Urinary Incontinence Could Be Controlled by an Inflatable Penile Prosthesis.

PURPOSE: Due to the increasing numbers of radical prostatectomies (RP) performed for prostate cancer, a substantial and increasing number of patients suffer from postoperative urinary incontinence and erectile dysfunction (ED). The objective of our study was to see whether an inflatable penile prosthesis implantation could control urinary incontinence for patients with the dual problems of ED and incontinence. MATERIALS AND METHODS: From March 2010 through May 2015, 25 post-RP patients were referred to our clinic with ED or incontinence. The degree of incontinence was classified according to the International Consultation on Incontinence Questionnaire-Short Form. Inflatable penile prostheses were implanted in all 25 patients. RESULTS: For one month after implantation, partial or full inflation was performed progressively to control urine leakage. Of 18 patients, 13 patients were categorized with mild or moderate stress incontinence. All 13 patients obtained control of incontinence with partial inflation (30% to 60%) and all reported satisfactory outcomes. Five out of the 18 patients were categorized with severe total incontinence. Three of the 5 patients could tolerate incontinence with full inflation on and off. Thirteen patients out of the total of 18 (72.2%) had their incontinence controlled by an inflating penile prosthesis. CONCLUSIONS: An inflatable penile prosthesis is highly recommended as an initial procedure, especially in patients with the dual problems of ED and incontinence.

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. MAIN OUTCOME MEASURES: Primary efficacy variable was the erectile function (EF) domain scores of the International Index of Erectile Dysfunction (IIEF) questionnaire. Secondary efficacy variables included change in the scores of IIEF question 3 and 4 (IIEF Q3 and Q4) from baseline, change in all domain scores in the IIEF from baseline, Sexual Encounter Profile questions 2 and 3 (SEP2 and SEP3), the Global Assessment Question (GAQ) and the Life Satisfaction Checklist (LSC). RESULTS: After 12 weeks of treatment, mirodenafil group showed significantly greater change in the IIEF-EF domain score from baseline compared with the placebo group (9.3 vs. 1.4, P < 0.0001). The changes from baseline in the mirodenafil group in IIEF Q3 (1.7 vs. 0.4, P < 0.0001) and Q4 (1.7 vs. 0.3, P < 0.0001) were higher compared with the placebo group. Differences between the mirodenafil and placebo groups were significant in the SEP2 (82.0% vs. 55.2%, P = 0.0003), SEP3 (68.9% vs. 22.3%, P < 0.0001). Difference in GAQ "YES" responses was also significant (76.9% vs. 19.1%, P < 0.0001). Normal EF domain scores (≥ 26) at study end were achieved by 32.7% and 9.4% in the mirodeniafl and placebo groups, respectively (P = 0.0031). As for the LSC scores, the mirodenafil group showed significantly greater improvements in sexual life and partner relationship than the placebo group. Most treatment-associated AEs were mild that resolved spontaneously. CONCLUSIONS: Mirodenafil is an effective and well-tolerated agent for the treatment of diabetic patients with ED in Korea.

AMS 700CX/CXM inflatable penile prosthesis has high mechanical reliability at long-term follow-up.

INTRODUCTION: AMS 700CX/CXM inflatable penile prosthesis is increasingly applied for the treatment of erectile dysfunction (ED). However, there are a few long-term survival data of the inflatable penile prosthesis (IPP) over 10 years. AIM: To determine the long-term mechanical reliability of AMS 700CX/CXM inflatable penile prosthesis in patients with ED. METHODS: A total of 438 consecutive patients with ED received implantation of an AMS 700CX/CXM penile prosthesis at our institution from January 1991 to April 2009. In 397 patients (90.7%), the medical records were available and current status of penile prosthesis could be obtained by a direct telephone interview. The overall and mechanical survival rates of penile prosthesis were evaluated using Kaplan-Meier method. MAIN OUTCOME MEASURES: Assessing the mechanical and overall survival rates of the AMS 700CX/CXM penile prosthesis using Kaplan-Meier analysis, and looking for clinical factors related to survival of the CX/CXM using log-rank test. RESULTS: Mean age of 397 patients was 63.1 years (range, 24-93) and follow-up duration was 113 months (range 1-219). Eighty-two patients (20.6%) experienced mechanical failure at a median follow-up of 82 months. Mechanical survival rate of the penile prosthesis was 97.6%, 93.2% and 78.2% at 3, 5, and 10 years after implantation, respectively. 12 patients (3.0%) experienced nonmechanical failure including infections, tissue erosion resulting in cylinder protrusion at the meatus and chronic discomfort. Overall survival rate of the penile prosthesis was 95.0%, 91.0% and 75.5% at 3, 5, and 10 years after implantation, respectively. Patients with neurogenic cause for ED showed lower median overall survival of penile prosthesis compared with patients with non-neurogenic cause. Patient age, obesity, and diabetes mellitus had no association with overall survival of penile prosthesis after implantation. CONCLUSIONS: The AMS 700CX/CXM could be accepted and applied in more patients as a reliable treatment alternative of ED.

Efficacy and safety of tadalafil taken as needed for the treatment of erectile dysfunction in Asian men: results of an integrated analysis.

We evaluated the efficacy and safety of as-needed tadalafil in a diverse clinical population (with varying patient demographics, disease severity, and comorbid medical conditions) of Asian men with erectile dysfunction (ED). An integrated analysis of five double-blind, placebo-controlled trials (N = 1 046) was performed. Patients were randomly assigned to receive 10 mg tadalafil (N = 185), 20 mg tadalafil (N = 510), or placebo (N = 351). Efficacy assessments included the International Index of Erectile Function (IIEF), Sexual Encounter Profile (SEP) diary and Global Assessment Question (GAQ). Patients receiving 10 mg or 20 mg tadalafil showed significant improvement from baseline-to-end point on the Erectile Function domain of the International Index of Erectile Function (IIEF-EF) domain score in all clinical sub-populations analyzed, compared with patients receiving placebo (P < 0.001). The 10-mg and 20-mg tadalafil groups showed a mean success rate of 64.1% and 70.5% for sexual intercourse attempts (SEP3, successful intercourse), respectively, compared with 33.4% in the placebo group (P < 0.001), and 85.5% and 85.4% reported improved erections at end point GAQ, respectively, versus 43.5% in the placebo group (P < 0.001). Tadalafil was well tolerated across all groups studied. Headache and back pain were the most frequently reported adverse events. Overall, tadalafil was effective and well tolerated across a diverse clinical spectrum of Asian men with ED.

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. Efficacy was assessed using the International Index of Erectile Function (IIEF), Sexual Encounter Profile (SEP), and the Global Assessment Question (GAQ). Safety was analyzed by adverse events, laboratory values and vital signs. RESULTS: At the end of the study, all the primary and secondary efficacy end-points were statistically significantly improved by SK3530 compared with placebo (P<0.05). Of the 89 patients in the treatment arm, 36 (42.3%) achieved normal erectile function after treatment, including six patients with severe ED. Treatment-related adverse events occurred in 32 patients. The most common adverse events were flushing, headache, dizziness and eye redness (10.9%, 7.6%, 2.5% and 2.5%, respectively), and most were mild. Only two patients discontinued treatment during the study period because of adverse events. CONCLUSION: The results of our phase II study have confirmed the efficacy and safety of SK3530 in a broad population of men with ED of various etiologies and severity. The optimal doses in terms of efficacy and safety were determined to be 50 mg and 100 mg, respectively.

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. MAIN OUTCOME MEASURES: Primary efficacy variable was change from baseline in erectile function (EF) domain scores of the International Index of Erectile Dysfunction (IIEF) questionnaire. Secondary efficacy variables include change from baseline in scores on the IIEF Questions 3 and 4 (IIEF Q3 and Q4), change from baseline in all domain scores of the IIEF, patients' responses to questions 2 and 3 of the Sexual Encounter Profile (SEP2 and SEP3), and patients' responses to the Global Assessment Question (GAQ). Any adverse events were also recorded during the trial. RESULTS: After 12 weeks of treatment, the patients treated with udenafil showed significantly greater change from baseline in the IIEF-EF domain score compared with placebo (placebo, 0.20; 100-mg udenafil, 7.52; and 200-mg udenafil, 9.93, respectively) (P < 0.0001). Compared with placebo, udenafil significantly enhanced the rates of successful penetration (SEP Q2) and maintenance of erection (SEP Q3) (P < 0.0001). Furthermore, significantly greater proportions of udenafil treatment groups responded positively to the GAQ compared with the placebo group (GAQ: placebo, 25.9%; 100-mg udenafil, 81.5%; and 200-mg udenafil, 88.5%, respectively) (P < 0.0001). Treatment-related adverse events were generally mild to moderate with facial flushing and headache being the most common. CONCLUSIONS: Udenafil is an effective and well-tolerated therapy for ED of broad-spectrum etiology and severity.

Plasma transforming growth factor-beta1 levels in patients with erectile dysfunction.

AIM: To evaluate the plasma TGF-beta1 level in erectile dysfunction (ED) patients of various causes. METHODS: Sixty-two patients with ED and 26 potent men were subjected to the study. Based on multidisciplinary work-ups, including medical history, physical examinations, blood tests with lipid profile and hormones, penile duplex Doppler ultrasonogram and neurophysiological tests, causes for ED were classified as psychogenic (n=15), neurogenic (n=16) and vasculogenic (n=31). The plasma TGF-beta1 level was measured by the ELISA method. RESULTS: The plasma TGF-beta1 level was significantly increased in the ED group (6.7+/-4.9 ng/mL), compared to the control (4.0 +/-2.1 ng/mL) (P<0.01). In the ED groups, there was a significant increase in the vasculogenic group (9.0 +/-5.5 ng/mL), compared to the psychogenic (3.8 +/-1.8 ng/mL) and neurogenic groups (4.8+/-3.2 ng/mL) (P<0.01). Of the vascular risk factors, both the smoking (7.5 +/-4.7 ng/mL) and dyslipidemia groups (7.4+/-4.4 ng/mL) showed significantly increased plasma TGF-beta1 levels, compared to the non-smokers (5.5+/-2.8 ng/mL), and those without dyslipidemia (4.8+/-2.8 ng/mL) (P<0.05). CONCLUSION: Vascular risk factors are associated with an elevated plasma TGF-beta1 level, which may contribute to cavernous fibrosis and ED.

The penile implant for erectile dysfunction.

INTRODUCTION: Penile prostheses, introduced as the first effective organic treatment for erectile dysfunction over three decades ago, have an important role in the treatment of erectile dysfunction when other nonprosthetic treatment options have proven unsatisfactory. Although they are the least chosen and most invasive treatment option, they have the highest satisfaction rate of all available ED options and provide a predictable and reliable result. AIM: To provide recommendations/guidelines concerning state-of-the-art knowledge for utilization of the penile prosthesis in the management of men with erectile dysfunction. METHODS: An International Consultation in collaboration with the major sexual medicine associations assembled over 200 multidisciplinary experts from 60 countries into 17 committees. Committee members established specific objectives and scopes for various sexual medicine topics. The recommendations concerning state-of-the-art knowledge in the respective sexual medicine topic represent the opinion of experts from five continents developed in a process over a 2-year period. There were 10 experts from seven countries concerning the Penile Implant for Erectile Dysfunction. MAIN OUTCOME MEASURE: Expert opinion was based on grading of evidence-based medical literature, widespread internal committee discussion, public presentation and debate. RESULTS: Recommendations/guidelines for penile prosthesis (hydraulic, semi-rigid and soft silicone) insertion for management of men with erectile dysfunction were updated. Consensed issues included: criteria for patient selection, informed consent procedures, strategies for preoperative preparation, operative incisions/technical considerations and outcome results in terms of patient satisfaction and device survival. Updated information was reviewed concerning therapies for device failures, device insertion in scarred corporal bodies and strategies for managing implant infections. CONCLUSIONS: There is a need for more research in developing management strategies for insertion of penile prostheses in men with ED.

SS-penogram: a new diagnostic test for erectile dysfunction.

The clinical reports on Sildenafil sulfate (Viagra) are mainly based on individual observations. However, there is a paucity of objective studies in the literature. In order to objectively examine the effect of Sildenafil, a SS (Sexual Stimulation)-Penogram that is a non-invasive, simple and physiologic method was developed using a radioisotope (RI). One hundred and four SS-penograms were performed on patients who had a documented erectile dysfunction (ED) lasting for more than 6 months. After an intravenous injection of 99mTc-RBC (15 mCi), the first penogram was taken immediately after sexual stimulation, which was done by 30 minutes of erotic videotape viewing. Forty minutes after administering 25 to 100 mg of Sildenafil, a second penogram was taken. The characteristics of each penogram were analyzed according to a previously reported method. The results were graded as follows; Type I(normal function; 5 min or more of peak erectile response with an induction period of 1 to 6 min), Type II-A (impossible function type; i.e., showing less than 2 times the basal radioactivity level), Type II-B (the unstable type; showing less than 5 min of peak erectile response), and Type II-C (the delayed type; which showed a delay of more than 15 min after the start of sexual stimulation). The patients were grouped according to their response after Sildenafil administration, and the effect of Sildenafil was assessed by comparing the radioactivity from between 7 to 22 minutes and the changes in the characteristics of the penogram. The mean age of the patients was 44.9 +/- 10.2 (23 - 68) years. In the first penogram, Type I was found in 12 patients, and Type II-A in 14, Type II-B in 73, Type II-C in 1 and a mixed (II-B + C) type was found in 4 patients. A second penogram after Sildenafil administration, showed Type I in 46 patients, and Type II-A in 10, Type II-B in 46 and a mixed type was found in 2 patients. The responses after Sildenafil were categorized as follows: 1) An excellent response group (consisting of 56 patients-53.9%); Those who showed greater than 50% increase in the RI area after Sildenafil treatment. 2) A good response group consisting of (23 patients-22.1%); i.e., those who showed a less than 50% but greater than a 20% increase in the RI area after Sildenafil administration. 3) A borderline group (consisting of 15 patients-14.4%); showing less than a 20% change in the RI area after Sildenafil treatment. 4) non-response group (consisting of 10 patients-9.6%). The therapeutic efficacy of Sildenafil, as determined by the SS-penograms, revealed that there was an augmentation in the erectile capabilities in 76% of men (79/104) but a non-response was observed in 9.6% (10/104). The efficacy of Sildenafil on the SS-penogram did not correlate with the patient's age (p=0.198). It is believed that the SS-penogram can be used to accurately evaluate the natural erectile status in sexual and pharmacological stimulation, and provides the most objective erectile response in any therapeutic trial. Consequently, the primary challenge for any erectile dysfunction remedy is to be able to demonstrate its efficacy. A further evaluation is warranted in the non-response group, which was not based on any severe organic dysfunction.