Clinical Efficacy and Safety of Imidafenacin as Add-on Treatment for Persistent Overactive Bladder Symptoms Despite alpha-Blocker Treatment in Patients With BPH: The ADDITION STUDY
ABSTRACT To evaluate the effects of add-on treatment with an anticholinergic (imidafenacin) on persistent overactive bladder (OAB) symptoms despite α-blocker (tamsulosin) treatment in patients with benign prostatic hyperplasia (BPH).
Patients with BPH ≥50 years old, with urinary urgency at least once per week and total OAB symptom score (OABSS) ≥3 points after ≥8-week treatment with tamsulosin were enrolled in a multicenter, open-label study (not double-blinded). Patients were randomized to receive tamsulosin (0.2 mg/day) alone or tamsulosin (0.2 mg/day) + imidafenacin (0.1 mg 2 times a day). Primary endpoint was 12-week change in OABSS; secondary endpoints were changes in OABSS, International Prostate Symptom Score (IPSS), micturition time chart (MTC), hours of undisturbed sleep (HUS), and quality of life (IPSS-QOL and BPH impact index [BII]). For statistical analysis, a mixed-effects model and t test were used.
In total, 308 men were enrolled. The change from baseline to 12 weeks in total OABSS was significantly greater with add-on imidafenacin than tamsulosin alone (2.11, 95% confidence interval [CI] 1.47-2.74, P <.0001). Improvements in frequencies of daytime urination, nighttime urination, urinary urgency, urgency incontinence, IPSS, HUS, IPSS-QOL, and BII, were significantly greater from 4 weeks through 12 weeks in the imidafenacin group. Between-group difference in postvoid residual volume at 12 weeks was not significant (-1.74 mL, 95% CI -8.19 to 4.72), and no events of urinary retention were reported.
Combined tamsulosin and imidafenacin treatment is effective and safe in patients with BPH with persistent OAB symptoms after tamsulosin monotherapy. Furthermore the combination treatment improved the QOL in BPH patients with OAB.
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ABSTRACT: Objectives: To compare the treatment outcome of tamsulosin 0.4 mg (TAM) with or without solifenacin 5 mg (SOL) for the most bothersome symptom in male lower urinary tract symptoms (LUTS) with overactive bladder (OAB). Subjects and Methods: Male LUTS/OAB (≥50 years) patients who had a total International Prostate Symptom Score (I-PSS) of ≥12, I-PSS urgency-related question of ≥2, and quality of life (QoL) of ≥3 points were enrolled. Patients who complained of storage symptoms as the most bothersome were included in the 'storage' group. Patients who complained of voiding symptoms as the most bothersome were included in the 'voiding' group. The change in the I-PSS was compared between the two groups 4 weeks after commencing treatment. Results: In the storage group, 172 were able to finish this study (TAM: 88, TAM + SOL: 84). The improvement of I-PSS and QoL with TAM + SOL was significantly greater than with TAM alone (p < 0.001). In the voiding group, 108 were able to finish the study (TAM: 54, TAM + SOL: 54). The improvement of I-PSS and QoL with TAM alone was significantly greater than with TAM + SOL (p < 0.001). Conclusions: The most bothersome symptom in male LUTS/OAB should be considered when choosing the appropriate medical treatment. © 2014 S. Karger AG, Basel.Urologia Internationalis 08/2014; 93(3). DOI:10.1159/000365335 · 1.15 Impact Factor
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ABSTRACT: Objectives To investigate urodynamic efficacy and safety of mirabegron add-on treatment with tamsulosin for Japanese male patients with overactive bladder (OAB).MethodsA prospective study was conducted in 26 consecutive male patients with OAB who had been taking tamsulosin. OAB was diagnosed by overactive bladder symptom score (OABSS). Before and 8 weeks after mirabegron add-on treatment with preceding tamsulosin, we assessed OABSS, International Prostate Symptom Score (IPSS), free uroflowmetry (UFM), filling cystometry and pressure-flow study (PFS).ResultsMean age and prostate volume of the study patients were 75 ± 7 years and 32 ± 19 mL, respectively. Mirabegron significantly improved OABSS (from 8.5 ± 2.3 to 4.7 ± 2.5, P < 0.001). On free UFM, mirabegron significantly increased voided volume (from 135 ± 47 to 182 ± 102 mL, P = 0.01), maximum (from 10.7 ± 3.7 to 13.5 ± 6.4 mL/sec, P < 0.01) and average flow rate (from 5.5 ± 1.9 to 7.1 ± 3.3 mL/sec, P < 0.01), while postvoid residual urine volume did not change significantly (from 47 ± 38 to 63 ± 61 mL, P = 0.23). Before mirabegron, 24 patients (92%) had detrusor overactivity (DO). After mirabegron add-on, maximum cystometric capacity significantly increased from 170 ± 98 to 212 ± 95 mL (P = 0.01) and DO disappeared in six patients (25%). In the other 18 patients with persistent DO, amplitude of involuntary contraction decreased and bladder volume at first involuntary contraction increased with statistical significance. On PFS, detrusor pressure at maximum flow rate (from 79 ± 31 to 68 ± 19 cmH2O, P = 0.10) or bladder contractility index (from 126 ± 39 to 120 ± 27, P = 0.45) did not change significantly.Conclusions Mirabegron add-on treatment with tamsulosin has efficacy and safety because it improves storage symptom without impairment of bladder contractility during voiding in male patients with OAB.Lower urinary tract symptoms 02/2015; DOI:10.1111/luts.12091 · 0.54 Impact Factor