Effect of low-dose tadalafil once daily on glycemic control in patients with type 2 diabetes and erectile dysfunction: a randomized, double-blind, placebo-controlled pilot study.

BACKGROUND: Phosphodiesterase type 5 inhibitors restore nitric oxide signaling, that plays a significant role in erectile function, and appears to counteract insulin resistance in animal and human models. This study was aimed to evaluate the glycemic and metabolic effects of low-dose tadalafil once daily in patients with type 2 diabetes and erectile dysfunction. METHODS: A 6-month, randomized, double-blind, placebo-controlled pilot trial was conducted. Eligible patients were randomly assigned in a ratio of 2:1 to the tadalafil 5 mg and placebo groups; all patients received either tadalafil or placebo once a day. The primary efficacy endpoint was the absolute change in glycated hemoglobin (HbA1c) levels during the 6-month study period. The secondary efficacy endpoints included metabolic parameters and erectile function. RESULTS: Of the 68 patients who completed this study, 45 and 23 patients were allocated to the tadalafil and placebo groups, respectively. The mean HbA1c level was significantly different between the groups over the 6-month study period (P = 0.021). After 6 months of treatment, the HbA1c decrement in the tadalafil group was greater than that in the placebo group (- 0.14 ± 0.53% vs. 0.20 ± 0.69%, P = 0.030). The International Index of Erectile Function-5 scores improvement was significantly greater in the tadalafil group than in the placebo group at 6 months (P = 0.003). CONCLUSION: This prospective pilot study showed that low-dose tadalafil administered once a day was effective in improving glycemic control and erectile function in patients with type 2 diabetes and erectile dysfunction. Trial registration KCT0005666.

Lower Urinary Tract Symptoms in Prostate Cancer Patients Treated With Radiation Therapy: Past and Present.

The incidence of prostate cancer (PCa) is increasing concomitantly with population aging. Accordingly, interest in radiation therapy (RT) and the frequency of RT are also increasing. The types of RT can be broadly divided into external beam RT (EBRT), brachytherapy (BT), and combination therapy (EBRT+BT). Lower urinary tract symptoms (LUTS) after RT for the treatment of PCa are common; however, there are few reviews on the relationship between RT and LUTS. Herein, we review the causes and incidence of LUTS, as well as the evaluation and treatment options. Because of the reported risks of RT, patients undergoing RT should be counseled regarding the challenges of treatment and informed that they may have higher failure rates than nonirradiated patients. Moreover, thorough evaluation and treatment strategies are needed to support treatment recommendations. With a review of the existing literature, this narrative article provides an overview to aid urologists in treating patients presenting with complications associated with RT for the treatment of PCa. Further research is required to provide evidence of the effectiveness and feasibility of the management approach to the care of patients with LUTS after RT for the treatment of PCa.

Effect of daily tadalafil on reported outcomes in patients with erectile dysfunction and depressive symptoms: STROBE, a case-control study.

Erectile dysfunction (ED) and depression are closely related. We sought to determine ED and depression were improved by tadalafil, a phosphodiesterase type 5 (PDE5) inhibitor, at 5 mg daily, in this case-control study.Participants were men aged 20 to 65 years with ED for >3 months, International Index of Erectile Function-5 (IIEF) score <21 points, and Zung Self-Rating Depression Scale (SDS) survey result >50 points who were willing to participate.On first visit (V1) and after 1 (V2) and 2 months (V3), clinical features were examined using IIEF-5 for diagnosing and evaluating ED, SDS for evaluating depression, and International Prostate Symptom Score and Quality of Life (IPSS/QoL) survey for examining lower urinary tract symptoms (LUTS). Tadalafil 5 mg was administered daily for 2 months.A total of 60 participants were an average age of 58.68 ± 6.71 years. Patient overall average IIEF was 8.76 ±â€Š5.98, showing mild ED symptoms, and total average IPSS 13.74 ±â€Š7.55 showed moderate LUTS. Average overall SDS index was 58.93 ±â€Š9.21, indicating moderate-to-severe findings. Average change in IIEF among all patients revealed significant improvement from V1 to V2 (-2.69 ±â€Š1.22, P = .03) and V1 to V3 (-4.38 ±â€Š1.20, P < 0.01). IPSS also significantly improved from V1 to V3 (3.48 ±â€Š1.37, P = .01), as did SDS index (V1, V2: 4.69 ±â€Š1.89, P = 0.02), (V1, V3: 5.43 ±â€Š1.89, P < .01). Patients with severe IIEF scores (group 1, n = 27) experienced significantly greater improvement in IIEF from V1 to V2 and V1 and V3, compared to those with mild-to-moderate IIEF scores. Both groups improved in SDS index from V1 to V2 and V1 to V3, with the greatest improvement between V1 and V3 for group 1 and V1 and V2 for group 2.Daily tadalafil 5 mg could be helpful for ED patients with depressive symptoms and improved LUTS and quality of life.

Can Prostate-Specific Antigen Kinetics before Prostate Biopsy Predict the Malignant Potential of Prostate Cancer?

PURPOSE: To predict the malignant potential of prostate cancer (PCa) according to prostate-specific antigen velocity (PSAV), PSA density (PSAD), free/total PSA ratio (%fPSA), and digital rectal examination (DRE). MATERIALS AND METHODS: From January 2009 to December 2012, 548 adult male patients were diagnosed with PCa by prostate biopsy at four hospitals in Korea. We retrospectively analyzed 155 adult male patients with an initial PSA level≤10 ng/mL and whose PSA levels had been checked more than two times at least 6 months before they had been diagnosed with PCa, with test intervals of more than 3 months. Patients with a urinary tract infection, and patients who had previously undergone cystoscopy or surgery of the prostate were excluded. We separated patients into two groups according to Gleason sum [Gleason sum≤7 (n=134) or Gleason sum≥8 (n=21)] and the presence of extracapsular invasion [organ confined (n=129) or extracapsular invasion (n=26)]. Differences between the groups were compared. RESULTS: The group with a Gleason sum≥8 or extracapsular invasion of PCa showed high PSAV and significantly lower %fPSA. There were no significant differences in PSAD and the presence of an abnormality on DRE between two groups. CONCLUSION: In PCa patients treated with other therapies besides prostatectomy, a high PSA velocity and a low %fPSA may predict high grade PCa with a Gleason sum≥8 or the presence of extracapsular invasion.

The effects of hyaluronic acid and carboxymethylcellulose in preventing recurrence of urethral stricture after endoscopic internal urethrotomy: a multicenter, randomized controlled, single-blinded study.

BACKGROUND: To evaluate the effects of hyaluronic acid (HA) and carboxymethylcellulose (CMC) on the recurrence of urethral stricture after treatment with endoscopic internal urethrotomy (EIU). METHODS: A total of 120 patients underwent EIU for urethral stricture. Recruited patients were randomly divided into two groups: group A and B. Patients in group A (60 patients, experimental group) received HA/CMC instillation and patients in group B (60 patients, control group) received lubricant instillation after internal urethrotomy. Each patient was evaluated at 4 weeks (V1), 12 weeks (V2), and 24 weeks (V3) after the surgery. The effectiveness of HA/CMC instillation was evaluated based on the International Prostate Symptom Score/Quality of Life, peak urine flow rate, voided volume and postvoiding residual urine volume. The visual analogue scale (VAS) pain score and degree of satisfaction were also determined for each participant. RESULTS: Among 120 initial participants, 53 patients in group A and 48 patients in group B had completed the experiment. VAS pain scores were 0.67±0.76 and 3.60±1.52 (p<0.001), and degrees of satisfaction were 0.28±0.50 and 0.80±0.81 in group A and group B at 1 month after surgery (p=0.001). The recurrence of urethral stricture was observed in five cases (9.4%) in group A and 11 (22.9%) in group B (p=0.029). CONCLUSIONS: HA/CMC instillation during EIU may decrease the incidence of urethral stricture recurrence. In addition, the use of HA/CMC was effective in reducing pain during the early postoperative period without an adverse effect.

Effects of hyaluronic acid and carboxymethylcellulose on urethral stricture after transurethral resections of the prostate for benign prostatic hyperplasia: a multicenter, single blinded, randomized controlled study.

PURPOSE: To evaluate the effect of hyaluronic acid (HA) and carboxymethylcellulose (CMC) instillation after transurethral resection of the prostate (TURP) on preventing urethral stricture. PATIENTS AND METHODS: A total of 180 patients underwent TURP for benign prostatic hyperplasia. Recruited patients were randomly divided into two groups: Groups A and B. Patients in group A (90 patients, experimental group) received HA/CMC instillation, and patients in the group B (90 patients, control group) received lubricant instillation after TURP. Each patient was evaluated at 4 weeks (V1), 12 weeks (V2), and 24 weeks (V3) after the surgery. The effectiveness of HA/CMC instillation was evaluated based on the International Prostate Symptom Score/Quality of Life, peak urine flow rate, voided volume, and postvoid residual volume. The visual analogue scale (VAS) pain score and degree of satisfaction were also determined for each participant. RESULTS: Among 180 initial participants, 80 patients in group A and 81 patients in group B had completed the experiment. VAS pain scores were 0.75±0.75 and 1.75±1.37 (P<0.001), and degrees of satisfaction were 0.63±0.66 and 0.91±0.51 in group A and group B at 1 month after surgery (P=0.002). By retrograde urethrography, urethral stricture after TURP was seen in 1 of 80 subjects in group A and 7 of 81 subjects in group B. CONCLUSIONS: HA/CMC instillation after TURP decreased the incidence of urethral stricture. In addition, HA/CMC was effective at reducing pain during the early postoperative period, with no adverse effects.

Inhibition of adhesion and fibrosis improves the outcome of epididymectomy as a treatment for chronic epididymitis: a multicenter, randomized controlled, single-blind study.

PURPOSE: We measured the effectiveness of inhibition of adhesion and fibrosis on patient outcomes after epididymectomy as a treatment for chronic epididymitis. MATERIALS AND METHODS: An initial cohort of 152 patients was treated conservatively for chronic epididymitis. Of these patients 43 did not respond to conservative treatment and following informed consent they were enrolled in the clinical trial. The patients were randomized into 2 groups so that 22 underwent epididymectomy with concurrent administration of the inhibitors of adhesion and fibrosis hyaluronic acid and carboxymethylcellulose (group 1), and 21 underwent epididymectomy only (group 2). Visual analog pain scores and patient satisfaction scores were obtained at postoperative weeks 4, 12 and 24. RESULTS: There were no postoperative complications such as wound infection or hematoma in either group. One patient was lost to followup from group 1 and 2 were lost from group 2. At postoperative week 24, 12 patients (57.1%) from group 1 and 3 (15.8%) from group 2 were pain-free, 6 (28.6%) from group 1 and 6 (31.6%) from group 2 exhibited limited pain relief, 2 (9.5%) from group 1 and 7 (36.8%) from group 2 exhibited no pain relief, and 1 (4.8%) from group 1 and 3 (15.8%) from group 2 exhibited recurrence of pain after initial resolution at earlier followup intervals (p = 0.028). CONCLUSIONS: Inhibition of adhesion and fibrosis after epididymectomy as a treatment for chronic epididymitis improves pain relief and patient satisfaction.

Usefulness of a myofascial trigger point injection for groin pain in patients with chronic prostatitis/chronic pelvic pain syndrome: a pilot study.

OBJECTIVE: To investigate the therapeutic effectiveness of trigger point injection into the muscles around the groin in patients with clinically diagnosed chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). DESIGN: Prospective, unicenter trial. SETTING: University rehabilitation hospital. PARTICIPANTS: Patients (N=21) with clinically diagnosed CP/CPPS who are suspected of having myofascial pain syndrome. INTERVENTION: Ultrasound-guided trigger point injection. MAIN OUTCOME MEASURES: Visual analog scale (VAS), National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score, and injection-associated complications. RESULTS: Ultrasound (US)-guided trigger point injection of the iliopsoas, hip adductor, and lower abdominal muscles resulted in excellent outcomes. The mean values of the NIH-CPSI score decreased significantly from 20.2 pretreatment to 12.5 after the first treatment (P<.05). The mean values of VAS decreased significantly from 6.3 pretreatment to 2.9 after the first treatment (P<.05). CONCLUSIONS: In patients with CP/CPPS, US-guided trigger point injections of the iliopsoas, hip adductor, and abdominal muscles are safe and effective for both diagnosis and treatment when the cause of groin pain is suspected to originate from muscles. In particular, the iliopsoas muscle was affected in all patients in this study.

Prostate cancer in patients with metabolic syndrome is associated with low grade Gleason score when diagnosed on biopsy.

PURPOSE: Studies on the relationship of metabolic syndrome (MS) and prostate cancer are controversial. We evaluated the association between MS and prostate cancer characteristics in patients who underwent transrectal ultrasound-guided prostate biopsy. MATERIALS AND METHODS: From October 2003 to May 2011, patients with a prostate-specific antigen (PSA) value≥4 ng/ml or abnormal digital rectal examination (DRE) result underwent transrectal ultrasound-guided prostate biopsy. MS was diagnosed according to the Adult Treatment Panel III. Clinicopathologic factors including PSA, DRE, prostate volume, age, waist circumference, body mass index (BMI), lipid profiles, fasting blood sugar level, and MS were considered for analysis. RESULTS: Three hundred fifty-four patients were enrolled (mean age, 68.86±8.95 years; mean PSA, 13.97±20.42 ng/ml). Seventy-five patients (21.2%) had MS and 90 patients (25.4%) were diagnosed as having prostate cancer, including 27 (30%) with MS and 63 (70%) without MS. Total PSA value and prostate volume were significant predictors for prostate cancer. However, MS and BMI were not significantly related to increased cancer risk. Prostate cancer patients with MS had significantly lower Gleason scores (average, 6.63±1.92) than did prostate cancer patients without MS (average, 7.54±1.71; p=0.029). CONCLUSIONS: Presence of MS was associated with a significantly decreased risk of high-grade prostate cancer. A larger, prospective, multicenter investigation is mandatory to clarify the relationship between MS and prostate cancer.

Combined tadalafil and α-blocker therapy for benign prostatic hyperplasia in patients with erectile dysfunction: a multicenter, prospective study.

This prospective study evaluated the safety of tadalafil 5 mg taken once a day in terms of hypotensive side effects and whether it improves lower urinary tract symptoms (LUTS) and restores sexual function in patients with erectile dysfunction who are receiving concomitant α-blocker (AB) therapy for benign prostatic hyperplasia (BPH). A total of 158 LUTS/BPH patients receiving AB therapy for ≥3 months were given tadalafil 5 mg once a day. Before treatment with tadalafil (V1), and 4 weeks (V2) and 12 weeks (V3) after starting tadalafil, blood pressure, heart rate, International Prostate Symptom Score (IPSS), maximal urine flow rate (Qmax), postvoiding residual urine volume, and International Index of Erectile Function (IIEF-5) score were measured. Of the 158 LUTS/BPH patients, a total of 119 completed the trial. Blood pressure (systolic and diastolic) and heart rate did not change. IPSS and IIEF-5 scores improved significantly, but Qmax and postvoiding residual urine volume did not; however, in the 39 men with a low baseline Qmax (≤10 mL/s), Qmax rose significantly from 7.97 ± 1.44 mL/s (baseline) to 8.91 ± 1.60 mL/s (V3; P = .012). The remaining patients (baseline Qmax >10 mL/s) did not change. At V2 and V3, adverse side effects were observed in 10 men (7.30%) and 6 men (5.04%), respectively. Facial flushing was the most common adverse side effect (6 men at V2 and 4 men at V3), followed by headache (2 men each at V2 and V3) and dizziness (2 men at V2). Two patients dropped out of the study because of adverse side effects. In conclusion, tadalafil 5 mg once a day in combination with AB appeared to have few adverse effects on hypotensive events and can improve LUTS and restore sexual function.

Factors affecting the improvement of the initial peak urinary flow rate after transurethral resection of the prostate or photoselective vaporization of the prostate for treating benign prostatic hyperplasia.

PURPOSE: We evaluated the factors that affect the improvement of the initial peak flow rate after transurethral resection of the prostate (TURP) or photoselective vaporization of the prostate (PVP) for benign prostatic hyperplasia (BPH) patients by using noninvasive tools. METHODS: One hundred and twenty seven BPH patients who had undergone TURP or PVP between January 2005 and May 2009 were evaluated. They were divided into 2 groups: the postoperative initial peak urinary flow rate (Qmax) was less than 10 mL/sec (Group 1; n=37, TURP=11, PVP=26) and more than 10 mL/sec (Group 2; n=90, TURP=41, PVP=49). We confirmed the patients' preoperative check lists. The check list were the international prostate symptom score (IPSS), the quality of life score, a past history of acute urinary retention (AUR), body mass index and/or pyuria, the serum prostate-specific antigen (PSA) level and the prostate volume, the prostate transitional zone volume and prostatic calcification. The initial Qmax was measured at the outpatient clinic one week after discharge. RESULTS: The improvement rate was not significant difference between the TURP group (78.8%) and the PVP group (65.3%). The efficacy parameters were the IPSS-storage symptom score, the prostate volume, the PSA level and a past history of AUR. The IPSS-storage symptom scores of Group 1 (12.3±3.3) was higher than those of Group 2 (10.5±1.7). The prostate volume of Group 2 (42.3±16.6 g) was bigger than that of Group 1 (36.6±7.8 g). The PSA level of Group 2 (3.8±2.6 ng/mL) was higher than that of Group 1 (2.6±2.6 ng/mL). A past history of AUR in Group 1 (35.1%) was more prevalent than that of Group 2 (15.6%). CONCLUSIONS: The non-invasive factors affecting the initial Qmax after TURP or PVP were the IPSS-storage symptom score, the prostate volume and a past history of AUR. Accordingly, in patients who have a higher IPSS-storage symptom score, a smaller prostate volume and a history of AUR, there might be a detrimental effect on the initial Qmax after TURP or PVP. These factors might also be used as long-term prognostic factors.

The effect of posterior colporrhaphy performed concurrently with midurethral sling surgery on the sexual function of women with stress urinary incontinence.

PURPOSE: Some women choose to undergo posterior colporrhaphy (PC) concurrently with procedures for SUI to regain sexual confidence and improve sexual function. We determine the effect of PC on sexual function in women requiring a midurethral sling for SUI. MATERIALS AND METHODS: A total of 119 women were retrospectively reviewed 81 women had the midurethral sling alone (Group A), and 38 women voluntarily had PC concurrently with the midurethral sling (Group B). Sexual function was evaluated using the FSFI before and after surgery. RESULTS: THE POSTOPERATIVE COMPOSITE SCORES WERE SIGNIFICANTLY INCREASED IN BOTH GROUPS (GROUP A: p=0.02; Group B: p=0.04), and significant increases were observed in 'desire,' 'arousal' and 'satisfaction'. However, there were no significant differences in the composite score or six domainscores between the two groups. CONCLUSION: PC performed concurrently with midurethral sling for treatment of SUI does not provide any additional benefits towards improving the sexual function.

Efficacy and Safety of Tadalafil 5 mg Administered Once Daily in Korean Men with Erectile Dysfunction: A Prospective, Multicenter Study.

PURPOSE: The aim of this study was to evaluate the efficacy of a daily dose of tadalafil 5 mg as well as its safety for the cardiovascular system in men with erectile dysfunction. MATERIALS AND METHODS: This study included a total of 162 men who were administered a daily dose of tadalafil 5 mg between April and December of 2009. A total of 127 men completed the 8-week clinical trial. The International Index of Erectile Function (IIEF)-5, blood pressure, and heart rate were measured before treatment with tadalafil (V1) and 4 (V2) and 8 weeks (V3) after treatment with tadalafil. Adverse effects were assessed at V1, V2, and V3. In cases in which the International Prostate Symptom Score (IPSS) was ≥8 at V1, maximal flow rate (Qmax) and postvoid residual volume (PVR) were measured. RESULTS: The IIEF-5 values were 11.25±3.18, 14.56±3.79, and 16.91±3.56 at V1, V2, and V3, respectively, with significant improvement (V1 vs. V2, p<0.001; V1 vs. V3, p<0.001). The IPSS values were 10.59±5.56, 9.07±6.06, and 8.15±6.10 at V1, V2, and V3, respectively, and the differences were statistically significant (V1 vs. V2, p<0.001; V1 vs. V3, p<0.001). There were no significant differences in blood pressure or heart rate. Adverse effects were observed in 7 men (5.51%) at V2 and in 5 men (3.94%) at V3. CONCLUSIONS: Tadalafil 5 mg administered once-a-day may be effective in improving erectile function. Adverse effects on the cardiovascular system may be minimal. In addition, it is believed that this may also be effective in improving voiding symptoms.

Usefulness of the NMP22BladderChek Test for Screening and Follow-up of Bladder Cancer.

PURPOSE: We evaluated the usefulness of the nuclear matrix protein 22 BladderChek (NMP22BC) test for the screening and follow-up of bladder cancer. MATERIALS AND METHODS: From February 2006 to September 2009, we enrolled 1,070 patients who had hematuria or who were being followed up for bladder cancer. We compared the sensitivity and specificity of the NMP22BC test with those of urine cytology. RESULTS: The sensitivity of the NMP22BC test (77.5%) was significantly higher than that of urine cytology (46.3%). The specificity of the NMP22BC test was 88.8%, compared with 97.9% for urine cytology. The sensitivity of the NMP22BC test (81.8%) in non-muscle-invasive bladder cancer was higher than that of cytology (36.4%). However, the sensitivity of the NMP22BC test and of urine cytology in invasive bladder cancer were 57.1% and 92.9%, respectively. The sensitivity of the NMP22BC test was higher for low-grade bladder cancer (83.9%) than for high-grade (62.5%), and the sensitivity of cytology was higher for high-grade bladder cancer (66.7%) than for low-grade (37.5%). Follow-up bladder cancer was detected in 262 patients. The sensitivity of the NMP22BC test in that group (72.7%) was decreased and the specificity (91.7%) was increased. The sensitivity of cytology (54.5%) in the follow-up group was increased and the specificity (95.6%) was decreased. The presence of pyuria was significantly associated with the lower specificity of the NMP22BC test. CONCLUSIONS: The greater sensitivity of the NMP22BC test may be more useful for the diagnosis of non-muscle-invasive bladder cancer and low-grade bladder cancer than for the diagnosis of invasive or high-grade bladder cancer. If the NMP22BC test is performed in the absence of pyuria, it may play a compensatory role for urine cytology.