title: Efficacy and Tolerability of Solifenacin 5 mg Fixed Dose in Korean Children with Newly Diagnosed Idiopathic Overactive Bladder: a Multicenter Prospective Study.
abstract: We investigated the efficacy and tolerability of solifenacin 5 mg fixed dose in children with newly diagnosed idiopathic overactive bladder (OAB). A total of 34 children (male/female patients = 16/18) aged under 13 years (mean age: 7.2 ± 2.3; range: 5-12) who were newly diagnosed with OAB from January 2012 to September 2014 were prospectively evaluated with open-label protocol. All patients were treated with solifenacin 5 mg fixed dose once daily for at least 4 weeks. The efficacy and tolerability of solifenacin were evaluated 4, 8, and 12 weeks after the initiation of treatment. The mean voiding frequency during daytime was decreased from 9.4 ± 3.0 to 6.5 ± 2.3 times after the 12-week treatment (P < 0.001). The mean total OAB symptom score (OABSS) decreased from 7.7 ± 4.2 to 3.1 ± 3.1 after the 12-week treatment (P < 0.001). The urgency and urgency urinary incontinence (UUI) domains significantly improved from the 12-week treatment, and complete resolution of urgency occurred in 38.9% of patients and the percentage of children with UUI among urgent patients decreased from 79.4% to 57.1%. According to 3-day voiding diaries, the average bladder capacity increased from 90.4 ± 44.4 to 156.2 ± 67.3 mL (P < 0.001). Drug-induced adverse effects (AEs) were reported in 7 patients (20.6%). Our results indicate that solifenacin 5 mg fixed dose is effective against OAB symptoms, and its tolerability is acceptable without significant AEs in children with OAB.
authors.affiliation: Department of Urology, Pusan National University Yangsan Hospital and Research Institute for Convergence of Biomedical Science and Technology, Yangsan, Korea.
authors.forename: Sang Don
authors.identifier: http://orcid.org/0000-0001-9459-3887
authors.initials: SD
authors.lastname: Lee
authors.affiliation: Department of Urology, Pusan National University Yangsan Hospital and Research Institute for Convergence of Biomedical Science and Technology, Yangsan, Korea.|Department of Urology, Kosin University College of Medicine, Busan, Korea.
authors.forename: Jae Min
authors.identifier: http://orcid.org/0000-0003-3593-9643
authors.initials: JM
authors.lastname: Chung
authors.affiliation: Department of Urology, Inje University Busan Paik Hospital, Busan, Korea.
authors.forename: Dong Il
authors.identifier: http://orcid.org/0000-0003-2283-4041
authors.initials: DI
authors.lastname: Kang
authors.affiliation: Department of Urology, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Korea.
authors.forename: Dong Soo
authors.identifier: http://orcid.org/0000-0002-7557-0820
authors.initials: DS
authors.lastname: Ryu
authors.affiliation: Department of Urology, Dong-A University Hospital, Dong-A University, Busan, Korea.
authors.forename: Won Yeol
authors.identifier: http://orcid.org/0000-0001-6640-7872
authors.initials: WY
authors.lastname: Cho
authors.affiliation: Department of Urology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea.|School of Life Sciences, Ulsan National Institute of Science and Technology, Ulsan, Korea. scpark@amc.seoul.kr.
authors.forename: Sungchan
authors.identifier: http://orcid.org/0000-0002-2337-983X
authors.initials: S
authors.lastname: Park
mesh_terms: D044466:Asian People; D002648:Child; D002675:Child, Preschool; D004361:Drug Tolerance; D005221:Fatigue / Q000209:etiology; D005260:Female; D006801:Humans; D008297:Male; D011446:Prospective Studies; D056910:Republic of Korea; D000069464:Solifenacin Succinate / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000188:drug therapy*; D014549:Urinary Incontinence / Q000473:pathology; D014554:Urination; D064804:Urological Agents / Q000009:adverse effects / Q000627:therapeutic use*; D014987:Xerostomia / Q000209:etiology
chemical_list: D064804:Urological Agents; D000069464:Solifenacin Succinate
keywords: Anticholinergics; Child; Efficacy; Overactive Bladder; Tolerability