A randomized controlled study of the efficacy of tadalafil monotherapy versus combination of tadalafil and mirabegron for the treatment of persistent overactive bladder symptoms in men presenting with lower urinary tract symptoms (CONTACT Study)

Abstract

A randomized controlled study of the efficacy of tadalafil monotherapy versus combination of tadalafil and mirabegron for the treatment of persistent overactive bladder symptoms in men presenting with lower urinary tract symptoms (CONTACT Study) Abstract Aim: To evaluate efficacy and safety of combination of tadalafil + mirabegron for overactive bladder/benign prostatic hyperplasia (OAB/BPH). Methods: Male patients with lower urinary tract symptoms (50 to 89 years), with remaining OAB symptoms even after administering tadalafil for more than 8 weeks were randomly assigned to either tadalafil monotherapy group (5 mg/day) or tadalafil/mirabegron combination therapy group (5 mg/50 mg/day). The primary endpoint was change from baseline in total OAB symptom score (OABSS) at week 12. The secondary endpoints were changes in International Prostate Symptom Score (IPSS), NIH-chronic prostatitis symptom index (NIH-CPSI), and micturition chart parameters at weeks 4 and 12.Results: A total of 176 patients were randomized to either monotherapy (87 patients) or combination therapy (89 patients). The baseline characteristics of patients in the two groups were similar. The total OABSS (95% confidence interval) of combination therapy was significantly decreased by 1.78 (1.05-2.50) points compared with that of monotherapy (P < .001). Changes from baseline in OABSS nighttime voiding score, urgency score, urgency incontinence score, IPSS storage subscores, NIH-CPSI total score, and numbers of voids, nighttime-voids, and urgency episodes/day in micturition chart were significantly reduced in combination therapy (all P < .001). Patient-reported outcome was significantly more satisfactory in combination therapy than in monotherapy (P < .001). One moderate adverse event (pain in hip joint) with hardly presumed causal relationship with therapy and seven mild adverse events were noted in monotherapy and combination therapy group, respectively.---

Beta 3 Adrenoreceptor Agonist for the Management of Lower Urinary Tract Symptoms in Men With Benign Prostatic Hyperplasia: A Systematic Review

“…We screened 10 full-text articles and excluded 6 articles that did not meet the inclusion criteria or were not relevant to the question being investigated [12,[19][20][21][22][23] (see Supplementary Material 2). Four studies ultimately met the inclusion criteria were included in the qualitative synthesis of this review [24][25][26][27]. The flow of literature through this assessment process is shown in the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) flowchart (Fig.…”

“…Table 1 shows baseline characteristics of the included studies. Three studies [24,26,27] were open-label studies, while one study [25] was double-blinded. The mean age of the men ranged from 64.9 to 75.9 years old.…”

“…The mean postvoid residual (PVR) was less than 50 mL in all included studies. All studies administered mirabegron as an oral agent (daily doses ranging from 25 mg to 50 mg) and compared it to ABs (tamsulosin [daily doses from 0.2 mg to 0.4 mg] and silodosin [daily dose of 8 mg]) [24][25][26], anticholinergics (fesoterodine [daily dose of 4 mg]) [26], and phosphodiesterase 5 inhibitors (PDE5I, tadalafil [daily dose of 5 mg]) [27]. Only one study used placebo in control group [25].…”

“…All studies reported short-term outcome data ranging from 8 weeks to 12 weeks after treatment. While all studies have no conflicts of interest, 3 were supported by pharmaceutical companies [24,25,27].…”

Mirabegron Add-On Therapy to Tamsulosin in Men with Overactive Bladder: Post Hoc Analyses of Efficacy from the MATCH Study

“…A recent study also reported improved symptoms for mirabegron in combination with a phosphodiesterase 5 inhibitor, tadalafil 5 mg ( n = 89), compared with tadalafil monotherapy ( n = 87) in male patients aged ≥ 50 years with residual OAB symptoms [ 18 ]. The primary endpoint, change from baseline in total OABSS, was statistically significantly decreased by 1.78 (95% CI 1.05–2.50) points in the combination group compared with the monotherapy group ( P < 0.001).…”