GSK Investigational Site
Thouars, 79100
Italy6 sites
GSK Investigational Site
Aradeo, Apulia, 73040
GSK Investigational Site
Civitella Paganico (GR), Tuscany, 58045
GSK Investigational Site
Cutrofiano (LE), Apulia, 73020
GSK Investigational Site
Galatina (LE), Apulia, 73013
GSK Investigational Site
Grosseto, Tuscany, 58100
GSK Investigational Site
Ruffano (LE), Apulia, 73049
Spain6 sites
GSK Investigational Site
Bormujo (Sevilla), 41930
GSK Investigational Site
Cadiz, 11009
GSK Investigational Site
Granada, 18014
GSK Investigational Site
Seville, 41014
GSK Investigational Site
Valencia, 46010
GSK Investigational Site
Valencia, 46026
About this study
Official title: Implementation of a Screening Tool for Subjects With Benign Prostatic Enlargement/Obstruction to Identify Men >=50 Years Presenting in General Practice With Other Co-morbidities Who Should be Assessed for BPH
This non-randomized, interventional study will be conducted in a general practice setting to assess the utility of a benign prostatic enlargement (BPE)/benign prostatic obstruction (BPO) screening tool in conjunction with prostate specific antigen (PSA) in finding men confirmed to have BPH on full urologist assessment of diagnostic test results. The tool may help a General Practitioners (GP) to identify subjects who may have BPH for further tests and improve the speed of referrals to specialists when this is appropriate. The utility of the screening tool will be compared to the validated tool in wide clinical use, the International Prostate Symptom Score (IPSS). This study does not have any formal hypothesis in terms of the primary and secondary endpoint proportions. A BPE/BPO screening tool identifies lower urinary tract symptoms (LUTS) probably due to BPH in men not yet presenting with LUTS. The results of this screening tool will be used for further investigation. All subjects testing positive on the BPE/BPO screening tool (score >=3) tool or on the IPSS (score >=8) will be enrolled and offered a PSA test and urinalysis to establish a diagnosis of probable BPH (Part I-Visit 1). The GP may perform a digital rectal examination (DRE) which will be repeated by the urologist to confirm the diagnosis and to rule out an abnormality suggesting prostate cancer. The GP will make a diagnosis of probable BPH based upon screening results and lab tests which suggest that they are related to BPH and not other causes of such symptoms. The GP will phone the subject to report yes or no for probable BPH Part II (Visit 2). If the subject has probable BPH, the GP will schedule the subject for Visit 3 with an urologist. If the subject does not have probable BPH, then it will be considered that the subject has completed the study. Subjects that proceed to Part II (Visit 3) will be scheduled for a urology assessment performed by an urologist. This assessment includes a DRE and a brief physical exam and review of the PSA test, for a confirmatory diagnosis of BPH and estimation of risk of progression of BPH. Approximately 1,500 subjects presenting to a GP for reasons unrelated to this study will be screened for probable BPH to yield 500 subjects being referred to an urologist. The duration of the study will be 1 week (+/- 4 days) and up to 6 weeks to allow for GP and urologist visit scheduling.
- Conditions
- Prostatic Hyperplasia
- Being tested
- Benign prostatic enlargement (BPE)/Benign prostatic obstruction (BPO) screening tool, International Prostate Symptom Score (IPSS) screening tool
- Keywords
- Screening tool, International Prostate Symptom Score, Lower urinary tract symptoms, BPO, BPE, Benign prostatic enlargement, Benign prostatic obstruction, LUTS, Benign prostatic hyperplasia, IPSS, BPH
- 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.
Benign prostatic enlargement (BPE)/Benign prostatic obstruction (BPO) screening toolOther
The BPE/BPO screening tool has been developed using the currently recommended Food and Drug Administration (FDA) 2009 guidelines for developing patient-completed questionnaires such as Patient Reported Outcomes. The tool to be used in this study in the General Practice setting has undergone validation in a urology setting to demonstrate the validity of the tool in populations with and without a definite diagnosis of BPH. Subjects who have a positive score on the BPE/BPO screening tool (total score >=3) and meet all other eligibility requirements will be enrolled in Part I of the study.
International Prostate Symptom Score (IPSS) screening toolOther
The International Prostate Symptom Score (IPSS) score is a validated tool to assess the severity of LUTS symptoms, and has similarly been used for assessing symptomatic efficacy of treatments for BPH. Subjects who have a positive score on the IPSS tool (score >=8) and meet all other eligibility requirements will be enrolled in Part I of the study.
| Study group | Role | What they receive |
|---|---|---|
| BPE/BPO screening and IPSS screening tool | Other | Subjects presenting to a GP with a primary complaint other than LUTS will be screened for probable BPH using BPE/BPO screening tool and the IPSS screening tool. Subjects testing positive on the BPE/BPO screening tool or on the IPSS will be enrolled and offered a prostate specific antigen (PSA) test and urinalysis to establish a diagnosis of probable benign prostatic hyperplasia (BPH) (Part I - Visit 1). If the GP determines that the subject has probable BPH (IPSS >=8 and/or BPE/BPO questionnaire >=3 with a PSA >=2 ng per ml), the subject will proceed to Part II and will be scheduled for an urologist assessment and diagnostic tests to confirm or refute a BPH diagnosis and to assess risk of progression of BPH. Receives: Other: Benign prostatic enlargement (BPE)/Benign prostatic obstruction (BPO) screening tool; Other: International Prostate Symptom Score (IPSS) screening tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Men With Confirmed Diagnosis of BPH
Confirmed diagnosis of BPH was based on full urologist diagnostic testing with a positive result on the BPE/BPO screening tool (score >=3) and serum PSA >=2 ng/mL. The BPE/BPO questionnaire consists of three questions each with a score ranging from 0= never experienced to 5= almost always experienced. Participants with probable BPH underwent full urologist diagnostic testing, which included review of medical history, symptoms and previous tests, brief physical examination, Digital rectal examination (DRE). Proportion of participants was calculated by dividing number of participants with a positive result on the BPE/BPO screening tool (Score >= 3) and a diagnosis of BPH by the urologist (Numerator) by number of participants with a positive result on the BPE/BPO screening tool (Score >= 3) and a BPH assessment by the urologist (Denominator). 95% confidence interval on the proportion was calculated by using the exact (Clopper-Pearson) method.
Measured: Up to 6 weeks
Secondary outcomes (4)
Number of Men That Are Confirmed to Have BPH Based on Full Urologist Assessment of Diagnostic Test Results Among Men With a Positive Result on the IPSS, BPE/BPO and IPSS, and BPE/BPO or IPSS Screening Tools and Serum PSA >=2 ng/mL
Confirmed diagnosis of BPH was based on full urologist diagnostic testing with a positive result on the IPSS, BPE/BPO and IPSS, BPE/BPO or IPSS screening tools and serum PSA >=2 ng/mL. The BPE/BPO questionnaire consists of three questions each with a score ranging from 0= never experienced to 5= almost always experienced. IPSS tool is used to assess the severity of LUTS symptoms with a score ranging from 0= never experienced to 5= almost always experienced. Participants with probable BPH underwent full urologist diagnostic testing, which included review of medical history, symptoms and previous tests, brief physical examination, DRE. Proportion of participants was calculated by dividing number of participants with a positive result on the screening tool and a diagnosis of BPH by the urologist (Numerator) by number of participants with a positive result on the screening tool and a BPH assessment by the urologist(Denominator).
Measured: Up to 6 weeks
Number of Men That Are Confirmed to be at Risk for BPH Progression Based Upon Full Urologist Assessment Among Men With a Positive Result on the BPE/BPO, IPSS, BPE/BPO and IPSS, and BPE/BPO or IPSS Screening Tools and Serum PSA >=2 ng/mL
Confirmed risk for BPH was based on full urologist diagnostic testing with a positive result on the BPE/BPO and/or IPSS screening tool and probable GP BPH diagnosis. The BPE/BPO questionnaire consists of 3 questions each with a score from 0= never experienced to 5= almost always experienced. IPSS tool is used to assess the severity of LUTS symptoms with a score from 0= never experienced to 5= almost always experienced. Participants with probable BPH underwent full urologist diagnostic testing, which included review of medical history, symptoms and previous tests, physical examination, DRE. Participants with PSA >=2.0 ng/mL and other tests were considered as at risk for BPH. Proportion of participants was calculated by dividing number of participants with a positive result on the screening tool and diagnosis of BPH progression risk (Numerator) by number of participants with a positive result on the screening tool and a BPH progression risk assessment by the urologist (Denominator).
Measured: Up to 6 weeks
Number of Men That Are Diagnosed With Probable BPH as Assessed by the GP Among Men With a Positive Result on the BPE/BPO, IPSS, BPE/BPO and IPSS, and BPE/BPO or IPSS Screening Tools
Diagnosis of probable BPH was based on GP assessment among men with a positive result on the BPE/BPO and/or IPSS screening tool. The BPE/BPO questionnaire consists of 3 questions each with a score from 0= never experienced to 5= almost always experienced. IPSS tool is used to assess the severity of LUTS symptoms with a score from 0= never experienced to 5= almost always experienced. Probable BPH is the presumptive diagnosis of urinary tract obstruction from an enlarged prostate based on clinical symptoms and findings where urinary symptoms are not apparently related to any other cause. Participants underwent GP assessment and lab result review by GP. Participants with PSA >=2 ng/mL were assessed for probable BPH. Proportion of participants was calculated by dividing number of participants with a positive result on the screening tool and diagnosis of probable BPH (Numerator) by number of participants with a positive result on the screening tool and a BPH assessment by GP (Denominator).
Measured: Up to 6 weeks
Summary of Agreement Between BPE/BPO and IPSS Screening Tools
Agreement between the IPSS and BPE/BPO tools had to utilize the screened population, as the evaluable population did not include any participants with IPSS <8 and BPE/BPO<3. All screened participants with IPSS and BPE/BPO results were utilized (2327 of the 2343 participants had IPSS and BPE/PO results). There were 16 participants (2343 minus 2327) in the screened population without IPSS and BPE/BPO results, and hence were not included in the calculation of the Kappa statistic. Kappa statistic values of <0 were characterized as no agreement, 0 to 0.20 as slight, 0.21 to 0.40 as fair, 0.41 to 0.60 as moderate, 0.61 to 0.80 as substantial, and 0.81 to 1.00 as almost perfect agreement. The 95% confidence interval for the Kappa statistic is based on the asymptotic standard error.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study start12 May 2016
- Primary completion27 Feb 2017
- Study completion27 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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 4
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,679 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02757963
- Sponsor's protocol ID
- 116114
- Status last verified
- Dec 2020
- First submitted
- 28 Apr 2016
- Last updated
- 5 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: IPD for this study is available via the Clinical Study Data Request site.
Publications
Tubaro A, Niero M, Adalig B, Lulic Z, Plastino J, Kimbrough C, Manyak MJ. Evaluation of a 3-item screening tool to identify men with benign prostatic enlargement/obstruction in a primary care cohort. Minerva Urol Nephrol. 2022 Feb;74(1):85-92. doi: 10.23736/S2724-6051.20.03834-5. Epub 2020 Sep 29.
PubMed 32993275
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Screening Tool for Subjects With Benign Prostatic Enlargement/Obstruction to Identify Men >=50 Years Presenting in General Practice With Other Co-morbidities Who Should be Assessed for BPH
- ClinicalTrials.gov ID
- NCT02757963
- Acronym / sponsor ID
- 116114
- Conditions
- Prostatic Hyperplasia
- Keywords
- Screening tool, International Prostate Symptom Score, Lower urinary tract symptoms, BPO, BPE, Benign prostatic enlargement, Benign prostatic obstruction, LUTS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,679 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 12 May 2016 (actual)
- Primary completion
- 27 Feb 2017 (actual)
- Study completion
- 27 Feb 2017 (actual)
- First posted
- 2 May 2016 (estimated)
- Results
- Posted 24 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This non-randomized, interventional study will be conducted in a general practice setting to assess the utility of a benign prostatic enlargement (BPE)/benign prostatic obstruction (BPO) screening tool in conjunction with prostate specific antigen (PSA) in finding men confirmed to have BPH on full urologist assessment of diagnostic test results. The tool may help a General Practitioners (GP) to identify subjects who may have BPH for further tests and improve the speed of referrals to specialists when this is appropriate. The utility of the screening tool will be compared to the validated tool in wide clinical use, the International Prostate Symptom Score (IPSS). This study does not have any formal hypothesis in terms of the primary and secondary endpoint proportions. A BPE/BPO screening tool identifies lower urinary tract symptoms (LUTS) probably due to BPH in men not yet presenting with LUTS. The results of this screening tool will be used for further investigation. All subjects testing positive on the BPE/BPO screening tool (score >=3) tool or on the IPSS (score >=8) will be enrolled and offered a PSA test and urinalysis to establish a diagnosis of probable BPH (Part I-Visit 1). The GP may perform a digital rectal examination (DRE) which will be repeated by the urologist to confirm the diagnosis and to rule out an abnormality suggesting prostate cancer. The GP will make a diagnosis of probable BPH based upon screening results and lab tests which suggest that they are related to BPH and not other causes of such symptoms. The GP will phone the subject to report yes or no for probable BPH Part II (Visit 2). If the subject has probable BPH, the GP will schedule the subject for Visit 3 with an urologist. If the subject does not have probable BPH, then it will be considered that the subject has completed the study. Subjects that proceed to Part II (Visit 3) will be scheduled for a urology assessment performed by an urologist. This assessment includes a DRE and a brief physical exam and review of the PSA test, for a confirmatory diagnosis of BPH and estimation of risk of progression of BPH. Approximately 1,500 subjects presenting to a GP for reasons unrelated to this study will be screened for probable BPH to yield 500 subjects being referred to an urologist. The duration of the study will be 1 week (+/- 4 days) and up to 6 weeks to allow for GP and urologist visit scheduling.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BPE/BPO screening and IPSS screening tool | Other | Other: Benign prostatic enlargement (BPE)/Benign prostatic obstruction (BPO) screening tool, Other: International Prostate Symptom Score (IPSS) screening toolSubjects presenting to a GP with a primary complaint other than LUTS will be screened for probable BPH using BPE/BPO screening tool and the IPSS screening tool. Subjects testing positive on the BPE/BPO screening tool or on the IPSS will be enrolled and offered a prostate specific antigen (PSA) test and urinalysis to establish a diagnosis of probable benign prostatic hyperplasia (BPH) (Part I - Visit 1). If the GP determines that the subject has probable BPH (IPSS >=8 and/or BPE/BPO questionnaire >=3 with a PSA >=2 ng per ml), the subject will proceed to Part II and will be scheduled for an urologist assessment and diagnostic tests to confirm or refute a BPH diagnosis and to assess risk of progression of BPH. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Greater than or equal to (>=) 50 years of age at the time of signing the informed consent form.
- Male.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and protocol.
- Present in a General Practice setting for a reason unrelated to this study.
- Positive IPSS score >=8 and/or positive BPE/BPO screening tool score >=3.
Key exclusion criteria (7 listed)
- History of BPH for which they have received test procedures, medical intervention and/or medicine.
- History of prostate-related LUTS for which they have received test procedures, medical intervention and/or medicine.
- History of prostatic surgery (including transurethral resection of the prostate (TURP), balloon dilatation, thermotherapy, and/or stent replacement) or other invasive or minimally invasive procedures to treat BPH.
- Has other conditions that may cause urinary symptoms (e.g., neurogenic bladder, bladder neck contracture, urethral stricture, bladder malignancy, acute or chronic prostatitis, or acute or chronic urinary tract infections, etc.).
- History or evidence of prostate cancer (e.g., positive biopsy or ultrasound, suspicious DRE and/or rising PSA).
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 |
|---|---|---|
| Benign prostatic enlargement (BPE)/Benign prostatic obstruction (BPO) screening toolThe BPE/BPO screening tool has been developed using the currently recommended Food and Drug Administration (FDA) 2009 guidelines for developing patient-completed questionnaires such as Patient Reported Outcomes. The tool to be used in this study in the General Practice setting has undergone validation in a urology setting to demonstrate the validity of the tool in populations with and without a definite diagnosis of BPH. Subjects who have a positive score on the BPE/BPO screening tool (total score >=3) and meet all other eligibility requirements will be enrolled in Part I of the study. | Other | BPE/BPO screening and IPSS screening tool |
| International Prostate Symptom Score (IPSS) screening toolThe International Prostate Symptom Score (IPSS) score is a validated tool to assess the severity of LUTS symptoms, and has similarly been used for assessing symptomatic efficacy of treatments for BPH. Subjects who have a positive score on the IPSS tool (score >=8) and meet all other eligibility requirements will be enrolled in Part I of the study. | Other | BPE/BPO screening and IPSS screening tool |
Primary outcome
Number of Men With Confirmed Diagnosis of BPH
Time frame: Up to 6 weeks
Confirmed diagnosis of BPH was based on full urologist diagnostic testing with a positive result on the BPE/BPO screening tool (score >=3) and serum PSA >=2 ng/mL. The BPE/BPO questionnaire consists of three questions each with a score ranging from 0= never experienced to 5= almost always experienced. Participants with probable BPH underwent full urologist diagnostic testing, which included review of medical history, symptoms and previous tests, brief physical examination, Digital rectal examination (DRE). Proportion of participants was calculated by dividing number of participants with a positive result on the BPE/BPO screening tool (Score >= 3) and a diagnosis of BPH by the urologist (Numerator) by number of participants with a positive result on the BPE/BPO screening tool (Score >= 3) and a BPH assessment by the urologist (Denominator). 95% confidence interval on the proportion was calculated by using the exact (Clopper-Pearson) method.
4 secondary outcomes
Number of Men That Are Confirmed to Have BPH Based on Full Urologist Assessment of Diagnostic Test Results Among Men With a Positive Result on the IPSS, BPE/BPO and IPSS, and BPE/BPO or IPSS Screening Tools and Serum PSA >=2 ng/mL
Time frame: Up to 6 weeks
Number of Men That Are Confirmed to be at Risk for BPH Progression Based Upon Full Urologist Assessment Among Men With a Positive Result on the BPE/BPO, IPSS, BPE/BPO and IPSS, and BPE/BPO or IPSS Screening Tools and Serum PSA >=2 ng/mL
Time frame: Up to 6 weeks
Number of Men That Are Diagnosed With Probable BPH as Assessed by the GP Among Men With a Positive Result on the BPE/BPO, IPSS, BPE/BPO and IPSS, and BPE/BPO or IPSS Screening Tools
Time frame: Up to 6 weeks
Summary of Agreement Between BPE/BPO and IPSS Screening Tools
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32993275Tubaro A, Niero M, Adalig B, Lulic Z, Plastino J, Kimbrough C, Manyak MJ. Evaluation of a 3-item screening tool to identify men with benign prostatic enlargement/obstruction in a primary care cohort. Minerva Urol Nephrol. 2022 Feb;74(1):85-92. doi: 10.23736/S2724-6051.20.03834-5. Epub 2020 Sep 29.
- Individual participant dataSharing planned: Yes. IPD for this study is available via the Clinical Study Data Request site.
Related trials for Prostatic Hyperplasia
Not yet recruiting
Anterior Bridge-Preserving Versus Conventional Early Apical Release in Bipolar Enucleation of the Prostate
Benign Prostatic Hyperplasia, Benign Prostatic Obstruction
Not yet recruitingPhase 3
Efficacy and Safety of Two Fixed-dose Combinations in Men With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia. (BENIPRO)
Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms
Not yet recruiting
Anterior Bridge-Preserving Versus Conventional Early Apical Release During Holmium Laser Enucleation of the Prostate
Benign Prostatic Hyperplasia, Benign Prostatic Obstruction
Active, not recruitingPhase 2
Effects of EPA on Prostate Cancer Cells Proliferation and Quality of Life
Prostate Cancer
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
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.
GSK Clinical Trials study director
GlaxoSmithKline
45 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Benign prostatic enlargement (BPE)/Benign prostatic obstruction (BPO) screening tool and International Prostate Symptom Score (IPSS) screening tool in people with Prostatic Hyperplasia, run by GlaxoSmithKline at 45 sites in 5 countries.
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 5 inclusion and 7 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 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in Russia, Germany, France, Italy, Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Men With Confirmed Diagnosis of BPH (time frame: Up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02757963, which also lists 1 linked publication.
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 5 Jan 2021.