Objective To evaluate the efficacy and safety of simultaneous administration of dutasteride,tadalafil and solifenacin in the treatment of benign prostatic hyperplasia(BPH)with overactive bladder symptoms and lower uri...Objective To evaluate the efficacy and safety of simultaneous administration of dutasteride,tadalafil and solifenacin in the treatment of benign prostatic hyperplasia(BPH)with overactive bladder symptoms and lower urinary tract obstruction in previously unsuccessfully treated men.Methods Patients in Group A(n=97)received dutasteride 0.5 mg/day,tadalafil 2.5 mg/day,and solifenacin 2.5 mg/day;Group B(n=95)received dutasteride 0.5 mg/day,tadalafil 5 mg/day,and solifenacin 5 mg/day;Group C(n=103)received dutasteride 0.5 mg/day,tadalafil 20 mg/day,and solifenacin 10 mg/day.The functional status of the lower urinary tract was assessed using the International Prostate Symptom Score(I-PSS),Overactive Bladder Questionnaire(OABq),International Index of Erectile Function(IIEF),and Male Sexual Health Questionnaire Ejaculatory Dysfunction(MSHQ-EjD)as well as uroflowmetry.Results The total score of the sexual function remained unchanged in Group B of patients 81.3 points vs.80.2 points(p>0.05)according to MSHQ-EjD,61.4 points vs.51.2 points(p>0.05)according to IIEF data.The total assessment of symptoms of hyperactivity significantly decreased in Group C according to OABq data after the 4th week of the study(17.5 points vs.26.1 points,p<0.05)and remained below the baseline until the end of the study(15.2 points).Conclusions The simultaneous administration of standard doses of dutasteride,solifenacin,and tadalafil for 3 months is safe,effective,and can be recommended for patients with BPH to reduce symptoms of obstruction and hyperactivity of the bladder and maintain sexual function.展开更多
We performed a meta-analysis to compare treatment with a combination of solifenacin plus tamsulosin oral controlled absorption system （TOCAS） with placebo or TOCAS monotherapy. The aim of the meta-analysis was to cl...We performed a meta-analysis to compare treatment with a combination of solifenacin plus tamsulosin oral controlled absorption system （TOCAS） with placebo or TOCAS monotherapy. The aim of the meta-analysis was to clarify the efficacy and safety of the combination treatments method for lower urinary tract symptoms （LUTS）. We searched for trials of men with LUTS that were randomized to combination treatment compared with TOCAS monotherapy or placebo. We pooled data from three placebo-controlled trials meeting inclusion criteria. Primary outcomes of interest included changes in International Prostate Symptom Score （IPSS） and urinary frequency. We also assessed postvoid residual, maximum urinary flow rate, incidence of urinary retention （UR）, adverse events. Data were pooled using random or fixed effect models for continuous outcomes and the ManteI-Haenszel method to generate risk ratio. Reductions in IPSS storage subscore and total urgency and frequency score （TUFS） were observed with solifenacin 6 mg plus TOCAS compared with placebo （P 〈 0.0001 and P 〈 0.0001, respectively）. Reductions in IPSS storage subscore and TUFS were observed with solifenacin 9 mg plus TOCAS compared with placebo （P= 0.003 and P = 0.0006, respectively）. Reductions in TUFS was observed with solifenacin 6 mg plus TOCAS compared with TOCAS （P = 0.01）. Both combination treatments were well tolerated, with low incidence of UR. Solifenacin 6 mg plus TOCAS significantly improved total IPSS, storage and voiding symptoms compared with placebo. Solifenacin 6 mg plus TOCAS also improved storage symptoms compared with TOCAS alone. There was no additional benefit of solifenacin 9 mg compared with 6 mg when used in combination with TOCAS.展开更多
A novel stability-indicating RP-HPLC method was developed and validated for simultaneous determination of Solifenacin Succinate & Tamsulosin Hydrochloride and its impurities in tablet dosage form. The method was d...A novel stability-indicating RP-HPLC method was developed and validated for simultaneous determination of Solifenacin Succinate & Tamsulosin Hydrochloride and its impurities in tablet dosage form. The method was developed using L1 column with gradient using the mobile phase consist of solvent-A (pH = 6.6, phosphate buffer + 0.5% Triethylamine) and solvent-B (90% Acetonitrile). The eluted compounds were monitored at 225 nm. Solifenacin Succinate & Tamsulosin Hydrochloride was subjected to oxidative, acid, base, hydrolytic, thermal and photolytic stress conditions. The developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of detection, limit of quantitation, accuracy, precision and robustness. The limit of quantification results was ranged from 0.135 - 0.221 μg/mL for Solifenacin Succinate impurities and 0.043 - 0.090 μg/mL for Tamsulosin Hydrochloride impurities. This method is suitable for the estimation of impurities and assay of Solifenacin Succinate & Tamsulosin Hydrochloride in tablets dosage form.展开更多
Objective: To evaluate and compare the safety and efficacy of Solifenacin, Tamsulosin, and Tadalafil in treating ureteral stent related symptoms (SRS) in patients with indwelling Double-J ureteral stents. Materials an...Objective: To evaluate and compare the safety and efficacy of Solifenacin, Tamsulosin, and Tadalafil in treating ureteral stent related symptoms (SRS) in patients with indwelling Double-J ureteral stents. Materials and Methods: A prospective randomized controlled study was conducted on 146 consecutive patients in the department of urology, Government Stanley Medical College & Hospital, Chennai, Tamilnadu, India between Sept 2017-March 2019, with SRS after taking informed consent and confirming DJ Stent position by X-ray KUB post-operatively. Patients were randomized into 4 groups: Group A (Placebo), Group B (Solifenacin 5 mg), and Group B (Tamsulosin 0.4 mg) and group D (Tadalafil 5 mg) at end of 1st week till the removal of DJ stent at end of 3 weeks. All patients were assessed for bothersome lower urinary tract symptoms (LUTS) using the validated Ureteral Stent Symptom Questionnaire (USSQ) at 1st week and 3 weeks after the starting of medications. Appropriate statistical analysis as carried out and the level of significance was set at P Results: LUTS, general health, and work performance improved with Solifenacin, Tamsulosin and Tadalafil and all the three were comparable in relieving urinary symptoms. Tadalafil was better at relieving body pain, additional problems and sexual problems better than Tamsulosin. Tadalafil showed comparable improvement in LUTS, better sexual health and decreased body pain compared to solifenacin, whereas the latter had better general health, additional problems & work performance scores. Conclusion: Solifenacin is more effective than Tamsulosin in alleviating LUTS associated with SRS and both show a distinctive advantage over placebo. PDE inhibitor Tadalafil can also be tried for SRS and is as effective as antimuscarinics and α-blockers in relieving urinary symptoms and is more efficacious in relieving sexual symptoms and body pain.展开更多
Aim: To explore in daily clinical practice the evolution in time of the fesoterodine and solifenacin dose pattern and assess the therapeutic benefit provided by the highest dose of these anti-muscarinics. Patients and...Aim: To explore in daily clinical practice the evolution in time of the fesoterodine and solifenacin dose pattern and assess the therapeutic benefit provided by the highest dose of these anti-muscarinics. Patients and Methods: This was a post-hoc analysis of data from an observational, cross-sectional, retrospective and multicenter study. Adult patients diagnosed with over active bladder (OAB) who initiated fesoterodine or solifenacin treatment were included. Data on the prescribed treatment and dose, change of dose, reasons for switching and treatment benefit were recorded. Results: A total of 828 subjects were analyzed (262 receiving solifenacin and 566 fesoterodine). Most subjects were women with a mean time since diagnosis of more than one year and aged around 60 years old. The majority of patients initiated the OAB treatment with the lowest available dose (64% fesoterodine vs. 77% solifenacin). At the follow-up visit 54% of the fesoterodine group and 66% of the solifenacin opted for dose escalation. At the study visit, 70.1% fesoterodine vs. 43.3% solifenacin remained on the highest dose. A significantly greater proportion of subjects receiving fesoterodine 8 mg, reported higher improvement in terms of both patient-reported-treatment benefit and clinical global impression compared with solifenacin 10 mg (p < 0.05). Conclusion: In routine clinical practice more than half of the patients opted for the higher dose and remained on it over time, suggesting a desire for greater efficacy. Fesoterodine 8 mg seems to provide greater benefits from the physician’s and the patient’s point of view compared with those provided by solifenacin 10 mg.展开更多
Objective: Detrusor hyperactivity with impaired contractility (DHIC) is not an uncommon bladder disorder, and is often difficult to treat. Therefore, using a rat model featuring both urinary frequency and residual uri...Objective: Detrusor hyperactivity with impaired contractility (DHIC) is not an uncommon bladder disorder, and is often difficult to treat. Therefore, using a rat model featuring both urinary frequency and residual urine, we investigated whether an anticholinergic agent (solifenacin) or a β3-agonist (mirabegron) is more suitable to combine with distigmine to treat DHIC. Methods: The partial bladder outlet obstruction (BOO) rat model was used. Rats were treated for 2 weeks: BOO/Solifenacin group was treated with 0.1 mg/kg solifenacin (n = 8), BOO/Mirabegron group was treated with 1 mg/kg mirabegron (n = 8), BOO/- group was not drug-treated but was given distilled water (n = 8), and the control group was also given distilled water (n = 8). Then the urethral ligature was removed under urethane anesthesia, and continuous cystometry was performed to evaluate bladder function. Baseline measurements were taken, then distigmine was administered to all groups, and cystometry was performed again to measure changes in bladder function. Results: Residual volumes increased in the BOO/- group, and the detrusor contractions were more frequent than that of the control group. Solifenacin treatment did not influence changes, except for threshold pressure, to any cystometric measurements. However, mirabegron treatment decreased the residual volume and residual volume rate;it also decreased detrusor contraction frequency similar to measurements obtained from the control group. Distigmine treatment enhanced detrusor contractions, which resulted in less residual volume, and decreased detrusor contraction frequency in the BOO model. Conclusions: The combination of distigmine and mirabegron was determined to be a better treatment than the combination of distigmine and solifenacin for DHIC.展开更多
Objective To evaluate the efficacy and safety of combination therapy of tamsulosin and solifenacin for benign prostatic hyperplasia ( BPH) with overactive bladder ( OAB) . Methods 82 patients with OAB and coexisting B...Objective To evaluate the efficacy and safety of combination therapy of tamsulosin and solifenacin for benign prostatic hyperplasia ( BPH) with overactive bladder ( OAB) . Methods 82 patients with OAB and coexisting BPH were randomly divided into tamsulosin group ( n展开更多
Objective To evaluate the efficacy of sollfenacin with or without tamsulosin in patients with overactive bladder ( OAB ) . Methods Fifty-three patients with OAB were randomly divided into two groups ( group
文摘Objective To evaluate the efficacy and safety of simultaneous administration of dutasteride,tadalafil and solifenacin in the treatment of benign prostatic hyperplasia(BPH)with overactive bladder symptoms and lower urinary tract obstruction in previously unsuccessfully treated men.Methods Patients in Group A(n=97)received dutasteride 0.5 mg/day,tadalafil 2.5 mg/day,and solifenacin 2.5 mg/day;Group B(n=95)received dutasteride 0.5 mg/day,tadalafil 5 mg/day,and solifenacin 5 mg/day;Group C(n=103)received dutasteride 0.5 mg/day,tadalafil 20 mg/day,and solifenacin 10 mg/day.The functional status of the lower urinary tract was assessed using the International Prostate Symptom Score(I-PSS),Overactive Bladder Questionnaire(OABq),International Index of Erectile Function(IIEF),and Male Sexual Health Questionnaire Ejaculatory Dysfunction(MSHQ-EjD)as well as uroflowmetry.Results The total score of the sexual function remained unchanged in Group B of patients 81.3 points vs.80.2 points(p>0.05)according to MSHQ-EjD,61.4 points vs.51.2 points(p>0.05)according to IIEF data.The total assessment of symptoms of hyperactivity significantly decreased in Group C according to OABq data after the 4th week of the study(17.5 points vs.26.1 points,p<0.05)and remained below the baseline until the end of the study(15.2 points).Conclusions The simultaneous administration of standard doses of dutasteride,solifenacin,and tadalafil for 3 months is safe,effective,and can be recommended for patients with BPH to reduce symptoms of obstruction and hyperactivity of the bladder and maintain sexual function.
文摘We performed a meta-analysis to compare treatment with a combination of solifenacin plus tamsulosin oral controlled absorption system （TOCAS） with placebo or TOCAS monotherapy. The aim of the meta-analysis was to clarify the efficacy and safety of the combination treatments method for lower urinary tract symptoms （LUTS）. We searched for trials of men with LUTS that were randomized to combination treatment compared with TOCAS monotherapy or placebo. We pooled data from three placebo-controlled trials meeting inclusion criteria. Primary outcomes of interest included changes in International Prostate Symptom Score （IPSS） and urinary frequency. We also assessed postvoid residual, maximum urinary flow rate, incidence of urinary retention （UR）, adverse events. Data were pooled using random or fixed effect models for continuous outcomes and the ManteI-Haenszel method to generate risk ratio. Reductions in IPSS storage subscore and total urgency and frequency score （TUFS） were observed with solifenacin 6 mg plus TOCAS compared with placebo （P 〈 0.0001 and P 〈 0.0001, respectively）. Reductions in IPSS storage subscore and TUFS were observed with solifenacin 9 mg plus TOCAS compared with placebo （P= 0.003 and P = 0.0006, respectively）. Reductions in TUFS was observed with solifenacin 6 mg plus TOCAS compared with TOCAS （P = 0.01）. Both combination treatments were well tolerated, with low incidence of UR. Solifenacin 6 mg plus TOCAS significantly improved total IPSS, storage and voiding symptoms compared with placebo. Solifenacin 6 mg plus TOCAS also improved storage symptoms compared with TOCAS alone. There was no additional benefit of solifenacin 9 mg compared with 6 mg when used in combination with TOCAS.
文摘A novel stability-indicating RP-HPLC method was developed and validated for simultaneous determination of Solifenacin Succinate & Tamsulosin Hydrochloride and its impurities in tablet dosage form. The method was developed using L1 column with gradient using the mobile phase consist of solvent-A (pH = 6.6, phosphate buffer + 0.5% Triethylamine) and solvent-B (90% Acetonitrile). The eluted compounds were monitored at 225 nm. Solifenacin Succinate & Tamsulosin Hydrochloride was subjected to oxidative, acid, base, hydrolytic, thermal and photolytic stress conditions. The developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of detection, limit of quantitation, accuracy, precision and robustness. The limit of quantification results was ranged from 0.135 - 0.221 μg/mL for Solifenacin Succinate impurities and 0.043 - 0.090 μg/mL for Tamsulosin Hydrochloride impurities. This method is suitable for the estimation of impurities and assay of Solifenacin Succinate & Tamsulosin Hydrochloride in tablets dosage form.
文摘Objective: To evaluate and compare the safety and efficacy of Solifenacin, Tamsulosin, and Tadalafil in treating ureteral stent related symptoms (SRS) in patients with indwelling Double-J ureteral stents. Materials and Methods: A prospective randomized controlled study was conducted on 146 consecutive patients in the department of urology, Government Stanley Medical College & Hospital, Chennai, Tamilnadu, India between Sept 2017-March 2019, with SRS after taking informed consent and confirming DJ Stent position by X-ray KUB post-operatively. Patients were randomized into 4 groups: Group A (Placebo), Group B (Solifenacin 5 mg), and Group B (Tamsulosin 0.4 mg) and group D (Tadalafil 5 mg) at end of 1st week till the removal of DJ stent at end of 3 weeks. All patients were assessed for bothersome lower urinary tract symptoms (LUTS) using the validated Ureteral Stent Symptom Questionnaire (USSQ) at 1st week and 3 weeks after the starting of medications. Appropriate statistical analysis as carried out and the level of significance was set at P Results: LUTS, general health, and work performance improved with Solifenacin, Tamsulosin and Tadalafil and all the three were comparable in relieving urinary symptoms. Tadalafil was better at relieving body pain, additional problems and sexual problems better than Tamsulosin. Tadalafil showed comparable improvement in LUTS, better sexual health and decreased body pain compared to solifenacin, whereas the latter had better general health, additional problems & work performance scores. Conclusion: Solifenacin is more effective than Tamsulosin in alleviating LUTS associated with SRS and both show a distinctive advantage over placebo. PDE inhibitor Tadalafil can also be tried for SRS and is as effective as antimuscarinics and α-blockers in relieving urinary symptoms and is more efficacious in relieving sexual symptoms and body pain.
文摘Aim: To explore in daily clinical practice the evolution in time of the fesoterodine and solifenacin dose pattern and assess the therapeutic benefit provided by the highest dose of these anti-muscarinics. Patients and Methods: This was a post-hoc analysis of data from an observational, cross-sectional, retrospective and multicenter study. Adult patients diagnosed with over active bladder (OAB) who initiated fesoterodine or solifenacin treatment were included. Data on the prescribed treatment and dose, change of dose, reasons for switching and treatment benefit were recorded. Results: A total of 828 subjects were analyzed (262 receiving solifenacin and 566 fesoterodine). Most subjects were women with a mean time since diagnosis of more than one year and aged around 60 years old. The majority of patients initiated the OAB treatment with the lowest available dose (64% fesoterodine vs. 77% solifenacin). At the follow-up visit 54% of the fesoterodine group and 66% of the solifenacin opted for dose escalation. At the study visit, 70.1% fesoterodine vs. 43.3% solifenacin remained on the highest dose. A significantly greater proportion of subjects receiving fesoterodine 8 mg, reported higher improvement in terms of both patient-reported-treatment benefit and clinical global impression compared with solifenacin 10 mg (p < 0.05). Conclusion: In routine clinical practice more than half of the patients opted for the higher dose and remained on it over time, suggesting a desire for greater efficacy. Fesoterodine 8 mg seems to provide greater benefits from the physician’s and the patient’s point of view compared with those provided by solifenacin 10 mg.
文摘Objective: Detrusor hyperactivity with impaired contractility (DHIC) is not an uncommon bladder disorder, and is often difficult to treat. Therefore, using a rat model featuring both urinary frequency and residual urine, we investigated whether an anticholinergic agent (solifenacin) or a β3-agonist (mirabegron) is more suitable to combine with distigmine to treat DHIC. Methods: The partial bladder outlet obstruction (BOO) rat model was used. Rats were treated for 2 weeks: BOO/Solifenacin group was treated with 0.1 mg/kg solifenacin (n = 8), BOO/Mirabegron group was treated with 1 mg/kg mirabegron (n = 8), BOO/- group was not drug-treated but was given distilled water (n = 8), and the control group was also given distilled water (n = 8). Then the urethral ligature was removed under urethane anesthesia, and continuous cystometry was performed to evaluate bladder function. Baseline measurements were taken, then distigmine was administered to all groups, and cystometry was performed again to measure changes in bladder function. Results: Residual volumes increased in the BOO/- group, and the detrusor contractions were more frequent than that of the control group. Solifenacin treatment did not influence changes, except for threshold pressure, to any cystometric measurements. However, mirabegron treatment decreased the residual volume and residual volume rate;it also decreased detrusor contraction frequency similar to measurements obtained from the control group. Distigmine treatment enhanced detrusor contractions, which resulted in less residual volume, and decreased detrusor contraction frequency in the BOO model. Conclusions: The combination of distigmine and mirabegron was determined to be a better treatment than the combination of distigmine and solifenacin for DHIC.
文摘Objective To evaluate the efficacy and safety of combination therapy of tamsulosin and solifenacin for benign prostatic hyperplasia ( BPH) with overactive bladder ( OAB) . Methods 82 patients with OAB and coexisting BPH were randomly divided into tamsulosin group ( n
文摘Objective To evaluate the efficacy of sollfenacin with or without tamsulosin in patients with overactive bladder ( OAB ) . Methods Fifty-three patients with OAB were randomly divided into two groups ( group
