Assessment of efficacy of mirabegron, solifenacin, tadalafil 5 mg and combination therapy in female patients with overactive bladder: a double blinded multicenter prospective placebo-controlled trial
Abstract
BACKGROUND
This study assess the efficacy of mirabegron, solifenacin, tadalafil 5 mg, and tadalafil 5 mg combination with solifenacin and mirabegron in the treatment of female patients with overactive bladder (OAB), comparing these to a placebo in a double-blinded, prospective, randomized, placebo-controlled trial.
METHODS
A total of 483 female patients diagnosed with OAB and confirmed detrusor overactivity were recruited from three university hospitals (Tanta, Kafrelsheikh, and Menoufia) between January and July 2024. Participants were randomly assigned to one of six groups: tadalafil 5 mg (Group I), solifenacin 5 mg (Group II), mirabegron 50 mg (Group III), mirabegron 50 mg + tadalafil 5 mg (Group IV), solifenacin 5 mg + tadalafil 5 mg (Group V), or placebo (Group VI). Assessments were performed at baseline, 1, 2, and 3 months.
RESULTS
At 3 months, the combination therapies (Groups IV and V) demonstrated significantly greater improvements in OABSS compared to mono-therapy groups (Groups I, II, III) and placebo (Group VI). Group V (tadalafil 5 mg + solifenacin) achieved the greatest symptom reduction, comparable with Group IV (tadalafil 5 mg + mirabegron). Urodynamic improvements were also notable in the combination therapy groups, with significant increases in bladder capacity and compliance, and reduction in detrusor contractions compared to placebo. With the exception of high post voiding residual was high with solifenacin monotherapy Adverse effects were similar across…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 483 participants or records.
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