Efficacy and Safety of Solifenacin or Mirabegron With Local Estrogen Versus Combination Treatment With Mirabegron and Solifenacin for Refractory Overactive Bladder

What this Trial Is About

This research aims to evaluate the effects of solifenacin or mirabegron combined with local estrogen compared to a combination of solifenacin and mirabegron alone in women with overactive bladder who have detrusor overactivity and have not responded to anti-muscarinic or mirabegron monotherapy. The study is a phase 4 interventional trial focusing on symptom distress and quality of life impacts related to urinary incontinence. Participants are divided into three treatment groups: one receives solifenacin 5mg plus mirabegron 25mg together; another receives solifenacin 5mg daily with vaginal conjugated equine estrogen cream twice a week; and the third receives mirabegron 25mg daily with the same vaginal estrogen cream schedule. Treatments are given over a year with assessments at 1 month, 3 months, 6 months, and 12 months. During the study, women will complete questionnaires including the Urinary Distress Inventory (UDI-6), Incontinence Impact Questionnaire (IIQ-7), and Overactive Bladder Symptom Score (OABSS) to assess symptoms and quality of life. Researchers will also track changes in daily episodes of urination, urgency, incontinence, and nighttime urination. Safety and symptom monitoring occur throughout the treatment period, which lasts up to one year.

Efficacy of Solifenacin or Mirabegron With Local Estrogen Versus Combination Pharmacotherapy for Overactive Bladder