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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Drug: 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 Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Astellas Pharma Korea, Inc; Phone Number: 800-888-7704; Email: Astellas.registration@astellas.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants with moderate to severe storage symptoms (pollakiuria, micturition urgency) and voiding symptoms associated with BPH.

Description

Inclusion Criteria:

• A patient (adult male) who receives treatment with Vesomni, according to the approved local label during the registration period.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Vesomni; Oral administration; Other Names: solifenacin succinate/tamsulosin hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	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.	Up to 24 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline, Week 12 and 24

Collaborators and Investigators

• Sponsor: Astellas Pharma Korea, Inc.
• Investigators: Study Director: Central Contact, Astellas Pharma Korea, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): November 30, 2030
• Study Completion (Estimated): November 30, 2030

Study Registration Dates

• First Submitted: May 26, 2026
• First Submitted That Met QC Criteria: May 26, 2026
• First Posted (Actual): June 1, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Tamsulosin hydrochloride; Solifenacin succinate; Vesomni; Pollakiuria; Micturition urgency; Voiding Symptoms
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Hyperplasia; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Amides; Benzene Derivatives; Benzenesulfonamides; Sulfonamides; Sulfones; Heterocyclic Compounds, Bridged-Ring; Tetrahydroisoquinolines; Isoquinolines; Quinuclidines; Tamsulosin; Solifenacin Succinate
• Other Study ID Numbers: EC905-PV-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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/.