Benign Prostatic HyperplasiaNCT07619105
A Study to Track the Safety of Vesomni in Men in South Korea Treated in Routine Clinical Practice for the Urinary Symptoms of Benign Prostatic Hyperplasia (Enlarged Prostate)
An observational study of Benign Prostatic Hyperplasia, run by Astellas Pharma Korea, Inc..
Trial summary
Benign prostatic hyperplasia (BPH), also known as an enlarged prostate, happens more often in men as they age. This condition causes a sudden need to pass urine, which is hard to control. Men with an enlarged prostate may need to pass urine many times during the day and night which can affect their wellbeing. Read more about this study
- Who is it for?
- Ages 19 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Vesomni
- Type of treatment
- Pill or oral medicine
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2026to 30 Nov 2030
- 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 19 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Participants with moderate to severe storage symptoms (pollakiuria, micturition urgency) and voiding symptoms associated with BPH.
Who may be able to join
- A patient (adult male) who receives treatment with Vesomni, according to the approved local label during the registration period.
Who cannot join
- A patient with any contraindication for Vesomni, according to the approved local label.
- A patient who enrolled or is planning to enroll in any study of an investigational medicine during the observation period.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Post-marketing Observational Study for Vesomni Modified Release Tablet 6 mg/0.4 mg (Solifenacin Succinate/Tamsulosin Hydrochloride) in Male Patients With Moderate to Severe Storage Symptoms and Voiding Symptoms Associated With BPH Who Are Not Adequately Responding to Treatment With Tamsulosin Monotherapy in South Korea
Benign prostatic hyperplasia (BPH), also known as an enlarged prostate, happens more often in men as they age. This condition causes a sudden need to pass urine, which is hard to control. Men with an enlarged prostate may need to pass urine many times during the day and night which can affect their wellbeing. There are treatments available, like tamsulosin but they don't work well in some men and can cause further health problems. Vesomni is approved in South Korea to treat urinary symptoms in men with an enlarged prostate, when treatment with tamsulosin doesn't work well enough.
This study will track the safety of Vesomni given to men in South Korea who have moderate to severe symptoms from an enlarged prostate, who have previously been treated with tamsulosin and found it didn't work well. The safety of Vesomni is tracked by mainly collecting information from their medical records. The sponsor will ask for extra information to be collected, and if any health problems were caused by Vesomni. In this study, researchers want to learn about the safety of Vesomni and how well it controls symptoms in men with an enlarged prostate.
The men's own doctor decides on treatment, as part of routine clinical practice, not the sponsor (Astellas). This study is about collecting information only. Most information about the safety and control of symptoms will be collected from medical records. The sponsor will also ask for extra information to be collected. All information will be collected for up to 24 weeks after the men start treatment with Vesomni.
Read the detailed description
Primary data collection will occur during the observation period for each participant, targeted for 12 weeks (or at least 24 weeks for long-term users) after receiving the first dose of Vesomni. Secondary data collection (extracting data from medical records, including hospital admission/discharge notes, prescription drug files, biological measurements, etc.) will occur for participants enrolled.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Vesomni
- Keywords
- Pollakiuria, Micturition urgency, Voiding Symptoms, Vesomni, Solifenacin succinate, Tamsulosin hydrochloride
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VesomniDrug
Also called solifenacin succinate/tamsulosin hydrochloride
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Vesomni | Participants who are not adequately responding to treatment with tamsulosin monotherapy who receive Vesomni modified release tablet 6 mg/0.4 mg in routine clinical practice according to the drug label approved at the time of marketing authorization. Receives: Drug: Vesomni |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs) or Adverse Drug Reactions (ADR)
An AE is defined as any untoward medical occurrence in a participant administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal (investigational) product.
An ADR is defined as any noxious and unintended response associated with the use of a drug in humans, at any dose, where a causal relationship is at least a reasonable possibility.
Measured: Up to 24 Weeks
Number of Participants With Serious AE (SAE)/ Serious ADR (SADR)
An AE is considered "serious" if it results in death or life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a medically important event or reaction
Measured: Up to 24 Weeks
Number of Participants With an Unexpected AE (UAE)/ Unexpected ADR (UADR)
An UAE is an AE that the nature or severity of which is not consistent with the information described in the approved Korean product label
Measured: Up to 24 Weeks
Number of Participants With Important Risks
An important risk is classified as either an important identified risk and/or an important potential risk.
An "Important Identified Risk" refers to an undesirable clinical outcome, with sufficient scientific evidence through clinical trials or post-marketing data to confirm that the undesirable clinical outcome is caused by the drug, and which have the potential to affect the risk-benefit balance of a product.
An "Important Potential Risk" refers to an undesirable clinical outcome, with some, but not sufficient, evidence to confirm that the undesirable clinical outcome is caused by the drug. These risks may have the potential to affect the risk-benefit balance of a product, and therefore require ongoing monitoring and assessment.
Measured: Up to 24 Weeks
Secondary outcomes (3)
Changes From Baseline in Total Score of the International Prostate Symptom Score (IPSS)
The IPSS is used to evaluate the degree of "bother" from urinary symptoms, based on answers to 7 questions concerning urinary symptoms related to BPH, and 1 additional question assessing the impact of these symptoms on the patient's QoL. Each of the 7 symptom questions is scored from 0 to 5, indicating increasing severity of the symptom, with a total score ranging from 0 to 35.
Measured: Baseline, Week 12 and 24
Change From Baseline in Storage Subscore of IPSS
The IPSS is used to evaluate the degree of "bother" from urinary symptoms, based on answers to 7 questions concerning urinary symptoms related to BPH, and 1 additional question assessing the impact of these symptoms on the patient's QoL. The storage sub-score of the IPSS, which is calculated from the frequency, urgency, and nocturia sections of the IPSS total score, is used to evaluate the degree of urinary storage symptoms related to BPH. Each question in the storage sub-score is scored from 0 to 5, indicating increasing severity of the symptom, with a total score range from 0 to 15.
Measured: Baseline, Week 12 and 24
Change From Baseline in Quality of Life (QoL) Score of IPSS
The IPSS is used to evaluate the degree of "bother" from urinary symptoms, based on answers to 7 questions concerning urinary symptoms related to BPH, and 1 additional question assessing the impact of these symptoms on the patient's QoL. The QoL question is scored separately on a scale from 0 (delighted) to 6 (terrible), reflecting the patient's subjective satisfaction with their urinary condition.
Measured: Baseline, Week 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start30 Nov 2026 (estimated)
- Primary completion30 Nov 2030 (estimated)
- Study completion30 Nov 2030 (estimated)
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.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Korea, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Central Contact, Study director, Astellas Pharma Korea, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07619105
- Sponsor's protocol ID
- EC905-PV-0001
- Status last verified
- Oct 2026
- First submitted
- 26 May 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Observational Study for Vesomni Modified Release Tablet 6 mg/0.4 mg (Solifenacin Succinate/Tamsulosin Hydrochloride) in Male Patients With Moderate to Severe Storage Symptoms and Voiding Symptoms Associated With BPH Who Are Not Adequately Responding to Treatment With Tamsulosin Monotherapy in South Korea
- ClinicalTrials.gov ID
- NCT07619105
- Acronym / sponsor ID
- EC905-PV-0001
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- Pollakiuria, Micturition urgency, Voiding Symptoms, Vesomni, Solifenacin succinate, Tamsulosin hydrochloride
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Astellas Pharma Korea, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 30 Nov 2030 (estimated)
- Study completion
- 30 Nov 2030 (estimated)
- First posted
- 1 Jun 2026 (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), also known as an enlarged prostate, happens more often in men as they age. This condition causes a sudden need to pass urine, which is hard to control. Men with an enlarged prostate may need to pass urine many times during the day and night which can affect their wellbeing. There are treatments available, like tamsulosin but they don't work well in some men and can cause further health problems. Vesomni is approved in South Korea to treat urinary symptoms in men with an enlarged prostate, when treatment with tamsulosin doesn't work well enough.
This study will track the safety of Vesomni given to men in South Korea who have moderate to severe symptoms from an enlarged prostate, who have previously been treated with tamsulosin and found it didn't work well. The safety of Vesomni is tracked by mainly collecting information from their medical records. The sponsor will ask for extra information to be collected, and if any health problems were caused by Vesomni. In this study, researchers want to learn about the safety of Vesomni and how well it controls symptoms in men with an enlarged prostate.
The men's own doctor decides on treatment, as part of routine clinical practice, not the sponsor (Astellas). This study is about collecting information only. Most information about the safety and control of symptoms will be collected from medical records. The sponsor will also ask for extra information to be collected. All information will be collected for up to 24 weeks after the men start treatment with Vesomni.
Detailed description
Primary data collection will occur during the observation period for each participant, targeted for 12 weeks (or at least 24 weeks for long-term users) after receiving the first dose of Vesomni. Secondary data collection (extracting data from medical records, including hospital admission/discharge notes, prescription drug files, biological measurements, etc.) will occur for participants enrolled.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vesomni | – | Drug: VesomniParticipants who are not adequately responding to treatment with tamsulosin monotherapy who receive Vesomni modified release tablet 6 mg/0.4 mg in routine clinical practice according to the drug label approved at the time of marketing authorization. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with moderate to severe storage symptoms (pollakiuria, micturition urgency) and voiding symptoms associated with BPH.
Key inclusion criteria (1 listed)
- A patient (adult male) who receives treatment with Vesomni, according to the approved local label during the registration period.
Key exclusion criteria (2 listed)
- A patient with any contraindication for Vesomni, according to the approved local label.
- A patient who enrolled or is planning to enroll in any study of an investigational medicine during the observation period.
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 |
|---|---|---|
| VesomniAlso: solifenacin succinate/tamsulosin hydrochlorideOral administration | Drug | Vesomni |
Primary outcome
Number of Participants With Adverse Events (AEs) or Adverse Drug Reactions (ADR)
Time frame: Up to 24 Weeks
An AE is defined as any untoward medical occurrence in a participant administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal (investigational) product. An ADR is defined as any noxious and unintended response associated with the use of a drug in humans, at any dose, where a causal relationship is at least a reasonable possibility.
Number of Participants With Serious AE (SAE)/ Serious ADR (SADR)
Time frame: Up to 24 Weeks
An AE is considered "serious" if it results in death or life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a medically important event or reaction
Number of Participants With an Unexpected AE (UAE)/ Unexpected ADR (UADR)
Time frame: Up to 24 Weeks
An UAE is an AE that the nature or severity of which is not consistent with the information described in the approved Korean product label
Number of Participants With Important Risks
Time frame: Up to 24 Weeks
An important risk is classified as either an important identified risk and/or an important potential risk. An "Important Identified Risk" refers to an undesirable clinical outcome, with sufficient scientific evidence through clinical trials or post-marketing data to confirm that the undesirable clinical outcome is caused by the drug, and which have the potential to affect the risk-benefit balance of a product. An "Important Potential Risk" refers to an undesirable clinical outcome, with some, but not sufficient, evidence to confirm that the undesirable clinical outcome is caused by the drug. These risks may have the potential to affect the risk-benefit balance of a product, and therefore require ongoing monitoring and assessment.
3 secondary outcomes
Changes From Baseline in Total Score of the International Prostate Symptom Score (IPSS)
Time frame: Baseline, Week 12 and 24
Change From Baseline in Storage Subscore of IPSS
Time frame: Baseline, Week 12 and 24
Change From Baseline in Quality of Life (QoL) Score of IPSS
Time frame: Baseline, Week 12 and 24
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 15 Oct 2026.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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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.
Central Contact study director
Astellas Pharma Korea, Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Prostatic Hyperplasia, run by Astellas Pharma Korea, Inc..
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 1 inclusion and 2 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: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Astellas Pharma Korea, Inc (800-888-7704, Astellas.registration@astellas.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AEs) or Adverse Drug Reactions (ADR) (time frame: Up to 24 Weeks). The study lists 4 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 15 Oct 2026.