fesoterodine and Prostatic-Hyperplasia

To compare the efficacy of fesoterodine or mirabegron add-on therapy for persistent overactive bladder (OAB) symptoms despite silodosin monotherapy in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia, in both subjective and objective aspects.. A total of 120 patients with persistent OAB symptoms despite silodosin monotherapy were randomized to receive add-on therapy with fesoterodine (4 mg/day) or mirabegron (50 mg/day) for 12 weeks. At week 12, changes from baseline in patients' subjective symptoms and voiding/storage functions, as assessed using the International Prostate Symptom Score (IPSS), OAB symptom score (OABSS), and urodynamic studies, were compared between the groups.. The final analysis included 50 and 52 patients in the fesoterodine and mirabegron groups, respectively. Although the IPSS and OABSS significantly improved in both groups, the fesoterodine (vs mirabegron) group showed significantly greater improvements in the OABSS-total (-2.8 vs -1.5, P = 0.004), IPSS-QOL (-1.5 vs -1.1, P = 0.04), and OABSS-urgency score (-1.5 vs -0.9, P = 0.008) at 12 weeks. Regarding storage functions, although both groups showed significant improvements, the fesoterodine group demonstrated greater improvements in the detrusor overactivity alleviation rate (52.6% vs 28.9%, P = 0.03). Voiding functions did not deteriorate in either group at 12 weeks; no significant inter-group differences were observed. Post-void residual urine significantly increased by 16 mL only in the fesoterodine group.. Add-on therapy of fesoterodine to silodosin was more effective than adding mirabegron to silodosin for improving OAB symptoms and storage functions, without deteriorating voiding symptoms or functions.

Topics: Acetanilides; Aged; Aged, 80 and over; Benzhydryl Compounds; Drug Therapy, Combination; Humans; Indoles; Male; Middle Aged; Prospective Studies; Prostatic Hyperplasia; Thiazoles; Treatment Outcome; Urinary Bladder, Overactive; Urodynamics; Urological Agents

For a long time, benign prostatic hyperplasia (BPH) was considered as only cause of lower urinary tract symptoms (LUTS) in elderly men. More than 30% of patients underwent surgery by the age of 80. Unsatisfactory outcome of surgical treatment of BPH are observed in 9-27% of cases. Various irritative symptoms, which are typical for detrusor overactivity, persist especially often. Currently, anticholinergic drug therapy (m-cholinoblockers) is the main treatment for detrusor overactivity. The aim of our study was to assess the effectiveness of m-cholinoblockers for the treatment of persisted LUTS in men with BPH who had undergone transurethral resection of prostate (TURP).. The study included 60 patients with BPH who underwent TURP. All patients were divided into two groups. In Group 1, anti-inflammatory therapy for 10 days with 1-month follow-up was prescribed. In Group 2, anti-inflammatory therapy was combined with the drug Toviaz for 1 month. Evaluation of the treatment effectiveness was carried out 3-5 days, 14-15 days and 1 month after TURP, respectively and included voiding diary, IPSS score, QOL, uroflowmetry, adverse events and acute urinary retention.. At baseline, in the Group 1 and 2, average urination frequency was 12.6 and 12.7 times per day, the number of urgency episodes was 9.2 and 9.0 times and number of nocturnal voiding episodes was 5,2 and 5.3 times, respectively. The average IPSS score was 19.8 and 19.7 points and Qmax was 6.5 and 6.7 ml/sec, respectively. By the 14th-15th day of therapy, in both groups positive changes were found. There was a significant decrease (p<0.05) in the urination frequency and nocturnal voiding episodes according to voiding diaries, an increase in Qmax and average IPSS and QOL score. The adverse events rate in group 2 was 16.7%. By the 30th day of therapy in the group 1 there were no significant changes. However, in group 2, urination frequency, number of urgency episodes, average IPSS and QOL score decreased to an average of 5.7 times a day, 0.4 times, 1.2 times, 9.3 points and 1.6 points, respectively. Average Qmax increased to 15.5 ml/sec. No adverse events were detected.. According to the results of our study, the use of m-cholinoblockers, in particular Fesoterodine (Toviaz), in combination with standard therapy in patients with detrusor overactivity after TURP is reasonable and allows to effectively and safely alleviate irritative symptoms.

Topics: Aged; Benzhydryl Compounds; Humans; Male; Prostatic Hyperplasia; Transurethral Resection of Prostate; Treatment Outcome; Urological Agents

To evaluate the efficacy and safety of fesoterodine extended-release (ER) plus tamsulosin in men with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).. Men aged ≥50 years, with LUTS, prostate volume ≤60 ml and International Prostate Symptom Score (IPSS) ≥13 were enrolled in this study. 173 consecutive patients were treated initially with tamsulosin (0.4 mg) for 1 week. At the second visit, 47 patients out of the sample of 173 who were still experiencing inconvenient LUTS were randomized into two groups. The first group received a therapy with tamsulosin and fesoterodine combination (group 1, n = 24) while the second continued the therapy with the single administration of tamsulosin (group 2, n = 23) for an additional 4-week period.. There was no statistically significant difference in age, prostate volume, Q, and postvoid residual urine between the two groups. A statistical significance appeared in the combination group regarding the storage and the total IPSS values among the second and third visits (10.5 ± 1.4 to 8.5 ± 1.3 and 16.1 ± 1.8 to 13.7 ± 1.5 respectively).. Regarding bothersome LUTS and storage symptoms, fesoterodine ER and tamsulosin combination was significantly more effective than the single administration of tamsulosin.

Topics: Adrenergic alpha-1 Receptor Antagonists; Aged; Benzhydryl Compounds; Cholinergic Antagonists; Delayed-Action Preparations; Drug Administration Schedule; Drug Therapy, Combination; Humans; Lower Urinary Tract Symptoms; Male; Middle Aged; Prospective Studies; Prostatic Hyperplasia; Sulfonamides; Tamsulosin; Urinary Tract

Study Type - Therapy (RCT) Level of Evidence 1b What's known on the subject? and What does the study add? Male lower urinary tract symptoms are often attributed to bladder outlet obstruction secondary to benign prostatic hyperplasia and treated with drugs targeting the prostate. However, many men with storage lower urinary tract symptoms may not respond adequately to these agents. Antimuscarinics, with or without an α-blocker, may be effective for the treatment of the storage symptoms of overactive bladder in some men. Flexible-dose fesoterodine as an add-on treatment significantly improved urinary frequency and symptom bother, but not urgency episodes (primary endpoint), versus add-on placebo and was well tolerated in men with persistent overactive bladder symptoms despite receiving α-blocker.. • To evaluate flexible-dose fesoterodine vs placebo in men with persistent overactive bladder (OAB) symptoms despite receiving α-blocker treatment. • This was a double-blind, 12-week, flexible-dose trial. • Men with persistent storage symptoms (≥ 8 micturitions and ≥ 3 urgency episodes per 24 h) after receiving an α-blocker for ≥ 6 weeks were randomized to add-on fesoterodine 4 mg or placebo, with optional dose escalation to 8 mg at week 4 and reduction back to 4 mg at week 8 (or matching placebo adjustments). • Subjects completed 3-day diaries, International Prostate Symptom Score (IPSS), Overactive Bladder Questionnaire (OAB-q), Patient Perception of Bladder Condition (PPBC), and Urgency Perception Scale (UPS) at baseline and weeks 4 and 12.. • A total of 943 men were randomized and received at least one dose of study treatment (fesoterodine, n= 471; placebo, n= 472). • Among these, 251 (53%) in the fesoterodine group and 300 (64%) in the placebo group requested dose escalation at week 4 and 35 (7%) and 15 (3%) requested dose reduction at week 8. Changes from baseline to week 12 in urgency episodes (primary endpoint) in the fesoterodine (-3.2) and placebo (-2.9) groups were not significantly different (P= 0.196), but improvements in micturitions (P= 0.009) and OAB-q symptom bother score (P= 0.007) were significantly greater with fesoterodine. • At week 4, significantly greater improvements in micturitions (P= 0.006), severe urgency episodes (P= 0.006), IPSS storage score (P= 0.022), OAB-q symptom bother score (P= 0.004), and OAB-q health-related quality of life (P= 0.041), but not urgency episodes (P= 0.062), were observed with add-on fesoterodine. • Dry mouth (fesoterodine, 21%; placebo, 6%) and constipation (fesoterodine, 6%; placebo, 2%) were the most common adverse events. Dysuria and urinary retention were reported by 3% and 2% of subjects, respectively, in the fesoterodine add-on group vs 1% and <1% of subjects, respectively in the placebo add-on group. One subject in each group had acute urinary retention requiring catheterization.. • Flexible-dose fesoterodine was well tolerated as an add-on treatment in men with persistent storage symptoms. • Changes in urgency episodes at week 12 (primary endpoint) and many secondary endpoints were not significantly different between fesoterodine and placebo add-on treatment; however, improvements in frequency and symptom bother were significantly greater with fesoterodine. • These data suggest that there remains a limited understanding of the optimal evaluation and treatment of men with LUTS.

Topics: Adrenergic alpha-Antagonists; Adult; Aged; Aged, 80 and over; Benzhydryl Compounds; Double-Blind Method; Drug Therapy, Combination; Humans; Male; Middle Aged; Muscarinic Antagonists; Prostatic Hyperplasia; Treatment Outcome; Urinary Bladder, Overactive