Efficacy and safety of Mirabegron for treatment OAB in the postmenopausal female patients -Evaluation using Pressure Flow Study

Phase 4

• Conditions: overactive bladder

• Registration Number: JPRN-UMIN000019272
• Lead Sponsor: Department of Urology Nagoya University Graduate School of Medicine

Brief Summary

A total of 60 patients with a mean age of 72.3 years (50-86 years) were included in the analysis. The subjective symptom parameter (i.e., the mean OABSS score) decreased significantly from 9.4 to 6.2 points (p < 0.001). In objective symptom parameters, both FDV and MCC significantly improved after treatment, and DO disappeared in 14 of 35 (40.0%) patients compared to that at baseline (p < 0.01). The voiding function parameters (i.e., mean Qmax, PdetQmax, and PVR) did not significantly change, demonstrating that mirabegron does not inhibit voiding function.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2014-03-31
• Study Start: 2015-10-08
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Patients were excluded if they received oral anticholinergic agents, alpha1-blockers, antidepressants, or anti-anxiety agents; had obvious neurogenic bladder dysfunction, bladder calculi, or active urinary tract infection; or had severe cardiac disease, renal dysfunction (serum-creatinine;2 mg/dL), and/or hepatic dysfunction (i.e., aspartate aminotransferase and alanine aminotransferase levels of more than twice the normal value).

Study & Design

• Study Type: Interventional
• Study Design: Not specified