The Pharmacological Costs of Second-Line Treatments for Recurrent Ovarian Cancer.

INTRODUCTION: In ovarian cancer, it is uncertain which chemotherapy regimen is more clinically effective and cost-effective for the treatment of recurrence; therefore, it might be interesting to make a balance between the cost of the drugs administered and the difference in progression-free survival (PFS) and overall survival (OS). METHODS: The present evaluation was restricted to pivotal phase 3 randomized controlled trials. We calculated the pharmacological costs necessary to get the benefit in PFS and OS. The costs of drugs are at the pharmacy of our hospital and are expressed in Euros (&OV0556;). We have subsequently applied the European Society for Medical Oncology Magnitude of Clinical Benefit Scale. RESULTS: Our study evaluated 3 phase 3 randomized controlled trials, including 2004 patients. The most relevant increase of costs was associated with the combination chemotherapy including trabectedin, with the highest costs for month of PFS gained (15,836 &OV0556;) and for month of OS gained (7198 &OV0556;), but it substantially differs considering the data of partially platinum-sensitive populations (platinum-free interval of 6-12 months), with 3959 &OV0556; for month of OS gained. CONCLUSIONS: The addition of trabectedin to pegylated liposomal doxorubicin for the treatment of recurrent ovarian cancer can lead to an increase of pharmacological costs. Differently, considering OS in patients with platinum-free interval of 6 to 12 months, there is a halving of pharmacological costs with the addition of trabectedin to pegylated liposomal doxorubicin. These costs are in line with the spending suggested as sustainable (thresholds of <$61,500 per life-year gained).

Vascular Toxicity Risk Assessment of MC18 and MC70, Novel Potential Diagnostic Tools for In Vivo PET Studies.

The P-glicoprotein (P-gp) inhibitor MC18 has been recently proposed as a valuable PET tracer to measure P-gp expression in vivo. The aim of this study was to evaluate the toxic hazard towards the vasculature of MC18 along with the structurally related and more potent P-gp inhibitor MC70. Their effects on A7r5 and EA.hy926 cells viability, on the mechanical activity of fresh and cultured rat aorta rings as well as on Cav 1.2 channel current (ICa1.2 ) of A7r5 cells were studied. At concentrations >10 µM, MC18 and MC70 decreased cell viability causing evident morphological changes. In fresh rat aorta rings, both compounds (0.1-100 µM) antagonized phenylephrine-induced contraction in a concentration-dependent manner, with IC50 values in the range of 1.67-14.49 µM, whereas only MC18 caused a concentration-dependent decrease of the 60 mM K+ (K60)-induced responses. In rings cultured for 7 days with both compounds (1-10 µM), 10 µM MC70 significantly reduced, while 10 µM MC18 completely prevented the contractile response to both phenylephrine and K60. MC18 and MC70 (0.1-100 µM) inhibited ICa1.2 in a concentration-dependent manner with IC50 values of 16.81 and 32.13 µM, respectively. These findings demonstrate that MC18-induced vascular effects took place at concentrations that are at least three orders of magnitude higher than those (≤10 nM) allowing in vivo measurement of P-gp expression. Thus, MC18, and possibly MC70, can be considered promising PET tools for in vivo P-gp quantification.

[ASSESSMENT OF EFFICIENCY OF TREATMENT OF OVERACTIVE BLADDER IN ELDERLY PATIENTS].

The effectiveness of overactive bladder treatment with M-cholinoblocker solifenacin (Vesicare) as monotherapy and in combination with α1-andrenoblocker terazosin (Setegis) or bladdrer training in elderly patients was evaluated. The results of 12 weeks treatment in all treatment modality groups were comparable. Use of solifenacin in combination with α1-andrenoblocker in comparison to solifenacin monotherapy resulted in longer symptoms remission.

A retrospective analysis of trabectedin infusion by peripherally inserted central venous catheters: a multicentric Italian experience.

The European Medicines Agency strongly recommends administration of trabectedin through a central venous catheter (CVC) to minimize the risk of extravasation. However, CVCs place patients at risk of catheter-related complications and have a significant budgetary impact for oncology departments. The most frequently used CVCs are subcutaneously implanted PORT-chamber catheters (PORTs); peripherally inserted central venous catheters (PICCs) are relatively new. We reviewed data of trabectedin-treated patients to evaluate the relative cost-effectiveness of the use of PORTs and PICCs in six Italian centres. Data on 102 trabectedin-treated patients (20 with sarcoma, 80 with ovarian cancer and two with cervical cancer) were evaluated. Forty-five patients received trabectedin by a PICC, inserted by trained nurses using an ultrasound-guided technique at the bedside, whereas 57 patients received trabectedin infusion by a PORT, requiring a day surgery procedure in the hospital by a surgeon. Device dislocation and infections were reported in four patients, equally distributed between PORT or PICC users. Thrombosis occurred in a single patient with a PORT. Complications requiring devices removal were not reported during any of the 509 cycles of therapy (median 5; range 1-20). PICC misplacement or early malfunctions were not reported during trabectedin infusion. The cost-efficiency ratio favours PORT over PICC only when the device is used for more than 1 year. Our data suggest that trabectedin infusion by PICC is safe and well accepted, with a preferable cost-efficiency ratio compared with PORT in patients requiring short-term use of the device (≤1 year).

Topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and gemcitabine for advanced recurrent or refractory ovarian cancer: a systematic review and economic evaluation.

BACKGROUND: Ovarian cancer is the fifth most common cancer in the UK, and the fourth most common cause of cancer death. Of those people successfully treated with first-line chemotherapy, 55-75% will relapse within 2 years. At this time, it is uncertain which chemotherapy regimen is more clinically effective and cost-effective for the treatment of recurrent, advanced ovarian cancer. OBJECTIVES: To determine the comparative clinical effectiveness and cost-effectiveness of topotecan (Hycamtin(®), GlaxoSmithKline), pegylated liposomal doxorubicin hydrochloride (PLDH; Caelyx(®), Schering-Plough), paclitaxel (Taxol(®), Bristol-Myers Squibb), trabectedin (Yondelis(®), PharmaMar) and gemcitabine (Gemzar(®), Eli Lilly and Company) for the treatment of advanced, recurrent ovarian cancer. DATA SOURCES: Electronic databases (MEDLINE(®), EMBASE, Cochrane Central Register of Controlled Trials, Health Technology Assessment database, NHS Economic Evaluations Database) and trial registries were searched, and company submissions were reviewed. Databases were searched from inception to May 2013. METHODS: A systematic review of the clinical and economic literature was carried out following standard methodological principles. Double-blind, randomised, placebo-controlled trials, evaluating topotecan, PLDH, paclitaxel, trabectedin and gemcitabine, and economic evaluations were included. A network meta-analysis (NMA) was carried out. A de novo economic model was developed. RESULTS: For most outcomes measuring clinical response, two networks were constructed: one evaluating platinum-based regimens and one evaluating non-platinum-based regimens. In people with platinum-sensitive disease, NMA found statistically significant benefits for PLDH plus platinum, and paclitaxel plus platinum for overall survival (OS) compared with platinum monotherapy. PLDH plus platinum significantly prolonged progression-free survival (PFS) compared with paclitaxel plus platinum. Of the non-platinum-based treatments, PLDH monotherapy and trabectedin plus PLDH were found to significantly increase OS, but not PFS, compared with topotecan monotherapy. In people with platinum-resistant/-refractory (PRR) disease, NMA found no statistically significant differences for any treatment compared with alternative regimens in OS and PFS. Economic modelling indicated that, for people with platinum-sensitive disease and receiving platinum-based therapy, the estimated probabilistic incremental cost-effectiveness ratio [ICER; incremental cost per additional quality-adjusted life-year (QALY)] for paclitaxel plus platinum compared with platinum was £24,539. Gemcitabine plus carboplatin was extendedly dominated, and PLDH plus platinum was strictly dominated. For people with platinum-sensitive disease and receiving non-platinum-based therapy, the probabilistic ICERs associated with PLDH compared with paclitaxel, and trabectedin plus PLDH compared with PLDH, were estimated to be £25,931 and £81,353, respectively. Topotecan was strictly dominated. For people with PRR disease, the probabilistic ICER associated with topotecan compared with PLDH was estimated to be £324,188. Paclitaxel was strictly dominated. LIMITATIONS: As platinum- and non-platinum-based treatments were evaluated separately, the comparative clinical effectiveness and cost-effectiveness of these regimens is uncertain in patients with platinum-sensitive disease. CONCLUSIONS: For platinum-sensitive disease, it was not possible to compare the clinical effectiveness and cost-effectiveness of platinum-based therapies with non-platinum-based therapies. For people with platinum-sensitive disease and treated with platinum-based therapies, paclitaxel plus platinum could be considered cost-effective compared with platinum at a threshold of £30,000 per additional QALY. For people with platinum-sensitive disease and treated with non-platinum-based therapies, it is unclear whether PLDH would be considered cost-effective compared with paclitaxel at a threshold of £30,000 per additional QALY; trabectedin plus PLDH is unlikely to be considered cost-effective compared with PLDH. For patients with PRR disease, it is unlikely that topotecan would be considered cost-effective compared with PLDH. Randomised controlled trials comparing platinum with non-platinum-based treatments might help to verify the comparative effectiveness of these regimens. STUDY REGISTRATION: This study is registered as PROSPERO CRD42013003555. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

[Pharmacoeconomic study of using solifenacin for the treatment of urge urinary incontinence in patients with overactive bladder syndrome].

Overactive bladder syndrome (OAB), accompanied by incontinence, is a relatively common disease. Currently, in the Russian Federation, unfortunately, management of patients with OAB includes the recommendations for symptomatic use of incontinence pads without pharmacotherapy. Along with this, the market is represented by a number of drugs that can reduce the occurrence of adverse symptoms associated with OAB syndrome. This study presents the pharmacoeconomic analysis of use of solifenacin for the treatment of patients with the OAB syndrome in Russia. Based on previous clinical studies, formal mathematical model for the development of OAB have been suggested, taking into account the concomitant symptoms (urinary incontinence), and complications (urinary tract infections, skin infections, depression and fractures). The model considers the direct medical and non-medical costs, as well as indirect social costs, arising from the traditional management of patients with OAB syndrome (no medication) and the use of solifenacin. As a result, it was found that the use of solifenacin is economically feasible option for the management of patients with OAB within 1 year, the difference in costs between these strategies per patient is 2,385 rubles. The use of solifenacin ceases to be a resource-saving if the cost of incontinence pads will reduced by more than half of the basic price included in the calculations, or if the effectiveness of solifenacin would be 15% lower than the value used in the basic model.

Acute oral intake of a higenamine-based dietary supplement increases circulating free fatty acids and energy expenditure in human subjects.

BACKGROUND: Higenamine, also known as norcoclaurine, is an herbal constituent thought to act as a beta-2 adrenergic receptor agonist-possibly stimulating lipolysis. It was the purpose of this study to determine the impact of a higenamine-based dietary supplement on plasma free fatty acids and energy expenditure following acute oral ingestion. METHODS: Sixteen healthy subjects (8 men; 26.1 ± 2.5 yrs; 8 women 22.4 ± 3.1 yrs) ingested a dietary supplement containing a combination of higenamine, caffeine (270 mg), and yohimbe bark extract or a placebo, on two separate occasions in a double-blind, randomized, cross-over design, separated by 6-8 days. Blood samples were collected immediately before ingestion, and at 30, 60, 120, and 180 minutes post ingestion, and analyzed for plasma free fatty acids (FFA) and glycerol. Breath samples were collected at the same times for a measure of kilocalorie expenditure and respiratory exchange ratio (RER) using indirect calorimetry. Heart rate and blood pressure were recorded at all times. Data collection occurred in the morning following a 10 hour overnight fast. RESULTS: A condition effect was noted for both FFA (p < 0.0001) and kilocalorie expenditure (p = 0.001), with values higher for supplement compared to placebo at 60, 120, and 180 minutes post ingestion. No statistically significant effects were noted for glycerol or RER (p > 0.05). A condition effect was noted for heart rate (p = 0.03) and systolic blood pressure (p < 0.0001), with values higher for supplement compared to placebo. CONCLUSION: Ingestion of a higenamine-based dietary supplement stimulates lipolysis and energy expenditure, as evidenced by a significant increase in circulating FFA and kilocalorie expenditure. The same supplement results in a moderate increase in heart rate (~3 bpm) and systolic blood pressure (~12 mmHg), which is consistent with previous studies evaluating moderate doses of caffeine and yohimbine, suggesting that higenamine contributes little to the increase in these hemodynamic variables. These findings are in reference to young, healthy and active men and women.

Cost-effectiveness analysis of solifenacin versus oxybutynin immediate-release in the treatment of patients with overactive bladder in the United Kingdom.

OBJECTIVE: To carry out a cost-utility analysis comparing initial treatment with solifenacin 5 mg/day vs oxybutynin immediate-release (IR) 15 mg/day for the treatment of patients with overactive bladder (OAB) from the perspective of the U.K. National Health Service (NHS). METHODS: A Markov model with six health states was developed to follow a cohort of OAB patients treated with either solifenacin or oxybutynin during a 1-year period. Costs and utilities were accumulated as patients transited through the health states in the model and a drop-out state. Some of the solifenacin patients were titrated from 5 mg to 10 mg/day at 8 weeks. A proportion of drop-out patients were assumed to continue treatment with tolterodine ER. Utility values were obtained from a Swedish study and pad use was based on a multinational clinical trial. Adherence rates for individual treatments were derived from a U.K. database study. For pad use and utility values, the drop-out state was split between those patients who were no longer receiving treatment and those on second-line therapy. Patients on second-line therapy who drop-out were referred for a specialist visit. Results were expressed in terms of incremental cost-utility ratios. RESULTS: Total annual costs for solifenacin and oxybutynin were £504.30 and £364.19, respectively. First-line drug use represents 49% and 4% of costs and pad use represent 23% and 40% of costs for solifenacin and oxybutynin, respectively. Differences between cumulative utilities were small but were greater for solifenacin (0.7020 vs. 0.6907). The baseline incremental cost-effectiveness ratio was £12,309/QALY. CONCLUSION: Under the baseline assumptions, solifenacin would appear to be cost-effective with an incremental cost-utility of less than £20,000/QALY. However, small differences in utility between the alternatives and the large number of drop-outs means that the results are sensitive to small adjustments in the values of utilities assigned to the drop-out state.

Cost-effectiveness of trabectedin plus pegylated liposomal doxorubicin for the treatment of women with relapsed platinum-sensitive ovarian cancer in the UK: analysis based on the final survival data of the OVA-301 trial.

OBJECTIVES: To estimate the cost-effectiveness of trabectedin plus pegylated liposomal doxorubicin (PLD) compared with PLD alone for the treatment of patients with relapsed platinum-sensitive ovarian cancer who are not expected to benefit from retreatment with platinum-based therapies based on the final survival data published in October 2012. METHODS: A decision-analytic model estimated the cost per quality-adjusted life-year (QALY) gained for trabectedin plus PLD compared with PLD alone from the UK National Health Service and Personal Social Services perspective over a lifetime horizon. Mean progression-free survival and overall survival were calculated by using parametric survival distributions adjusted for imbalances discovered in the final survival data. Between-arm imbalances included the platinum-free interval, cancer antigen 125 (CA-125), and Eastern Cooperative Oncology Group performance score. Cost categories included drug, administration, medical management, and treatment of adverse events. Quality of life was measured by using the EuroQol five-dimensional questionnaire. Uncertainty was addressed by deterministic and probabilistic sensitivity analysis. RESULTS: Over a lifetime horizon, trabectedin plus PLD increased mean progression-free survival by 3.0 months and overall survival by 9.7 months compared with PLD alone. The additional cost and QALYs of trabectedin plus PLD were £18,476 and 0.49, resulting in an incremental cost-effectiveness ratio of £38,026 per QALY. Sensitivity analyses showed that results were sensitive to platinum-free interval adjustment and the choice of survival distributions. CONCLUSIONS: The analysis estimated a significant improvement in mean overall survival and incremental cost per QALY compared with that calculated in the original National Institute for Health and Clinical Excellence assessment, which was based on immature survival data.

A simplified protocol employing elacridar in rodents: a screening model in drug discovery to assess P-gp mediated efflux at the blood brain barrier.

In the present study we have developed a simple, time, and cost effective in vivo rodent protocol to screen the susceptibility of a test compound for P-glycoprotein (P-gp) mediated efflux at the blood brain barrier (BBB) during early drug discovery. We used known P-gp substrates as test compounds (quinidine, digoxin, and talinolol) and elacridar (GF120918) as a chemical inhibitor to establish the model. The studies were carried out in both mice and rats. Elacridar was dosed intravenously at 5 mg/kg, 0.5 h prior to probe substrate administration. Plasma and brain samples were collected and analyzed using UPLC-MS/MS. In the presence of elacridar, the ratio of brain to plasma area under the curve (B/P) in mouse increased 2, 4, and 38-fold, respectively, for talinolol, digoxin, and quinidine; whereas in rat, a 70-fold increase was observed for quinidine. Atenolol, a non P-gp substrate, exhibited poor brain penetration in the presence or absence of elacridar in both species (B/P ratio ~ 0.1). Elacridar had no significant effect on the systemic clearance of digoxin or quinidine; however, a trend towards increasing volume of distribution and half life was observed. Our results support the utility of elacridar in evaluation of the influence of P-gp mediated efflux on drug distribution to the brain. Our protocol employing a single intravenous dose of elacridar and test compound provides a cost effective alternative to expensive P-gp knockout mice models during early drug discovery.

Canadian cost-effectiveness analysis of solifenacin compared to oxybutynin immediate-release in patients with overactive bladder.

OBJECTIVE: To estimate the cost effectiveness of solifenacin 5 mg/day compared to oxybutynin immediate-release (IR) 15 mg/day in patients with overactive bladder, from the perspective of the Canadian healthcare (payer) system. RESEARCH DESIGN AND METHODS: A Markov model was adapted to estimate the incremental cost per quality-adjusted life-year (QALY) of solifenacin and oxybutynin IR over a 1-year time horizon, based on efficacy and discontinuation data from the Canadian VECTOR (VEsicare in Comparison To Oxybutynin for oveRactive bladder patients) study. In the model, patients who discontinued treatment were offered tolterodine extended release 4 mg/day as second-line. Model robustness was tested using various sensitivity analyses. Utility values were derived from published literature; incontinence pads were included in a secondary analysis. RESULTS: In the base-case analysis, total costs over 1 year were CAN$695 and CAN$550 in the solifenacin and oxybutynin IR groups, respectively. When including incontinence pad costs, there was an incremental saving of CAN$1,831 per patient with solifenacin. Solifenacin was associated with an incremental QALY gain of 0.01 over 1 year. In the base-case analysis without incontinence pads, the incremental cost-utility ratio for solifenacin was CAN$14,092. Probabilistic analyses showed no overlap in the 95% confidence intervals for total costs or QALYs with or without incontinence pads. Solifenacin was cost effective in >90% of cases, based on a willingness-to-pay threshold of CAN$50,000 per additional QALY, irrespective of whether pad costs were included in the model. The most influential variables were the discontinuation rates and the cost of incontinence pads. Limitations of the analysis relate mainly to the fact that data in the VECTOR study were collected using a direct questioning approach, which might have increased the reporting of dry mouth. CONCLUSIONS: Solifenacin 5 mg/day was a cost-effective treatment compared with oxybutynin IR 15 mg/day. TRIAL REGISTRATION: NCT00431041 (of the VECTOR study, upon which the analysis in this paper was based).

Dose-response assessment of tariquidar and elacridar and regional quantification of P-glycoprotein inhibition at the rat blood-brain barrier using (R)-[(11)C]verapamil PET.

PURPOSE: Overactivity of the multidrug efflux transporter P-glycoprotein (P-gp) at the blood-brain barrier (BBB) is believed to play an important role in resistance to central nervous system drug treatment. (R)-[(11)C]verapamil (VPM) PET can be used to measure the function of P-gp at the BBB, but low brain uptake of VPM hampers the mapping of regional differences in cerebral P-gp function and expression. The aim of this study was to evaluate the dose-response relationship of two potent P-gp inhibitors and to investigate if increased brain uptake of VPM mediated by P-gp inhibition can be used to assess regional differences in P-gp activity. METHODS: Two groups of Sprague-Dawley rats (n = 12) underwent single VPM PET scans at 120 min after administration of different doses of the P-gp inhibitors tariquidar and elacridar. In an additional six rats, paired VPM PET scans were performed before and after administration of 3 mg/kg tariquidar. RESULTS: Inhibitor administration resulted in an up to 11-fold increase in VPM brain distribution volumes (DV) with half-maximum effective dose (ED(50)) values of 3.0 +/- 0.2 and 1.2 +/- 0.1 mg/kg for tariquidar and elacridar, respectively. In paired PET scans, 3 mg/kg tariquidar resulted in regionally different enhancement of brain activity distribution, with lowest DV in cerebellum and highest DV in thalamus. CONCLUSION: Our data show that tariquidar and elacridar are able to increase VPM brain distribution in rat brain up to 11-fold over baseline at maximum effective doses, with elacridar being about three times more potent than tariquidar. Regional differences in tariquidar-induced modulation of VPM brain uptake point to regional differences in cerebral P-gp function and expression in rat brain.

Cost-effectiveness analysis of solifenacin flexible dosing in patients with overactive bladder symptoms in four Nordic countries.

OBJECTIVE: The purpose of the present analysis was to analyze and compare the cost-effectiveness of solifenacin flexible dosing (5-10 mg) with tolterodine 4 mg sustained release (SR) or placebo (assumed to be comparable to no treatment) for patients with overactive bladder (OAB) symptoms. DESIGN: A decision-analytic model was constructed. METHODS: Costs and effects were evaluated for the three treatment options in a one-year timeframe. Costs included were treatment costs, cost of pad use, and patients productivity loss based on data from the Nordic countries. SAMPLE: Results from two randomized controlled trials were used as input data in the cost-effectiveness analysis. MAIN OUTCOME MEASURES: Quality adjusted life years and incremental cost-effectiveness ratio. RESULTS: Solifenacin flexible dosing was more effective with respect to reducing OAB symptoms compared to both placebo and tolterodine 4 mg. Treatment with both solifenacin and tolterodine was more costly compared to placebo, but treatment with solifenacin was a less costly alternative compared to tolterodine 4 mg SR. Sensitivity analyses revealed that the conclusions were robust. CONCLUSION: Solifenacin flexible dosing was a cost-effective treatment alternative compared to tolterodine 4 mg SR.

Impact of solifenacin on resource utilization, work productivity and health utility in overactive bladder patients switching from tolterodine ER.

OBJECTIVE: Assess changes in resource utilization, work and activity impairment, and health utility among OAB patients continuing to have urgency symptoms with tolterodine ER 4 mg and willing to try solifenacin 5/10 mg. RESEARCH DESIGN AND METHODS: This was an open-label, non-comparative, flexible-dosing, multicenter, 12-week study assessing the efficacy and safety of solifenacin 5/10 mg/day. Patients receiving tolterodine ER 4 mg/day for >/=4 weeks but continuing to experience residual urgency symptoms (>/=3 urgency episodes/24 h) were enrolled into the study. After a 14-day washout, patients began treatment with solifenacin 5 mg/day with dosing adjustments allowed at Weeks 4 and 8. MAIN OUTCOME MEASURES: Outcomes were assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP), Health Utilities Index (HUI), and a resource utilization questionnaire administered at Pre-Washout and Week 12. RESULTS: Patients (n=440) reported significantly fewer physician office visits (p<0.0001), UTIs (p<0.0001), and pads/diapers (p=0.0009) during the study period while receiving solifenacin 5/10 mg/day, compared with the Pre-Washout period when receiving tolterodine ER 4 mg/day. After 12 weeks of treatment with solifenacin 5/10 mg/day, patients reported a reduction in work time missed (p=0.0017), less impairment while working (p<0.0001), less overall work impairment (p<0.0001) and a reduction in activity impairment (p<0.0001) compared to Pre-Washout. There was no significant difference in health utility scores. Treatment-emergent adverse events were mostly anticholinergic in nature, and were mild to moderate in severity. CONCLUSION: Overall, solifenacin 5/10 mg/day improved work productivity, activity participation, and reduced medical care use in OAB patients who continued to have urgency symptoms with tolterodine ER 4 mg/day and wished to switch to solifenacin 5/10 mg. This was an open-label, non-comparative study; therefore, further research is needed to confirm these results.

[Assessment of symptoms severity in patients with overactive bladder].

Symptoms severity was assessed in 533 patients with urinary bladder overactivity (mean age 56.4 +/- 0.6 years). All the patients kept urination diary for 3 days, some patients filled in KHQ questionnaire to find out quality of life, were examined urodynamically. Overactive bladder (OAB) symptoms were studied in 52 patients before and after 12 weeks of solifenacin treatment in a dose 5 mg/day. The statistical analysis identified three degrees of OAB symptoms. The severity was calculated according to the formula in points (S): S = 2 x number of urinations for 3 days + number of urges for 3 days + 1*(*--in the presence of urgent urine incontinence). In 62 points and less the diagnosis was "mild severity" of the symptoms (degree 1), in 63-80 points--"moderate severity" (degree 2), in 80 points and more--"great severity" (degree 3). Of 533 patients, 119 (22.3%) had symptoms of degree 1, 148 (27.8%)--of degree 2, 266 (49.9%)--of degree 3. The patients with more severe disease had more distinct changes in urodynamic indices and worse quality of life. Solifenacin treatment reduced severity of the symptoms in most patients treated. Before solifenacin administration degrees 1, 2 and 3 of the symptoms severity were detected in 12 (23.1%), 13 (25.0%) and 27 (51.9%) patients, respectively. After treatment--in 26 (50.0%), 16 (30.8%) and 6 (11.5%) patients, respectively. OAB symptoms were absent in 4 (7.7%) patients. Thus, it is shown that the proposed system of the system assessment reflects severity of OAB clinical symptoms, the degree of urodynamic disorders and deterioration of quality of life. This classification system can be used for follow-up assessment of OAB symptoms in the treatment process. It is simple and perspective for wide application.