Sergey Loparev

Effectiveness of combined high–dosed trospium and solifenacin depending on severity of OAB symptoms in elderly men and women under cyclic therapy

Material and methods 313 patients, 196 women and 117 men over 65 (average age 68.6) were included in this study. All patients underwent urodynamic examination before enrollment and after the study was completed. For clinical evaluation of LUT state ICIQ-SF questionnaires and bladder diaries were used. Patients with moderate (А, n = 155) and severe (В, n = 158) symptoms of OAB. Each group was divided into subgroups in which patients received Trospium 60 mg/day and Solifenacin 20 mg/day during two cycles – 1.5 and 1 month with one month interval (А1 and В1); subgroups in which second cycle was substituted with placebo (А2, В2), and control groups (А3, В3). Results In groups with moderate symptoms of OAB ratio of patients demonstrated decrease of frequency of EI ≥1.5 a day remained at the level of 45-60% during all observation period. In subgroups with severe symptoms of OAB percentage of such patients was 55.3% for the subgroup which received two cycle therapy, and decreased to 26% in the subgroup which underwent 1 cycle therapy. Urodynamic indices for state of LUT correlated with clinical indicators (r =0.57-0.71 at p≤ 0.05). Conclusions Short single cycle of high-dosed Solifenacin and Trospium in elderly patients with moderate symptoms of OAB enables to maintain long therapeutic effect with acceptable level of side effects. This treatment algorithm applied in two cycle course is an effective and safe method for management of severe symptoms of OAB in elderly patients without increased risk of side effects.

Additional correction of OAB symptoms by two anti-muscarinics for men over 50 years old with residual symptoms of moderate prostatic obstruction after treatment with Tamsulosin.

Abstract Objectives: To study the effectiveness and safety of combined standard-dosed Solifenacin and Trospium for management of symptoms of overactive bladder (OAB) in elderly patients after the treatment with Tamsulosin. Patients and methods: A total of 417 men over 50 years of age (average age 57.9 (8.3)) with diagnosed prostatic obstruction (score 8–19 according to I-PSS), who had not taken Tamsulosin before, were enrolled in the study. I-PSS questionnaire (from 8 to 19 – moderate) and Awareness Tool questionnaire for evaluating OAB symptoms (total score for OAB symptoms over 8) were used at the beginning and at the end of the observation. Also, urodynamic parameters were examined. Result: Percentage of patients with prevalent symptoms of obstruction of urethra decreases after the treatment with Tamsulosin and then rises again (36.2%), but absolute number of patients remains smaller than initial data. Percentage of patients with relative prevalence of symptoms of overactive bladder slightly increases against administration of Tamsulosin and reaches initial values at the time of administration of anti-muscarinic drugs with absolute decrease in number of such patients. Conclusion: Combination of Trospium and Solifenacin is an effective way to manage residual symptoms of hyperactive bladder during treatment of early obstruction of urinary bladder.

Comparative effectiveness of combined low- and standard-dose trospium and solifenacin for moderate overactive bladder symptoms in elderly men and women.

Objective: To increase the safety and effectiveness of treatments for overactive bladder (OAB) with moderate symptoms in elderly patients. Patients and Methods: Patients were examined at the Urodynamic Department of the Regional Diagnostic Center (Vladivostok, Russian Federation) from September 1, 2012 to December 31, 2012. The assignment of patients [n = 177, average age 69. 4 years, 98 women (55.4%) and 79 men (44.6%)] was random and blind in this placebo-controlled study. Patients were distributed into subgroups according to the method of treatment as follows: group А1: n = 57, trospium 30 mg/day + solifenacin 10 mg/day; group А2: n = 61, trospium 15 mg/day + solifenacin 5 mg/day; group А3: n = 59, placebo. All patients underwent a urodynamic examination in accordance with international standards before and 2 months after treatment. ICIQ-SF questionnaires recommended by the International Continence Society (ICS) and bladder diaries were used to evaluate the clinical results. The clinical severity of the OAB symptoms and the effectiveness of the treatment were evaluated based on the frequency of episodes of incontinence (EI) per day. Three or fewer EI per day were considered moderate dysfunction of the lower urinary tract. Results: Groups of elderly patients with moderate symptoms of OAB who were treated with standard- and low-dose trospium and solifenacin demonstrated a significant increase in the median values of reflex volume, bladder capacity, and detrusor compliance and a decrease in the frequency of urination and urinary urgencies. The frequency of EI in both of the main groups decreased by almost 2-fold in comparison to the initial data and reached the following values: group А1: 1.27 (-1.08), p ≤ 0.05; group A2: 1.49 (-1.18), p ≤ 0.05. The correlation with the decrease in the frequency of EI in these groups was r = 0.85 (p ≤ 0.01). The percentage of patients with a significant decrease (EI ≥1.0) among those treated with standard- and low-dose trospium and solifenacin increased synchronously, prompting us to suppose the absence of a direct correlation between medicine dose and therapeutic effect for moderate OAB symptoms. Conclusion: The combination of low-dose trospium and solifenacin provides good clinical and urodynamic effects in elderly patients with moderate symptoms of OAB. Combination of these drugs in standard doses for such patients is excessive.

Cognitive functions and health-related quality of life in men with benign prostatic hyperplasia and symptoms of overactive bladder when treated with a combination of tamsulosin and solifenacin in a higher dosage

Abstract Aim: To study the cognitive functions and health-related quality of life (HRQoL) in individuals taking a combination of tamsulosin and solifenacin in a higher dosage. Methods: All patients (n = 262) were assigned to group A (N = 93, tamsulosin 0.4 mg + solifenacin 10 mg per day), group B (N = 83, tamsulosin 0.4 mg + solifenacin 20 mg), and control group C (N = 86; tamsulosin 0.4 mg + placebo). The lower urinary tract (LUT) condition was assessed on the scales International Prostate Symptom Score, Over Active Bladder Awareness Tool and uroflowmetry. The state of cognitive status was assessed on the scales Mini-mental State Examination, Controlled Oral Word Association Test, Wechsler Adult Intelligence Scale-Revised, Wechsler III, Color Trails Test, California Verbal Learning Test. Results: The values of cognitive function indicators in the individuals from all groups after treatment did not significantly differ from the respective values at the baseline (p > .05). The values of most HRQoL parameters of the functional state of the LUT significantly improved in groups A and B. A significant correlation between the state of cognitive status and HRQoL, as well as LUT was absent (r <0.3). Conclusion: The combination of solifenacin in a double dosage along with tamsulosin can be recommended for elderly benign prostatic hyperplasia patients with overactive bladder symptoms.

The effective tool for self-assessment of adherence to treatment in patients with benign prostatic obstruction and overactive bladder symptoms

Abstract Purpose: Study of validity of the Medication Adherence Self-Report Inventory (MASRI) for use in clinical practice to treat patients with benign prostatic obstruction (BPO) accompanied with overactive bladder (OAB) symptoms. Methods: During 12 weeks of the randomized study, 452 patients with BPO and OAB symptoms (mean age of 61.3 (12.7)) were studied for adherence to the treatment with Tamsulosin, Solifenacin and Trospium using the MASRI. External monitoring instruments included the Brief Medication Questionnaire (BMQ) and the visual remaining pill count. The state of the prostate gland and the lower urinary tract was monitored using questionnaires I-PSS, OAB Awareness Tool, uroflowmetry and voiding diaries. Result: Correlation between the percentage of men non-adherent to treatment (MASRI) and the percentage of patients having a belief barrier on the screen of the BMQ was r = 0.89, p ≤0.05, r = 0.92, p ≤0.01, r = 0.85, p ≤0.05, a number of missed doses on the Regimen Screen of the BMQ was r = 0.79; p ≤0.05; r = 0.81; p ≤0.05; r = 0.75, p ≤0.05, a number of non-adherent patients according to the BMQ was r = 0.83 (p ≤0.05), r = 0.88 (p ≤0.05), r = 0.79, p ≤0.05, the results of the pill count were r = 0.65–0.76; p ≤0.05-0.01. These data confirm high validity of the MASRI. Conclusion: The MASRI is a valid tool for rapid assessment of adherence to treatment of patients with BPO and OAB receiving Tamsulosin and antimuscarinic drugs and may be recommended for use in clinical practice.

Treatment compliance of working persons to high-dose antimuscarinic therapies: a randomized trial

Aim: The aim of this work was to study the factors affecting the stability of working patients in antimuscarinic (AM) drug treatment. Background: The prevalence of urge urinary incontinence (UUI) is an average of between 8.2% and 16.0% of the population. UUI is a condition that adversely affects the health-related quality of life. The first-line therapy in managing UUI is AM treatment. Methods: In 1006 patients between 18 and 60 years old (627 women, 379 men, mean age 69.4) who received AM treatment for one year, the possible demographic, socioeconomic and health factors influencing compliance were studied. Also, the functional state of the lower urinary tract (LUT) was studied in this randomized, prospective survey. The study instruments were the documents of employers, tax offices, outpatient records, OABq-SF (overactive bladder - short form) questionnaires, MOS SF-36 (Medical Outcomes Study short form-36), voiding charts, and uroflowmetry data. Results: The compliance to AM treatment within 6 months was retained in 49.5% patients; during the year, in 32.3% of patients. The average time for reaching the 30-day break in taking trospium was 194 days. In the course of the experiment it was revealed that compliance to AM treatment was significantly higher in patients taking solifenacin and trospium in high dosages (p ⩽ 0.01, p ⩽ 0.05), suffering from severe symptoms of urgency (p ⩽ 0.01), and having a low level of side effects (p ⩽ 0.01). A satisfactory level of compliance is characteristic of patients with a high level of monthly and annual income (p ⩽ 0.01, p ⩽ 0.01), a low percentage of expenses to AM (p ⩽ 0.05), and rarely changing employers (p ⩽ 0.05). In addition, the compliance to treatment is higher in older adults (p ⩽ 0.05), living in the urban district (p ⩽ 0.01), and working in educational (p ⩽ 0.05) and health (p ⩽ 0.01) institutions, having a high level of the indices of Social Functioning (p ⩽ 0.05), Role-Emotional (p ⩽ 0.05), and Mental Health (p ⩽ 0.01). Conclusion: As a result of this study, under the control of the objective functional state of LUT, the influence of various factors on the patients’ stability in the treatment with AM drugs was revealed.

Comparison of objective and subjective factors in the adherence to antimuscarinics when treating overactive bladder in employed persons

Background: This study examines subjective reasons for the refusal of treatment and the state of objective status markers of various factors influencing the resistance of patients when treating overactive bladder by antimuscarinic drugs (AMs). Methods: The socioeconomic and medical parameters were studied in 2465 patients aged 18–60 years (1446 women (58.7%), 1019 men (41.3%); mean age was 52.1) taking AMs during the year. The study control was carried out by studying passport data, employers’ income certificates, patients’ ambulatory medical records, the use of OABq-SF and MOS SF-36 questionnaires, voiding diaries and uroflowmetry. Results: The average time to reach the 30-day break in the AM administration was 177 days. During the 12-month follow up, 74.7% of patients discontinued their participation. In total, 35.9% of patients stated medical reasons for the refusal of AM treatment; in 31.9% of individuals in the group the deviation of objective health status markers from average sample values was established. Economic reasons for the refusal were given by 20.4% of patients; in 18.5% of individuals economic status markers were different from average sample values. In 24.1% of cases of refusal of treatment, patients indicated social and psychological reasons; objective social and psychological status markers were altered in 35.9%. Conclusions: The percentage of patients indicating economic and medical reasons for the refusal of AM treatment is statistically uniform with respect to the percentage of patients with objective disturbances of health and economic statuses. The percentage of patients indicating social and psychological factors as a reason for the refusal of treatment was significantly lower than the percentage of patients with altered social and psychological status markers. These results can be used in practical healthcare when predicting adherence to AM use.

Self-assessment of treatment compliance with antimuscarinic drugs and lower urinary tract condition among women with urinary incontinence

AimOur aim was to determine the efficiency of the Medication Compliance Self-Report Inventory (MASRI) in self-reporting antimuscarinic drug treatment compliance among women with urinary incontinence (UI).Materials and methodsThe study assessed 347 women aged 18–65 (averaging 49.7) years with more than one urinary incontinence (UI) episode per day. Treatment compliance was tested at the beginning and at weeks 4, 8, and 12 using the MASRI, the Brief Medication Questionnaire (BMQ), and visual pill counts. The MASRI’s constructive, concurrent, and discriminate validity was studied in comparison with an external standard that uses the chi-square and Spearman coefficient. Receiver operating characteristic (ROC) analysis was performed to identify optimum MASRI cutoffs that would predict noncompliance. Furthermore, the functional condition of the lower urinary tract was tested using voiding diaries, uroflowmetry, and cystometry.ResultThe correlation between the percentage of noncompliant women according to the MASRI, and individuals with a belief barrier with respect to the BMQ screen was r = 0.81 (p ≤0.05), r = 0.84 (p ≤0.05), and r = 0.79 (p ≤0.05). The correlation between the percentage of noncompliant women according to the MASRI and of women who missed >20% of their doses according to the Regimen Screen of the BMQ was r = 0.79, p ≤0.05, r = 0.82, p ≤0.01, r = 0.77, and p ≤0.05 at the control points. Finally, the percentage of noncompliant patients who self-reported correctly according to the MASRI data compared with the BMQ was 95.6%, 95.7%, and 96.6% at the control points.ConclusionThe MASRI entails acceptable validity for accurately predicting treatment compliance with antimuscarinic drugs among women who have had UI for >3 months.

Comprehensive Assessment of Compliance with Antimuscarinic Drug Treatment in the Case of Urge Urinary Incontinence of Older Patients

AIM To investigate the heterogeneous factors affecting the stability of patients older than 60 years in the UI treatment with Antimuscarinics. BACKGROUND The prevalence of Urge Incontinence (UI) in older persons reaches 29.3%. The symptoms of urinary incontinence in older people reduce the health related life quality. MATERIALS AND METHODS In 1257 patients over 60 years (857 (68.2%) women - average age 67.8, 400 (31.8%) men - 71.4), who received AM for one year, demographic, socio-economic and health parameters were studied. OABq-SF questionnaires, MOS SF-36, urination diaries, uroflowmetry, income information from the tax offices and outpatient records were used. RESULT The compliance to AM treatment within 6 months was retained in 44.2%, and within the year - 26.8% of older patients. At least 40% of the total number of patients refused to continue the treatment for medical reasons. The persons taking Solifenacin (p≤ 0.01), Trospium (p≤ 0.05), or Darifenacin (p≤ 0.05), suffering from severe UI symptoms (p≤ 0.01), and experiencing minor side effects (p≤ 0.01), well-informed about UI treatment methods (p≤ 0.01) prevailed among the treatment compliant patients. At least 20.4% of the patients discontinued their treatment due to economic reasons. The persons with significantly larger annual income (p≤ 0.05) and annual medical cost (p≤ 0.01) prevailed among the treatment compliant patients. About 12.2% of the patients stopped their treatment for reasons related to the social background and psychological status. CONCLUSION In this experiment, we found that AM treatment compliance in older patients, in addition to medical parameters and health conditions, is largely affected by the economic as well as social, demographic and psychological factors. The study results can be claimed by practitioners involved in correcting UI symptoms in older people.

Influence of different doses of trospium and solifenacin on manageability of OAB symptoms with different severity in elderly men and women

Objective: We studied the rationale for using standard and increased dosages of solifenacin and trospium against overactive bladder (OAB) symptoms of different severity among elderly patients. Methods: A total of 327 patients took part in the study: 199 women and 128 men older than 65 years (median age 69.1). The state of the lower urinary tracts was estimated by cystometry, ICIQ-SF and bladder diaries. Frequency of urgency urinary incontinence (UUI) was taken as a criterion of OAB symptom severity. Result: Administration of double-dosed trospium and solifenacin leads to decrease of frequency of UUI both in the group with severe symptoms (B1: 6.1 (0.5) →2.4 (0.9), p ⩽ 0.05), and in the group with moderate symptoms of OAB (A1: 2.8 (0.8) →0.5 (0.4), p ⩽ 0.001). Under a combination of trospium and solifenacin in doses recommended by manufacturers, UUI decreased authentically in the group with moderate symptoms (A2: 2.9 (0.5) →0.9 (0.5), p ⩽ 0.05) and unauthentically in the group with severe symptoms of detrusor dysfunction (B2: 7.0 (1.2) → 4.3 (1.5), p ⩾ 0.05). During the experiment six patients (1.8%) elected not to participate because of intolerable adverse events. Forty-seven more individuals (14.4%) felt adverse effects, among which the most frequent were: xerostomia (15 patients or 4.6%), faintness (nine patients or 3.8%), dryness of integuments (six patients or 1.8%). Conclusion: A standard-dose combination of solifenacin and trospium in older patients with moderate symptoms of OAB enables a good therapeutic effect in a short time without increasing risk of side effects. High therapeutic doses of antimuscarinic drugs are reasonable for older men and women with severe symptoms of OAB. Increasing the dose of simultaneous use of solifenacin and trospium yields a good therapeutic effect to correct UUI; however, it raises the hazard of appearance of adverse effects. The number of side effects in the group of elderly individuals who were taking the combination of increased and standard dosages of solifenacin and trospium does not significantly differ.