Prospective clinical study of switch to vibegron for overactive bladder patients with inadequate effect of antimuscarinics and mirabegron treatment

JRCT ID: jRCT1071230070

Registered date:29/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Problem(s) Studied
• Date of first enrollment: 29/09/2023
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Vibegron medication

Outcome(s)

• Primary Outcome: Change from baseline in the total OAB symptom score(OABSS)
• Secondary Outcome: Improvement of at least 3 points in the total OABSS score (clinically meaningful improvement)(A "responder" is defined as a patient who has improved by at least 3 points), objective measures of dysuria include changes in flow and residual urine volume measurements, and changes in urinalysis and changes in subjective symptoms of dysuria, IPSS score and total score for each item.

Key inclusion & exclusion criteria

• Age minimum: > 18age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Patients with OAB defined as an OAB symptom score (OABSS) for Q3 (urgency) of two or more and a total score of three or more and patients who have been taking a treatment other than Vivegron for overactive bladder for at least 12 weeks.

Exclude criteria

(1) Patients who have already been diagnosed with overactive bladder and have previously taken Vivegron.
(2) Patients who are unable to complete the questionnaire on their own.
(3) Patients with severe hepatic dysfunction and renal dysfunction.
(4) Patients who wish to become pregnant or have a baby in the future
(5) Patients who are allergic to be-ta 3 agonists.
(6) Pregnant women, women who may become pregnant, and nursing mothers.
(7) Patients with serious cardiac disease.
(8) Patients with urinary retention.
(9) Patients who are currently participating in a clinical study involving an intervention or who have participated in another clinical study involving an intervention within 4 months (If the patient is participating in an observational study, check whether the patient violates the exclusion or discontinuation criteria of the observational study).
(10) Patients deemed inappropriate as research subjects by the principal investigator.
those who are allergic to mirabegron and vibegron, are unable to complete the questionnaire on their own, wish to become pregnant or have a baby in the future, are participating in clinical studies involving interventions and those who are considered to be inappropriate by the physician, pregnant women, women who may be pregnant, and nursing mothers and patients with severe hepatic dysfunction and renal dysfunction, serious cardiac disease and urinary retention.

Related Information

• Primary Sponsor: Imamura Ryoichi