Efficacy and safety of combination therapy with tamsulosin, dutasteride and imidafenacin for the management of overactive bladder symptoms associated with benign prostatic hyperplasia: A multicenter, randomized, open‐label, controlled trial (<scp>DI</scp>recT Study)

Yamanishi, Tomonori; Asakura, Hirotaka; Seki, Nobuhiko; Shoji, Tetsuo

doi:10.1111/iju.13359

Cited by 15 publications

(20 citation statements)

References 21 publications

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“…For the treatment of “LUTS/BPH” with large prostate (prostate volume >30 mL), the combination of an α‐blocker and a 5α‐reductase inhibitor (dutasteride) has been reported to be more effective, even in the storage symptoms, compared to each monotherapy 16,17 . However, the combination of α‐blocker, dutasteride, and anticholinergic drug has been reported to be more effective than the combination of α‐blocker plus dutasteride for the treatment of “BPH/OAB” with large prostate (DIrecT study) 18,19 …”

Section: Discussionmentioning

confidence: 99%

“…16,17 However, the combination of α-blocker, dutasteride, and anticholinergic drug has been reported to be more effective than the combination of α-blocker plus dutasteride for the treatment of "BPH/OAB" with large prostate (DIrecT study). 18,19 The purpose our study is to evaluate whether the combination of tadalafil and mirabegron is more effective than monotherapy with tadalafil in men with remaining OAB symptoms despite monotherapy with tadalafil. Thus, we recruited patients who had been taking tadalafil monotherapy but had remaining OAB symptoms.…”

Section: Discussionmentioning

confidence: 99%

“…And there are many good quality RCTs without placebo. 3,5,7,[16][17][18][19] Although this study was not double-blinded using placebo, the quality of this study seemed considerable because randomization and analyses of data were strictly centrally organized and computer-based.…”

Section: Discussionmentioning

confidence: 99%

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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)

Yamanishi

Kaga

Sakata³

et al. 2020

Neurourology and Urodynamics

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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.---

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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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)

Yamanishi

Kaga

Sakata³

et al. 2020

Neurourology and Urodynamics

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“…Imidafenacin was investigated for the treatment of lower urinary tract symptoms in males in combination with tamsulosin and dutasteride . A comparison and combination of imidafenacin with mirabegron was also presented .…”

Section: Discussionmentioning

confidence: 99%

“…12 Imidafenacin was investigated for the treatment of lower urinary tract symptoms in males in combination with tamsulosin and dutasteride. 13 A comparison and combination of imidafenacin with mirabegron was also presented. 14 A meta-analysis published by Huang et al 12 assembled five randomized clinical trials and indicates that imidafenacin was similar to propiverine 15 or solifenacin 16 in its efficacy for the OAB and was better tolerated than propiverine or solifenacin.…”

Section: Safety and Adverse Eventsmentioning

confidence: 99%

Randomized, open‐label, tolterodine‐controlled, comparative study of the novel antimuscarinic agent imidafenacin in patients with overactive bladder

Pushkar

Kasyan

Колонтарев

et al. 2019

Neurourology and Urodynamics

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Background The role of the selective antimuscarinic imidafenacin in Caucasian patients with overactive bladder (OAB) has not been previously assessed. Objective To evaluate the safety and efficacy of imidafenacin 0.2 mg vs tolterodine 4 mg per day in patients with OAB. Design Setting and Participants This study was a randomized, open‐label, tolterodine‐controlled, comparative multicenter trial of 300 randomized patients with OAB symptoms for 12 weeks with full analysis of 289 patients. Outcome Measurements and Statistical Analysis Based on 5‐day bladder diaries, the primary efficacy endpoint was the change in the mean number of micturitions per day. The secondary endpoints were the change in the mean incontinence episodes, voiding frequency, the OAB Awareness Tool score, and the European Quality of Life Questionnaire (EQ‐5D) score. The superiority of tolterodine over imidafenacin in the mean number of micturitions/24 hours was the null hypothesis. Results and Limitation The median age was 46.6 years, and 82% of patients were female. After treatment, the change in the mean number of incontinence episodes was −2.1 ± 2.2 in the imidafenacin group and −1.9 ± 1.8 in the tolterodine group (P = .001). The change in the mean number of daytime incontinence episodes was −1.7 ± 1.7 and −1.5 ± 1.4 ( P = .01). The OAB Awareness Tool score decreased by 14.2 ± 8.5 and 14.5 ± 8.0, respectively ( P = 0.5). Most adverse events were mild and resolved without treatment. Conclusions The clinical efficacy and safety of imidafenacin are not inferior to those of tolterodine for the treatment of Caucasian patients with OAB. Patient Summary Imidafenacin is as effective as tolterodine for the treatment of OAB.

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Efficacy of a combination of dutasteride, tadalafil, and solifenacin in the treatment of previously unsuccessful patients

Kosilov

Kuzina

Kuznetsov

et al. 2022

Asian Journal of Urology

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Efficacy and safety of combination therapy with tamsulosin, dutasteride and imidafenacin for the management of overactive bladder symptoms associated with benign prostatic hyperplasia: A multicenter, randomized, open‐label, controlled trial (DIrecT Study)

Cited by 15 publications

References 21 publications

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)

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)

Randomized, open‐label, tolterodine‐controlled, comparative study of the novel antimuscarinic agent imidafenacin in patients with overactive bladder

Efficacy of a combination of dutasteride, tadalafil, and solifenacin in the treatment of previously unsuccessful patients

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