Jeong Man Cho

Safety and Efficacy of Once Daily Administration of 50 mg Mirodenafil in Patients with Erectile Dysfunction: a Multicenter, Double-Blind, Placebo Controlled Trial

PURPOSE We evaluated the improvement in erectile dysfunction and lower urinary tract symptoms as well as the safety of once daily administration of 50 mg mirodenafil in men with erectile dysfunction. MATERIALS AND METHODS A total of 226 patients visited for treatment of erectile dysfunction and were recruited for the study. Of these men 180 met the study inclusion criteria after completing a 2-week screening period (visit [V]1). The patients were randomly allocated into 2 groups. Group 1 (90 patients) received 50 mg mirodenafil once daily and group 2 (90 patients) received a placebo daily. Blood pressure, heart rate, IIEF-5 (5-item version of the International Index of Erectile Function), and SEP (Sexual Encounter Profile) questions 2 and 3 were assessed at 4 (V2), 8 (V3) and 12 weeks after the start of treatment (V4). I-PSS (International Prostate Symptom Score), maximal flow rate and post-void residual volume were also assessed for the evaluation of lower urinary tract symptoms. RESULTS Of the 180 patients 71 in group 1 and 63 in group 2 completed the 12-week clinical trial. IIEF-5 and I-PSS significantly improved in group 1 (p <0.001 for both). Facial flushing was the most common adverse effect, followed by headaches. Notably there were no statistically significant differences in either of the variables related to the cardiovascular system. CONCLUSIONS Once daily administration of 50 mg mirodenafil was efficacious and safe for the treatment of erectile dysfunction and lower urinary tract symptoms.

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.

Clinical and Urodynamic Significance of Morphological Differences in Intravesical Prostatic Protrusion

Purpose The objectives of this study were to evaluate whether morphologic differences correlated with urodynamic and clinical characteristics in patients with benign prostatic hyperplasia (BPH) with intravesical prostatic protrusion (IPP) of trilobar or bilobar adenoma. Materials and Methods Between January 2008 and June 2009, 72 male patients who had undergone transurethral resection (TUR) owing to BPH with IPP were included in this study. They underwent preoperative urodynamic studies, the International Prostate Symptom Score (IPSS)/quality of life (QoL), maximal flow rate (Qmax), post-voiding residual urine volume (PVR), transrectal ultrasonography (TRUS), and serum prostate-specific antigen (PSA) measurement. The patients were classified into 2 groups (the trilobar and bilobar adenoma groups) on the basis of video findings during the TUR operation. Results The trilobar and bilobar adenoma groups consisted of 37 patients and 35 patients, respectively. The Mean±SD IPP, prostate volume (PV), and transition zone volume of the trilobar and bilobar adenoma groups were 11.8±5.2 mm and 9.0±3.8 mm (p=0.014), 81.1±25.8 g and 59.3±22.5 g (p<0.001), and 49.6±20.6 g and 34.8±19.4 g (p=0.003), respectively. The Mean±SD PSA, bladder contractility index (BCI), and bladder outlet obstruction index (BOOI) were 4.6±2.5 ng/ml and 3.5±1.7 ng/ml (p=0.042), 119.8±33.4 and 87.7±24.4 (p<0.001), and 62.6±29.5 and 44.6±20.4 (p=0.005), respectively. There were no significant differences in IPSS/QoL, Qmax, PVR, acute urinary retention, or detrusor overactivity in the 2 groups. Conclusions IPP has two morphologic types of trilobar or bilobar enlargement. The PV, BOOI, and BCI were significantly smaller in the bilobar adenoma group than in the trilobar adenoma group.

Experience with robot-assisted laparoscopic radical prostatectomy at a secondary training hospital: operation time, treatment outcomes, and complications with the accumulation of experience.

Purpose To investigate the learning curve and outcomes of robot-assisted laparoscopic radical prostatectomy (RALP) performed by a relatively lower volume surgeon at a secondary training hospital. Materials and Methods The medical records and the surgery video recordings of 100 patients who underwent RALP by a single surgeon between March 2010 and January 2013 were reviewed. The first 10 cases were grouped into period 1, cases 11 to 40 into period 2, cases 41 to 70 into period 3, and cases 71 to 100 into period 4. The interval between the operations, the operative time for each step of the surgery, the total console time, and the operative outcomes were investigated. Results The mean interval between surgeries was 10.6±9.3 days. The console time decreased progressively after the first 10 cases and reached under 3 hours after 75 cases. The time taken to begin dissection of the dorsal vein complex, for the division of the bladder neck, for lateral dissection with neurovascular bundle preservation, and for apex dissection decreased significantly with experience, although the time for vesicourethral anastomosis did not. The margin-positive rate of stage T2 patients was 27.4% (20/73), and the transfusion rate was 50% in period 1 patients and 3.3% in period 4 patients. No major complications occurred. Conclusions It is difficult to shorten the learning curve of surgeons in secondary training hospitals owing to the smaller number of cases and the irregular surgical intervals. Although the operation time was relatively longer, the surgical outcome and complication rates were comparable with those of surgeons at larger hospitals.

Effect of Transurethral Resection of the Prostate Based on the Degree of Obstruction Seen in Urodynamic Study

Purpose We retrospectively investigated the effect of transurethral resection of the prostate (TURP) on the basis of the degree of obstruction seen in preoperative urodynamic study in patients with benign prostatic hyperplasia (BPH) who complained of lower urinary tract symptoms (LUTS). Materials and Methods The subjects of this study were 285 patients who were diagnosed with BPH with LUTS and who subsequently underwent TURP. The Abrams-Griffiths number was calculated from the urodynamic results to divide the patients into the following groups: unobstructed, equivocal, and obstructed. There were 26 patients (9.1%) in the unobstructed group, 98 patients (34.4%) in the equivocal group, and 161 patients (56.5%) in the obstructed group. The preoperative and postoperative uroflowmetry, residual urine, International Prostate Symptom Score (IPSS), and quality of life (QoL) score were compared between the three groups to evaluate the outcome of the treatment. Results The reduction in the IPSS was 14.4 in the obstructed group, which was higher than the reductions of 12.7 in the equivocal group and 9.5 in the unobstructed group, but this difference was not statistically significant (p=0.227). The QoL score was also not significantly different across the three groups (p=0.533). The postoperative maximum flow rate was significantly improved in all three groups. The obstructed group had an improvement of 7.8±7.2 mL/s, which was higher than the improvement of 3.7±6.2 mL/s in the unobstructed group (p=0.049) but was not significantly different from the improvement of 5.6±6.9 mL/s in the equivocal group (p=0.141). Conclusions TURP led to an improvement in the maximum flow rate and LUTS even in BPH patients without BOO. Therefore, TURP can be expected to improve LUTS in BPH patients without definite urodynamic obstruction.

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.

Comparison of efficacy for erectile function and lower urinary tract symptoms of tadalafil 20 mg on-demand and 5 mg once daily in patients with erectile dysfunction

Aim:  To compare the improvement in erectile dysfunction (ED) and lower urinary tract symptoms (LUTS) as well as safety of tadalafil dosed at 20 mg on‐demand and 5 mg once daily among ED patients.

Comparison of an Indwelling Period Following Ureteroscopic Removal of Stones between Double-J Stents and Open-Ended Catheters: A Prospective, Pilot, Randomized, Multicenter Study

Purpose The aim of this study was to evaluate whether long-term, postoperative ureteral stenting is necessary after ureteroscopic removal of stones (URS) during an uncomplicated surgical procedure. Materials and Methods We prospectively examined 54 patients who underwent URS for lower ureteral stones from February 2010 to October 2010. Inclusion criteria were a stone less than 10 mm in diameter, absence of ureteral stricture, and absence of ureteral injury during surgery. We randomly placed 5 Fr. open-tip ureteral catheters in 26 patients and removed the Foley catheter at postoperative day 1. The remaining 28 patients received double-J stents that were removed at postoperative day 14 by cystoscopy under local anesthesia. All patients provided visual analogue scale (VAS) pain scores at postoperative days 1, 7, and 14 and completed the storage categories of the International Prostate Symptom Score (IPSS) at postoperative day 7. Results The VAS scores were not significantly different on postoperative day 1 but were significantly smaller in the 1-day ureteral catheter group at postoperative days 7 and 14 (p<0.01). All of the storage categories of the IPSS were significantly lower in the 1-day ureteral stent group (p<0.01). The ratio of patients who needed intravenous analgesics because of severe postoperative flank pain was not significantly different between the two groups (p=0.81). No patients experienced severe flank pain after postoperative day 2, and no patients in either group had any other complications. Conclusions One-day ureteral catheter placement after URS can reduce postoperative pain and did not cause specific complications compared with conventional double-J stent placement.

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.

Efficacy of Alfuzosin After Shock Wave Lithotripsy for the Treatment of Ureteral Calculi

Purpose We evaluated the efficacy of alfuzosin for the treatment of ureteral calculi less than 10 mm in diameter after extracorporeal shock wave lithotripsy (ESWL). Materials and Methods A randomized, single-blind clinical trial was performed prospectively by one physician between June 2010 and August 2011. A total of 84 patients with ureteral calculi 5 to 10 mm in diameter were divided into two groups. Alfuzosin 10 mg (once daily) and loxoprofen sodium 68.1 mg (as needed) were prescribed to group 1 (n=41), and loxoprofen sodium 68.1 mg (as needed) only was prescribed to group 2 (n=44). The drug administration began immediately after ESWL and continued until stone expulsion was confirmed up to a maximum of 42 days after the procedure. Results Thirty-nine of 41 (95.1%) patients in group 1 and 40 of 43 (93.0%) patients in group 2 ultimately passed stones (p=0.96). The number of ESWL sessions was 1.34±0.65 and 1.41±0.85 in groups 1 and 2, respectively (p=0.33). The patients who required analgesics after ESWL were 8 (19.5%) in group 1 and 13 (30.2%) in group 2 (p=0.31). Visual analogue scale pain severity scores were 5.33±1.22 and 6.43±1.36 in groups 1 and 2, respectively (p=0.056). The time to stone expulsion in groups 1 and 2 was 9.5±4.8 days and 14.7±9.8 days, respectively (p=0.005). No significant adverse effects occurred. Conclusions The use of alfuzosin in combination with ESWL seems to facilitate stone passage and to reduce the time of stone expulsion but does not affect the stone-free rate.