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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.
Purpose
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.
Results
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.
Conclusions
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.
doi:10.4111/kju.2011.52.1.49
PMCID: PMC3037507  PMID: 21344031
Prostatic hyperplasia; Sexual dysfunction, physiological; Solifenacin; Tamsulosin
2.  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.
doi:10.1155/2013/752382
PMCID: PMC3819880  PMID: 24235970
3.  Efficacy and Tolerability of Tamsulosin 0.4 mg in Patients with Symptomatic Benign Prostatic Hyperplasia 
Korean Journal of Urology  2011;52(7):479-484.
Purpose
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.
Results
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.
Conclusions
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.
doi:10.4111/kju.2011.52.7.479
PMCID: PMC3151636  PMID: 21860769
Prostatic hyperplasia; Tamsulosin
4.  Ramelteon combined with an α1-blocker decreases nocturia in men with benign prostatic hyperplasia 
BMC Urology  2013;13:30.
Background
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.
Methods
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.
Results
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.
Conclusions
Ramelteon in combination with an α1-blocker could be a treatment option for reducing nocturia in men with BPH.
doi:10.1186/1471-2490-13-30
PMCID: PMC3687682  PMID: 23758651
Ramelteon; Melatonin; Nocturia; Benign prostate hyperplasia; α1-blocker
5.  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.
doi:10.1155/2011/714978
PMCID: PMC3130959  PMID: 21747845
6.  The relationship between bladder wall thickness and lower urinary tract symptoms: Does bladder wall thickness change after alpha-blocker therapy with alfuzosin? 
Introduction:
We evaluate the association between lower urinary tract symptoms (LUTS) and bladder wall thickness (BWT) and investigate whether alfuzosin might improve BWT.
Methods:
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.
Results:
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.
Conclusion:
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.
doi:10.5489/cuaj.1513
PMCID: PMC3896555  PMID: 24454597
7.  Effects of Tamsulosin, Solifenacin, and Combination Therapy for the Treatment of Ureteral Stent Related Discomforts 
Korean Journal of Urology  2011;52(7):485-488.
Purpose
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.
Results
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.
Conclusions
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.
doi:10.4111/kju.2011.52.7.485
PMCID: PMC3151637  PMID: 21860770
Pain; Stents; Ureter
8.  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.
Purpose
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.
Results
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.
Conclusions
Tamsulosin may be more effective in improving symptom scores and Qmax in patients with mild IPP than in those with moderate or severe IPP.
doi:10.4111/kju.2012.53.2.92
PMCID: PMC3285715  PMID: 22379587
Prostate; Prostatic hyperplasia; Ultrasonography
9.  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.
Purpose
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.
Results
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.
Conclusions
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.
doi:10.4111/kju.2011.52.4.274
PMCID: PMC3085621  PMID: 21556215
Cholinergic antagonists; Propiverine; Prostatic hyperplasia
10.  Clinical Factors Associated With Dose Escalation of Solifenacin for the Treatment of Overactive Bladder in Real Life Practice 
Purpose
To determine the baseline clinical characteristics associated with dose escalation of solifenacin in patients with overactive bladder (OAB).
Methods
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.
Results
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.
Conclusions
Patients who have urgency urinary incontinence and high total OABSS have a tendency for dose escalation of solifenacin.
doi:10.5213/inj.2014.18.1.23
PMCID: PMC3983505  PMID: 24729924
Overactive urinary bladder; Muscarinic antagonists; Solifenacin
11.  Measurement properties of the benign prostatic hyperplasia impact index in tadalafil studies 
Background
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.
Methods
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.
Results
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.
Conclusions
Results show that the BII is reliable, shows responsiveness to change in patients with BPH-LUTS, and demonstrates construct validity.
doi:10.1186/1477-7525-8-131
PMCID: PMC2998470  PMID: 21073697
12.  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.
doi:10.1038/aja.2012.102
PMCID: PMC3739107  PMID: 23223034
benign prostatic hyperplasia (BPH); KMD-3213; lower urinary tract symptoms (LUTS); silodosin; tamsulosin; systematic review; meta-analysis
13.  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.
Background
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.
Methods
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).
Results
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).
Conclusions
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.
doi:10.1186/1471-2490-12-30
PMCID: PMC3503561  PMID: 23134716
Patient global impression scale; Lower urinary tract symptoms; Construct validity
14.  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.
Purpose
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.
Results
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.
Conclusions
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.
doi:10.5534/wjmh.2012.30.3.160
PMCID: PMC3623531  PMID: 23596606
Prostatic hyperplasia; KTP lasers; Transurethral resection of prostate; Urinary bladder neck obstruction
15.  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.
doi:10.3346/jkms.2010.25.1.117
PMCID: PMC2800025  PMID: 20052356
Urination Disorders; Female; Adrenergic alpha-Antagonists; Outcomes Assessment
16.  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.
Purpose
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.
Results
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.
Conclusions
Silodosin 8 mg once daily may be effective and safe in Korean patients with severe LUTS associated with BPH.
doi:10.4111/kju.2014.55.5.335
PMCID: PMC4026660  PMID: 24868338
α1A-Adrenoceptor antagonis; Benign prostatic hyperplasia; Lower urinary tract symptoms; Selective; Silodosin
17.  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.
Objective
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.
Methods
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.
Results
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.
Conclusion
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.
doi:10.1371/journal.pone.0085588
PMCID: PMC3893218  PMID: 24454896
18.  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.
doi:10.1038/aja.2011.167
PMCID: PMC3735080  PMID: 22231295
benign prostatic obstruction; laser; prostate; Revolix; Tm:YAG; ThuVEP; VapoEnucleation
19.  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 
Purpose
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.
Methods
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.
Results
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.
Conclusions
Alfuzosin may be less effective in improving symptom scores, PVR, and Qmax in the treatment of LUTS/BPH in the presence of IPP.
doi:10.5213/inj.2012.16.4.187
PMCID: PMC3547180  PMID: 23346485
Prostate; Lower urinary tract symptoms; Prostatic hyperplsia; Urinary bladder neck obstruction; Adrenergic alpha-1 receptor antagonists
20.  120 W Greenlight HPS Laser Photoselective Vaporization of the Prostate for Treatment of Benign Prostatic Hyperplasia in Men with Detrusor Underactivity 
Korean Journal of Urology  2011;52(12):824-828.
Purpose
Most men with benign prostatic hyperplasia (BPH) have bothersome lower urinary tract symptoms (LUTS). This study aimed to investigate the safety and efficacy of high-performance system (HPS) laser photoselective vaporization of the prostate (PVP) for the treatment of BPH in men with detrusor underactivity (DU).
Materials and Methods
From March 2009, 371 patients with BPH were divided into 2 groups according to the findings of preoperative urodynamic study: 239 (64.4%) patients with bladder outlet obstruction (BOO) and 132 (35.6%) patients with bladder outlet obstruction with detrusor underactivity (BOO+DU). 120 W HPS laser PVP was performed to resolve the BOO. The perioperative data and postoperative results at 1 month and 12 months, including the International Prostate Symptom Score (IPSS), maximum urinary flow (Qmax), and postvoid residual urine (PVR) values, were evaluated.
Results
Compared with the preoperative parameters, significant improvements in IPSS, Qmax, and PVR were observed in each group at 1 and 12 months after the operation. In addition, IPSS, Qmax, and PVR were not significantly different between the BOO and BOO+DU groups at 1 and 12 months after the operation.
Conclusions
Surgery to relieve BOO in the patients with BPH seems to be an appropriate treatment modality regardless of the existence of DU.
doi:10.4111/kju.2011.52.12.824
PMCID: PMC3246514  PMID: 22216394
Bladder dysfunction; Laser therapy; Prostatic hyperplasia
21.  Efficacy of Anticholinergics for Chronic Prostatitis/Chronic Pelvic Pain Syndrome in Young and Middle-Aged Patients: A Single-Blinded, Prospective, Multi-Center Study 
Purpose
Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) exhibits variable lower urinary tract symptoms (LUTS). The aim of this study was to evaluate the incidence of LUTS and the efficacy of an anticholinergic agent in young and middle-aged CP/CPPS patients.
Methods
Ninety-six men with CP/CPPS were randomly assigned in a single-blind fashion and received either ciprofloxacin (group 1, 49 patients) or ciprofloxacin and solifenacin (5 mg/day; group 2, 47 patients) for 8 weeks. The National Institutes of Health chronic prostatitis symptom index (NIH-CPSI), the International Prostate Symptom Score (IPSS), and the International Index of Erectile Function-5 (IIEF-5) were used to grade the patients' symptoms and the quality of life impact at the start of the study, and at 4 and 8 weeks from the initiation of the study.
Results
There was no significant difference between groups 1 and 2 with respect to age, duration of disease, or sub-domains of the IPSS, NIH-CPSI, or IIEF-5 at baseline. Of these patients, 67.4% had LUTS. Statistically significant differences were determined via the NIH-CPSI for total score and the pain and urinary domain scores. Statistically significant differences were determined via the IPSS for total score and the storage domain score. The total score of the IIEF-5 increased, but the change was not significant. There was no statistically significant difference in residual urine.
Conclusions
Many CP/CPPS patients had LUTS. Solifenacin in CP/CPPS demonstrated improvements in the NIH-CPSI and the IPSS total score and storage score. Storage factors significantly improved via the NIH-CPSI and IPSS assessments in the solifenacin treatment group.
doi:10.5213/inj.2011.15.3.172
PMCID: PMC3212592  PMID: 22087427
Prostate; Cholinergic antagonists; Prostatitis
22.  International Prostatic Symptom Score — Voiding/Storage Subscore Ratio in Association with Total Prostatic Volume and Maximum Flow Rate Is Diagnostic of Bladder Outlet-Related Lower Urinary Tract Dysfunction in Men with Lower Urinary Tract Symptoms 
PLoS ONE  2013;8(3):e59176.
Objectives
The aim of this study was to investigate the predictive values of the total International Prostate Symptom Score (IPSS-T) and voiding to storage subscore ratio (IPSS-V/S) in association with total prostate volume (TPV) and maximum urinary flow rate (Qmax) in the diagnosis of bladder outlet-related lower urinary tract dysfunction (LUTD) in men with lower urinary tract symptoms (LUTS).
Methods
A total of 298 men with LUTS were enrolled. Video-urodynamic studies were used to determine the causes of LUTS. Differences in IPSS-T, IPSS-V/S ratio, TPV and Qmax between patients with bladder outlet-related LUTD and bladder-related LUTD were analyzed. The positive and negative predictive values (PPV and NPV) for bladder outlet-related LUTD were calculated using these parameters.
Results
Of the 298 men, bladder outlet-related LUTD was diagnosed in 167 (56%). We found that IPSS-V/S ratio was significantly higher among those patients with bladder outlet-related LUTD than patients with bladder-related LUTD (2.28±2.25 vs. 0.90±0.88, p<0.001). TPV was similar between the two groups; however, in contrast to patients with bladder-related LUTD, patients with bladder outlet-related LUTD had higher detrusor voiding pressure, lower Qmax values, and greater postvoid residual volumes. The combination of TPV30 ml and Qmax10 ml/sec had a PPV of 68.8% and a NPV of 53.5% for bladder outlet-related LUTD. When IPSS-T12 or IPSS-T15 was considered as an additional criterion, PPV increased to 75.0% and 78.5%, respectively, and the NPV decreased to 50.9% and 50.2%, respectively. When IPSS-V/S>1 or >2 was factored into the equation instead of IPSS-T, PPV were 91.4% and 97.3%, respectively, and NPV were 54.8% and 49.8%, respectively.
Conclusions
Combination of IPSS-T with TPV and Qmax increases the PPV of bladder outlet-related LUTD. Furthermore, including IPSS-V/S>1 or >2 into the equation results in a higher PPV than IPSS-T. IPSS-V/S>1 is a stronger predictor of bladder outlet-related LUTD than IPSS-T.
doi:10.1371/journal.pone.0059176
PMCID: PMC3601066  PMID: 23527124
23.  Effects of Low-Dose Tamsulosin on Sexual Function in Patients With Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia 
Korean Journal of Urology  2013;54(10):697-702.
Purpose
The aim of the present study was to evaluate the effects of low-dose tamsulosin on sexual function in patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia.
Materials and Methods
A total of 138 male LUTS patients aged more than 50 years with an International Prostate Symptom Score (IPSS) ≥8 were enrolled in this open-label, multicenter, prospective, noncomparative observational study. Clinical assessments included IPSS, quality of life (QoL) index, International Index of Erectile Function (IIEF), Danish Prostate Symptom Score (DAN-PSS), and an early morning erection questionnaire. The data were recorded at baseline and at 1 and 3 months after treatment with tamsulosin 0.2 mg/d. Adverse events were analyzed in all patients.
Results
During the study period of 3 months, the IPSS and QoL index significantly improved from baseline by -11.40±9.40 and -1.11±1.36, respectively (p<0.001). However, there were no clinically relevant changes in total IIEF score (mean difference, 1.63±15.50; p=0.406) or the 5 subdomains (p>0.05). Furthermore, DAN-PSS weighted scores (A×B) showed no clinically relevant changes (mean difference on Q1, Q2, and Q3: -0.45±2.94, 0.27±2.50, and -1.27±2.27, p>0.05). In addition, there were no clinically significant changes in responses on the early morning erection questionnaire.
Conclusions
Tamsulosin at the dose of 0.2 mg significantly improved the IPSS and the QoL index compared with baseline. However, tamsulosin did not exhibit any significant impact on sexual function or any negative impact on ejaculatory function.
doi:10.4111/kju.2013.54.10.697
PMCID: PMC3806995  PMID: 24175045
Ejaculation; Erectile dysfunction; Lower urinary tract symptoms; Prostatic hyperplasia; Tamsulosin
24.  Medium term outcome of bipolar plasma vaporization in prostate cancer patients – A palliative modality of preserving spontaneous voiding 
Journal of Medicine and Life  2012;5(4):433-438.
Objectives:This retrospective analysis evaluated the efficiency, safety, and medium term postoperative results of bipolar plasma vaporization (BPV) in prostate cancer (PCa) cases associating complete urinary retention.
Materials and Methods: A series of 40 patients diagnosed with locally advanced or metastatic PCa and complete urinary retention requiring a Foley catheter indwelling underwent BPV aiming to restore spontaneous voiding. A total of 35 patients completed the one year evaluation protocol consisting of International Prostate Symptom Score (IPSS), quality of life score (QoL), maximum flow rate (Qmax) and post-voiding residual urinary volume (PVR), measured at 1, 3, 6 and 12 months after surgery.
Results: BPV was successfully performed in all cases with satisfactory efficiency, as confirmed by the mean operation time (42.8 minutes) and hemoglobin drop (0.7 g/dl). A fast and safe postoperative recovery period was described in this series (hematuria rate – 7.5%; mean catheterization period – 36 hours; mean hospital stay – 2.5 days; early-irritative symptoms’ rate – 15%). At 1, 3, 6 and 12 months, satisfactory values were determined in terms of IPSS, Qmax, QoL and PVR. These parameters emphasized a stable evolution throughout the entire follow-up, as 88.6% of the patients maintained spontaneous voiding.
Conclusions: The present trial confirmed the plasma-button vaporization as a promising therapeutic approach in PCa cases associating complete urinary retention. The technique displayed good efficacy, low perioperative morbidity, short convalescence, and satisfactory urodynamics and symptom score parameters during the one-year follow-up period.
Abbreviations: BPV – bipolar plasma vaporization; PCa – prostate cancer; TURP – transurethral resection of the prostate; BPH – benign prostatic hyperplasia; BOO – bladder outlet obstruction; LUTS – lower urinary tract symptoms; IPSS – International Prostate Symptom Score; QoL – quality of life score; Qmax – maximum flow rate; RV – post-voiding residual urinary volume
PMCID: PMC3539841  PMID: 23346246
bipolar plasma vaporization; prostate cancer; complete urinary retention
25.  Effect of Patient-Optimized Doses of Tamsulosin on Erectile Function in Men With Erectile Dysfunction and Lower Urinary Tract Symptoms 
Korean Journal of Urology  2013;54(2):100-105.
Purpose
To investigate the relationship of improvement in erectile function (EF) with improvement in lower urinary tract symptoms (LUTS) and to assess the contribution of tamsulosin dose to the improvement of EF apart from the indirect influence of LUTS improvement in men with LUTS and erectile dysfunction (ED).
Materials and Methods
Fifty patients received tamsulosin 0.2 mg/d for the first 4 weeks and were subsequently divided into two groups by patient-reported outcomes. Nonescalators were maintained starting dose and escalators increased to 0.4 mg for the remaining 8 weeks. International Prostatic Symptom Score (IPSS) and International Index of Erectile Function (IIEF-5), and underwent uroflowmetry were evaluated at baseline, and weeks 4 and 12.
Results
LUTS parameters were significantly improved in both groups but insignificant between the 2 groups. The degree of the improvement in the total IPSS and in the voiding, storage, and quality of life (QoL) subscores were significantly correlated with the degree of the improvement in EF; this was especially prominent in patients successfully treated LUTS. The escalators experienced a significantly greater increase in IIEF-5 scores than did the nonescalators (3.3 vs. 1.5).
Conclusions
Dose escalation provided similar LUTS improvement in patients with refractory to starting dose. The improvements of LUTS were correlated with the improvement of EF. The increase in the IIEF-5 score was significantly higher in escalators. These findings imply that tamsulosin may contribute to the improvement in EF through the improvement of LUTS and QoL and direct relaxation of the corpus cavernosum in a dose-dependent fashion.
doi:10.4111/kju.2013.54.2.100
PMCID: PMC3580298  PMID: 23550146
Erectile dysfunction; Prostatic hyperplasia; Tamsulosin

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