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

Phase 4

Recruiting

• Conditions: Problem(s) Studied; overactive bladder, overactive bladder symptom score, vibegron

• Registration Number: JPRN-jRCT1071230070
• Lead Sponsor: Imamura Ryoichi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-09-29
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion 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.

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified