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)

NCT07619105 | Not Yet Recruiting

• 1 other identifier: EC905-PV-0001
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Benign Prostatic Hyperplasia

Keywords

Pollakiuria; Micturition urgency; Voiding Symptoms; Vesomni; Solifenacin succinate; Tamsulosin hydrochloride

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Changes From Baseline in Total Score of the International Prostate Symptom Score (IPSS)

  Baseline, Week 12 and 24

• Change From Baseline in Storage Subscore of IPSS

  Baseline, Week 12 and 24

• Change From Baseline in Quality of Life (QoL) Score of IPSS

  Baseline, Week 12 and 24

Study Arms (1)

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

Interventions

Vesomni DRUG

Oral administration

Also known as: solifenacin succinate/tamsulosin hydrochloride

Vesomni

Eligibility Criteria

• Age: 19 Years+
• Gender Eligibility Details: Adult male patients with moderate to severe storage symptoms (pollakiuria, micturition urgency) and voiding symptoms associated with BPH who are not adequately responding to treatment with tamsulosin monotherapy and who are prescribed Vesomni.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Astellas Pharma Korea, Inc.: lead

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Solifenacin Succinate; Tamsulosin

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Central Contact

  Astellas Pharma Korea, Inc.

  STUDY DIRECTOR

Central Study Contacts

Astellas Pharma Korea, Inc

CONTACT

800-888-7704; Astellas.registration@astellas.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 1, 2026
• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): November 30, 2030
• Study Completion (Estimated): November 30, 2030
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share