1.Are Solifenacin and Ramosetron Really Ideal to Treat Irritable Bowel Syndrome?: Author's Reply.
Hidekazu SUZUKI ; Juntaro MATSUZAKI
Journal of Neurogastroenterology and Motility 2012;18(4):459-459
No abstract available.
Benzimidazoles
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Quinuclidines
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Tetrahydroisoquinolines
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Solifenacin Succinate
2.Are Solifenacin and Ramosetron Really Ideal to Treat Irritable Bowel Syndrome?.
Journal of Neurogastroenterology and Motility 2012;18(4):457-458
No abstract available.
Benzimidazoles
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Quinuclidines
;
Tetrahydroisoquinolines
;
Solifenacin Succinate
3.Meta-Analysis of the Efficacy and Safety of Mirabegron Add-On Therapy to Solifenacin for Overactive Bladder.
Yankai XU ; Ruihua LIU ; Chu LIU ; Yuanshan CUI ; Zhenli GAO
International Neurourology Journal 2017;21(3):212-219
PURPOSE: We performed a meta-analysis to evaluate the efficacy and safety of mirabegron add-on therapy to solifenacin for patients with overactive bladder (OAB). METHODS: We conducted a systematic literature review to identify all randomized, double-blind, controlled trials (RCTs) of this combination (mirabegron and solifenacin) for OAB. Embase, MEDLINE, and the Cochrane Central Register of Controlled Trials were searched. A manual search was also performed to investigate relevant references from the retrieved studies. RESULTS: Four publications describing 5 RCTs that compared combination therapy with solifenacin, including a total of 3,309 patients, were analyzed. The mean number of micturitions per 24 hours (mean difference [MD], -0.45; 95% confidence interval [CI], -0.65 to -0.26; P < 0.00001), number of episodes of incontinence per 24 hours (MD, -0.71; 95% CI, -0.14 to -0.02; P=0.04), volume voided per micturition, and number of urgency episodes per 24 hours demonstrated that combination therapy was more effective than solifenacin therapy alone. Safety assessments, including common treatment-emergent adverse events (odds ratio, 1.09; 95% CI, 0.95–1.27; P=0.23) and discontinuations due to adverse events (P=0.30), demonstrated that the combination therapy was well tolerated. CONCLUSIONS: This meta-analysis suggests that mirabegron therapy as an add-on to solifenacin provides a satisfactory therapeutic effect for OAB symptoms with a low occurrence of side effects.
Humans
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Solifenacin Succinate*
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Urinary Bladder, Overactive*
;
Urination
4.Clinical Factors Associated With Dose Escalation of Solifenacin for the Treatment of Overactive Bladder in Real Life Practice.
Ji Youn CHUN ; Miho SONG ; Ji Yeon HAN ; Selee NA ; Bumsik HONG ; Myung Soo CHOO
International Neurourology Journal 2014;18(1):23-30
PURPOSE: To determine the baseline clinical characteristics associated with dose escalation of solifenacin in patients with overactive bladder (OAB). METHODS: We analyzed the data of patients with OAB (micturition frequency > or =8/day and urgency > or =1/day) who were treated with solifenacin and followed up for 24 weeks. According to our department protocol, all the patients kept voiding diaries, and OAB symptom scores (OABSS) were monitored at baseline and after 4, 12, and 24 weeks of solifenacin treatment. RESULTS: In total, 68 patients (mean age, 60.8+/-10.0 years) were recruited. The dose escalation rate by the end of the study was 41.2%, from 23.5% at 4 weeks and 17.6% at 12 weeks. At baseline, the dose escalator group had significantly more OAB wet patients (53.6% vs. 20.0%) and higher total OABSS (10.2+/-2.4 vs. 7.9+/-3.5, P=0.032) than the nonescalator group. OAB wet (odds ratio [OR], 4.615; 95% confidence interval [CI], 1.578-13.499; P<0.05) and total OABSS (OR, 1.398; 95% CI, 1.046-1.869; P<0.05) were found to be independently associated with dose escalation. CONCLUSIONS: Patients who have urgency urinary incontinence and high total OABSS have a tendency for dose escalation of solifenacin.
Elevators and Escalators
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Humans
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Muscarinic Antagonists
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Solifenacin Succinate
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Urinary Bladder, Overactive*
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Urinary Incontinence
5.Review of the Anticholinergics for the Treatment of Overactive Bladder: 2009 Update.
Journal of the Korean Continence Society 2009;13(1):7-22
Overactive bladder is a chronic condition defined by bothersome urgency with or without urgency incontinence, usually associated with daytime frequency and nocturia. The treatment of this condition is to control bothersome urinary symptoms and is therefore to improve quality of life. The Korean Continence Society published the overactive bladder guideline in 2007, which suggested the mainstay of management is behavioral therapy and antimuscarinic pharmacotherapy. With growing awareness toward overactive bladder and quality of life, clinical information regarding antimuscarinic agents should be updated. There are several agents with good level of evidence and good grade of recommendation. Newer antimuscarinic agents are available or will be available in near future. The pharmacological properties, efficacy and tolerability of oxybutynin, trospium, propiverine, tolterodine, darifenacin, solifenacin, fesoterodine and imidafenacin are reviewed and discussed here. The results of major clinical studies are summarized.
Cholinergic Antagonists*
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Drug Therapy
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Muscarinic Antagonists
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Nocturia
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Quality of Life
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Urinary Bladder, Overactive*
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Solifenacin Succinate
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Tolterodine Tartrate
6.Effect of Desmopressin with Anticholinergics in Female Patients with Overactive Bladder.
Young Kook HAN ; Won Ki LEE ; Seong Ho LEE ; Dae Yul YANG ; Hayoung KIM
Korean Journal of Urology 2011;52(6):396-400
PURPOSE: The aim of this study was to evaluate the effect of desmopressin combined with anticholinergics on daytime frequency and urgency in female patients with overactive bladder (OAB). MATERIALS AND METHODS: We included 68 female patients with OAB. Patients were randomly assigned to receive 5 mg of solifenacin (group I) or 5 mg of solifenacin and 0.2 mg of desmopressin (group II) for 2 weeks. A pre/post-treatment 3-day voiding diary and the Urinary Distress Inventory (UDI-6) and Incontinence Impact Questionnaire (IIQ-7) were used to assess changes in voiding symptoms and quality of life (QoL); results were compared between the two groups. RESULTS: Groups I and II included 31 and 37 patients, respectively. Time to first void was 12 min later in group II (105 min vs. 117 min), but this difference was not statistically significant. However, time to the second and third voids (203 min vs. 255 min, 312 min vs. 368 min) and the first urgency episode (212 min vs. 255 min) were significantly longer in group II. Compared with group I, patients in group II showed significant improvement in QoL scores. When improvement after treatment was defined as increase in time to first void of greater than 10% after 2 weeks of treatment, desmopressin with anticholinergics was more effective in patients over the age of 65 years and with more than 150 ml of voided volume. CONCLUSIONS: Desmopressin combined with anticholinergics was more effective than anticholinergics only in the treatment of female patients with OAB.
Cholinergic Antagonists
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Deamino Arginine Vasopressin
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Female
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Humans
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Quality of Life
;
Quinuclidines
;
Tetrahydroisoquinolines
;
Urinary Bladder, Overactive
;
Solifenacin Succinate
7.Efficacy and Tolerability of Solifenacin 5 mg Fixed Dose in Korean Children with Newly Diagnosed Idiopathic Overactive Bladder: a Multicenter Prospective Study.
Sang Don LEE ; Jae Min CHUNG ; Dong Il KANG ; Dong Soo RYU ; Won Yeol CHO ; Sungchan PARK
Journal of Korean Medical Science 2017;32(2):329-334
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.
Child*
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Cholinergic Antagonists
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Humans
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Prospective Studies*
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Solifenacin Succinate*
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Urinary Bladder
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Urinary Bladder, Overactive*
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Urinary Incontinence
8.Effects of Tamsulosin, Solifenacin, and Combination Therapy for the Treatment of Ureteral Stent Related Discomforts.
Kyoung Taek LIM ; Yong Tae KIM ; Tchun Yong LEE ; Sung Yul PARK
Korean Journal of Urology 2011;52(7):485-488
PURPOSE: To evaluate the effect of tamsulosin, solifenacin, and combination therapy of two agents in improving the lower urinary tract symptoms of patients with indwelling double-J ureteral stents. MATERIALS AND METHODS: A total of 168 patients underwent placement of a double-J ureteral stent after retrograde ureteroscopy for urinary stone disease. All patients received polyurethane double-J ureteral stents (6 Fr, 24 or 26 cm), which were removed a mean of 14 days postoperatively. A total of 48 patients were given no medication (Group 1), 43 patients were given tamsulosin 0.2 mg once daily (Group 2), 45 patients were given solifenacin 5 mg once daily (Group 3), and 32 patients were given a combination of two agents postoperatively (Group 4). International Prostate Symptom Score/quality of life (IPSS/QoL) and visual analogue pain scale (VAPS) questionnaires were completed by each patient at 1 day postoperatively and on the day of stent removal. RESULTS: In the total group of patients, the mean age was 50.24+/-12.90 years. There was a significant difference in the IPSS total score between group 1 and groups 3 and 4. Group 4 also differed significantly from group 1 in the irritative subscore. The obstructive subscore differed between groups 2 and 4 and group 1. There was a statistically significant difference between group 1 and group 4 in the QoL score. There were no significant differences in the VAPS. CONCLUSIONS: Combination therapy with tamsulosin and solifenacin improved both irritative and obstructive symptoms more than in the other groups. Combination therapy should be strongly considered for patients who complain of stent-related symptoms.
Humans
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Lower Urinary Tract Symptoms
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Pain Measurement
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Polyurethanes
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Prostate
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Quinuclidines
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Stents
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Sulfonamides
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Tetrahydroisoquinolines
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Ureter
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Ureteroscopy
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Urinary Calculi
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Solifenacin Succinate
9.Clinical Efficacy of Solifenacin in the Management of Diabetes Mellitus-Associated Versus Idiopathic Overactive Bladder Symptoms: A Multicenter Prospective Study.
Hoon CHOI ; Jae Hyun BAE ; Cheol Young OH ; Seong Jin JEONG ; Woo Jin KO ; Jong Bo CHOI ; Ju Tae SEO ; Dong Hwan LEE ; Joon Chul KIM ; Kwang Woo LEE ; Young Ho KIM
International Neurourology Journal 2018;22(1):51-57
PURPOSE: To compare the clinical efficacy of anticholinergics for managing diabetes mellitus-associated overactive bladder (DM OAB) versus idiopathic overactive bladder (OAB) in Korean women. METHODS: We conducted a multicenter, prospective, parallel-group, open-label, 12-week study. Women (20–65 years old) with OAB symptoms for over 3 months were assigned to the DM OAB and idiopathic OAB groups. Changes in the Overactive Bladder Symptom Score (OABSS), urgency, urinary urgency incontinence, nocturia, daytime frequency according to a voiding diary, uroflowmetry, and postvoid residual urine volume (PVR) at the first visit (V1), week 4 (V2), and week 12 (V3) were compared. RESULTS: No significant difference was found between the baseline patient characteristics of the DM OAB and idiopathic OAB groups. Treatment with solifenacin was associated with improvements in urgency, urinary urgency incontinence, nocturia, frequency according to a voiding diary, and the total OABSS between V1 and V2 and between V1 and V3. Moreover, a significant improvement in urgency and urge incontinence was found between V2 and V3 in the DM OAB group. However, no significant changes were found in any other parameters. There were no significant differences between the DM OAB group and the idiopathic OAB group except for urgency and urge incontinence at V2 (3.71 vs. 2.28 and 0.47 vs. 0.32, respectively). CONCLUSIONS: The patients who received solifenacin demonstrated improved urgency, urinary urgency incontinence, nocturia, frequency according to a voiding diary, and total OABSS. Management with solifenacin was equally effective for both DM-related OAB and idiopathic OAB.
Cholinergic Antagonists
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Diabetes Mellitus
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Female
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Humans
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Nocturia
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Prospective Studies*
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Solifenacin Succinate*
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Treatment Outcome*
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Urinary Bladder, Overactive*
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Urinary Incontinence, Urge
10.Pharmacokinetics comparison of solifenacin tartrate and solifenacin succinate: a randomized, open-label, single-dose, 2-way crossover study in healthy male volunteers
Yu mi KIM ; Ji Young JEON ; Seol Ju MOON ; Jina JUNG ; Hankil SON ; Min Gul KIM
Translational and Clinical Pharmacology 2018;26(2):73-78
Solifenacin is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms. Solifenacin tartrate is a newly developed salt formulation of solifenacin. This study compared the pharmacokinetic and safety properties after single-dose administration of solifenacin tartrate (test formulation) and solifenacin succinate (reference formulation) in healthy male volunteers. A total of 36 subjects were enrolled in this randomized, open-label, single-dose, two-way crossover study. During each treatment period, subjects received the test formulation or reference formulation. Plasma samples were collected at pre-dose and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 and 72 hours post-dose. Safety was assessed by adverse events, physical examinations, laboratory assessments, 12-lead electrocardiograms, and vital signs. Thirty-three subjects completed the study and were included in the pharmacokinetic analysis. The mean (standard deviation) values of AUC(last) for the test and reference formulations were 486.98 (138.47) and 469.07 (128.29) h·ng/mL, respectively. The mean (standard deviation) values of C(max) for the test and reference formulations were 14.66 (3.85) and 14.10 (3.37) ng/mL, respectively. The 90% confidence intervals for AUC(last) and C(max) were 0.9702 to 1.1097 and 0.9779 to 1.0993, respectively. All adverse events were mild or moderate, and there were no serious adverse events. The pharmacokinetic properties of solifenacin tartrate were similar to those of solifenacin succinate and met the acceptance criteria for bioequivalence. Both formulations were safe, and no significant difference was observed in the safety assessments of the formulations.
Cross-Over Studies
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Electrocardiography
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Humans
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Male
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Pharmacokinetics
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Physical Examination
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Plasma
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Solifenacin Succinate
;
Therapeutic Equivalency
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Urinary Bladder, Overactive
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Vital Signs
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Volunteers