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Efficacy and safety of vibegron in patients with overactive bladder aged 80 years or over

Efficacy and safety of vibegron in very elderly patients with overactive bladder - HOKUTO2 study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000055668
Enrollment
40
Registered
2024-09-29
Start date
2023-06-13
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

overactive bladder

Interventions

None listed

Sponsors

Department of Urology, University of Yamanashi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who meet all of the following. Patients who visited the department of urology of the research collaborating hospitals from the date of approval by the head of the research institution to July 31,2025. Over 80 years old. Patients scheduled to receive vibegron. Urinary urgency score 2 or over and total score 3 or over on the overactive bladder symptom score. Patients who give written consent to participate in this study.

Exclusion criteria

Exclusion criteria: Patients with any of the following. long QT syndrome. Patients with a history of serious cardiac disease. Patients with severe abdominal pressure incontinence. Patients with residual urine volume over 100 mL, severe dysuria, active urinary tract infection, bladder stones, or urinary tract malignancy. Patients scheduled to continue treatment with mirabegron. Patients who are determined to be ineligible by a physician's judgment.

Design outcomes

Primary

MeasureTime frame
Overactive Bladder Symptom Score (OABSS) at 4, 8 and 12 weeks after starting treatment with vibegron.

Secondary

MeasureTime frame
Adverse events, International Prostate Symptom Score (IPSS), Overactive Bladder Questionnaire (OAB-q), Mini-Mental State Examination (MMSE), Vulnerable Elders Survey-13 (VES-13), uroflowmetry, and residual urine measurement at 4, 8 and 12 weeks after starting treatment with vibegron.

Countries

Japan

Contacts

Public ContactHiroshi Shimura

University of Yamanashi Department of Urology

shimurah@yamanashi.ac.jp055-273-9643

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026