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1.  Impact of Lower Urinary Tract Symptoms/Benign Prostatic Hyperplasia Treatment with Tamsulosin and Solifenacin Combination Therapy on Erectile Function 
Korean Journal of Urology  2011;52(1):49-54.
To examine the effects on erectile function of concomitant treatment with an alpha-blocker (tamsulosin) and an antimuscarinic agent (solifenacin) in patients with lower urinary tract symptoms (LUTS)/benign prostatic hyperplasia (BPH).
Materials and Methods
Fifty-seven male patients with LUTS/BPH were assessed for the degree of LUTS and erectile function. In group 1 (tamsulosin) and group 2 (tamsulosin and solifenacin), changes in the International Prostate Symptom Score [IPSS: total scores, storage symptoms (ST), voiding symptoms (VD), and quality of life (QoL)], prostate-specific antigen, trans-rectal ultrasonography, urine flowmetry, residual urine, and a 5-item version of the International Index of Erectile Function (IIEF-5) were assessed after a 3-month treatment period. In both groups, it was determined whether treatment was associated with changes in LUTS and erectile function and whether improvement in the IPSS was correlated with the IIEF-5. Comparative analysis was also done to examine the linear relationship between improved IPSS scores and IIEF-5 scores.
A comparison of the degree of improvement in all the parameters indicated that both groups showed significant improvement in total IPSS, IPSS-ST, IPSS-VD, and IPSS-QoL (p<0.05). A comparison of the degree of improved sexual function associated with improved LUTS in each patient showed significant improvement in the IIEF-5 score associated with the degree of improvement in the IPSS-ST domain in group 1, but no significant associations were found in group 2. In cases in which tamsulosin was administered, the IIEF-5 score significantly improved as the IPSS-ST domain score improved. In the group in which tamsulosin and solifenacin were concomitantly administered, improvement of the IPSS-ST domain score had no significant effect on the IIEF-5 score.
In patients with LUTS/BPH, tamsulosin and solifenacin combination therapy was effective for LUTS, but erectile function was not significantly improved. Therefore, although effective for improving LUTS, combination therapy with an alpha-blocker and an antimuscarinic agent was not effective for improving erectile function.
PMCID: PMC3037507  PMID: 21344031
Prostatic hyperplasia; Sexual dysfunction, physiological; Solifenacin; Tamsulosin
2.  Effect of Improvement in Lower Urinary Tract Symptoms on Sexual Function in Men: Tamsulosin Monotherapy vs. Combination Therapy of Tamsulosin and Solifenacin 
Korean Journal of Urology  2014;55(9):608-614.
To evaluate how much the improvement of lower urinary tract symptoms (LUTS) affects sexual function and which storage symptoms or voiding symptoms have the greatest effect on sexual function.
Materials and Methods
A total of 187 patients were enrolled in this study. Patients were randomly assigned to receive either tamsulosin 0.2 mg (group A) or tamsulosin 0.2 mg and solifenacin 5 mg (group B). At 4 weeks and 12 weeks, the LUTS and sexual function of the patients were evaluated by use of the International Index of Erectile Function-5 (IIEF5), International Prostate Symptom Score (IPSS), Overactive Bladder Symptom Score (OABSS) questionnaire, uroflowmetry, and bladder scan.
Both groups A and B showed statistically significant improvements in IPSS, OABSS, and quality of life (QoL). Group A showed improved maximum flow rate, mean flow rate, and residual urine volume by time. Group B did not show an improvement in flow rate or residual urine volume but total voiding volume increased with time. The IIEF5 score was not improved in either group. In group A, the IIEF5 score dropped from 13.66±4.97 to 11.93±6.14 after 12 weeks (p=0.072). Group B showed a decline in the IIEF5 score from 13.19±5.91 to 12.45±6.38 (p=0.299). Although group B showed a relatively smaller decrease in the IIEF5 score, the difference between the two groups was not significant (p=0.696).
Tamsulosin monotherapy and combination therapy with solifenacin did not improve erectile function despite improvements in voiding symptoms and QoL. The improvement in storage symptoms did not affect erectile function.
PMCID: PMC4165924  PMID: 25237463
Erectile dysfunction; Lower urinary tract symptoms; Overactive urinary bladder
3.  Randomized Controlled Trial to Compare the Safety and Efficacy of Tamsulosin, Solifenacin, and Combination of Both in Treatment of Double-J Stent-Related Lower Urinary Symptoms 
Advances in Urology  2013;2013:752382.
Purpose. We evaluated the effectiveness and safety of tamsulosin, solifenacin, and combination of both in reducing double-J stent-related lower urinary symptoms. Materials and Methods. A total of 338 patients with double-J ureteral stenting were randomly divided, postoperatively, into 4 groups. In group I (n = 84), no treatment was given (control group), group II (n = 85) received tamsulosin 0.4 mg daily, group III (n = 84) received solifenacin 10 mg daily, and group IV (n = 85) received a combination of both medications. Before insertion and 2 weeks after, all patients completed the International Prostate Symptom Score (IPSS), quality of life component of the IPSS (IPSS/Qol), Overactive Bladder Questionnaire (OAB-q), and Visual Analogue Pain Scale (VAPS) questionnaire. Results. The demographics and preoperative questionnaires scores of all groups were comparable. There were statistically significant differences in all scores in favour of groups II, III, and IV as compared to control group (P value < 0.005). Group IV showed statistically significant differences in total IPSS, QoL score, and OAB-q score as compared to groups II and III (P value < 0.001). Conclusions. Combined therapy of tamsulosin and solifenacin significantly alleviated lower urinary symptoms associated with double-J stents as compared to either medication alone.
PMCID: PMC3819880  PMID: 24235970
4.  Efficacy and Tolerability of Tamsulosin 0.4 mg in Patients with Symptomatic Benign Prostatic Hyperplasia 
Korean Journal of Urology  2011;52(7):479-484.
To evaluate the efficacy and tolerability of tamsulosin 0.4 mg once daily in Korean patients with symptomatic benign prostatic hyperplasia (BPH) and investigate whether tamsulosin 0.4 mg can improve symptoms in patients with refractory lower urinary tract symptoms (LUTS) who were previously receiving tamsulosin 0.2 mg once daily.
Materials and Methods
A total of 116 patients from 3 urology centers participated. All study subjects entered a nonblind phase consisting of 8 weeks of tamsulosin 0.2 mg monotherapy followed by an additional 8 weeks of tamsulosin 0.2 mg (0.2 mg group) or 8 weeks of tamsulosin 0.4 mg (0.4 mg group). At week 8, we chose the 0.4 mg group on the basis of International Prostate Symptom Score (IPSS), quality of life (QoL), maximal urinary flow rate (Qmax), and adverse effects. At week 16, we compared the efficacy and tolerability of tamsulosin between the 0.2 and 0.4 mg groups.
A total of 26 patients (22.4%) were escalated to tamsulosin 0.4 mg at week 8. There were significant differences in IPSS, QoL, and Qmax at week 8 in both groups. There were significant differences in improvement in IPSS, QoL, Qmax, and postvoid residual urine volume from baseline to week 16 in both groups. There were no significant differences in efficacy or tolerability between the groups at week 16.
Our trial demonstrated that tamsulosin 0.4 mg has favorable efficacy and tolerability in Korean patients with symptomatic BPH refractory to tamsulosin 0.2 mg. No patients experienced any serious adverse effects when we escalated the dose of tamsulosin to 0.4 mg.
PMCID: PMC3151636  PMID: 21860769
Prostatic hyperplasia; Tamsulosin
5.  Ramelteon combined with an α1-blocker decreases nocturia in men with benign prostatic hyperplasia 
BMC Urology  2013;13:30.
Nocturia is defined as waking one or more times during the night due to the urge to void. Recently, the effectiveness of several sedatives and analgesics for nocturia has been reported. We herein investigated the effects of ramelteon, an antioxidant and sleep inducer, on nocturia unresponsive to α1-blocker monotherapy in males with lower urinary tract symptoms (LUTS) as a pilot study.
Subjects were 19 patients who had LUTS suggestive of benign prostate hyperplasia, received α1-blockers (tamsulosin, silodosin, or naftopidil), and continued to have two or more episodes of nocturia per night before starting ramelteon. Ramelteon at 8 mg once daily for one month was added to the α1-blocker. A self-administered questionnaire including the International Prostate Symptom Score (IPSS), quality of life (QoL) index, Overactive Bladder Symptom Score (OABSS), and Nocturia Quality-of-Life Questionnaire (N-QOL) were assessed before and one month after starting ramelteon.
The mean score on IPSS question 7 (nocturia) decreased significantly from 2.88 before starting ramelteon to 2.41 one month after starting the medication (P = 0.03). The mean total OABSS decreased significantly from 6.31 to 5.38 (P = 0.03), and the mean for OABSS question 2 (nighttime frequency of nocturia) also significantly decreased from 2.63 to 2.13 (P = 0.01). The mean total N-QOL score did not change significantly. Two patients had dizziness; the remaining patients had no adverse drug-related events.
Ramelteon in combination with an α1-blocker could be a treatment option for reducing nocturia in men with BPH.
PMCID: PMC3687682  PMID: 23758651
Ramelteon; Melatonin; Nocturia; Benign prostate hyperplasia; α1-blocker
6.  The Efficacy and Safety of Propiverine Hydrochloride in Patients with Overactive Bladder Symptoms Who Poorly Responded to Previous Anticholinergic Agents 
Advances in Urology  2011;2011:714978.
Objectives. To prospectively examine the efficacy and safety of propiverine hydrochloride in patients with overactive bladder (OAB) symptoms who poorly responded to previous treatment with solifenacin, tolterodine or imidafenacin. Methods. Patients aged ≥20 with persisting OAB symptoms (≥6 in OAB symptom score (OABSS)) even after at least 4-week treatment using solifenacin, tolterodine or imidafenacin were enrolled. Propiverine 20 mg/day was administered for 12 weeks to 70 patients who desired the further improvement of OAB symptoms and 3 who had intolerable adverse events of previous drugs. The OABSS and postvoid residual urine volume (PVR) were determined before and at 4 and 12 weeks of treatment. Results. Of 73 patients enrolled (29 males and 44 females, median age 71 years), 52 completed the protocol treatment. The OABSS was significantly improved by propiverine treatment (9.0 at baseline, 6.2 at 4 weeks, 6.3 at 12 weeks (P < 0.001)). The scores of OAB symptoms (nighttime frequency, urgency and urge incontinence) except daytime frequency also improved significantly. No increase in PVR was observed. The most frequent adverse event was dry mouth (13.7%), followed by constipation (6.8%). Conclusions. Propiverine is useful to improve OAB for patients who poorly respond to solifenacin, tolterodine or imidafenacin.
PMCID: PMC3130959  PMID: 21747845
7.  Tolterodine extended release in the treatment of male oab/storage luts: a systematic review 
BMC Urology  2014;14(1):84.
Overactive bladder (OAB)/ storage lower urinary tract symptoms (LUTS) have a high prevalence affecting up to 90% of men over 80 years. The role of sufficient therapies appears crucial. In the present review, we analyzed the mechanism of action of tolterodine extended-release (ER) with the aim to clarify its efficacy and safety profile, as compared to other active treatments of OAB/storage LUTS.
A wide Medline search was performed including the combination of following words: “LUTS”, “BPH”, “OAB”, “antimuscarinic”, “tolterodine”, “tolterodine ER”. IPSS, IPSS storage sub-score and IPSS QoL (International Prostate Symptom Score) were the validated efficacy outcomes. In addition, the numbers of urgency episodes/24 h, urgency incontinence episodes/24 h, incontinence episodes/24 h and pad use were considered. We also evaluated the most common adverse events (AEs) reported for tolterodine ER.
Of 128 retrieved articles, 109 were excluded. The efficacy and tolerability of tolterodine ER Vs. tolterodine IR have been evaluated in a multicenter, double-blind, randomized placebo controlled study in 1529 patients with OAB. A 71% mean reduction in urgency incontinence episodes was found in the tolterodine ER group compared to a 60% reduction in the tolterodine IR (p < 0.05). Few studies evaluated the clinical efficacy of α-blocker/tolterodine combination therapy. In patients with large prostates (prostate volume >29 cc) only the combination therapy significantly reduced 24-h voiding frequency (2.8 vs. 1.7 with tamsulosin, 1.4 with tolterodine, or 1.6 with placebo). A recent meta-analysis evaluating tolterodine in comparison with other antimuscarinic drugs demonstrated that tolterodine ER was significantly more effective than placebo in reducing micturition/24 h, urinary leakage episodes/24 h, urgency episodes/24 h, and urgency incontinence episodes/24 h. With regard to adverse events, tolterodine ER was associated with a good adverse event profile resulting in the third most favorable antimuscarinic. Antimuscarinic drugs are the mainstay of pharmacological therapy for OAB / storage LUTS; several studies have demonstrated that tolterodine ER is an effective and well tolerated formulation of this class of treatment.
Tolterodine ER resulted effective in reducing frequency urgency and nocturia and urinary leakage in male patients with OAB/storage LUTS. Dry mouth and constipation are the most frequently reported adverse events.
PMCID: PMC4230346  PMID: 25348235
Lower urinary tract symptoms; Overactive bladder; Storage LUTS; Tolterodine; Urge incontinence; Frequency; Nocturia
8.  The relationship between bladder wall thickness and lower urinary tract symptoms: Does bladder wall thickness change after alpha-blocker therapy with alfuzosin? 
We evaluate the association between lower urinary tract symptoms (LUTS) and bladder wall thickness (BWT) and investigate whether alfuzosin might improve BWT.
We retrospectively reviewed the data of 164 patients with LUTS. Patients were divided into 2 groups according to BWT (Group 1: BWT ≤5 mm, n = 69; Group 2: BWT >5 mm, n = 95). Age, international prostate symptom score (IPSS), maximum and average urinary flow rates (Qmax and Qave), quality of life (QoL), postvoid residual (PVR) urine volume, prostate volume and prostate-specific antigen (PSA) were compared between the 2 groups. In total, 102 patients underwent transurethral resection of the prostate (TURP) and 62 patients were treated with alfuzosin. We compared BWT, Qmax, Qave, IPSS, QoL, PVR and PSA before and at the sixth month of alfuzosin therapy. A p value of <0.05 was considered statistically significant.
The mean BWT of Group 1 was 3.72 ± 0.56 mm and Group 2 was 6.43 ± 1.13 mm. There was a significant difference between the 2 groups in terms of mean Qmax and PVR. There was no statistical difference between the groups in terms of Qave, IPSS, QoL, prostate volume and PSA. There was significant difference between BWT before (6.8 ± 2.1) and after (4.6 ± 1.3) treatment with alfuzosin in 62 patients (p = 0.02). There was a significant difference between pre- and post-treatment values of mean Qmax, Qave, IPSS, QoL score, and PVR with alfuzosin.
BWT is a non-invasive and effective test to evaluate patients with lower urinary tract obstruction and may be used for showing the effectiveness of alpha-blocker therapy in patients with LUTS.
PMCID: PMC3896555  PMID: 24454597
9.  Correlation of Prostatic Urethral Angle with the Severity of Urinary Symptom and Peak Flow Rate in Men with Small Prostate Volume 
PLoS ONE  2014;9(8):e104395.
To evaluate the effects of prostatic anatomical factors on male lower urinary tract symptoms (LUTS) and the peak flow rate (Qmax) in patients with small prostate volume (PV).
Materials and Methods
Records were obtained from a prospectively maintained database of first-visit men with LUTS. Patients whose total PV (TPV) was greater than 30 mL were excluded; 444 patients were enrolled in the study. The TPV, transitional zone volume (TZV), transitional zone index (TZI), intravesical prostatic protrusion (IPP), and prostatic urethral angle (PUA) were measured by transrectal ultrasonography. LUTS were evaluated using the International Prostate Symptom Score (IPSS) and the Overactive Bladder Symptom Score (OABSS) questionnaires. Uroflowmetric measurements were also made.
PUA (r = 0.269, P<0.001), TZV (r = 0.160, P<0.001), and TZI (r = 0.109, P = 0.022) significantly correlated with the IPSS. Qmax (r = −0.334, P<0.001) and OABSS (r = 0.211, P<0.001) correlated only with PUA. In a multivariate regression analysis, PUA and age were independently associated with IPSS, OABSS, and Qmax. For IPSS of 20 or greater, the area under the ROC curve (AUC) of PUA was 0.667 and the cut-off value was 43.7°. When Qmax was 10 mL/s or less, the AUC of PUA was 0.664 and the cut-off value was 43.5°.
PUA has a significant association with symptom severity and Qmax among prostatic anatomical factors analyzed in men with LUTS and small PV. PUA should be considered as an important clinical factor in male LUTS management. Furthermore, the impact of PUA on response to medical treatment and disease progression needs to be investigated.
PMCID: PMC4134204  PMID: 25127394
10.  Efficacy of Alpha Blocker Treatment According to the Degree of Intravesical Prostatic Protrusion Detected by Transrectal Ultrasonography in Patients with Benign Prostatic Hyperplasia 
Korean Journal of Urology  2012;53(2):92-97.
To analyze the effectiveness of tamsulosin 0.2 mg once daily for 3 months according to the degree of intravesical prostatic protrusion (IPP) in patients with benign prostatic hyperplasia (BPH).
Materials and Methods
A total of 134 BPH patients over 40 years of age treated with tamsulosin 0.2 mg between January 2007 and January 2009 were enrolled retrospectively. The patients were classified into three groups according to the degree of IPP: below 5 mm (group A), between 5 and 10 mm (group B), and over 10 mm (group C). Prostate volume, prostate-specific antigen (PSA), prostatic urethral length (PUL), and prostatic adenoma urethral length (PAUL) were evaluated before treatment. International Prostate Symptom Score and Quality of Life (IPSS/QoL), maximal urine flow rate (Qmax), and postvoid residual (PVR) volume were measured before treatment, and improvement in the three groups was compared after 3 months.
The mean age of the patients was 65.01±7.38 years. Mean IPPs were 0.90±1.39 mm (group A, n=90), 6.92±1.10 mm (group B, n=24), and 16.60±4.06 mm (group C, n=20). Prostate volume, PUL, PAUL, PSA, Qmax, and PVR showed significant correlations with IPP (p<0.05), but not with IPSS/QoL score (p>0.05). Comparison of parameters before and after 3 months showed that medication improved total IPSS and subscores (p<0.001), QoL (p<0.001), Qmax (p<0.001), and PVR (p=0.030) in group A. In group B, it improved total IPSS (p=0.01), irritative subscore (p<0.001), and obstructive subscore (p=0.03). In group C, only total IPSS (p=0.01) and irritative score (p<0.001) were significantly improved.
Tamsulosin may be more effective in improving symptom scores and Qmax in patients with mild IPP than in those with moderate or severe IPP.
PMCID: PMC3285715  PMID: 22379587
Prostate; Prostatic hyperplasia; Ultrasonography
11.  Effects of Tamsulosin, Solifenacin, and Combination Therapy for the Treatment of Ureteral Stent Related Discomforts 
Korean Journal of Urology  2011;52(7):485-488.
To evaluate the effect of tamsulosin, solifenacin, and combination therapy of two agents in improving the lower urinary tract symptoms of patients with indwelling double-J ureteral stents.
Materials and Methods
A total of 168 patients underwent placement of a double-J ureteral stent after retrograde ureteroscopy for urinary stone disease. All patients received polyurethane double-J ureteral stents (6 Fr, 24 or 26 cm), which were removed a mean of 14 days postoperatively. A total of 48 patients were given no medication (Group 1), 43 patients were given tamsulosin 0.2 mg once daily (Group 2), 45 patients were given solifenacin 5 mg once daily (Group 3), and 32 patients were given a combination of two agents postoperatively (Group 4). International Prostate Symptom Score/quality of life (IPSS/QoL) and visual analogue pain scale (VAPS) questionnaires were completed by each patient at 1 day postoperatively and on the day of stent removal.
In the total group of patients, the mean age was 50.24±12.90 years. There was a significant difference in the IPSS total score between group 1 and groups 3 and 4. Group 4 also differed significantly from group 1 in the irritative subscore. The obstructive subscore differed between groups 2 and 4 and group 1. There was a statistically significant difference between group 1 and group 4 in the QoL score. There were no significant differences in the VAPS.
Combination therapy with tamsulosin and solifenacin improved both irritative and obstructive symptoms more than in the other groups. Combination therapy should be strongly considered for patients who complain of stent-related symptoms.
PMCID: PMC3151637  PMID: 21860770
Pain; Stents; Ureter
12.  Efficacy and Safety of Low-Dose Propiverine in Patients with Lower Urinary Tract Symptoms/Benign Prostatic Hyperplasia with Storage Symptoms: A Prospective, Randomized, Single-Blinded and Multicenter Clinical Trial 
Korean Journal of Urology  2011;52(4):274-278.
The aim of this study was to evaluate whether low-dose anticholinergics combined with an α1-receptor antagonist would continue the effect of an alpha-blocker, decrease the side effects of anticholinergics, and improve the symptoms of lower urinary tract symptoms/benign prostatic hyperplasia (LUTS/BPH).
Materials and Methods
Two hundred nine men with LUTS/BPH with storage symptoms (International Prostate Symptom Score [IPSS] ≥12; storage symptoms ≥4) were randomly assigned in a prospective, multicentered, and single-blind fashion to either the control group (alfuzosin 10 mg, once daily) or the combined group (alfuzosin 10 mg, once daily, and propiverine 10 mg, once daily) for 2 months. IPSS, maximal urinary flow rate (Qmax), and postvoid residual volume (PVR) were used to grade symptoms, side effects, and the impact on quality of life (QoL) at the start of the study and after 1 and 2 months.
There were no significant differences in patient background, including age, prostate size, Qmax, and PVR, between the control group and the combined group. In the combined group, the IPSS total score and the IPSS storage symptom score were significantly improved compared with the control group. The IPSS voiding symptom score, QoL, Qmax, and PVR did not differ significantly. There were no serious side effects in either group.
Management with an α1-receptor antagonist combined with a low-dose anticholinergic improved the total score and storage symptom score of the IPSS compared with α1-receptor antagonist only group without causing serious side effects. This initial combination medication can be considered an effective and safe treatment modality for LUTS/BPH patients with storage symptoms.
PMCID: PMC3085621  PMID: 21556215
Cholinergic antagonists; Propiverine; Prostatic hyperplasia
13.  Measurement properties of the benign prostatic hyperplasia impact index in tadalafil studies 
To assess the measurement properties of the Benign Prostatic Hyperplasia Impact Index (BII) for use in men with Lower Urinary Tract Symptoms (LUTS) secondary to Benign Prostatic Hyperplasia (BPH) treated with tadalafil.
Data from a dose-titration (Study 1) and a dose-finding placebo-controlled (Study 2) tadalafil studies of men 45 years of age or older with moderate to severe LUTS (N = 281; N = 1053) were included in this post-hoc analysis. Measures included the BII, International Prostate Symptom Score (IPSS), IPSS Quality of Life Index (IPSS-QoL), LUTS Global Assessment Question, uroflowmetry measure peak flow rate (Qmax) and postvoid residual volume (PVR). Spearman rank and Pearson correlation coefficients were computed between the BII score and the other measures at each visit. Wilcoxin two-sample tests, t-tests and general linear modeling compared BII scores of subjects with global ratings of improvement versus no improvement, and subjects taking tadalafil versus placebo. Effect size, standardized response mean and Guyatt's responsiveness statistic were calculated for BII and IPSS change scores.
There were high correlations between BII and IPSS & IPSS-QoL and low correlations between BII and Qmax & PVR at each visit. There were significant differences in BII at the End-of-Study Visit between subjects reporting improvement versus subjects reporting no improvement (Studies 1 and 2, P < .0001) and subjects taking tadalafil versus subjects taking placebo (Study 1, P = .0045; Study 2, P = .0064). The BII and IPSS were both responsive to change.
Results show that the BII is reliable, shows responsiveness to change in patients with BPH-LUTS, and demonstrates construct validity.
PMCID: PMC2998470  PMID: 21073697
14.  Silodosin is effective for treatment of LUTS in men with BPH: a systematic review 
Asian Journal of Andrology  2012;15(1):121-128.
The aim of this study was to systematically review the evidence on the efficacy and safety of silodosin treatments on lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH) from randomized controlled trials. We searched PubMed (1966–December 2011), Embase (1974–December 2011) and the Cochrane Library Database (2011, Issue 12). The assessed outcome measures were the change from baseline for the International Prostate Symptom Score (IPSS), quality of life (QoL) score, peak urine maximum flow rate (Qmax), QoL related to urinary symptoms and adverse effects. Two authors independently assessed the study quality and extracted data. All data were analysed using RevMan 5.1. The meta-analysis included four randomized controlled trials with a total of 2504 patients. The study durations were each 12 weeks. At the follow-up end points, the pooled results showed that the change from baseline for the silodosin group was significantly higher than the placebo group for the IPSS, QoL score and Qmax(mean difference (MD)=−2.78, P<0.00001; MD=−0.42, P=0.004; MD=1.17, P<0.00001,respectively) and patients felt more satisfied with QoL related to urinary symptoms in the silodosin group than the placebo group. Ejaculation disorder was the most commonly reported adverse effect. The pooled results also showed that the silodosin group was superior to the 0.2 mg tamsulosin group with respect to the IPSS and QoL score (IPSS: MD=−1.14, P=0.02; QoL score: MD=−0.26, P=0.02) and inferior to the 0.2 mg tamsulosin group with respect to Qmax (MD=−0.85, P=0.01). In contrast, there was no significant difference in the incidence of ejaculation disorder and dizziness between the silodosin and 0.2 mg tamsulosin groups. The current meta-analysis suggested that silodosin is an effective therapy for LUTS in men with BPH and is not inferior to 0.2 mg tamsulosin.
PMCID: PMC3739107  PMID: 23223034
benign prostatic hyperplasia (BPH); KMD-3213; lower urinary tract symptoms (LUTS); silodosin; tamsulosin; systematic review; meta-analysis
15.  Clinical Factors Associated With Dose Escalation of Solifenacin for the Treatment of Overactive Bladder in Real Life Practice 
To determine the baseline clinical characteristics associated with dose escalation of solifenacin in patients with overactive bladder (OAB).
We analyzed the data of patients with OAB (micturition frequency ≥8/day and urgency ≥1/day) who were treated with solifenacin and followed up for 24 weeks. According to our department protocol, all the patients kept voiding diaries, and OAB symptom scores (OABSS) were monitored at baseline and after 4, 12, and 24 weeks of solifenacin treatment.
In total, 68 patients (mean age, 60.8±10.0 years) were recruited. The dose escalation rate by the end of the study was 41.2%, from 23.5% at 4 weeks and 17.6% at 12 weeks. At baseline, the dose escalator group had significantly more OAB wet patients (53.6% vs. 20.0%) and higher total OABSS (10.2±2.4 vs. 7.9±3.5, P=0.032) than the nonescalator group. OAB wet (odds ratio [OR], 4.615; 95% confidence interval [CI], 1.578-13.499; P<0.05) and total OABSS (OR, 1.398; 95% CI, 1.046-1.869; P<0.05) were found to be independently associated with dose escalation.
Patients who have urgency urinary incontinence and high total OABSS have a tendency for dose escalation of solifenacin.
PMCID: PMC3983505  PMID: 24729924
Overactive urinary bladder; Muscarinic antagonists; Solifenacin
16.  Construct validation of patient global impression of severity (PGI-S) and improvement (PGI-I) questionnaires in the treatment of men with lower urinary tract symptoms secondary to benign prostatic hyperplasia 
BMC Urology  2012;12:30.
Lower urinary tract symptoms (LUTS) in aging men are often associated with benign prostatic hyperplasia (BPH). While regulatory evaluations of treatment benefit require an assessment of specific symptoms, a simpler approach to measuring patients’ perceptions of severity and symptom change may be particularly useful for clinical practice. The aim of this study was to provide evidence of the validity of the 1-item Patient Global Impression of Severity (PGI-S) and Improvement (PGI-I) questionnaires for use as outcome measures in the treatment of BPH-LUTS.
This was a secondary analysis of data from 4 randomized placebo-controlled 12-week trials evaluating tadalafil for the treatment of BPH-LUTS (N=1694). Visit 2 (V2 [beginning of a 4-week placebo lead-in period]) and endpoint assessments included International Prostate Symptom Score (IPSS), IPSS Quality of Life Index (IPSS-QoL), BPH Impact Index (BII), and peak urine flow (Qmax). PGI-S was only administered at V2 and PGI-I only at endpoint. Associations between the PGI-S or the PGI-I and the other assessments were analyzed by calculating Spearman rank correlation coefficients and performing analysis of variance (ANOVA).
Spearman correlation coefficients were 0.43, 0.43, 0.53, and −0.09, between the PGI-S and IPSS, IPSS-QoL, BII, and Qmax baseline results (all P<0.001). Similar results were seen across race, ethnicity, and baseline severity (moderate LUTS versus severe LUTS). IPSS, IPSS-QoL, BII baseline scores (P <0.001) and Qmax values (P=0.003) were significantly different among the 4 PGI-S severity levels. Spearman correlation coefficients were 0.56, 0.53, 0.47 and −0.15 between the PGI-I and change in IPSS, IPSS-QoL, BII scores, and Qmax values from baseline to endpoint (all P<0.001). Similar results were seen across race, ethnicity, and baseline severity. Change in IPSS, IPSS-QoL, BII scores, and Qmax values (P<0.001) were significantly different among the PGI-I levels (i.e., patient perception of change in urinary symptoms).
This study demonstrated patients’ overall perceptions of their severity and change in BPH-LUTS can be captured in a way that is simple, valid, and easily administered in a research setting or clinical practice. Clinical parameters are weakly associated with patients’ perception of urinary symptoms, emphasizing the importance of a patient-reported assessment in the evaluation of BPH-LUTS treatment benefit.
PMCID: PMC3503561  PMID: 23134716
Patient global impression scale; Lower urinary tract symptoms; Construct validity
17.  Can 80 W KTP Laser Vaporization Effectively Relieve the Obstruction in Benign Prostatic Hyperplasia?: A Nonrandomized Trial 
The World Journal of Men's Health  2012;30(3):160-165.
There is little data evaluating the changes of severity of bladder outlet obstruction after 80 W-potassium-titanyl-phosphate (KTP) photoselective laser vaporization prostatectomy (PVP) by pressure-flow study. We evaluated the efficacy of PVP to relieve the obstruction in benign prostate hyperplasia (BPH) compared with transurethral resection of the prostate (TURP).
Materials and Methods
This is a prospective, non-randomized single center study. The inclusion criteria were as follows: Men suffering from lower urinary tract symptoms (LUTS) secondary to BPH, age ≥50 years, International Prostatic Symptom Score (IPSS) ≥13, maximum flow rate (Qmax) ≤15 ml/s, and ability to give fully informed consent. Patients with neurogenic cause or detrusor underactivity were excluded. The IPSS, bother score, Qmax, postvoid residual volume (PVR), detrusor pressure at maximum flow rate (PdetQmax), bladder outlet obstruction index (BOOI), and prostate volume were measured before and 6 months after surgery and compared between PVP and TURP.
Sixty-seven patients (53 in PVP, 14 in TURP) were evaluable. In both groups, the IPSS, bother score, Qmax, and PVR had significantly improved (p<0.05), and there were no differences between the changes in those parameters. PVP could effectively reduce the PdetQmax, prostate volume, and BOOI from baseline (from 68.7±23.3 to 40.6±11.2 cmH2O, 49.5±16.3 to 31.3±12.1 ml, 49.8±25.6 to 9.8±20.7), similar to TURP. There were no differences in postoperative PdetQmax, prostate volume, or BOOI between the two groups. The percentage of patients with BOOI ≥40 was decreased from 64% to 4% in the PVP group and from 86% to 14% in the TURP group.
PVP could reduce the prostate volume effectively and relieve bladder outlet obstruction similar to TURP by the 6-month follow up in men with BPH.
PMCID: PMC3623531  PMID: 23596606
Prostatic hyperplasia; KTP lasers; Transurethral resection of prostate; Urinary bladder neck obstruction
18.  Prostatic urethral angle might be a predictor of treatment efficacy of α-blockers in men with lower urinary tract symptoms 
We investigated the association of the prostatic urethral angle (PUA) with peak urinary flow rate (Qmax) and the severity of lower urinary tract symptoms (LUTS) on the aging male. We also evaluated the effect of the PUA on the treatment efficacy of tamsulosin on men with LUTS.
Materials and methods
The records were obtained from a prospective database for first-visit male patients with LUTS in the outpatient department of our institution. These patients underwent a detailed physical examination and taking of medical history. A transrectal ultrasound was performed on these patients. The prostate size, length of intravesical prostatic protrusion (IPP), PUA, and International Prostate Symptom Score (IPSS) of the patients were evaluated. Uroflowmetry and a bladder scan for residual urine were also performed on every patient. Tamsulosin 0.2 mg per day was prescribed. The IPSS and uroflowmetry were reevaluated after they had received treatment for 3 months.
A total of 178 patients were included, and 149 of them completed this cohort study. The mean PUA was 48.32°±13.74°. The mean prostate volume was 39.19±20.87 mL, and the mean IPP was 5.67±7.85 mm. On multivariate linear regression analysis, the PUA was independently associated with the IPSS (P<0.001), Qmax (P=0.004), post-treatment IPSS change (P=0.032), and post-treatment Qmax change (P<0.001). However, the prostate volume and IPP were not associated with these clinical items.
The PUA is significantly associated with Qmax and IPSS in men with LUTS. The PUA is also inversely correlated with changes in Qmax and IPSS after tamsulosin treatment. Namely, the PUA might be a predictor for the treatment efficacy of α-blockers in aging men with LUTS.
PMCID: PMC4106922  PMID: 25075177
prostatic urethral; prostate; International Prostate Symptom Score; benign prostatic hyperplasia
19.  Comparative evaluation of naftopidil and tamsulosin in the treatment of patients with lower urinary tract symptoms with benign prostatic hyperplasia 
Urology Annals  2014;6(3):181-186.
Naftopidil, approved initially in Japan, is an α1d-adrenergic receptor antagonist (α1-blocker) used to treat lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). It is different from tamsulosin hydrochloride and silodosin, in that it has a higher affinity for the α1D-adrenergic receptor subtype than for the α1A subtype and has a superior efficacy to a placebo and comparable efficacy to other α1-blockers such as tamsulosin. The incidences of ejaculatory disorders and intraoperative floppy iris syndrome induced by naftopidil may also be lower than that for tamsulosin and silodosin, which have a high affinity for the α1A-adrenergic receptor subtype. However, it remains unknown if the efficacy and safety of naftopidil in Japanese men is applicable to Indian men having LUTS/BPH.
Material and Methods:
Two groups of 60 patients each, having LUTS due to BPH, were treated with tamsulosin 0.4 mg and Naftopidil 75 mg for three months. Ultrasonography (for prostate size, post-void residual volume), uroflowmetry, and the International Prostate Symptom Score (IPSS) and Quality of Life (QOL) score were recorded at the beginning of the study, and then at one and three months.
The prostate size, post-void residual volume, all the uroflowmetry variables, and the IPSS QOL scores showed a statistically significant improvement (P < 0.001) in both the groups. The improvement in the average flow rate and the QOL index was better in the naftopidil group on the intergroup comparison and was statistically significant (P < 0.001).
Although the QOL life index was significantly better in the naftopidil group, overall both naftopidil and tamsulosin were found to be equally effective in the treatment of LUTS due to BPH.
PMCID: PMC4127851  PMID: 25125888
Benign prostatic hyperplasia; LUTS; naftopidil; tamsulosin
20.  Efficacy and Safety of Tamsulosin for the Treatment of Non-neurogenic Voiding Dysfunction in Females: A 8-Week Prospective Study 
Journal of Korean Medical Science  2009;25(1):117-122.
We evaluated the therapeutic effects of tamsulosin for women with non-neurogenic voiding dysfunction. Women who had voiding dysfunctions for at least 3 months were included. Inclusion criteria were age ≥18 yr, International Prostate Symptom Score (IPSS) of ≥15, and maximum flow rate (Qmax) of ≥12 mL/sec and/or postvoid residuals (PVR) of ≥150 mL. Patients with neurogenic voiding dysfunction or anatomical bladder outlet obstruction were excluded. All patients were classified according to the Blaivas-Groutz nomogram as having no or mild obstruction (group A) or moderate or severe obstruction (group B). After 8 weeks of treatment, treatment outcomes and adverse effects were evaluated. One hundred and six patients were evaluable (70 in group A, 36 in group B). After treatments, mean IPSS, bother scores, Qmax, PVR, diurnal and nocturnal micturition frequencies and scored form of the Bristol Female Lower Urinary Tract Symptoms questionnaire (BFLUTS-SF) were changed significantly. Eighty-nine patients (84%) reported that the treatment was beneficial. The proportion of patients reported that their bladder symptoms caused "moderate to many severe problems" were significantly decreased. No significant difference were observed between the groups in terms of IPSS, bother score, Qmax, PVR, micturition frequency, and BFLUTS-SF changes. Adverse effects related to medication were dizziness (n=3), de novo stress urinary incontinence (SUI) (n=3), aggravation of underlying SUI (n=1), fatigue (n=1). Tamsulosin was found to be effective in female patients with voiding dysfunction regardless of obstruction grade.
PMCID: PMC2800025  PMID: 20052356
Urination Disorders; Female; Adrenergic alpha-Antagonists; Outcomes Assessment
21.  Efficacy and Safety of the Selective α1A-Adrenoceptor Blocker Silodosin for Severe Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia: A Prospective, Single-Open-Label, Multicenter Study in Korea 
Korean Journal of Urology  2014;55(5):335-340.
To evaluate the efficacy and safety of silodosin 8 mg once daily in a 12-week treatment of subjects with severe lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).
Materials and Methods
A total of 100 subjects from 10 urology centers in Korea were included in this study. The inclusion criteria were as follows: age ≥50 years, International Prostate Symptom Score (IPSS) ≥20, quality of life (QoL) score ≥3, urine volume ≥120 mL and maximal urinary flow rate (Qmax) <15 mL/s, and postvoid residual volume (PVR) <100 mL. We assessed the improvement of LUTS with change in IPSS, QoL score, Qmax, PVR, and adverse events at baseline and 4 and 12 weeks after treatment with silodosin 8 mg once daily.
The IPSS values were 23.27±3.34, 15.89±6.26, and 13.80±6.31 at baseline, 4, and 12 weeks, respectively, with significant improvements (p<0.0001, p=0.0214, respectively). QoL scores were 4.44±0.85, 3.38±1.20, and 3.04±1.20 at baseline, 4, and 12 weeks, respectively, and the differences were statistically significant (p<0.0001). There was a significant difference in Qmax between baseline and 12 weeks (p<0.0001) but not in PVR (p=0.9404) during the clinical trial. The most frequent adverse event in this study was ejaculation failure with 13 cases. However, no subject dropped out because of ejaculation failure, and in 12 of the 13 cases it was fully resolved without further treatment.
Silodosin 8 mg once daily may be effective and safe in Korean patients with severe LUTS associated with BPH.
PMCID: PMC4026660  PMID: 24868338
α1A-Adrenoceptor antagonis; Benign prostatic hyperplasia; Lower urinary tract symptoms; Selective; Silodosin
22.  Increased Serum C-Reactive Protein Level Is Associated with Increased Storage Lower Urinary Tract Symptoms in Men with Benign Prostatic Hyperplasia 
PLoS ONE  2014;9(1):e85588.
Chronic inflammation is considered as one of the contributing mechanisms of lower urinary tract symptoms (LUTS). Serum C-reactive protein (CRP) level is the widely used biomarker of inflammatory status. This study investigated the association between serum CRP level in men with benign prostatic hyperplasia (BPH) and lower urinary tract symptoms (LUTS) before and after medical treatment.
A total of 853 men with BPH and LUTS were enrolled. All patients completed the International Prostate Symptoms Score (IPSS) questionnaire and urological examinations. The parameters of uroflowmetry (maximum flow rate, Qmax; voided volume, VV), post-void residual (PVR), total prostate volume (TPV) and transition zone index (TZI), serum prostate specific antigen (PSA), and serum CRP levels were obtained. All patients were treated with alpha-blocker or antimuscarinic agent based on the IPSS voiding to storage subscore ratio (IPSS-V/S). Correlation analyses were performed between serum CRP levels with age, IPSS, TPV, TZI, Qmax, PVR, VV, PSA and between baseline and post treatment.
The mean age was 66.9±11.6 years old and the mean serum CRP levels were 0.31±0.43 mg/dL. Univariate analyses revealed serum CRP levels were significantly associated with age (p<0.001), PSA levels (p = 0.005) and VV (p = 0.017), but not significantly associated with TPV (p = 0.854) or PVR (p = 0.068). CRP levels were positively associated with urgency (p<0.001) and nocturia (p<0.001) subscore of IPSS, total IPSS (p = 0.008) and storage IPSS (p<0.001) and negatively associated with IPSS- V/S ratio (p = 0.014). Multivariate analyses revealed that serum CRP levels were significantly associated with age (p = 0.004) and storage IPSS subscore p<0.001). Patients with IPSS-V/S<1 and treated with tolterodine for 3 months had significant decrease of CRP levels after treatment.
Serum CRP levels are associated with storage LUTS and sensory bladder disorders, suggesting chronic inflammation might play a role in the patients with storage predominant LUTS.
PMCID: PMC3893218  PMID: 24454896
23.  Thulium:YAG VapoEnucleation of the prostate in large glands: a prospective comparison using 70- and 120-W 2-µm lasers 
Asian Journal of Andrology  2012;14(2):325-329.
This study compared the efficacy of 70- and 120-w 2-µm thulium:YAG VapoEnucleation of the prostate (ThuVEP) for patients with benign prostatic obstruction (BPO). A prospective analysis of 84 patients with symptomatic BPO and prostatic enlargement (≥60 ml) who underwent either 70-w (n=44) or 120-w ThuVEP (n=40) non-randomly was carried out. Patient demographics and perioperative and 12-month follow-up data were analysed. The mean prostate volume was 79.90±27.49 ml in patients who had received 70-w ThuVEP, which was less than in those who had received 120-w ThuVEP (88.53±25.10; P=0.033). The mean enucleation (resected weight/laser time, 2.16±1.21 g min−1 vs. 1.23±0.60 g min−1; P=0.013), operation efficiency (resected weight/total operation time, 0.76±0.35 g min−1 vs. 0.42±0.27 g min−1; P=0.000) and percentage of resected tissue (66.93%±22.79% vs. 45.41%±23.33% P=0.000) were higher with 120-w treatment compared to 70-w ThuVEP. One patient (1.2% of total patients) (in the 120-w group) required a blood transfusion postoperatively. Sixty-one patients (73%) were available for review at the 12-month follow-up time point. The quality of life (QoL), International Prostate Symptom Score (IPSS), maximum urinary flow rate (Qmax), postvoiding residual urine (PVR) and prostate volume improved significantly after treatment (P≤0.035) and were not significantly different between those treated with the different devices (70- and 120-w). The median prostate volume reduction was 81.70% and 82.19% with 70- and 120-w ThuVEP, respectively. The incidence of complications was low and did not differ between groups treated with the different devices. Two patients (2.4%) (one per group) had a bladder neck contracture at the follow-up. ThuVEP is a safe and efficacious procedure for the treatment of symptomatic BPO. The incidence of complications was low with both devices. The 120-w thulium:YAG device enhances the effectiveness of ThuVEP with regard to the percentage of resected tissue and the enucleation/operation efficiency.
PMCID: PMC3735080  PMID: 22231295
benign prostatic obstruction; laser; prostate; Revolix; Tm:YAG; ThuVEP; VapoEnucleation
24.  Measuring the improvement in health-related quality of life using King’s health questionnaire in non-obese and obese patients with lower urinary tract symptoms after alpha-adrenergic medication: a preliminary study 
BMC Urology  2014;14:60.
The efficacy of medical treatment among obese men with lower urinary tract symptoms (LUTS) has been less clear, especially regarding the improvement of QoL. We aimed to investigate the difference in efficacy and consequent satisfaction of life quality after medical treatment of male LUTS according to obesity.
An 8-week prospective study was performed for a total of 140 patients >50 years old with International Prostate Symptom Scores (IPSS) > 12 points and prostate volume > 20 mL. Obesity was determined by either body mass index (BMI) or waist circumference (WC). Patients were divided into 2 groups according to BMI or WC. Patients received tamsulosin at a dose of 0.4 mg daily for 8 weeks. The changes from baseline in the IPSS, maximal urinary flow rate (Qmax), post-void residual volume, questionnaire of quality of life (QoL), and King’s Health Questionnaire (KHQ) were analyzed.
Of the 150 enrolled patients, 96 completed the study. Seventy-five patients (78.1%) had BMI ≥ 23 kg/m2, and 24 (25.0%) had WC > 90 cm. Overall, the IPSS, IPSS QoL, and total KHQ showed significant improvement. Obese (BMI ≥ 23 kg/m2) and non-obese (BMI < 23 kg/m2) both showed improvement of the IPSS and IPSS QoL scores, but only the obese (BMI ≥ 23 kg/m2) group showed improvement of the total KHQ score (P < 0.001 vs. P = 0.55). Only the obese (WC > 90 cm) group showed improvement of the IPSS and total KHQ scores (P < 0.001).
Our preliminary study showed the different efficacy of an alpha-blocker for improvement of LUTS and life quality according to obesity. Obese patients, defined by BMI or WC, showed the tendency toward a more favorable improvement of LUTS and life quality.
Trial registration
Current Controlled Trials 2010–058. Registered 2 September 2010 in Soonchunhyang Univeristy Hospital
PMCID: PMC4126641  PMID: 25099073
Alpha-blocker; Prostatic hyperplasia; Body mass index; Waist circumference
25.  Impact of Intravesical Protrusion of the Prostate in the Treatment of Lower Urinary Tract Symptoms/Benign Prostatic Hyperplasia of Moderate Size by Alpha Receptor Antagonist 
To evaluate whether intravesical protrusion of the prostate (IPP) is related to the treatment effect of alpha-1 receptor antagonist in patients with lower urinary tract symptoms (LUTS)/benign prostatic hyperplasia (BPH) with a prostate size of less than 40 g.
A total of 77 BPH patients over 50 years of age treated with alfuzosin (alpha blocker) were enrolled prospectively. The study included only patients with BPH of 40 g or less. The patients were classified into two groups depending on the presence of IPP at baseline: the IPP group (41 patients) and the non-IPP group (36 patients). Prostate volume, prostate-specific antigen (PSA), International Prostate Symptom Score and quality of life (IPSS/QoL), maximum flow rate (Qmax), and postvoid residual (PVR) volume were compared between the groups. The clinical significance of IPP was evaluated after the patients had been taking alfuzosin for 8 weeks.
PSA and IPSS (total and voiding subscore) showed significant correlations with IPP (P<0.05). Comparison of parameters before and after 8 weeks showed that alfuzosin improved the total IPSS and all subscores (P<0.001), QoL (P<0.001), Qmax (P<0.001), and PVR (P=0.030) in the non-IPP group.
Alfuzosin may be less effective in improving symptom scores, PVR, and Qmax in the treatment of LUTS/BPH in the presence of IPP.
PMCID: PMC3547180  PMID: 23346485
Prostate; Lower urinary tract symptoms; Prostatic hyperplsia; Urinary bladder neck obstruction; Adrenergic alpha-1 receptor antagonists

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