Benign Prostatic HyperplasiaKALLIRROINCT06528613
Real World Study in Greek Patients with BPH for Disease Control and QoL Under FDC Treatment with Solifenacin/Tamsulosin.
An observational study of Benign Prostatic Hyperplasia, run by Elpen Pharmaceutical Co. Inc. at 6 sites in Greece.
Trial summary
Benign prostatic hyperplasia (BPH) is an age-related progressive condition of the prostate gland that results in an increase in prostate size. Although the "normal" prostate in adult men usually has a volume of 15-30 ml, a value above 30 ml is usually considered "enlarged". Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- How many people
- 450 participants
- Where
- 6 sitesGreece
- Study dates
- 23 Oct 2024to 30 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Male adult patients with moderate to severe symptoms of BPH received monotherapy and did not respond adequately and are receiving FDC of Solifenacin/Tamsulosin.
Who may be able to join
- Male adult patient with moderate to severe symptoms of BPH receiving monotherapy and not responding adequately.
- Male adult patient with BPH who has fully understood the study procedures and signed an informed consent form.
Who cannot join
- -
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Greece6 sites, 6 recruiting
- Not yet recruiting
Second Department of Urology, Sismanoglio Hospital, Athens, Greece.
Athens, Greece, 15126
Andreas Skolarikos, +302132058253, ourologiki@sismanoglio.gr
- Recruiting
Department of Urology, Venizelio General Ηospital
Heraklion, Greece, 71409
Ioannis Heretis, 2813408059, gheretis@yahoo.gr
- Recruiting
Department of Urology, General Hospital of Messinia
Kalamata, Greece, 24100
Konstadinos Skrepetis, +306976762446, skrepetis@hotmail.com
- Recruiting
Department of Urology, General Hospital of Larissa
Larissa, Greece, 41221
Michael Samarinas, 6946006798, mikesamih@hotmail.com
- Recruiting
Department of Urology, University Hospital of Rion
Pátrai, Greece, 26504
Panagiotis Kallidonis, 6944699193, pkallidonis@yahoo.com
- Recruiting
First Department of Urology, School of Medicine, Aristotle University of Thessaloniki
Thessaloniki, Greece, 54635
Georgios Dimitriadis, +302310992520, gdimit@auth.gr
About this study
Official title: Real World Study in Greek Patients with BPH for the Evaluation of Disease Control and QoL Under FDC Treatment with Solifenacin/tamsulosin
Benign prostatic hyperplasia (BPH) is an age-related progressive condition of the prostate gland that results in an increase in prostate size.
Although the "normal" prostate in adult men usually has a volume of 15-30 ml, a value above 30 ml is usually considered "enlarged". However, the threshold at which a prostate is considered enlarged has not been strictly defined and therefore for many physicians an enlarged prostate is a subjective finding on examination.
Read more
BPH can only be defined histologically (increase in the number of epithelial cells and stromal cells), but in clinical practice it is characterized by lower urinary tract symptoms [LUTS]. The disease leads to increased pressure in the urethra, causing resistance to urine flow, known as Bladder Outlet Obstruction (BOO). This resistance can also lead to changes in bladder function caused by the obstruction, such as overactivity of the bladder detrusor muscle or, conversely, reduced detrusor contractility. BOO can present as LUTS, infections or retention, as well as other conditions.
LUTS can be divided into storage (irritant), obstructive (urinary) and post-urinary symptoms and appear frequently causing intense discomfort, reducing the quality of life. LUTS are traditionally associated with bladder outlet resistance (BOO), most commonly when histologic BPH progresses through benign prostatic enlargement (BPE) to benign prostatic obstruction (BPO).The European Urological Association (EAU) reports that LUTS are a common problem in adult men with a significant impact on quality of life (QoL). Accordingly, he suggests the use of the a1-blocker/muscarinic receptor antagonist combination in men with moderate to severe storage symptoms, voiding symptoms and PVR < 150 ml, in order to reduce the risk of acute urinary retention and relieve irritants. (storage) symptoms, leading to an improvement in the patient's quality of life. Given the small abundance of data for patients in Greece with BPH, this study will evaluate the fixed combination of solifenacin/tamsulosin in terms of disease control and improvement of the quality of life of patients with BPH. Before enrolling in the study and before signing the consent form, patients must have already received the drug with solifenacin/tamsulosin and then they are enrolled in the observational study where the physician applies his/her standard clinical practice.
Read the detailed description
The only clearly defined risk factors for BPH are age and the presence of elevated androgens in the blood. But there are other factors that can influence the prevalence of clinical disease such as metabolic syndrome, diabetes, obesity, hypertension, diet and heredity.
Clinical BPH often occurs within the same family. If one or more first-degree relatives have had BPH, then a person is at greater risk of developing the disease. The probability of developing BPH and the rates of occurrence and progression of LUTS increase significantly with age. In a study of 278 men with an average age of 58 years, it was shown that prostate volume increased at an average rate of 0.6ml per year.
Although the severity of symptoms cannot be directly related to prostate volume, having a large prostate volume is a risk factor for developing LUTS (a larger prostate is associated with an increased risk of urinary retention).
Data support that the metabolic syndrome may influence the natural course regarding the development of BPH and BOO. Metabolic syndrome includes hypertension, dyslipidemia, glucose intolerance, obesity, and insulin resistance with compensatory hyperinsulinemia.
In a meta-analysis it was shown that the obese, the elderly, patients with low HDL cholesterol values and patients with metabolic syndrome had a significantly higher total prostate volume.
Diabetes mellitus as a cause of bladder dysfunction can manifest either as overactivity or as poor detrusor function. Diet has been reported as a risk factor for the development of BPH. High amounts of vegetables and soy products in the diet may explain the lower rate of BPH in Eastern compared to Western countries. The association of alcohol, diet, and other lifestyle factors with obstructive uropathy was investigated in a cohort of 6,581 Japanese-American men, 846 of whom were later diagnosed with BPH (after 17 years of follow-up). Total alcohol intake was inversely associated with the risk of developing obstructive uropathy or BPH (i.e., reduced risk of developing the disease).
In the present study purpose is to evaluate the symptoms of the lower urinary tract in patients with BPH; the International Prostate Symptom Score (IPSS) questionnaire will be used, which is a modification of the AUA Symptom Index by adding a question that evaluates the quality of life in relation to the disease.
Both the AUA index and the IPSS questionnaire, although not specific for BPH, prostate volume, urine flow rate, residual urine volume after voiding or bladder obstruction, have been validated and are sufficiently sensitive for be used in symptom assessment and treatment selection. Although the assessment of specific symptoms is necessary for the treatment outcome of LUTS due to BPH, it is also important to have a simpler approach that addresses the patients' perception of the severity and change of their symptoms.
The Patient Global Impression of Severity (PGI-S) questionnaire assesses the patient's overall impression of the severity of his condition due to BPH symptoms and is a record of perception of the patient in a simple, valid and easily administered manner in clinical practice. The Patient Global Impression of Change (PGI-C) is the questionnaire it assesses the patient's overall impression of the change in their condition due to a treatment choice and is widely used in studies to assess chronic pain and/or for the patient's self-assessment of the overall improvement of a treatment.
- Conditions
- Benign Prostatic Hyperplasia
- Medical subject headings
- Prostatic Hyperplasia
What is being measured
The primary outcome is the main question the study is designed to answer.
The assessment of disease control (BPH) and quality of life of patients.
The change in the total score (questions 1-7) and the quality-of-life question score of the International Prostate Symptom Score (IPSS) questionnaire after six months of treatment with a fixed combination of solifenacin/tamsulosin. The total disease control score is calculated by summing the scores of the seven symptom-related questions.
In particular :
Questions 1-6: 6-point response scale from 0 (not at all) to 5 (almost always). Question 7: 6-point response scale from 0 (none) to 5 (5 or more).
This gives an overall score ranging from 0 to 35 where :
0-7: mildly symptomatic, 8-19: moderately symptomatic, 20-35: severely symptomatic. Concerning the quality-of-life question score : 7-point response scale from 0 (no impact on QOL) to 6 (high impact on QOL).
Measured: 6 months
Secondary outcomes (2)
The assessment of patients' overall impression of their condition from Benign Prostatic Hyperplasia (BPH).
Assessment from baseline and after six months of solifenacin/tamsulosin fixed-combination treatment of the patient's global impression of change in severity and overall impression of change in condition due to BPH using the PGI- S (Patient Global Impression of Severity) and PGI-C (Patient Global Impression of Change), respectively.
The Patient Global Impression of Change (PGI-C) scale measured patients' ratings of overall change in condition due to BPH compared to study baseline and range from 0 [very much better] to 7 [very much worse].
The Patient Global Impression of Severity (PGI-S) scale measured patients' ratings of overall severity compared to study baseline and range from none to 7 very severe).
Measured: 6 months
Assessment of the safety of the solifenacin/tamsulosin fixed dose combination during the study.
The recording of Adverse Events (AE) if they occur during the study. All directly observed adverse events and all adverse events (ΑΕ) spontaneously reported by the patient will be recorded, using accurate and comprehensive medical terminology. The ΑΕ reporting period for this study will begin at the 1st (selection) visit after the patient signs the informed consent form and end at the final follow-up visit. All AEs occurring during the adverse event reporting period must be reported, whether or not the event is considered to be related to the study drug. In all cases, the investigator should indicate whether there is a causal relationship between the reported event and the investigational medicinal product. In addition, any adverse event occurring after the adverse event reporting period that the investigator considers to be possibly related to the study drug should also be reported as an AE.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start23 Oct 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elpen Pharmaceutical Co. Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexandros Ginis, Study director, Elpen Pharmaceutical Co. Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06528613
- Sponsor's protocol ID
- Elpen Pharmaceutical Co. Inc.
- Acronym
- KALLIRROI
- Status last verified
- Nov 2024
- First submitted
- 18 Jul 2024
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shibata K, Hirasawa A, Moriyama N, Kawabe K, Ogawa S, Tsujimoto G. Alpha 1a-adrenoceptor polymorphism: pharmacological characterization and association with benign prostatic hypertrophy. Br J Pharmacol. 1996 Jul;118(6):1403-8. doi: 10.1111/j.1476-5381.1996.tb15552.x.
PubMed 8832064Lepor H. Pathophysiology of benign prostatic hyperplasia in the aging male population. Rev Urol. 2005;7 Suppl 4(Suppl 4):S3-S12.
PubMed 16986052Ekman P. The prostate as an endocrine organ: androgens and estrogens. Prostate Suppl. 2000;10:14-8. No abstract available.
PubMed 11056488GBD 2019 Benign Prostatic Hyperplasia Collaborators. The global, regional, and national burden of benign prostatic hyperplasia in 204 countries and territories from 2000 to 2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Healthy Longev. 2022 Nov;3(11):e754-e776. doi: 10.1016/S2666-7568(22)00213-6. Epub 2022 Oct 20.
PubMed 36273485Johnson TV, Abbasi A, Ehrlich SS, Kleris RS, Owen-Smith A, Raison CL, Master VA. IPSS quality of life question: a possible indicator of depression among patients with lower urinary tract symptoms. Can J Urol. 2012 Feb;19(1):6100-4.
PubMed 22316511Viktrup L, Hayes RP, Wang P, Shen W. Construct validation of patient global impression of severity (PGI-S) and improvement (PGI-I) questionnaires in the treatment of men with lower urinary tract symptoms secondary to benign prostatic hyperplasia. BMC Urol. 2012 Nov 7;12:30. doi: 10.1186/1471-2490-12-30.
PubMed 23134716
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Study in Greek Patients with BPH for the Evaluation of Disease Control and QoL Under FDC Treatment with Solifenacin/tamsulosin
- ClinicalTrials.gov ID
- NCT06528613
- Acronym / sponsor ID
- KALLIRROI / Elpen Pharmaceutical Co. Inc.
- Conditions
- Benign Prostatic Hyperplasia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Elpen Pharmaceutical Co. Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 30 Jul 2024 (actual)
- 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.
Benign prostatic hyperplasia (BPH) is an age-related progressive condition of the prostate gland that results in an increase in prostate size.
Although the "normal" prostate in adult men usually has a volume of 15-30 ml, a value above 30 ml is usually considered "enlarged". However, the threshold at which a prostate is considered enlarged has not been strictly defined and therefore for many physicians an enlarged prostate is a subjective finding on examination.
BPH can only be defined histologically (increase in the number of epithelial cells and stromal cells), but in clinical practice it is characterized by lower urinary tract symptoms [LUTS]. The disease leads to increased pressure in the urethra, causing resistance to urine flow, known as Bladder Outlet Obstruction (BOO). This resistance can also lead to changes in bladder function caused by the obstruction, such as overactivity of the bladder detrusor muscle or, conversely, reduced detrusor contractility. BOO can present as LUTS, infections or retention, as well as other conditions.
LUTS can be divided into storage (irritant), obstructive (urinary) and post-urinary symptoms and appear frequently causing intense discomfort, reducing the quality of life. LUTS are traditionally associated with bladder outlet resistance (BOO), most commonly when histologic BPH progresses through benign prostatic enlargement (BPE) to benign prostatic obstruction (BPO).The European Urological Association (EAU) reports that LUTS are a common problem in adult men with a significant impact on quality of life (QoL). Accordingly, he suggests the use of the a1-blocker/muscarinic receptor antagonist combination in men with moderate to severe storage symptoms, voiding symptoms and PVR < 150 ml, in order to reduce the risk of acute urinary retention and relieve irritants. (storage) symptoms, leading to an improvement in the patient's quality of life. Given the small abundance of data for patients in Greece with BPH, this study will evaluate the fixed combination of solifenacin/tamsulosin in terms of disease control and improvement of the quality of life of patients with BPH. Before enrolling in the study and before signing the consent form, patients must have already received the drug with solifenacin/tamsulosin and then they are enrolled in the observational study where the physician applies his/her standard clinical practice.
Detailed description
The only clearly defined risk factors for BPH are age and the presence of elevated androgens in the blood. But there are other factors that can influence the prevalence of clinical disease such as metabolic syndrome, diabetes, obesity, hypertension, diet and heredity.
Clinical BPH often occurs within the same family. If one or more first-degree relatives have had BPH, then a person is at greater risk of developing the disease. The probability of developing BPH and the rates of occurrence and progression of LUTS increase significantly with age. In a study of 278 men with an average age of 58 years, it was shown that prostate volume increased at an average rate of 0.6ml per year.
Although the severity of symptoms cannot be directly related to prostate volume, having a large prostate volume is a risk factor for developing LUTS (a larger prostate is associated with an increased risk of urinary retention).
Data support that the metabolic syndrome may influence the natural course regarding the development of BPH and BOO. Metabolic syndrome includes hypertension, dyslipidemia, glucose intolerance, obesity, and insulin resistance with compensatory hyperinsulinemia.
In a meta-analysis it was shown that the obese, the elderly, patients with low HDL cholesterol values and patients with metabolic syndrome had a significantly higher total prostate volume.
Diabetes mellitus as a cause of bladder dysfunction can manifest either as overactivity or as poor detrusor function. Diet has been reported as a risk factor for the development of BPH. High amounts of vegetables and soy products in the diet may explain the lower rate of BPH in Eastern compared to Western countries. The association of alcohol, diet, and other lifestyle factors with obstructive uropathy was investigated in a cohort of 6,581 Japanese-American men, 846 of whom were later diagnosed with BPH (after 17 years of follow-up). Total alcohol intake was inversely associated with the risk of developing obstructive uropathy or BPH (i.e., reduced risk of developing the disease).
In the present study purpose is to evaluate the symptoms of the lower urinary tract in patients with BPH; the International Prostate Symptom Score (IPSS) questionnaire will be used, which is a modification of the AUA Symptom Index by adding a question that evaluates the quality of life in relation to the disease.
Both the AUA index and the IPSS questionnaire, although not specific for BPH, prostate volume, urine flow rate, residual urine volume after voiding or bladder obstruction, have been validated and are sufficiently sensitive for be used in symptom assessment and treatment selection. Although the assessment of specific symptoms is necessary for the treatment outcome of LUTS due to BPH, it is also important to have a simpler approach that addresses the patients' perception of the severity and change of their symptoms.
The Patient Global Impression of Severity (PGI-S) questionnaire assesses the patient's overall impression of the severity of his condition due to BPH symptoms and is a record of perception of the patient in a simple, valid and easily administered manner in clinical practice. The Patient Global Impression of Change (PGI-C) is the questionnaire it assesses the patient's overall impression of the change in their condition due to a treatment choice and is widely used in studies to assess chronic pain and/or for the patient's self-assessment of the overall improvement of a treatment.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male adult patients with moderate to severe symptoms of BPH received monotherapy and did not respond adequately and are receiving FDC of Solifenacin/Tamsulosin.
Key inclusion criteria (2 listed)
- Male adult patient with moderate to severe symptoms of BPH receiving monotherapy and not responding adequately.
- Male adult patient with BPH who has fully understood the study procedures and signed an informed consent form.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The assessment of disease control (BPH) and quality of life of patients.
Time frame: 6 months
The change in the total score (questions 1-7) and the quality-of-life question score of the International Prostate Symptom Score (IPSS) questionnaire after six months of treatment with a fixed combination of solifenacin/tamsulosin. The total disease control score is calculated by summing the scores of the seven symptom-related questions. In particular : Questions 1-6: 6-point response scale from 0 (not at all) to 5 (almost always). Question 7: 6-point response scale from 0 (none) to 5 (5 or more). This gives an overall score ranging from 0 to 35 where : 0-7: mildly symptomatic, 8-19: moderately symptomatic, 20-35: severely symptomatic. Concerning the quality-of-life question score : 7-point response scale from 0 (no impact on QOL) to 6 (high impact on QOL).
2 secondary outcomes
The assessment of patients' overall impression of their condition from Benign Prostatic Hyperplasia (BPH).
Time frame: 6 months
Assessment of the safety of the solifenacin/tamsulosin fixed dose combination during the study.
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Background: PubMed 8832064Shibata K, Hirasawa A, Moriyama N, Kawabe K, Ogawa S, Tsujimoto G. Alpha 1a-adrenoceptor polymorphism: pharmacological characterization and association with benign prostatic hypertrophy. Br J Pharmacol. 1996 Jul;118(6):1403-8. doi: 10.1111/j.1476-5381.1996.tb15552.x.
- Background: PubMed 16986052Lepor H. Pathophysiology of benign prostatic hyperplasia in the aging male population. Rev Urol. 2005;7 Suppl 4(Suppl 4):S3-S12.
- Background: PubMed 11056488Ekman P. The prostate as an endocrine organ: androgens and estrogens. Prostate Suppl. 2000;10:14-8. No abstract available.
- Background: PubMed 36273485GBD 2019 Benign Prostatic Hyperplasia Collaborators. The global, regional, and national burden of benign prostatic hyperplasia in 204 countries and territories from 2000 to 2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Healthy Longev. 2022 Nov;3(11):e754-e776. doi: 10.1016/S2666-7568(22)00213-6. Epub 2022 Oct 20.
- Background: PubMed 22316511Johnson TV, Abbasi A, Ehrlich SS, Kleris RS, Owen-Smith A, Raison CL, Master VA. IPSS quality of life question: a possible indicator of depression among patients with lower urinary tract symptoms. Can J Urol. 2012 Feb;19(1):6100-4.
- Background: PubMed 23134716Viktrup L, Hayes RP, Wang P, Shen W. Construct validation of patient global impression of severity (PGI-S) and improvement (PGI-I) questionnaires in the treatment of men with lower urinary tract symptoms secondary to benign prostatic hyperplasia. BMC Urol. 2012 Nov 7;12:30. doi: 10.1186/1471-2490-12-30.
- Individual participant dataSharing planned: No
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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.
Alexandros Ginis study director
Elpen Pharmaceutical Co. Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Prostatic Hyperplasia, run by Elpen Pharmaceutical Co. Inc. at 6 sites in Greece.
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 1 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: looking for participants now, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Greece. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Polyanthi Papanastasiou (+302111865777, p.papanastasiou@elpen.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The assessment of disease control (BPH) and quality of life of patients. (time frame: 6 months). 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 NCT06528613, which also lists 6 linked publications.
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 12 Mar 2025; AzTrials last refreshed its copy on 6 Nov 2026.