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

UMIN ID: UMIN000055668

Registered date:29/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: overactive bladder
• Date of first enrollment: 2023/06/13
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: Overactive Bladder Symptom Score (OABSS) at 4, 8 and 12 weeks after starting treatment with vibegron.
• Secondary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: 80years-old
• Age maximum: 110years-old
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Department of Urology, University of Yamanashi
• Source(s) of Monetary Support: No funding organization