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1.
Int. braz. j. urol ; 47(3): 596-609, May-June 2021. tab, graf
Article in English | LILACS | ID: biblio-1154501

ABSTRACT

ABSTRACT Background: Many medical therapies have been tested to deal with urinary stent-related symptoms (USRS). Several preventive and pharmaceutical methods have been already used for better compatibility of stents. However, the existing evidence for pharmacological treatment is still controversial. This study aims to evaluate the effects of pregabalin, solifenacin, and combination therapy on ureteral double-J stent-related symptoms following ureteroscopy and transureteral lithotripsy (TUL). Materials and methods: In a randomized controlled clinical trial, from November 2017 to March 2019, 256 patients who underwent ureteroscopy were enrolled. Patients were randomly divided into four groups including: group A received pregabalin 75mg BID (twice daily), group B received solifenacin 5mg orally once daily, group C received combination of pregabalin and solifenacin and the group D (control) given no drugs. Results: One hundred and fifty-one (58.9%) males and 101 (41.1%) females were enrolled in this study with a mean age of 43.47±7 (p=0.32, p=0.67). USSQ domains score such as urinary symptoms, pain, general condition, work performance, sexual matters and additional problems were significantly differenced during second and fourth week of follow-up among study groups (p <0.0001). In Tukey's multiple comparison test, urinary symptoms (p=0.735), pain (p=0.954) and sexual matters (p=0.080) in second week and work performance in forth week in group B was not significantly better than group D. Only group C in all indexes of USSQ showed significantly beneficial effects over group D (p <0.0001). Conclusion: Combination therapy of pregabalin and solifenacin has a significant effect on stent-related symptoms and is preferred over monotherapy of the respected medications.


Subject(s)
Humans , Male , Female , Adult , Ureter , Stents/adverse effects , Solifenacin Succinate/therapeutic use , Quality of Life , Pregabalin/therapeutic use , Middle Aged
2.
Int. braz. j. urol ; 47(1): 73-81, Jan.-Feb. 2021. tab, graf
Article in English | LILACS | ID: biblio-1134307

ABSTRACT

ABSTRACT Introduction: Nocturnal enuresis (enuresis) is one of the most common developmental problems of childhood, which has often a familial basis, causes mental and psychological damage to the child and disrupts family solace. Objectives: In this study, we compared therapeutic efficacy and tolerability of treating primary nocturnal enuresis (PNE) with solifenacin plus desmopressin, tolterodine plus desmopressin, and desmopressin alone. Because we don't have enough information about this comparison especially about solifenacin plus desmopressin. Patients and Methods: This clinical trial study was performed on 62 patients with enuresis aged 5-15 years who referred to the urology clinic of Imam Khomeini Hospital in Ahwaz in 2017-2018. Patients were randomly assigned to one of the three different therapeutic protocols and any participants were given a specific code. After that, we compared the therapeutic response and the level of satisfaction of each therapeutic group in different months. Data were analyzed using SPSS 22 software and descriptive and analytical statistics. Results: The mean age of patients was 8.70±66 years. In the therapeutic group with desmopressin and solifenacin, 19 of 20 patients (95%) achieved complete remission (1) after a 3-month treatment in comparison with monotherapy group in which 14 of 22 patients (63.63%) achieved complete remission; and in the combination therapy group of desmopressin and tolterodine, in the study and the evaluation of the consequences of 3-month treatment of this group, it was found that 17 of 20 patients (85%) had complete remission. Overall, the therapeutic response in combination therapy groups of desmopressin plus anticholinergic was higher than the monotherapy group of desmopressin alone. Conclusion: Our results demonstrate that the combination of desmopressin and an anticholinergic agent is highly effective in treatment of children with PMNE. Although desmopressin has long been a first - line treatment for PMNE, desmopressin monotherapy often fails to achieve a successful response in patients with PMNE.


Subject(s)
Humans , Child, Preschool , Child , Adolescent , Enuresis , Nocturnal Enuresis/drug therapy , Cholinergic Antagonists , Deamino Arginine Vasopressin/therapeutic use , Tolterodine Tartrate , Solifenacin Succinate
3.
Int. braz. j. urol ; 46(2): 185-193, Mar.-Apr. 2020. tab, graf
Article in English | LILACS | ID: biblio-1090573

ABSTRACT

ABSTRACT Objective To evaluate the effects of solifenacin, darifenacin, and propiverine on nasal-, subfoveal-, temporal choroidal thicknesses (NCT, SFCT, TCT), intraocular pressure (IOP) and pupil diameter (PD). Materials and Methods Patients with overactive bladder (OAB) diagnosed according to The International Continence Society were administered with solifenacin, darifenacin or propiverine on a daily basis between November 2017 and May 2018. NCT, SFCT, TCT, IOP, and PD of these patients were measured and compared as initial, fourth and twelfth weeks. Results A total of 165 patients (330 eyes) with OAB were evaluated. Solifenacin (n=140) significantly reduced IOP from 17.30±2.72 mmHg to 16.67±2.56 mmHg (p=0.006) and 16.57±2.41 mmHg (p=0.002), at the fourth and twelfth weeks, respectively. Darifenacin (n=110) significantly reduced NCT from 258.70±23.96 μm to 257.51±22.66 μm (p=0.002) and 255.36±19.69 μm (p=0.038), at the fourth and twelfth weeks, respectively. Propiverine (n=80) significantly increased PD from 4.04±0.48 mm to 4.08±0.44 mm (p=0.009) and 4.09±0.45 mm (p=0.001), at the fourth and twelfth weeks, respectively. Conclusion These findings can help to decide appropriate anticholinergic drug choice in OAB patients. We finally suggest further well-designed randomized prospective studies with a larger population to evaluate the anticholinergic-related complications in eyes.


Subject(s)
Humans , Male , Female , Adult , Aged , Aged, 80 and over , Young Adult , Pyrrolidines/adverse effects , Benzilates/adverse effects , Benzofurans/adverse effects , Pupil/drug effects , Choroid/drug effects , Muscarinic Antagonists/adverse effects , Solifenacin Succinate/adverse effects , Intraocular Pressure/drug effects , Pyrrolidines/administration & dosage , Benzilates/administration & dosage , Benzofurans/administration & dosage , Prospective Studies , Follow-Up Studies , Muscarinic Antagonists/administration & dosage , Urinary Bladder, Overactive/drug therapy , Solifenacin Succinate/administration & dosage , Middle Aged
4.
Int. braz. j. urol ; 46(4): 575-584, 2020. tab, graf
Article in English | LILACS | ID: biblio-1134201

ABSTRACT

ABSTRACT Objective and Hypothesis We aimed to investigate the reasons of storage symptoms ( SS) after transurethral resection of the prostate (TURP). The hypothesis was that a positive correlation would be identified between preoperative and postoperative SS in patients with undergoing TURP and starting early solifenacin treatment in patients with high preoperative SS would be reasonable. In addition, we aimed to analyze multiple other risk factors for post-TURP SS. Materials and Methods A total of 160 patients undergoing TURP were prospectively evaluated and divided into two groups according to their OABS. Those with a score of ≥10 points were Group 1 (G1), and those with <10 points Group 2 (G2). In addition, patients in each group were randomly further divided into two subgroups: those who were started on 5 mg solifenacin succinate in the early postoperative period (G1/G2 A) and those who were not (G1/G2 B). In additions to SS Preop, perop and at the 3rd-month of postoperatively 14 variable were evaluated. The effects of these factors, surgery and the efficacy of an early medical treatment on the postoperative SS were investigated. LUTS were assessed by International Prostate Symptom Score (IPSS) and SS were assessed by sum of IPSS 2, 4 and 7 questionnaires (Storage, S- IPSS). Results Preoperative IPSS and S-IPSS were significantly higher in G1 (p<0.001); there was a significant improvement at IPSS, S-IPSS, QoL score, Qmax, and PVR for all groups after surgery. Only preoperative S-IPSS was found to have significant effect on postoperative SS (p<0.001). There was a significant difference between G1A and G1B but no significant difference between G2A and G2B in terms of SS at postoperatively. In addition to this, prostatic volume was found smaller than non-symptomatic patients in de novo SS patients. Conclusion TURP provides significant improvement in both storage and voiding symptoms. The predictive value of the preoperative S-IPSS on postop SS is significant. These results suggest that 5 mg solifenacin succinate treatment in the early postoperative period may be beneficial for patients with high preoperative SS and may not be beneficial in others. Small prostatic volume may bode ill for postoperative SS in the patients with de novo SS.


Subject(s)
Humans , Male , Aged , Transurethral Resection of Prostate , Prostatic Hyperplasia/surgery , Prostatic Hyperplasia/drug therapy , Risk Factors , Treatment Outcome , Solifenacin Succinate/therapeutic use , Middle Aged
5.
Int. braz. j. urol ; 45(4): 782-789, July-Aug. 2019. tab
Article in English | LILACS | ID: biblio-1019895

ABSTRACT

ABSTRACT Purpose To evaluate the efficacy and tolerability of mirabegron in females with overactive bladder (OAB) symptoms after surgical treatment for stress urinary incontinence (SUI). Materials and Methods The study was conducted with a prospective, randomized and double-blinded design. 62 patients over the age of 40 who met the inclusion-exclusion criterias of the study were enrolled and randomly divided into two groups as Group A (mirabegron 50mg) and B (solifenacin 5mg). Patients were compared based on efficacy of treatment [Patient Perception of Bladder Condition (PPBC) scale and micturition diaries], safety of treatment (heart rate, systolic and diastolic blood pressure, adverse events), number of micturitions per day, patient's satisfaction status after treatment [Visual Analog Scale(VAS)] and quality of life. Results The mean age of the population was 48.2±3.8 years and the duration of OAB symptoms was 5.9±2.9 months. Baseline values for the mean number of micturitions, volume voided in each micturition, nocturia episodes, urgency and urgency incontinence episodes were 15.3±0.34, 128±3.88mL, 3.96±1.67, 5.72±1.35 and 4.22±0.69, respectively. After treatment, values for these parameters were 11.7±0.29, 164.7±2.9mL, 2.25±0.6, 3.38±0.71, 2.31±0.49 respectively. Quality of life score, symptom bother score, VAS for treatment satisfaction score, PPBC score after treatment were 66.1±0.85, 43.7±0.77, 4.78±0.14, 4.78±0.14, respectively. There were no significant differences between two groups on any parameter. However, mirabegron showed better tolerability than solifenacin, particularly after 6 months. Conclusion Mirabegron is safe, effective and tolerable in the long-term treatment of females with OAB symptoms after surgery for stress urinary incontinence.


Subject(s)
Humans , Female , Adult , Thiazoles/therapeutic use , Urinary Incontinence, Stress/surgery , Urinary Bladder, Overactive/drug therapy , Adrenergic beta-3 Receptor Agonists/therapeutic use , Acetanilides/therapeutic use , Quality of Life , Reference Values , Urinary Incontinence, Stress/physiopathology , Double-Blind Method , Prospective Studies , Reproducibility of Results , Treatment Outcome , Muscarinic Antagonists/therapeutic use , Urinary Bladder, Overactive/physiopathology , Visual Analog Scale , Solifenacin Succinate/therapeutic use , Middle Aged
6.
Rev. Assoc. Med. Bras. (1992) ; 65(4): 487-492, Apr. 2019.
Article in English | LILACS | ID: biblio-1003062

ABSTRACT

The Guidelines Project, an initiative of the Brazilian Medical Association, aims to combine information from the medical field in order to standardize producers to assist the reasoning and decision-making of doctors. The information provided through this project must be assessed and criticized by the physician responsible for the conduct that will be adopted, depending on the conditions and the clinical status of each patient.


Subject(s)
Humans , Thiazoles/administration & dosage , Muscarinic Antagonists/administration & dosage , Urinary Bladder, Overactive/drug therapy , Adrenergic beta-3 Receptor Agonists/administration & dosage , Acetanilides/administration & dosage , Pyrrolidines/administration & dosage , Benzilates/administration & dosage , Benzofurans/administration & dosage , Brazil , Drug Therapy, Combination , Tolterodine Tartrate/administration & dosage , Solifenacin Succinate/administration & dosage , Clinical Decision-Making , Mandelic Acids/administration & dosage , Antidepressive Agents/administration & dosage , Nortropanes/administration & dosage
7.
Int. braz. j. urol ; 44(1): 102-108, Jan.-Feb. 2018. tab
Article in English | LILACS | ID: biblio-892947

ABSTRACT

ABSTRACT Purpose To assess effectiveness and durability of Solifenacin (SS) versus tibial nerve stimulation (PTNS) versus combination therapy (PTNS + SS) in women with overactive bladder syndrome (OAB). Materials and Methods 105 women with OAB were divided randomly into three groups of 35 patients each. In group A women received SS, in group B women underwent PTNS, in group C women underwent combination of PTNS + SS. Improvements in OAB symptoms were assessed with OABSS questionnaire; patients' quality of life was assessed with OAB-q SF questionnaire. Evaluation of effectiveness of treatments was performed with PGI-I questionnaire. OABSS and PGI-I were also assessed monthly for ten months. Results All treatments were effective on symptoms. PTNS showed a greater effectiveness than SS, but PTNS + SS was more effective than SS and PTNS. Furthermore, PTNS + SS showed a greater duration of effectiveness than PTNS and SS. Conclusions Combination of PTNS with SS showed more effectiveness and more durability than PTNS and SS alone.


Subject(s)
Humans , Female , Adult , Transcutaneous Electric Nerve Stimulation/methods , Urinary Bladder, Overactive/drug therapy , Urinary Bladder, Overactive/therapy , Urological Agents/administration & dosage , Solifenacin Succinate/administration & dosage , Tibial Nerve , Follow-Up Studies , Treatment Outcome , Combined Modality Therapy , Middle Aged
8.
Article in English | WPRIM | ID: wpr-713568

ABSTRACT

PURPOSE: The aim of this study was to investigate the safety and the effects of elevated doses of solifenacin and trospium on cognitive function and health-related quality of life (HRQoL) in elderly women receiving treatment for urinary incontinence. METHODS: The study included 312 women aged 60–83 years (mean age, 69.4 years). All participants had scored at least 24 points on the Mini-Mental State Examination (MMSE) scale, and all of them had been diagnosed with urge urinary incontinence (UUI) or mixed urinary incontinence (MUI). The women were randomly assigned to 3 groups: group A, individuals who were simultaneously administered solifenacin at a high dosage of 20 mg per day and trospium at a high dosage of 60 mg per day; group B, persons taking solifenacin and trospium at the usual dosage of 10 and 30 mg per day, respectively; and group C, persons who received a placebo. Participants’ cognitive status was assessed by the MMSE, Controlled Oral Word Association Test, Wechsler Adult Intelligence Scale-Revised, Wechsler Memory Scale III, Colour Trails Test, and California Verbal Learning Test scales. The HRQoL assessment was performed using the Medical Outcomes Study 36-Item Health Survey. RESULTS: The cognitive function parameters did not differ at the start and end of the study across the groups (P>0.05). Additionally, the cognitive function parameters did not differ significantly within each group between the start and end of the study (P>0.05). The values of most HRQoL parameters regarding the functional state of the lower urinary tract (LUT) after the termination of treatment significantly improved in groups A and B (P < 0.05). A significant correlation between cognitive status and HRQoL or LUT parameters was absent (r < 0.3), while the correlations between HRQoL and LUT parameters were r=0.31–0.83, P < 0.05. CONCLUSIONS: The use of elevated doses of solifenacin and trospium did not increase the risk of cognitive impairment in women with UUI and MUI. The combination of solifenacin and trospium at a double dosage may be recommended to elderly women with treatment-resistant symptoms of UUI and MUI. However, the safety of combining antimuscarinic drugs in women with an increased volume of residual urine requires further study.


Subject(s)
Adult , Aged , California , Cognition Disorders , Cognition , Female , Health Surveys , Humans , Intelligence , Memory , Muscarinic Antagonists , Quality of Life , Solifenacin Succinate , Urinary Incontinence , Urinary Tract , Verbal Learning , Weights and Measures , Word Association Tests
9.
Article in English | WPRIM | ID: wpr-713567

ABSTRACT

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.


Subject(s)
Cholinergic Antagonists , Diabetes Mellitus , Female , Humans , Nocturia , Prospective Studies , Solifenacin Succinate , Treatment Outcome , Urinary Bladder, Overactive , Urinary Incontinence, Urge
10.
Article in English | WPRIM | ID: wpr-742403

ABSTRACT

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.


Subject(s)
Cross-Over Studies , Electrocardiography , Humans , Male , Pharmacokinetics , Physical Examination , Plasma , Solifenacin Succinate , Therapeutic Equivalency , Urinary Bladder, Overactive , Vital Signs , Volunteers
11.
Pakistan Journal of Medical Sciences. 2017; 33 (4): 988-992
in English | IMEMR | ID: emr-188626

ABSTRACT

Objective: To analyze the clinical effect of tamsulosin and Solifenacin in the treatment of benign prostatic hyperplasia in combination with overactive bladder and its safety. Another objective was to investigate the clinical effect and safety of mega dose of tamsulosin in the treatment of benign prostatic hyperplasia in combination with overactive bladder


Methods: One hundred and twenty-four patients who were admitted to the Dept. of Urology at Binzhou People's Hospital, , China with confirmed benign prostatic hyperplasia [BPH] with overactive bladder were randomly divided into two groups. Sixty-two patients in the control group were treated with tamsulosin, while sixty-two patients in the observation group were treated with tamsulosin in combination with solifenacin. The treatment of both groups lasted for 12 weeks. The effect and adverse reaction were compared between the two groups


Results: The international prostate symptom score [IPSS], quality of life [QOL] and overactive bladder symptom score [OABSS], Q[max] pulmonary vascular resistance [PVR], daytime urination frequency, urgent urination frequency, urge urinary incontinence frequency and night urinary frequency of both groups improved after treatment, and the difference had statistical significance [P<0.05]


The differences of the observation indexes [except PVR] in the observation group before and after treatment was significantly different with those of the control group [P<0.05]


The incidence of adverse reactions in the observation group was lower than that in the control group, but the difference had no statistical significance [X[2]=2.843, P>0.05]


Conclusion: Treating benign prostatic hyperplasia in combination with overactive bladder with tamsulosin in combination with solifenacin is more effective than tamsulosin, without significantly increasing adverse reactions. Thus the therapy is worth clinical promotion


Subject(s)
Humans , Male , Adult , Middle Aged , Aged , Aged, 80 and over , Urinary Bladder, Overactive/drug therapy , Solifenacin Succinate/therapeutic use , Urinary Incontinence, Urge
12.
Article in English | WPRIM | ID: wpr-205045

ABSTRACT

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.


Subject(s)
Humans , Solifenacin Succinate , Urinary Bladder, Overactive , Urination
13.
Article in English | WPRIM | ID: wpr-200232

ABSTRACT

We compared changes in nocturia and sleep-related parameters between daytime and nighttime solifenacin dosing in patents with overactive bladder (OAB) and nocturia. We comparatively analyzed the data of a 12-week prospective, open-label, multicenter, randomized study. All 127 patients who presented to 5 centers in Korea for the treatment of OAB with nocturia between January 2011 and December 2013 were enrolled in this study. The patients were divided into 2 groups by medication timing: group 1, daytime (n = 62); and group 2, nighttime (n = 65). The International Prostate Symptom Score (IPSS), Overactive Bladder Symptom Score (OABSS), and Athens Insomnia Scale (AIS) were used to assess OAB symptoms and sleep quality. We evaluated the parameter changes before and 12 weeks after daytime or nighttime solifenacin administration. Baseline data, which included sex, age, body mass index (BMI), total AIS, IPSS, and OABSS, did not differ between the 2 groups. Total IPSS, OABSS, and total AIS significantly improved after solifenacin administration regardless of timing (P < 0.001). After solifenacin administration, the number of nocturia episodes decreased in the group 1 and 2 (P < 0.001). There were no significant intergroup differences in changes in AIS, IPSS, OABSS, and number of nocturia episodes 12 weeks after solifenacin administration. Treating OAB with solifenacin may improve nocturia and sleep quality, but advantages did not differ significantly by medication timing.


Subject(s)
Body Mass Index , Humans , Korea , Nocturia , Prospective Studies , Prostate , Sleep Initiation and Maintenance Disorders , Solifenacin Succinate , Urinary Bladder, Overactive
14.
Article in English | WPRIM | ID: wpr-193553

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.


Subject(s)
Child , Cholinergic Antagonists , Humans , Prospective Studies , Solifenacin Succinate , Urinary Bladder , Urinary Bladder, Overactive , Urinary Incontinence
15.
Lima; s.n; oct. 2016.
Non-conventional in Spanish | LILACS, BRISA | ID: biblio-848477

ABSTRACT

INTRODUCCIÓN: Antecedentes: El presente dictamen presenta la evaluación de la eficacia y seguridad del uso de solifenacina para el tratamiento de hiperactividad vesical. Aspectos Generales: La hiperactividad vesical es un síndrome definido por la presencia de urgencia urinaria, usualmente acompañada de alta frecuencia urinaria durante el día y/o la noche, y/o incontinencia urinaria de urgencia. Una alta frecuencia urinaria se refiere a frecuencia miccional de ocho o más veces durante el día, o 2 o más veces durante la noche. La incontinencia urinaria, como signo, es la fuga involuntaria de orina. La urgencia urinaria es la sensación aguda y repentina de necesidad de miccionar inmediatamente, la cual se da por la contracción del músculo detrusor en la vejiga.Tecnología Sanitaria de Interés: El succinato de solifenacina es un antagonista competitivo de los receptores muscarínicos. Su naturaleza es química, siendo un ácido butanodioico, con fórmula empírica C23H26N202 • C4H604 y peso molecular de 480.55. La solifenacina ejerce su acción bloqueando los receptores muscarínicos en el músculo vesical (músculo detrusor), los cuales son mediadores de las funciones colinérgicas como la contracción de dichos músculos. Al unirse a los receptores muscarínicos en el tejido muscular de la vejiga, la solifenacina impide la unión de la acetilcolina (neurotransmisor colinérgico) e interrumpe la señal que estimula la contracción. De esta manera, la solifenacina evita las contracciones repentinas que originan la urgencia urinaria en el síndrome de hiperactividad vesical. MÉTODOLOGÍA: Estrategia de Búsqueda: Se llevó a cabo una búsqueda de la literatura con respecto a la eficacia y seguridad de solifenacina en el tratamiento de hiperactividad vesical en las bases de datos de PubMed, TRIPDATABASE y www.clinicaltrials.gov. Adicionalmente, se realizó una búsqueda de evaluaciones de tecnologías y guías de práctica clínica en las páginas web de grupos dedicados a la investigación y educación en salud en general como The National Institute for Health and Care Excellence (NICE), the American Urological Association (AUA), the International Continence Society (ICS), the International Consultation on Incontinence (ICI), the International Urogynecological Association (IUGA), the European Association of Urology (EAU), the Urinary Incontinence Treatment Network (UITN), the Society of Obstetricians and Gynecologists of Canada (SOGC), y the American Congress of Obstetricians and Gynecologists (ACOG). RESULTADOS: Sinopsis de la Evidencia: De acuerdo con la pregunta PICO, se llevó a cabo una búsqueda de evidencia científica relacionada al uso de solifenacina en el tratamiento de pacientes con hiperactividad vesical. En la presente sinopsis se describe la evidencia disponible según el tipo de publicación, siguiendo lo indicado en los criterios de elegibilidad (GPC, ETS, RS, MA y ECA fase III). CONCLUSIONES: Las GPC encontradas no emiten recomendaciones acerca del uso de solifenacina en pacientes refractarios al tratamiento con oxibutinina. Sin embargo, la GPC de AUA menciona que en los casos de refractariedad al tratamiento con algún agente farmacológico (anti-muscarínicos), por principio clínico, es posible cambiar la dosis o el agente. Aunque esta afirmación se basa en opinión de expertos y estudios observacionales. No se ha encontrado un ECA que evalúe la eficacia del uso de solifenacina en pacientes refractarios a oxibutinina. Se identificó únicamente un estudio observacional que sugiere un efecto positivo del uso de solifenacina en pacientes refractarios o intolerantes a oxibutinina. A pesar de que dicho estudio presenta una serie de limitaciones serias, se rescata la fuerza de las asociaciones encontradas. Adicionalmente, estudios sobre eventos adversos relacionados al uso de solifenacina reportan que este fármaco es seguro en el tratamiento de hiperactividad vesical. El Instituto de Evaluación de Tecnologías en Salud e Investigación (IETSI) aprueba el uso de solifenacina como alternativa de tratamiento en pacientes con hiperactividad vesical refractaria a oxibutinina. El periodo de vigencia de este dictamen es de un año y la continuación de dicha aprobación estará sujeta a los resultados obtenidos de los pacientes que se beneficien con dicho tratamiento y a nueva evidencia que pueda surgir en el tiempo.


Subject(s)
Humans , Adult , Solifenacin Succinate/administration & dosage , Urinary Incontinence, Urge/drug therapy , Technology Assessment, Biomedical , Treatment Outcome , Urinary Bladder, Overactive
16.
Article in English | WPRIM | ID: wpr-44715

ABSTRACT

PURPOSE: We investigated improvements in overactive bladder symptoms and depressive symptoms after solifenacin treatment in overactive bladder patients with or without depressive symptoms. METHODS: We performed a prospective study of patients who had been diagnosed with overactive bladder from July 2013 to June 2014. Based on the Beck Depression Inventory questionnaire, the test subjects were divided into group 1, without depressive symptoms (0–9 points), and group 2, with depressive symptoms (10 or more points). The patients were administered 5 mg of solifenacin for 3 months. The following outcomes were analyzed at the first visit, 4 weeks, and 12 weeks: the overactive bladder symptom score (OABSS), International Prostate Symptom Score (IPSS), patients’ perceptions of their bladder condition, and the Beck Depression Inventory. RESULTS: A total of 72 patients participated, and 52 patients completed the study. Most outcome measures showed improvements in both groups at weeks 4 and 12. Especially in group 2, the questionnaires showed significant improvements from baseline to week 12, indicating that solifenacin was effective at treating overactive bladder symptoms (group 1 vs. group 2: OABSS, −2.67±0.80 vs. −3.00±0.77; P<0.01; IPSS-total, −2.14±2.15 vs. −4.94±1.70; P<0.01). Statistically significant decreases in the Beck Depression Inventory score from baseline to weeks 4 and 12 were observed in group 2 (group 1 vs. group 2: 1.43±0.74 vs. −2.68±4.05 at week 4, P<0.001; 0.10±3.37 vs. −5.52±5.82 at week 12, P<0.001). CONCLUSIONS: In overactive bladder patients with depressive symptoms, solifenacin can help improve quality of life and depressive symptoms at the same time.


Subject(s)
Depression , Humans , Outcome Assessment, Health Care , Prospective Studies , Prostate , Quality of Life , Solifenacin Succinate , Urinary Bladder , Urinary Bladder, Overactive
17.
Article in English | WPRIM | ID: wpr-124498

ABSTRACT

PURPOSE: The prevalence of hyperactive-type lower urinary tract symptoms is 45.2%, with shares of overactive bladder (OAB) and urge incontinence (UI) symptoms of 10.7% and 8.2%, respectively. We investigated the possible impact of a wide range of social, economic, and medical factors on compliance with solifenacin treatment in the working population. METHODS: Social, economic, and medical factors as well as the Overactive Bladder questionnaire – the OAB-q Short Form (OAB-q SF), bladder diaries, and uroflowmetry of 1,038 people who were administered solifenacin for a year were gathered from employer documentation. RESULTS: Among the subjects, 32% maintained their compliance with solifenacin treatment throughout the year. Only 65% of the patients had compliance exceeding 80%, and 17% of patients had compliance of ≥50%, yet less than 80% were still taking solifenacin 12 months after the beginning of this experiment. Working people whose compliance level was, at least, 80% had reliably higher (P≤0.01) average age, annual salary, and treatment efficacy, and a greater treatment satisfaction level, as well as a lack of satisfaction with other antimuscarinic treatments and higher rate of urge UI diagnosis. The same cohort also featured a lower level (P≤0.01) of caffeine abuse and lower share of salary spent purchasing solifenacin. CONCLUSIONS: This study has shown that compliance with solifenacin treatment is associated with a number of significant medical, social, and economic factors. The medical factors included the type of urination disorder, severity of incontinence symptoms, presence of side effects, treatment efficacy and patients’ satisfaction with it, and experience using other antimuscarinic treatments. Among the social and economic factors, those with the strongest correlation to compliance were patient age, employment in medicine and education, annual income level, percentage of solifenacin purchase expenditures, and caffeine abuse. Factors with a weaker, but still significant, association were gender, employment in the transportation industry, and monthly income level.


Subject(s)
Caffeine , Cohort Studies , Compliance , Diagnosis , Education , Employment , Health Expenditures , Humans , Lower Urinary Tract Symptoms , Muscarinic Antagonists , Prevalence , Salaries and Fringe Benefits , Solifenacin Succinate , Transportation , Treatment Outcome , Urinary Bladder , Urinary Bladder, Overactive , Urinary Incontinence, Urge , Urination Disorders
18.
Article in English | WPRIM | ID: wpr-90689

ABSTRACT

PURPOSE: To determine the duration of antimuscarinic therapy for overactive bladder syndrome (OAB) appropriate for assessment of the efficacy of treatment, and to evaluate the possible predictive factors for response to therapy. METHODS: All OAB patients who visited a urology outpatient clinic of a tertiary referral center and who were prescribed 5 mg of solifenacin or 4 mg of tolterodine extended release capsules daily were enrolled in the study. Patients were asked to continue therapy for 6 months. All enrolled patients completed the patient perception of bladder condition, overactive bladder symptom score (OABSS), and the modified Indevus Urgency Severity Scale questionnaires. All patients underwent uroflowmetry. RESULTS: A total of 164 patients were enrolled and 125 patients (76%) had at least one follow-up visit. The mean follow-up interval was 1 month (range, 0.5-6 months). Sixty-two patients (49.6%; 95% confidence interval [CI], 40.7-58.5) responded to antimuscarinic treatment. The median time for the onset of response was 3 months (95% CI, 1-6). Multivariate Cox proportional-hazards model revealed that elevated baseline OABSS was an independent predictor of responsiveness to therapy. Receiver operating characteristic (ROC) curve analysis revealed an optimal OABSS cutoff value of > or =7, with an area under the ROC curve of 0.79 (95% CI, 0.70-0.88; sensitivity, 91.9%; specificity, 60.7%). CONCLUSIONS: The median time for a therapeutic response was 3 months, and OABSS was the only predictor for responsiveness. These findings may serve as a guideline when prescribing antimuscarinic treatment for OAB patients.


Subject(s)
Ambulatory Care Facilities , Capsules , Cholinergic Antagonists , Follow-Up Studies , Humans , ROC Curve , Sensitivity and Specificity , Solifenacin Succinate , Tertiary Care Centers , Tolterodine Tartrate , Treatment Outcome , Urinary Bladder , Urinary Bladder, Overactive , Urology
19.
Bogotá; IETS; dic. 2014. ilus.
Monography in Spanish | LILACS, BRISA | ID: biblio-847059

ABSTRACT

Introducción: Alrededor del 16% al 45% de los adultos tiene síntomas de vejiga hiperactiva, que se manifiestan con urgencia para orinar, aumento en la frecuencia de micciones o incontinencia urinaria de urgencia, o ambos, denominado síndrome de vejiga hiperactiva. Los fármacos anticolinérgicos son los tratamientos más comunes para el tratamiento farmacológico y entre ellos la oxibutinina y la tolterodina. Esta evaluación tecnológica se desarrolló en el marco de la actualización integral del Plan Obligatorio de Salud para el año 2015. Objetivo: evaluar la efectividad y seguridad de la oxibutinina o la tolterodina para la incontinencia urinaria, comparadas con otros medicamentos antimuscarínicos como: solifenacina, darifenacina, fesoterodina para informar la toma de decisiones. Metodología: la evaluación fue realizada de acuerdo al protocolo definido previamente por el grupo desarrollador. Se realizó una búsqueda sistemática en MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects y LILACS, sin restricciones de idioma y limitada a revisiones sistemáticas publicadas en los últimos cinco años. Las búsquedas electrónicas fueron hechas entre octubre y noviembre de 2014 y se complementaron mediante búsqueda manual en bola de nieve y una consulta con expertos temáticos. La tamización de referencias se realizó por dos revisores de forma independiente y los desacuerdos fueron resueltos por consenso. La selección de estudios fue realizada mediante la revisión en texto completo de las referencias preseleccionadas, verificando los criterios de elegibilidad. La calidad de los estudios fue valorada con la herramienta AMSTAR. Las características de los estudios fueron extraídas a partir de las publicaciones originales. Se realizó una síntesis narrativa de las estimaciones del efecto para las comparaciones y desenlaces de interés a partir de los estudios de mejor calidad con AMSTAR. Resultados: se seleccionó una revisión sistemática que incluyó un total de 86 ensayos clínicos (31,249 pacientes) con medicamentos muscarínicos incluyendo a la Oxibutinina y la Tolterodina. Se realizaron comparaciones directas entre medicamentos y comparaciones intratecnología (dosis y presentaciones). Cuando se comparó la Tolterodina versus la Oxibutinina, no se encontró diferencia estadisticamente significativa en los desenlaces de calidad de vida, la percepción de cura o mejora y cuantificación de los síntomas. Cuando se comparó solifenacina versus tolterodina, se encontró diferencia estadisticamente significativa en los mismos desenlaces a favor de la solifenacina, e igual se reportó en la comparación fesoterodina versus tolterodina, a favor de la fesoterodina. Respecto a seguridad se comparó tolterodina versus oxibutinina y el retiro por eventos adversos fue más frecuente en el grupo de la oxibutinina RR 0.52 IC95% 0.40 a 0.66. En la comparación de soliferacina versus oxibutinina el retiro por eventos adversos fue más frecuente en el grupo de oxibutinina RR 0.45 IC95% 0.22 a 0.91 y al comparar la fesoterodina versus la tolterodina el retiro por eventos adversos fue más frecuente en el grupo de la fesoterodina RR 1.45 IC95% 1.07 a 1.98. Conclusiones: Efectividad: No se evidenció diferencia en efectividad entre la Oxibutinina y Tolterodina en los desenlaces de calidad de vida y la percepción de cura o mejora. Para la comparación de efectividad entre Oxibutinina versus Darifenacina y Solifenacina, no se reportaron resultados. La Solfenacina y Fesoterodina son más efectivas que la Tolterodina, en los desenlaces de calidad de vida y la percepción de cura o mejora. Seguridad: Tolterodina fue más seguro que la Oxibutinina, respecto al abandono por eventos adversos. La comparación entre Darifenacina versus oxibutinina no reportó resultados. Solifenacina fue más seguro que la oxibutinina, respecto al abandono por eventos adversos. Tolterodina fue más seguro que Fesoterodina, respecto al abandono por eventos adversos y boca seca.(AU)


Subject(s)
Humans , Urinary Bladder, Overactive , Urinary Incontinence/drug therapy , Biomedical Technology , Cholinergic Antagonists/administration & dosage , Colombia , Receptor, Muscarinic M3/antagonists & inhibitors , Reproducibility of Results , Solifenacin Succinate/administration & dosage , Tolterodine Tartrate/administration & dosage , Treatment Outcome
20.
Article in English | WPRIM | ID: wpr-112732

ABSTRACT

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.


Subject(s)
Elevators and Escalators , Humans , Muscarinic Antagonists , Solifenacin Succinate , Urinary Bladder, Overactive , Urinary Incontinence
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