Safety of autologous bone marrow-derived mesenchymal stem cells in erectile dysfunction: an open-label phase 1 clinical trial.

Background Aims: The efficacy of phosphodiesterase type 5 inhibitors (PDE5Is), which are commonly used to treat erectile dysfunction (ED), is not satisfactory in patients with denervation of the cavernous nerve due to pelvic surgeries and diabetes mellitus (DM). Pre-clinical studies using bone marrow-derived mesenchymal stem cells (BMSCs) to treat ED have shown promising results. The authors conducted a phase 1 clinical trial with autologous BMSCs in patients with ED due to radical prostatectomy or DM.

Establishment of NOAEL for intracavernous injections of human bone marrow-derived mesenchymal stem cells in rats.

Purpose: To assess the possible negative health effects of human bone marrow-derived mesenchymal stem cells (hBMSCs) on fertility and early embryonic development following intracavernous injections in rats.

Materials And Methods: A total of 88 Crl:CD(SD) male and female rats were equally divided into 4 groups in a random manner: control group (normal saline), low-dose group (2×10 hBMSCs), moderate-dose group (1×10 hBMSCs), and high-dose group (2×10 hBMSCs). hBMSCs or normal saline was injected into the penis of the rats 3 times at 2-week-intervals prior to mating.

Cross-Sectional Association of Metabolic Syndrome and Its Components with Serum Testosterone Levels in a Korean-Screened Population.

Purpose: We evaluated the associations of metabolic syndrome (MetS) and its components with testosterone levels in the Korean population.

Materials And Methods: This cross-sectional study was performed among 6,967 adult (age≥20 years) men who attended health screening during 2006 to 2015. MetS was defined using the National Cholesterol Education Program Adult Treatment Panel III criteria.

Efficacy and Safety of a Fixed-Dose Combination Therapy of Tamsulosin and Tadalafil for Patients With Lower Urinary Tract Symptoms and Erectile Dysfunction: Results of a Randomized, Double-Blinded, Active-Controlled Trial.

Background: Phosphodiesterase type 5 inhibitors and α-adrenergic blocking agents (α-blockers) are widely used for the treatment of erectile dysfunction (ED) and lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).

Aims: To assess the efficacy and safety of fixed-dose combinations (FDCs) of tamsulosin and tadalafil compared with tadalafil monotherapy in patients with comorbid BPH-associated LUTS and ED.

Methods: A randomized, double-blinded, active-controlled trial was conducted of 510 men with BPH-associated LUTS and ED.

A Phase 3 Study to Evaluate the 1-Year Efficacy and Safety of Udenafil 75 mg Once Daily in Patients With Erectile Dysfunction.

Introduction: Once-daily administration of phosphodiesterase type 5 inhibitors has been shown to correct erectile dysfunction (ED).

Aim: To evaluate the long-term efficacy and safety after once-daily oral administration of udenafil 75 mg in men with ED.

Methods: This clinical trial was an open-label, fixed-dose, 24-week extension study (DA8159_EDDL_III) of a 24-week double-blinded efficacy and safety study of once-daily udenafil (parent study: DA8159_EDD_III).

Bone marrow-derived mesenchymal stromal cell therapy in a rat model of cavernous nerve injury: Preclinical study for approval.

Background Aims: Although clinical studies using stem cells to treat erectile dysfunction have been performed or are ongoing, there is little consensus on the optimal protocol. We aimed to develop a protocol optimizing human bone marrow-derived mesenchymal stromal cell (hBMSC) therapy in a rat model of cavernous nerve injury.

Methods: We performed, in order, a dose-finding study, a toxicokinetic study of hBMSCs, and a study to determine the timing and number of cell injections.

Prospective investigation of change in the prostate-specific antigens after various urologic procedures.

Purpose: Prostate-specific antigen (PSA) is the most important marker in the diagnosis and follow-up of patients with prostate cancer. The primary objective of this study was to evaluate the effect of various urologic procedures in prostatic area on serum free and total PSA levels.

Subjects And Methods: A series of 62 patients (8 after digital rectal examination [DRE], 12 after transrectal ultrasonography [TRUS], 11 after rigid cystoscopy, 13 after prostatic massage, 8 after TRUS-guided prostate biopsy, and 10 after transurethral resection of prostate [TURP]) were enrolled in the study.

Kidney Laterality and the Safety of Hand-assisted Live Donor Nephrectomy: Review of 1000 Consecutive Cases at a Single Center.

Objective: To determine the feasibility of performing right-sided, hand-assisted, laparoscopic donor nephrectomy (HALDN) and compare with the results of left-sided surgeries in both donors and recipients.

Methods: Between September 2006 and September 2013, 1000 consecutive patients underwent HALDN at our institution. Patient characteristics and the intraoperative or postoperative parameters of the donors and recipients were retrospectively evaluated.

Antibiotic prophylaxis with intravenous ceftriaxone and fluoroquinolone reduces infectious complications after transrectal ultrasound-guided prostatic biopsy.

Purpose: To assess the rates of infectious complications before and after the change of prophylactic antibiotic regimens in prostate needle biopsy.

Materials And Methods: The records of 5,577 patients who underwent prostate needle biopsy at Asan Medical Center between August 2005 and July 2012 were retrospectively reviewed. Group 1 (n=1,743) included patients treated between 2005 and 2009 with fluoroquinolone for 3 days, group 2 (n=2,723) included those treated between 2009 and 2012 with ceftriaxone once before the biopsy and fluoroquinolone before biopsy and continue therapy for 3 days, and group 3 (n=1,111) received the same treatment for more than 7 days after the biopsy.

Comparative study of autologous stromal vascular fraction and adipose-derived stem cells for erectile function recovery in a rat model of cavernous nerve injury.

The abilities of intracavernous injection of autologous stromal vascular fraction (SVF) and adipose-derived stem cells (ADSCs) to facilitate recovery of erectile function in a rat model of cavernous nerve (CN) injury were compared. Forty male Sprague-Dawley rats were randomly divided into four groups: sham and control groups (intracavernous injection of phosphate-buffered saline), SVF group (intracavernous injection of SVF), and ADSC group (intracavernous injection of ADSCs). Rats in the latter three groups underwent bilateral CN injury prior to injection.

Is intravesical Bacillus Calmette-Guérin therapy superior to chemotherapy for intermediate-risk non-muscle-invasive bladder cancer? An ongoing debate.

The objective of this study was to evaluate the risk of recurrence in patients with intermediate-risk non-muscle-invasive bladder cancer (NMIBC) after intravesical instillation with chemotherapeutic agents or Bacillus Calmette-Guérin (BCG) therapy. A cohort of 746 patients with intermediate-risk NMIBC comprised the study group. The primary outcome was time to first recurrence.

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.

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.

Evaluation of sperm deoxyribonucleic acid (DNA) damage and effects on embryo development using a mouse cryptorchidism model.

Objective: To investigate the effects of sperm deoxyribonucleic acid (DNA) damage on fertilization and embryo development using a mouse cryptorchidism model of sperm DNA damage induction.

Materials And Methods: Male ICR mice (aged 5-6 weeks) underwent cryptorchidism on their left testicles and sham operations on their right testicles. Spermatogenesis and sperm DNA fragmentation were assessed after 1, 2, and 4 weeks using hematoxylin-eosin staining, terminal deoxynucleotidyl transferase-mediated deoxyuridine triphosphate-biotin nick end labeling assays.

Comparative analysis of periprostatic implantation and intracavernosal injection of human adipose tissue-derived stem cells for erectile function recovery in a rat model of cavernous nerve injury.

Background: We compared periprostatic implantation (PPI) and intracavernosal injection (ICI) of human adipose tissue-derived stem cell (ADSC) to facilitate recovery of erectile function in a rat model of cavernous nerve (CN) injury.

Methods: Bilateral CN dissection (BCND) was induced in Sprague-Dawley rats. After BCND 10 rats each were treated with PPI and/or ICI of ADSCs.

Efficacy and safety of avanafil for treating erectile dysfunction: results of a multicentre, randomized, double-blind, placebo-controlled trial.

Unlabelled: Study Type--Therapy (RCT) Level of Evidence 1b. What's known on the subject? and What does the study add? Avanafil is a potent selective phosphodiesterase type 5 (PDE5) inhibitor newly developed for treating erectile dysfunction (ED). Preclinical and clinical phase I studies showed that avanafil had enhanced selectivity, faster onset of action and a favourable side-effect profile relative to currently available PDE5 inhibitors.

Tadalafil Administered Once Daily for Treatment of Lower Urinary Tract Symptoms in Korean men with Benign Prostatic Hyperplasia: Results from a Placebo-Controlled Pilot Study Using Tamsulosin as an Active Control.

Objectives: Assess the efficacy and safety of once-daily tadalafil or tamsulosin versus placebo during 12 weeks on lower urinary tract symptoms (LUTS) in Korean men with benign prostatic hyperplasia (BPH).

Methods: Following a 4-week placebo run-in period, 151 Korean men were randomly assigned to receive once-daily tadalafil 5 mg, tamsulosin 0.2 mg, or placebo for 12 weeks.

A therapeutic confirmatory study to assess the safety and efficacy of Zydena (udenafil) for the treatment of erectile dysfunction in male patients with diabetes mellitus.

Introduction: Patients with diabetes mellitus (DM) are reported to experience more severe erectile dysfunction (ED) symptoms and respond less to ED treatments compared with patients with ED of other etiologies.

Aim: This study was undertaken to evaluate the safety and efficacy of udenafil for the treatment of ED in a larger number of patients with DM.

Methods: A placebo-controlled, randomized, double-blind, double-dummy, parallel-group design multicenter study, fixed-dose trial was conducted.

Efficacy and safety of once-daily dosing of udenafil in the treatment of erectile dysfunction: results of a multicenter, randomized, double-blind, placebo-controlled trial.

Background: A once-daily dosing regimen with a phosphodiesterase type 5 inhibitor is needed for the treatment of erectile dysfunction (ED), in part because of the behavioral complexities associated with sexual intimacy. Many patients prefer spontaneous rather than scheduled sexual activities or they anticipate frequent sexual encounters. The pharmacokinetic profiles of udenafil with a time of maximal concentration of 1.

Efficacy and safety of oral mirodenafil in the treatment of erectile dysfunction in diabetic men in Korea: a multicenter, randomized, double-blind, placebo-controlled clinical trial.

Introduction: Mirodenafil is a newly developed selective phosphodiesterase type 5 (PDE5) inhibitor for the treatment of erectile dysfunction (ED).

Aim: To evaluate the efficacy, safety and tolerability of mirodenafil in the treatment of ED in Korean men with diabetes.

Methods: A multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study was conducted with 112 subjects who were randomized to either placebo or mirodenafil 100 mg on demand for 12 weeks.

Changes in Serum Prostate-Specific Antigen Levels after Potassium-Titanyl-Phosphate (KTP) Laser Vaporization of the Prostate.

Purpose: The prostate-specific antigen (PSA) level decreases after transurethral resection of the prostate (TURP). However, changes in the PSA level after potassium-titanyl-phosphate (KTP) laser vaporization of the prostate are not well known. The aim of this study was to investigate the effect of KTP laser vaporization of the prostate on PSA levels in patients with benign prostatic hyperplasia (BPH).

The efficacy and safety of testosterone undecanoate (Nebido(®)) in testosterone deficiency syndrome in Korean: a multicenter prospective study.

Introduction: Long-acting injectable testosterone undecanoate (TU, Nebido(®)), a new parenteral testosterone preparation, has recently been introduced to avoid frequent injections of the conventional injectable esters.

Aims: To assess the efficacy and safety of long-acting injectable testosterone undecanoate (TU, Nebido(®)) in Korean patients with testosterone deficiency syndrome (TDS).

Methods: One hundred thirty-three patients who complain of erectile dysfunction with serum testosterone level less than 3.

Efficacy and safety of oral SK3530 for the treatment of erectile dysfunction in Korean men: a multicenter, randomized, double-blind, placebo-controlled, fixed dose, parallel group clinical trial.

Aim: To evaluate the efficacy and safety of SK3530, a newly developed type 5 phosphodiesterase inhibitor (PDE5I), in Korean men with erectile dysfunction (ED).

Methods: A total of 119 patients were randomized at 10 centers in Korea to receive either SK3530 (50, 100, or 150 mg; n = 89) or placebo (n = 30) taken l h before anticipated sexual activity for an 8-week period. The patients were evaluated at baseline and 4 and 8 weeks after beginning therapy.

The efficacy and safety of udenafil, a new selective phosphodiesterase type 5 inhibitor, in patients with erectile dysfunction.

Introduction: Udenafil is a potent selective phosphodiesterase type 5 (PDE5) inhibitor newly developed for the treatment of erectile dysfunction (ED).

Aim: This study was performed to evaluate the efficacy and safety of udenafil therapy in patients with ED.

Methods: In this multicenter, double-blind, placebo-controlled, fixed-dose, parallel-group phase III trial, 167 patients with ED of diverse origin and severity were randomized to take placebo or udenafil at fixed doses of 100 or 200 mg as needed for 12 weeks.