Tokyo, April 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059810) titled 'Study on the Carry-over Effect of Vibegron Treatment in Women with Overactive Bladder' on April 1.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Sapporo Medical University

Condition: Condition - Overactive bladder Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Among pharmacological treatments for overactive bladder (OAB), vibegron, a beta3-adrenoceptor agonist, has been reported to be associated with few adverse events and to be suitable for long-term administration. In clinical practice, however, many patients whose symptoms improve subsequently discontinue treatment, and we occasionally encounter cases in which symptoms do not immediately recur after discontinuation. This sustained symptom relief, hereafter referred to as a carry-over effect, has been reported for other agents, but there are no published data regarding vibegron. In particular, no study has prospectively evaluated the carry-over effect of beta3-adrenoceptor agonist therapy from the initiation of treatment.

The aim of the present study is to prospectively evaluate, in real-world clinical practice, the carry-over effect after discontinuation of vibegron therapy in female patients with OAB.

The findings of this study are expected to help establish evidence-based guidance to avoid unnecessary continuation of pharmacotherapy after symptom improvement and to contribute to reductions in healthcare expenditures. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - After completion of the initial assessment, oral vibegron will be started. After at least 12 weeks of treatment, patients will be re-evaluated, and if the OABSS has improved by 3 or more points, discontinuation of vibegron will be proposed. Patients will return 4 weeks after discontinuation, at which time the appropriateness of maintaining discontinuation will be assessed. If symptom recurrence is observed and the patient wishes to resume treatment, vibegron will be re-prescribed at that time.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Female Key inclusion criteria - Patients with overactive bladder (OABSS total score 3 or more and question 3 score 2 or more)

Patients who are newly initiated on vibegron for OAB

Patients who have provided informed consent to participate in the study Key exclusion criteria - Patients who are minors or who lack the capacity to provide consent

Patients with a history of prior pharmacological treatment for OAB (e.g. anticholinergic agents, beta3-adrenergic agonists, intravesical botulinum toxin injection therapy, sacral neuromodulation, magnetic stimulation therapy, etc.)

Patients managed with intermittent catheterization or an indwelling urethral catheter

Patients with active cystitis (eligible after appropriate treatment)

Any other patients deemed inappropriate for inclusion by the treating physician Target Size - 80

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 31 Day Anticipated trial start date - 2026 Year 04 Month 01 Day Last follow-up date - 2029 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068391

Disclaimer: Curated by HT Syndication.