Efficacy and safety of mirabegron in the treatment of overactive bladder syndrome after radical prostatectomy: a prospective randomized controlled study
ObjectivesTo evaluate the effects of mirabegron in the treatment of overactive bladder syndrome (OAB) after radical prostatectomy (RP). Patients and methodsA total of 108 post-operative RP patients were randomly assigned to either the mirabegron (study) or the placebo (control) group. The Overactive Bladder Syndrome Self-Assessment Scale (OABSS) was selected as the primary endpoint, and the International Prostate Symptom Score (IPSS) and Quality of Life (QOL) score were selected as secondary endpoints. Statistical analysis was performed using IBM SPSS Statistics 26, and the treatment effects were compared between the two groups using independent samples t-test. ResultsIn total, 55 patients were included in the study group and 53 patients in the control group. The mean age was(70.08 +/- 7.54)years. There was no statistical difference in the baseline data between the two groups. OABSS scores decreased significantly in the study group compared to the control group during drug treatment (6.67 +/- 1.06 vs. 9.14 +/- 1.83, p < 0.01) and were better than the control group during the follow-up at week 8 and week 12. In addition, the decrease in IPSS scores (11.29 +/- 3.89 and 15.34 +/- 3.54, p<0.01) and the increase in QOL scores (2.40 +/- 0.81 vs. 3.20 +/- 1.00) were statistically significant in the study group. And the patients in the study group had better improvement in voiding symptoms and quality of life than the control group during the follow-up period. ConclusionDaily administration of 50 mg mirabegron after RP surgery significantly improved the symptoms of OAB after surgery with fewer side effects. Additional randomized controlled trials should be conducted in the future to further evaluate the efficacy and safety of mirabegron.
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Sapienza Univ, St Andrea Hosp, Dept Urol, Via Grottarossa 1035-1039, I-00189 Rome, ItalySapienza Univ, St Andrea Hosp, Dept Urol, Via Grottarossa 1035-1039, I-00189 Rome, Italy
Tubaro, Andrea
Batista, Jose E.
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URD Hosp Quiron Teknon, Urodynam Unit, Barcelona, SpainSapienza Univ, St Andrea Hosp, Dept Urol, Via Grottarossa 1035-1039, I-00189 Rome, Italy
Batista, Jose E.
Nitti, Victor W.
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NYU, Langone Med Ctr, Dept Urol, New York, NY USASapienza Univ, St Andrea Hosp, Dept Urol, Via Grottarossa 1035-1039, I-00189 Rome, Italy
Nitti, Victor W.
Herschorn, Sender
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Univ Toronto, Dept Surg Urol, Toronto, ON, CanadaSapienza Univ, St Andrea Hosp, Dept Urol, Via Grottarossa 1035-1039, I-00189 Rome, Italy
Herschorn, Sender
Chapple, Christopher R.
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Royal Hallamshire Hosp, Dept Urol, Sheffield, S Yorkshire, EnglandSapienza Univ, St Andrea Hosp, Dept Urol, Via Grottarossa 1035-1039, I-00189 Rome, Italy
Chapple, Christopher R.
Blauwet, Mary Beth
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Astellas, Dept Biostat, Northbrook, IL USASapienza Univ, St Andrea Hosp, Dept Urol, Via Grottarossa 1035-1039, I-00189 Rome, Italy
Blauwet, Mary Beth
Siddiqui, Emad
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Astellas Pharma Europe Ltd, Chertsey, Surrey, EnglandSapienza Univ, St Andrea Hosp, Dept Urol, Via Grottarossa 1035-1039, I-00189 Rome, Italy
Siddiqui, Emad
Huang, Moses
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Astellas Pharma Europe Ltd, Chertsey, Surrey, EnglandSapienza Univ, St Andrea Hosp, Dept Urol, Via Grottarossa 1035-1039, I-00189 Rome, Italy
Huang, Moses
Oelke, Matthias
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Univ Maastricht, Acad Med Hosp, Dept Urol, Maastricht, NetherlandsSapienza Univ, St Andrea Hosp, Dept Urol, Via Grottarossa 1035-1039, I-00189 Rome, Italy
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Seoul Natl Univ, Seoul Natl Univ Hosp, Coll Med, Dept Urol, 101 Daehak Ro, Seoul 03080, South KoreaSeoul Natl Univ, Seoul Natl Univ Hosp, Coll Med, Dept Urol, 101 Daehak Ro, Seoul 03080, South Korea
Cho, Sung Yong
Jeong, Seong Jin
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Seoul Natl Univ, Bundang Hosp, Dept Urol, Seongnam Si, Gyeonggi Do, South KoreaSeoul Natl Univ, Seoul Natl Univ Hosp, Coll Med, Dept Urol, 101 Daehak Ro, Seoul 03080, South Korea
Jeong, Seong Jin
Lee, Sangchul
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Seoul Natl Univ, Bundang Hosp, Dept Urol, Seongnam Si, Gyeonggi Do, South KoreaSeoul Natl Univ, Seoul Natl Univ Hosp, Coll Med, Dept Urol, 101 Daehak Ro, Seoul 03080, South Korea
Lee, Sangchul
Kim, Janghwan
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Yonsei Univ, Severance Hosp, Coll Med, Dept Urol, Seoul, South Korea
Yonsei Univ, Severance Hosp, Coll Med, Urol Sci Inst, Seoul, South KoreaSeoul Natl Univ, Seoul Natl Univ Hosp, Coll Med, Dept Urol, 101 Daehak Ro, Seoul 03080, South Korea
Kim, Janghwan
Lee, Seong Ho
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Hallym Univ, Dongtan Sacred Heart Hosp, Coll Med, Dept Urol, Hwaseong, South KoreaSeoul Natl Univ, Seoul Natl Univ Hosp, Coll Med, Dept Urol, 101 Daehak Ro, Seoul 03080, South Korea
Lee, Seong Ho
Choo, Min Soo
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Seoul Natl Univ, Boramae Med Ctr, Seoul Metropolitan Govt, Seoul, South KoreaSeoul Natl Univ, Seoul Natl Univ Hosp, Coll Med, Dept Urol, 101 Daehak Ro, Seoul 03080, South Korea
Choo, Min Soo
Oh, Seung-June
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Seoul Natl Univ, Seoul Natl Univ Hosp, Coll Med, Dept Urol, 101 Daehak Ro, Seoul 03080, South KoreaSeoul Natl Univ, Seoul Natl Univ Hosp, Coll Med, Dept Urol, 101 Daehak Ro, Seoul 03080, South Korea