Retraction notice to: The effect of parenteral testosterone administration prior to hypospadias surgery: A prospective, randomized and controlled study [J Pediatr Urol 11 (2015) 143.e1-143.e6].

This article has been retracted: please see Elsevier Policy on Article Withdrawal (https://www.elsevier.com/about/our-business/policies/article-withdrawal). This article has been retracted at the request of the Editor-in-Chief. Readers of the journal highlighted issues with the study design and statistical analysis of the results which affected the validity of the findings in the paper. Further review by the editors and journal statistician confirmed that there were issues in the paper that needed to be addressed. The authors were given the opportunity to address the problems in the paper but did not respond.

The effect of fibrinogen concentrate on perioperative bleeding in transurethral resection of the prostate: a double-blind placebo-controlled and randomized study.

Essentials Perioperative bleeding during prostate surgery is still a common morbidity. Anticoagulant and antiplatelet medications contribute to the risk of hemorrhage and prolonged hospital stay. Multiple pharmacological agents have been proposed, but none of them have been widely accepted. It is crucial to find a safe and effective modality to reduce hemorrhage. SUMMARY: Background Hemorrhage during transurethral resection of the prostate (TUR-P) has always been a concern. Several studies have shown preoperative administration of fibrinogen concentrate to have promising results in reducing hemorrhage in cardiac surgery. Objectives To investigate the hemostatic effect of fibrinogen concentrate administration on reducing the amount of bleeding during TUR-P in patients with benign prostatic hyperplasia. Methods Sixty men with benign prostatic hyperplasia, who were chosen to undergo TUR-P, entered this prospective randomized double-blind placebo-controlled study. The participants were randomly assigned to two groups: treatment (n = 31) and placebo (n = 29). They received an infusion of 2 g of fibrinogen concentrate (treatment group) or normal saline (placebo group) before surgery. Data regarding the amount of bleeding, the operation and complications were recorded and analyzed. Results No difference was observed in bleeding between the fibrinogen and placebo groups during (521 mL versus 557 mL, respectively) and after (291 mL versus 341 mL, respectively) surgery. This lack of difference was also seen in operation time (43 min versus 42 min), irrigating fluid volume used during (17 L versus 19 L) and after (29 L versus 28 L) surgery, and resected adenoma volume (19 g versus 19 g). The mean blood pressure was also similar in both groups as a confounding factor for the amount of bleeding. Conclusion Preoperative administration of fibrinogen concentrate had no significant influence on intraoperative and postoperative bleeding in TUR-P surgery.

High success rate with new modified endoscopic treatment for high-grade VUR: A pilot study with preliminary report.

PURPOSE: Despite the benefits of the minimally invasive endoscopic treatment for vesicoureteral reflux (VUR) it has a major drawback which is low success rate in high grade VUR. For overcoming this problem, we introduce a new modified technique of endoscopic treatment called periureteral injection technique (PIT). MATERIALS AND METHODS: In a prospective study a total of 37 ureters in 19 boys and 14 girls were treated, including 3 bilateral cases. Of 37 units, 30 (81.1%) had grade IV and 7 (18.9%) had grade V primary VUR (18 right, 13 left and 3 bilateral units). Subureteral injection of Vantris(®) was done at the 5-o'clock and 7-o'clock positions in which the direction of injecting needles were almost parallel. Pre- and post-operative evaluation included urinalysis, urinary tract ultrasonography, voiding cystourethrography (VCUG), dimercaptosuccinic acid scan and urodynamic studies. RESULTS: The median age was 38 months (range 8-125). At 6 months follow up period confirmed with VCUG, the VUR has been disappeared in 34 (91.8%) units and 3 units [2 (5.4%) grade II and 1 (2.7%) had grade III)] had downgraded VUR. Complications included early fever due to urinary tract infection in 1 children, transient dysuria in 2 patients and low back pain in one patient (Summary Table). CONCLUSION: The success rate of PIT for treatment of high grade VUR is high. However, further studies with more patients and longer follow up periods are needed to draw final conclusion.

The effect of parenteral testosterone administration prior to hypospadias surgery: A prospective, randomized and controlled study.

INTRODUCTION: The goal of hypospadias surgery is to provide a functionally and cosmetically normal penis. Whether this goal will be to the patient's satisfaction depends largely on the original anatomy, surgical technique and surgeon's experience. It has been suggested that androgen administration is associated with better outcomes in hypospadias repair; however, few studies have included control groups and the issue is still controversial. PURPOSE: To evaluate the effects of parenteral testosterone administration on the results of hypospadias repair in children with untreated hypospadias. MATERIALS AND METHODS: A total of 182 children with midshaft or distal hypospadias and a mean age of 30 months (range 18-52 months) were enrolled in this study. Consecutive children were randomly allocated to the study group (testosterone administration) (Group 1, n = 91) or control group (Group 2, n = 91). Only children with a flat urethral plate were included in this study. The control group did not receive any pre-operative treatment. Children with a previous history of hypospadias repair and any proven endocrine disorder were excluded. The study children received 2 mg/kg testosterone enanthate monthly for two months before surgery. Tubularized incised plate (TIP) urethroplasty, with or without chordee correction, was performed for all children in both groups by the same urologist. Hypospadias repair was performed 4 weeks after the second dose of testosterone administration. Postoperative complications were recorded, including: urethrocutaneous fistulas, urethral diverticula, meatal stenosis, and glanular dehiscence. The mean stretched penile length and circumference were measured at baseline and at 1 month and 2 months post operation. All children were examined every month for any adverse affects to testosterone treatment, like pubic and axillary hair, and height acceleration, up to 3 months post operation. RESULTS: An increase in penile length (from 28.1 ± 2.2 mm to 38.5 ± 2.6 mm) (P = 0.001) and penile circumference (from 35.1 ± 1.6 mm to 45.5 ± 2.2 mm) (P = 0.001) were noticed in all but four children in Group 1. The actual values for increase in penile length in the study group were, 22.0%, 35.0% and 36.0%, at postinjection months 1, 2 and 3, respectively (P = 0.01, P = 0.001 and P = 0.001, respectively) (Figure). The actual values for increase in penile circumference in the study group were, 16.0%, 27.0% and 29.0%, at postinjection months 1, 2 and 3, respectively (P=0.01, P=0.001 and P =0.001, respectively). The overall complication rates were significantly higher in Group 2 [12 children, 13.18%) compared to Group 1 (five children, 5.45%) (P=0.03). Urethrocutaneous fistula was the most common complication in both groups (four children [4.39%] in Group 1 and seven children [7.69%] in Group 2) (P=0.02), followed by meatal stenosis (one child [1.09%] in Group 1 and three children [3.29%] in Group 2) (P=0.03). All children in Group 1 developed pigmentation of the genitalia, and scant pubic hair appeared in 14 of them. These side effects disappeared by the 3 months postoperation follow-up visit. DISCUSSION: Tubularized incised plate urethroplasty is a popular reconstructive method for hypospadias repair and is widely accepted by pediatric urologists. It is a reliable and simple technique with low complication rates. Testosterone administration before hypospadias repair decreases complication rates, reduces the need for reoperation and results in better cosmetic outcomes. Some studies have demonstrated temporary side effects like pubic hair growth and aggressive behavior, which gradually became normalized after treatment cessation. Nowadays, many pediatric urologists administer testosterone prior to hypospadias surgery; however, this can be variable. CONCLUSION: Parenteral testosterone administration before hypospadias repair is beneficial in decreasing complication rates.

Quality of life after radical cystectomy for bladder cancer in men with an ileal conduit or continent urinary diversion: A comparative study.

AIM: To investigate quality of life (QoL) domains with three forms of urinary diversions, including ileal conduit, MAINZ pouch, and orthotopic ileal neobladder after radical cystectomy in men with muscle-invasive bladder cancer. MATERIALS AND METHODS: In a prospective study, 149 men underwent radical cystectomy and urinary diversion (70 ileal conduit, 16 MAINZ pouch, and 63 orthotopic ileal neobladder). Different domains of QoL, including general and physical conditions, psychological status, social status, sexual life, diversion-related symptoms, and satisfaction with the treatment were assessed using an author constructed questionnaire. Assessment was performed at three months postoperatively. RESULTS: In questions addressing psychological status, social status, and sexual life, patients with continent diversion had a more favorable outcome (P = 0.002, P = 0.01, and P = 0.002, respectively). The rate of erectile dysfunction did not differ significantly between the three groups (P = 0.21). The rate and global satisfaction was higher with the MAINZ pouch (68.7%) and ileal neobladder (76.2%) as compared with the ileal conduit group (52.8%) (P = 0.002). CONCLUSION: Continent urinary diversion after radical cystectomy provides better results in terms of QoL as compared with ileal conduit diversion.

Sexual function after non-nerve-sparing radical cystoprostatectomy: a comparison between ileal conduit urinary diversion and orthotopic ileal neobladder substitution.

OBJECTIVE: To compare the erectile function (EF) and sexual desire (SD) in men after radical cystoprostatectomy (RCP) who had either an ileal conduit urinary diversion or orthotropic ileal neobladder substitution. MATERIALS AND METHODS: Eighty one sexually active men with bladder cancer were enrolled in this prospective study. After RCP according to patients' preferences they underwent either ileal conduit urinary diversion (n = 41) or orthotropic ileal neobladder substitution (n = 40). EF and SD were assessed using International Index of Erectile Function (IIEF) questionnaire. Patients were assessed at 4-week before surgery and were followed up at 1, 6, and 12-month postoperatively using the same questionnaire. RESULTS: Postoperatively the EF and SD domains deteriorated significantly in both groups, but in a small proportion of the patients submitted to ileal neobladder they gradually improved with time (P = 0.006). At 12-month postoperative period, 4 (9.8 %) and 14 (35.0 %) patients in ileal conduit and ileal neobladder groups were able to achieve erections hard enough for vaginal penetration and maintained their erection to completion of intercourse, respectively (P = 0.006). Among patients in the ileal conduit and ileal neobladder groups, additional 4 (9.8 %) and 7 (17.1 %) patients were able to get some erection, but were unable to maintain their erection to completion of intercourse (P = 0.02). At 12-month follow up period 24.4 % of the ileal conduit and 45.0 % of the ileal neobladder patients rated their sexual desire very high or high (P = 0.01). CONCLUSION: When performed properly, orthotopic ileal neobladder substitution after RCP offers better long-term results in terms of EF and SD.

Sexual Function after Non-Nerve-Sparing Radical Cystoprostatectomy: A Comparison between Ileal Conduit Urinary Diversion and Orthotopic Ileal Neobladder Substitution

Objective To compare the erectile function (EF) and sexual desire (SD) in men after radical cystoprostatectomy (RCP) who had either an ileal conduit urinary diversion or orthotropic ileal neobladder substitution. Materials and Methods Eighty one sexually active men with bladder cancer were enrolled in this prospective study. After RCP according to patients' preferences they underwent either ileal conduit urinary diversion (n = 41) or orthotropic ileal neobladder substitution (n = 40). EF and SD were assessed using International Index of Erectile Function (IIEF) questionnaire. Patients were assessed at 4-week before surgery and were followed up at 1, 6, and 12-month postoperatively using the same questionnaire. Results Postoperatively the EF and SD domains deteriorated significantly in both groups, but in a small proportion of the patients submitted to ileal neobladder they gradually improved with time (P = 0.006). At 12-month postoperative period, 4 (9.8%) and 14 (35.0%) patients in ileal conduit and ileal neobladder groups were able to achieve erections hard enough for vaginal penetration and maintained their erection to completion of intercourse, respectively (P = 0.006). Among patients in the ileal conduit and ileal neobladder groups, additional 4 (9.8%) and 7 (17.1%) patients were able to get some erection, but were unable to maintain their erection to completion of intercourse (P = 0.02). At 12-month follow up period 24.4% of the ileal conduit and 45.0% of the ileal neobladder patients rated their sexual desire very high or high (P = 0.01). Conclusion When performed properly, orthotopic ileal neobladder substitution after RCP offers better long-term results in terms of EF and SD. .

Methylenetetrahydrofolate reductase (MTHFR) gene C677T, A1298C and G1793A polymorphisms: association with risk for clear cell renal cell carcinoma and tumour behaviour in men.

AIMS: Methylenetetrahydrofolate reductase (MTHFR) plays a crucial role in regulating folate metabolism, which affects DNA synthesis and methylation. This study investigated whether MTHFR C677T, A1298C and G1793A polymorphisms modified clear cell renal cell carcinoma (CCRCC) risk independently as well as in combination with serum total homocysteine (Hcy) and folate levels. MATERIALS AND METHODS: A case-control study of 152 cases (men) and 304 age-matched healthy controls was conducted in one geographical area of Iran. Genotyping of MTHFR gene polymorphisms was carried out using a polymerase chain reaction restriction fragment length polymorphism technique. Serum levels of total Hcy, folate and vitamin B12 were also determined. RESULTS: The MTHFR 677T and 1298C allele frequencies were 42.8 and 47.4% in cases, compared with 33.7 and 33.1% in controls. After controlling for confounding factors, a significant increase in CCRCC risk was found among carriers of the 677CT genotype compared with those with the 677CC genotype (odds ratio 2.21, 95% confidence interval 1.31-3.76), with a significant trend (P=0.014). Statistically significant odds ratios were also found in patients homozygous for MTHFR C677T, who have a 1.58-fold higher risk of developing CCRCC (95% confidence interval=1.21-2.44; P=0.024). Compared with the MTHFR 677CC genotype, the odds ratio (95% confidence interval) for the MTHFR 677TT genotype was 6.18 (95% confidence interval=4.75-8.34) for stage IV cancer and 4.68 (95% confidence interval=2.72-6.54) for grade 3 CCRCC (both P=0.0001). After adjustment for selected variants, the MTHFR 1298AC genotype showed a significantly increased risk of CCRCC compared with the wild-type (odds ratio=3.71, 95% confidence interval=2.22-5.33; P=0.001), and the 1298C allele carrier showed a positive association with the risk of CCRCC compared with the wild-type (odds ratio=3.9, 95% confidence interval=2.55-6.02; P=0.001). Furthermore, subjects carrying at least one copy of the variant allele showed a 4.4 times increased risk of developing CCRCC than their control counterparts (odds ratio=4.40, 95% confidence interval=2.41-6.72; P=0.0001). There was not a significant interaction between MTHFR polymorphisms and serum levels of total Hcy and folate in increasing the risk of CCRCC. CONCLUSIONS: Our results provide evidence that the MTHFR polymorphisms might contribute to increased CCRCC risk in men.

Effect of omega-3 polyunsaturated fatty acid supplementation on semen profile and enzymatic anti-oxidant capacity of seminal plasma in infertile men with idiopathic oligoasthenoteratospermia: a double-blind, placebo-controlled, randomised study.

Effective medical treatments of infertile men with idiopathic oligoasthenoteratospermia (OAT) have yet to be determined. This study considered two major aims: (i) to measure the changes in semen parameters, omega-3 fatty acids (FA) compositions and anti-oxidant activity; (ii) to determine if the administration of omega-3 FA affect semen quality in infertile men with OAT. Two hundred thirty-eight infertile men with idiopathic OAT were randomised to eicosapentaenoic (EPA) and docosahexaenoic acids (DHA), 1.84 g per day (EPAX 5500TG; Lysaker, Norway), or placebo for 32 weeks. The semen parameters were assessed according to WHO criteria, and the EPA and DHA concentrations were determined in red blood cells (RBCs), seminal plasma and sperm cells at baseline and 32-week treatment period. Of randomised subjects, 211 (88.7%) completed the full 32-week randomisation period. The anti-oxidant status of seminal plasma was also evaluated by measuring the superoxide dismutase (SOD) and catalase-like activity. In the total group of participants, all EPA and DHA levels in RBC, and seminal plasma, were statistically significantly correlated with those in spermatozoa (both P = 0.001). A significant improvement of sperm cell total count (from 38.7 ± 8.7 ' 106 to 61.7 ± 11.2 ' 106, P = 0.001) and sperm cell concentration (from 15.6 ± 4.1 ' 106 per ml to 28.7 ± 4.4 ' 106 per ml, P = 0.001) was observed in the omega-3 group. A significant positive correlation was found between the EPA and DHA in seminal plasma and the semen parameters. Seminal plasma EPA and DHA concentrations were positively correlated with seminal plasma SOD-like and catalase-like activity (both P = 0.001). In seminal plasma, both SOD-like and catalase-like activity were positively correlated with sperm count, sperm motility, and sperm morphology. Oligoasthenoteratospermic men with low levels of EPA and DHA may benefit from omega-3 FA supplementation. Further studies are warranted to shed more light on this important issue.

Glutathione S-transferase gene polymorphisms (GSTM1, GSTT1, GSTP1) and prostate cancer: a case-control study in Tehran, Iran.

We evaluated the relationship between polymorphisms in the glutathione S-transferases (GSTs) GSTM1, GSTT1 and GSTP1 genes and prostate cancer (PCa). PCR-restriction fragment length polymorphism assay was used to genotype the GSTM1, GSTT1, and GSTP1 polymorphisms in 168 PCa cases and 336 frequency matched controls. The GSTM1 null, and GSTT1 null genotypes were associated with an increased odds ratio (OR) for PCa (OR=3.28, 95% confidence interval (CI): 2.47-5.64; P=0.005, and OR=3.21, 95% CI: 2.52-5.64; P=0.005, respectively) (Pcorrected=0.0062). The frequency of GSTP1 Val/Val genotype was 14.3% in cases compared with 2.4% in controls, this polymorphism thus being associated with a significantly increased risk of PCa (OR=3.72, 95% CI: 1.67-5.65; P=0.002). The risk associated with the concurrent absence of both of the genes (OR=4.8, 95% CI: 2.34-6.78) was greater than the product of risk in men with either null (OR=1.52, 95% CI: 0.82-2.31) genotype combinations (P=0.001, Pcorrected=0.0045). The combination of GSTP1 Ile/Val or Val/Val polymorphism with the GSTT1 null and GSTM1 null type resulted in an OR of 6.21 (95% CI: 4.83-16.87) (P=0.0001, Pcorrected=0.0062). A higher frequency of the GSTM1 null genotype and GSTT1 null genotype was observed in patients with Gleason score >7, with an OR for GSTM1 null 4.67 (95% CI: 3.64-7.62; P=0.001) and with an OR for GSTT1 null 3.62 (95% CI: 2.31-5.74; P=0.004). The results obtained demonstrated that simultaneous presence of three potentially risk alleles (GSTM1 null, GSTT1 null and GSTP1 Val) lead to a significant OR increase for PCa.

Safety and efficacy of sildenafil citrate in the treatment of Parkinson-emergent erectile dysfunction: a double-blind, placebo-controlled, randomized study.

Parkinson's disease (PD) is one of the most commonly occurring neurodegenerative disorders, with lifetime incidence between 1 and 2% among people older than 65 years. ED is one of the more disabling and poorly addressed aspects of PD. The purpose of this study was to assess the efficacy and safety of sildenafil citrate in Parkinson-emergent ED. Sexual function of participants was assessed using responses to the 15-question International Index of Erectile Function (IIEF), Sexual Encounter Profile (SEP) diary questions 2 and 3, Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire and a Global Efficacy Question 'Has the treatment you have been taking over the study period improved your erections?' This randomized, double-blind, placebo-controlled study, comprised a screening period of at least 1 month, a placebo-lead in period of 1 week and treatment period. Two hundred thirty-six patients entered the trial. These patients had mild-to-moderate PD (stages I-III Hoehn-Yahr) and were experiencing Parkinson-emergent neurogenic ED. They were randomized to receive 100 mg sildenafil on demand 1 h before sexual activity (group 1, n=118), or similar regimen of placebo (group 2, n=118). Patients were instructed to use at least 24 doses/attempts at home. At the end of the trial, differences between sildenafil and placebo groups were significant for the IIEF erectile function (EF) score (22.6 ± 4.6 vs 14.8 ± 4.2, P=0.01), for percent Global Efficacy Question 'Yes' responses (68.1 ± 4.6 vs 12.2 ± 3.2, P=0.001), for SEP2 'Yes' responses (68.1 ± 4.2 vs 32.5 ± 2.2, P=0.003), for SEP3 'Yes' responses (75.9 ± 5.4 vs 33.5 ± 4.4, P=0.004) and for mean EDITS score (69.8 ± 4.2 vs 13.0 ± 2.7, P=0.004). A normal EF domain score (>or=26) at end point was achieved by 56.9 and 8.7% of the patients in the sildenafil and placebo groups, respectively (P=0.001). Sildenafil can be considered as an effective treatment in patients with Parkinson-emergent ED.

Safety and efficacy of coenzyme Q10 supplementation in early chronic Peyronie's disease: a double-blind, placebo-controlled randomized study.

No oral medication has proved to be clearly beneficial for Peyronie's disease (PD). We investigated the safety and efficacy of coenzyme Q(10) (CoQ(10)) supplementation in patients with early chronic PD. We conducted a randomized clinical trial of 186 patients with chronic early PD. Patients were randomly assigned to either 300 mg CoQ(10) daily (n=93) or similar regimen of placebo (n=93) for 24 weeks. Erectile function (EF), pain during erection, plaque volume, penile curvature and treatment satisfaction using patient versions of the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire were assessed at baseline and every 4 weeks during study period. EF was assessed using International Index of Erectile Function (IIEF-5), and pain was evaluated with a visual analog scale (VAS, 0-10). All patients also responded to a Global Assessment Question, 'Has the treatment you have been taking during this study improved your erections?' After 24 weeks, mean IIEF-5 score, mean VAS score and mean EDITS score improved significantly in patients receiving CoQ(10) (all P<0.01). Mean plaque size and mean penile curvature degree were decreased in the CoQ(10) group, whereas a slight increase was noted in the placebo group (both P=0.001). Mean index of IIEF-5 in 24-week treatment period was 17.8 ± 2.7 in the CoQ(10) group and 8.8 ± 1.5 in the placebo group (P=0.001). Of the patients in CoQ(10) group, 11 (13.6%) had disease progression vs 46 (56.1%) in placebo group (P=0.01). In patients with early chronic PD, CoQ(10) therapy leads plaque size and penile curvature reduction and improves EF.

An open label, randomized, fixed-dose, crossover study comparing efficacy and safety of sildenafil citrate and saffron (Crocus sativus Linn.) for treating erectile dysfunction in men naïve to treatment.

Saffron (Crocus sativus Linn.) have been perceived by the public as a strong aphrodisiac herbal product. However, studies addressing the potential beneficial effects of saffron on erectile function (EF) in men with ED are lacking. Our aim was to evaluate the efficacy and safety of saffron administration on EF in men with ED. After a 4-week baseline assessment, 346 men with ED (mean age 46.6+/-8.4 years) were randomized to receive on-demand sildenafil for 12 weeks followed by 30 mg saffron twice daily for another 12 weeks or vice versa, separated by a 2-week washout period. To determine the type of ED, penile color duplex Doppler ultrasonography before and after intracavernosal injection with 20 microg prostaglandin E(1), pudendal nerve conduction tests and impaired sensory-evoked potential studies were performed. Subjects were assessed with an International Index of Erectile Function (IIEF) questionnaire, Sexual Encounter Profile (SEP) diary questions, patient and partner versions of the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire and the Global Efficacy Question (GEQ) 'Has the medication you have been taking improved your erections?' No significant improvements were observed with regard to the IIEF sexual function domains, SEP questions and EDITS scores with saffron administration. The mean changes from baseline values in IIEF-EF domain were +87.6% and +9.8% in sildenafil and placebo groups, respectively (P=0.08). We did not observe any improvement in 15 individual IIEF questions in patients while taking saffron. Treatment satisfaction as assessed by partner versions of EDITS was found to be very low in saffron patients (72.4 vs 25.4, P=0.001). Mean per patient 'yes' responses to GEQ was 91.2 and 4.2% for sildenafil and saffron, respectively (P=0.0001). These findings do not support a beneficial effect of saffron administration in men with ED.