Short-term revision rate of Rigicon Testi10TM testicular prosthesis in adolescents and adults: a retrospective chart review.

Testicular prosthesis implantation is a valuable solution for the physical, cosmetic, and psychological challenges associated with testicular loss which may affect males of any age. We evaluated the safety and reliability of the new Rigicon Testi10TM testicular prosthesis in adults and adolescents by performing an IRB-approved retrospective study of data drawn from Patient Information Forms (PIFs). A total of 427 patients (382 adults and 45 adolescents) had at least one testicular prosthesis implanted. Only one adult patient required revision surgery due to rupture of the Rigicon Testi10 TM saline-filled prosthesis. A 40-year-old patient was found to have a leaking prosthesis approximately one week postoperatively, which was suspected to be due to inadvertently punctured by the surgeon during the sterile saline filling process. There were no post-implantation revisions required for adolescent patients. According to our results, Kaplan-Meier calculation of survival from removal or revision was 99.8% for all patients at 54 months (99.7% for adults and 100% for adolescents). The complication rates among patients in this study are lower than those reported in previous published studies. Our study underscores the generally safe nature of testicular prosthesis implantation, as well as the very rare incidence of revision surgery for this new device.

Safety outcomes of the first Rigi10™ malleable penile prostheses implanted worldwide.

Implantation of penile prosthesis is considered when conservative measures fail or are unacceptable to patients' wishing treatment for erectile dysfunction. In the United States (US), inflatable penile prostheses are more often used than malleable penile prostheses (MPP). Outside the US, the reverse is true because third-party reimbursement is not available, and MPP is considerably cheaper. Two American manufacturers make MPP; presently, a new manufacturer, Rigicon (Ronkonkoma NY), has recently begun to sell its MPP worldwide. Patient information forms submitted to the manufacturer between March 1, 2019, and December 8, 2022, were used to conduct an initial safety study for 605 first-time patients implanted with Rigicon10® by 46 physicians in 15 countries with a mean follow-up of 21.6 months. It has the same configuration of trimmable, paired silicone rods containing a twisted stainless-steel wire for bendability. However, it is available in six widths with hydrophilic coating compared to three widths offered by competitors. Revision or explantation was needed in 6 of 605 patients (0.99%) with half of those being removed for dissatisfaction (0.50%). Two (0.33%) suffered device infection and one (0.16%) required removal for erosion. Kaplan-Meier's statistical analysis showed three-year implant survival from revision = 99.2%. It demonstrated a comparable safety record with less than 1.00% of patients requiring reoperation.

First safety outcomes for rigicon conticlassic® artificial urinary sphincter.

The Rigicon ContiClassic® is a new sphincteric device designed to treat male stress urinary incontinence. This study evaluates the surgical outcomes and safety profile of the first 116 patients who received the implant between September 2021 and April 2022. Data were collected from patient information forms completed at the time of the implant and submitted by implanting surgeons, nursing staff in the Operating Room or company representatives present during the surgery. The study analyzed patient demographics, surgical details, and etiology of incontinence. The mean age of patients was 68.3 years +/- 9.65 yrs. Minimum age was 23 and maximum age was 83. The most common reason for implantation was urinary incontinence (58.6%) after radical prostatectomy. The results showed a revision rate of 6.90%, with three cases of fluid loss, four cases of iatrogenic mistaken sizing, and one case of patient dissatisfaction. There were no reported infections. Kaplan-Meier calculation showed survival rate of 93.2% at 12 months. This study shows the early safety outcomes for the Rigicon ContiClassic® sphincter device to be comparable to others presently on the market.

Rigicon disposable Furlow insertion tool has the potential to decrease infection rates after inflatable penile prosthesis implantation.

Furlow insertion tool is frequently used during the insertion of the inflatable penile prosthesis cylinders inside the corporal bodies. Although these devices are completely disassembled and separately sterilized after each operation, the residual blood clots and tissues after inadequate cleaning may become the primary sources of penile prosthesis infection. In order to minimize the risk of infection, Rigicon, Inc. (NY, USA) has developed the first disposable Furlow insertion tool. Head-to-head comparison studies with conventional and disposable Furlow insertion tools are necessary to confirm if there is a significant difference in post-implant infection rates.

Comparison of Tumor Enucleation and Standard Partial Nephrectomy According to Trifecta Outcomes: A Multicenter Study by the Turkish Academy of Urology, Uro-Oncology Working Group.

INTRODUCTION: We aimed to evaluate the impact of the resection technique (tumor enucleation (TE) or standard partial nephrectomy (SPN)) on trifecta outcomes in patients having undergone partial nephrectomy (PN). MATERIALS AND METHODS: We retrospectively analyzed the clinical and pathologic parameters in patients with localized renal cell carcinoma (pT1-2N0M0) who had undergone PN between January 2001-December 2018 at one of 15 different tertiary referral centers. Multivariable logistic regression analysis was applied to investigate independent predictors of trifecta failure, decreased postoperative renal functions (decreased estimated glomerular filtration rate (eGFR) > 10%), perioperative complications (Clavien-Dindo > 1), and positive surgical margins. RESULTS: A total of 1070 patients with a mean age 56.11 ± 11.88 years were included in our study. PN was performed with TE in 848 (79.25%) and SPN in 222 (20.75%) patients. Trifecta failure rate was 56.2% for TE and 64.4% for SPN (p = 0.028). On multivariable analysis, TE was associated with less trifecta failure (p = 0.025) and eGFR decrease >10% rates (p = 0.024). On the other hand, there was no statistically significant difference between TE and SPN according to positive surgical margins (p = 0.450) and complication > Clavien-Dindo grade 1 (p = 0.888) rates. The only independent predictive factor for complications > Clavien-Dindo 1 was the Charlson comorbidity index (CCI) (p = 0.001). CONCLUSION: TE is associated with less trifecta failure than SPN. This result is mainly due to better preservation of renal function with TE.

The Role of Educational Level and Cognitive Status in Men Undergoing Artificial Urinary Sphincter Implantation.

OBJECTIVE: To examine the relationship between education level, cognitive function of patients and the success/ revision rates of artificial urinary sphincter (AUS) implantation in men with postprostatectomy incontinence. METHODS: Between January 2010 and March 2018, 163 patients (mean age, 68 ± 6.8 years) with moderate-to-severe stress urinary incontinence who underwent AUS implantation were retrospectively examined. Demographic data, body mass index, comorbidities, surgical technique, previous strictures, and radiation therapy were recorded. Incontinence was measured by daily pad use and evaluated by International Consultation on Incontinence Questionnaire-short form. Patients' overall improvement was assessed using the Patient Global Impression of Improvement questionnaire. Education level was determined using the International Standard Classification of Education. Cognitive status was assessed using the Mini-Mental State Examination. Treatment success was defined as the need for ≤1 pad/day at last follow-up. RESULTS: AUS was successful in 77.3% of patients. The International Consultation on Incontinence Questionnaire-short form score improved significantly from 19.9 ± 2.9 to 4.4 ± 5.4 (P = .001). The median outcome reported subjectively on the Patient Global Impression of Improvement scale was 2.1 ± 1.5 (1-7) and self-reported as "much better." Patients' education level had statistically no significant relationship with AUS success and revision rates. Similarly, there was no significant relationship between cognitive status, educational level and the need for revision of AUS (P >.05). However, patients with moderate cognitive impairment and a body mass index >30 showed significantly lower AUS success rates (P <.05). CONCLUSION: AUS implantation is safe and effective treatment option especially for nonobese and cognitively intact patients of all educational levels.

Protective Effect of Udenafil Against Ischemia Reperfusion Injury Due to Testicular Torsion/Detorsion in Rat Model.

OBJECTIVE: Testicular torsion causes migration of neutrophils to the ischemic region and formation of free oxygen radicals that have a critical effect on ischemic reperfusion (I/R) injury. Udenafil is a selective, strong, and reversible inhibitor of phosphodiesterase type enzyme. In our study, we evaluate the protective effect of udenafil against reperfusion injury due to I/R. MATERIALS AND METHODS: Twenty-one male, adult, Wistar-Albino rats aged 8 months were randomly divided into three groups; sham, I/R, and I/R+udenafil. One hour before the detorsion operation, the sham and I/R groupssaline, and I/R+udenafil groups were administered 2 mg/kg udenafil intraperitoneally. Blood samples were collected to evaluate the inflammatory mediators. Spermatogenic factors were evaluated according to Johnsen criteria. RESULTS: Histopathological and molecular parameters from all groups were compared. Mean values of TNF-α and IL-1ß in venous blood samples were calculated. We observed that TNF-a values were statistically significantly increased in the I/R group than those in sham groups, and these values were decreased with udenafil treatment Furthermore, the glutathione peroxidase (GPx) level was statistically significantly decreased in the I/R group, and treatment with udenafil prevented this decrease. Evaluation of spermatogenesis using the Johnsen scoring system showed no statistically significant difference in mean scores between the groups. CONCLUSION: We concluded that deterioration of biochemical and histopathological parameters are reversed, and injury due to I/R in testicle tissue may be decreased with udenafil treatment. Results of this experimental study show that efficacy of the udenafil treatment in testis torsion should be investigated.

How reliable are imaging techniques in aging males with bladder cancer?

INTRODUCTION: The aim of this study was to evaluate consistency between clinical lymph node positivity and pathological lymph node positivity in patients undergoing open radical cystectomy and pelvic lymph node dissection due to bladder cancer. MATERIAL AND METHOD: A total of 135 patients who had open radical cystectomy, extended lymph node dissection, and clear preoperative contrast-enhanced abdominopelvic computed tomography (CT) or magnetic resonance imaging (MRI) images were included in the study. Positive clinical lymph nodes and positive pathological lymph nodeswere recorded. The largest positive clinical and pathological lymph nodeswere recorded. In terms of clinical lymph node involvement, compatibility between radiological findings and pathological results was evaluated. RESULTS: In the CT group, the sensitivity was 25.81%, specificity was 95.45%, positive predictive value (PPV) was 66.67%, negative predictive value (NPV) was 78.50%, and accuracy was 77.31%. In the MRI group, the sensitivity was 50.00%, specificity was 100%, PPV was 100%, NPV was 76.92%, and accuracy was 81.25%. For consistency between pathological lymph nodes and clinical lymph nodes according to the imaging type, there was no statistically significant difference in the sensitivity, specificity, NPV, and accuracy rates between the imaging techniques (p > 0.05). However, the PPV was significantly higher in the MRI group than the CT group (100% vs.66.67%, respectively; p = 0.014). CONCLUSION: Positive lymph nodes play a critical role in the prognosis of patients with bladder cancer and the sensitivity of contrast-enhanced abdominopelvic CT and MRI used routinely in clinical practice is low in lymph node detection. MRI seems more reliable than CT in lymph node detection.

Effect of artificial urinary sphincter implantation on erectile function and sexual satisfaction.

Artificial urinary sphincter (AUS) implantation is the gold standard treatment in total stress urinary incontinence (SIU). Our aim is to evaluate the effect of AUS implantation on erectile function and sexual satisfaction (SS). Fourteen patients aged 58-73 years (mean: 66.92 ± 4.51 years) who underwent AUS implantation by a perineal approach between May 2015 and April 2018 were included in our study. Patients with neurogenic disease or very low or no erectile function and those who underwent non-nerve-sparing radical prostatectomy were excluded. Erectile function and intercourse satisfaction were evaluated pre-operatively and post-operatively at 6-month follow-up using international index of erectile function (IIEF) questionnaires. After AUS implantation; eight patients were totally dry, four achieved social continence (less than one pad/day), and two still had SUI (two or more pads/day). Mean pre- and post-operative IIEF values of the patients were 16.14 ± 3.18 and 17.42 ± 4.43 respectively. Mean pre- and post-operative SS values were 8.57 ± 1.78 and 8.71 ± 2.19 respectively. There was no statistically significant difference between pre- and post-operative IIEF-5 and intercourse satisfaction scores (p > 0.05). Although we did not see a significant effect of AUS implantation in our study, in SIU patients, coital incontinence or unpleasant odour during intercourse can lead to sexual avoidance and reduced SS, and AUS implantation may improve SS.

The effect of metabolic syndrome on prostate cancer final pathology.

AIM OF STUDY: Metabolic syndrome (MetS) is an abnormality that increases the risk of cardiovascular disease and diabetes. In the recent years, studies showed that MetS is associated with increased risk of incidence, aggressiveness, and mortality of prostate cancer (PCa). We examined the influence of MetS at final pathology in Turkish patients with PCa. MATERIALS AND METHODS: MetS was defined according to the American Heart Association, National Heart, Lung, Blood Institute, and International Diabetes Federation and requires any three of five components. The patients without and with MetS were in Group 1 and 2, respectively. Data were compared with independent sample t-test and Chi-squared test. RESULTS: There were 117 patients in the study. The patients' age was between 51 and 77 years with a median of 64.87 ± 5.65 and 62.29 ± 5.57, and prostate-specific antigen (PSA) level of the patients was 8.19 ± 5.35 and 8.68 ± 2.22 ng/ml in Group 1 and 2. Of these patients; Group 1 and 2 had 86 and 31 patients. High-grade PCa (Gleason >7) and advanced PCa (T3, T4) at final pathology were reported in 44.18-18.60% and 38.70-32.25% in Group 1 and 2. CONCLUSION: The patients with MetS are diagnosed significantly younger and had higher PSA levels than the other patients. Advanced disease of PCa is seen much more in patients with MetS.

The effect of urethroplasty surgery on erectile and orgasmic functions: a prospective study

ABSTRACT Objectives: to examine the effects of urethroplasty surgery on sexual functions by taking into account age, location of stenosis, length of stenosis and surgical technique parameters. Materials and Methods: The prospective study was conducted between January 2015 and August 2017 with 60 cases. Patients were categorized according to age groups (19-65 / 65-75 years), surgery technique and stricture localization and length. Before the urethroplasty operation and postoperative 6th month follow-up, the international index of erectile function (IIEF) form (15 questions), was filled, the relevant domains of sexual function; erectile function (Q1,2,3,4,5,15), orgasmic function (Q9,10) and overall satisfaction (Q13,14) were assessed. Results: The mean age of the cases is 54 ± 13. However, preoperative IIEF, sexual satisfaction and orgasmic function averages of patients with a stenosis segment length of 1-3 cm was found to be significantly higher than that of patients with a stenosis segment length of 4-7 cm. Between stenosis segment length groups, there was no statistical difference in terms of preoperative and postoperative sexual functions. And also, there was no statistically significant change in patients' preoperative and postoperative sexual function scores in terms of localization of stricture and surgery techniques. However, there were statistically significant change in the postoperative IIEF and sexual satisfaction averages according to preoperative averages. Conclusion: Our study suggests that urethroplasty surgery itself does not significantly affect erectile function, orgasmic function, and general sexual satisfaction regardless of the type of surgery, localization and length of stenosis. Besides, there was a significant decrease in erectile function in senior adults.

Evaluation of germ-cell neoplasia in situ entity in testicular tumors.

OBJECTIVE: Germ-cell neoplasia in situ (GCNIS) is accepted as the precursor of the testicular tumors. The aim in our study is to compare the lymphadenopathy and metastasis parameters in patients diagnosed with testicular tumor with or without GCNIS based on pathological evaluation. MATERIAL AND METHODS: Data from 108 patients who underwent orchiectomy for testicular tumor between January 2007 and December 2014 in our clinic were retrospectively analyzed and included in the study. Patients were divided into two groups based on the pathology reports as GCNIS or not. Groups were compared regarding lymphadenopathy, metastasis, tumor marker levels, tumor size, lymphovascular invasion, rete testis invasion. Mann-Whitney U test was used for statistical evaluation. RESULTS: Mean age of the patients included in the study were calculated as 34.6±9.3 years. Eighty-five (78.7%) patients had GCNIS, while 23 (21.3%) of them had not. In terms of metastasis, lymphadenopathy, marker levels, tumor size, lymphovascular invasion and rete testis invasion, no statistical significant difference were observed between two groups (p>0.05). CONCLUSION: In our study, no statistical significant difference was observed on the prognostic factors concerning the GCNIS entity, which is reported frequently in testicular tumor pathologies. For presently these findings show us that GCNIS cannot be used as a prognostic factor.

Characteristics of the urethroplasty and our approach-Experience in patients with urethral stricture.

OBJECTIVE: Urethral stricture is a common pathology with different etiologic factors in different age groups and societies. In our research, patients who underwent urethroplasty because of urethral stricture were evaluated in terms of etiology, localization, surgical technique and demographic characteristics. MATERIAL AND METHODS: One hundred and sixty-three patients with a mean age of 53.43±16.5 years, operated between January 2008 and May 2016 because of urethral stricture were retrospectively included in the study. Diagnosis of the urethral stricture was established based on the complaints of the patient, results of urinalysis, urine culture, uroflowmetry, retrograde urethrography and/or voiding urethrography, and urethroscopy in case of need. Postoperative success for the patients was determined based on urinary flow rate and maximum flow rate of over 15 mL/sec were evaluated as success. RESULTS: Etiologic factors for urethral stricture included trauma in 40 (24.5%), urethral catheterization in 45 (27.6%), endoscopic procedure in 59 (36.2%), infection in 10 (6.2%), idiopathic etiologies in 9 (5.5%) out of 163 patients. Mean length of the stricture was 3.6±1.7 cm. While the indicated number of patients had buccal mucosa graft (n=73, 44.7%), penile skin flap (n=21, 12.8%), Heineke-Mikulicz repair (n=5, 3.0%), and end-to-end anastomosis (n=64, 39.1%). Mean follow-up period was 43.2±33.7 months. Buccal mucosa graft was applied as ventral (n=32, 43.8%), dorsal (n=22, 30.2%), and dorsolateral (n=14, 19.2%) onlay, and transventrally dorsal inlay (n=5, 6.8%) grafts. Average success rates were 83.5% (n=61/73) in buccal mucosa, 76.2% (n=16/21) in penile skin grafts; 85.9% (n=55/64) in end-to-end anastomosis and 80.0% (n=4/5) in Heineke-Mikulicz repair. CONCLUSION: Our assumption is that urethroplasty procedures have satisfactory long-term results, regardless of the location and size of the stenosis. According to our clinical experience, deciding on the most appropriate surgical technique by assessing each patient individually in experienced centers will increase success rates.

The effect of urethroplasty surgery on erectile and orgasmic functions: a prospective study.

OBJECTIVES: To examine the effects of urethroplasty surgery on sexual functions by taking into account age, location of stenosis, length of stenosis and surgical technique parameters. MATERIALS AND METHODS: The prospective study was conducted between January 2015 and August 2017 with 60 cases. Patients were categorized according to age groups (19-65 / 65-75 years), surgery technique and stricture localization and length. Before the urethroplasty operation and postoperative 6th month follow-up, the international index of erectile function (IIEF) form (15 questions), was filled, the relevant domains of sexual function; erectile function (Q1,2,3,4,5,15), orgasmic function (Q9,10) and overall satisfaction (Q13,14) were assessed. RESULTS: The mean age of the cases is 54 ± 13. However, preoperative IIEF, sexual satisfaction and orgasmic function averages of patients with a stenosis segment length of 1-3 cm was found to be significantly higher than that of patients with a stenosis segment length of 4-7 cm. Between stenosis segment length groups, there was no statistical difference in terms of preoperative and postoperative sexual functions. And also, there was no statistically significant change in patients' preoperative and postoperative sexual function scores in terms of localization of stricture and surgery techniques. However, there were statistically significant change in the postoperative IIEF and sexual satisfaction averages according to preoperative averages. CONCLUSION: Our study suggests that urethroplasty surgery itself does not significantly affect erectile function, orgasmic function, and general sexual satisfaction regardless of the type of surgery, localization and length of stenosis. Besides, there was a significant decrease in erectile function in senior adults.

The positive immunostaining of TMPRSS2-ERG is not associated with unfavourable outcomes and biochemical recurrence after radical prostatectomy in Turkish patients.

INTRODUCTION: Prostate cancer is the second most common cancer and a major significant health problem amongst men in the world. Radical prostatectomy with open, laparoscopic and robotic techniques is the gold standard treatment for localized and local advanced disease. There are some risk factors including gleason score, T stage and prostate-specific antigen (PSA) level to predict the biochemical recurrence. We investigated the association with biochemical recurrence and TMPRSS2:ERG fusion in patients who were treated with open radical prostatectomy. MATERIAL AND METHODS: The expression of TMPRSS2:ERG was defined as positive (Group 1) and negative (Group 2). The positive staining of the patients is classified into three groups; weak positive, moderate positive and strong positive. In the statistical analyses; chi squared test and Mann Whitney U were used and p <0.05 was defined as statistical significance. RESULTS: The present study includes 87 patients, 32 and 55 patients were in group 1 and 2 respectively. The mean age of the patients was 62.81 +5.55 and 64.45 +5.18 in the groups without significant difference. Extraprostatic extension was reported in 27 patients; 11 of these patients were in group 1 and 16 patients were in group 2 (p = 0.60). Biochemical recurrence was detected in 15 patients. Of these patients, 5 were in group 1 and 10 were in group 2 (p = 0.76). CONCLUSIONS: The current study found no association between TMPRSS2:ERG fusion and biochemical recurrence and unfavourable pathological results in Turkish patients. Further research including a large number of patients from different regions of Turkey is needed to investigate the ERG status and biochemical recurrence for patients.

Safety and efficacy of PNL vs RIRS in the management of stones located in horseshoe kidneys: A critical comparative evaluation.

AIM: To assess the efficacy and safety of two different techniques (Percutaneous nephrolithotomy (PNL) vs Retrograde intrarenal surgery (RIRS)) in the management of stones in patients with horseshoe kidneys (HSK). PATIENTS AND METHODS: Departmental files of 88 cases with radiopaque kidney stones in horseshoe kidneys undergoing two different approaches (PNL vs RIRS) were evaluated with respect to the success and complication rates of in a retrospective manner. In addition to the factors related with the procedures (success and complication rates, additional procedures), patient and stone characteristics were all well evaluated. Findings obtained in both groups were evaluated in a comparative manner with respect to the statistical significance. RESULTS: Stone free rates were comparable in both groups after 1-week period (81.6% PNL vs 80% RIRS). As well as 3 months evaluation (84.2% PNL and 82.0% RIRS). The percentage of the cases with residual fragments (> 4 mm) were similar in both groups and while all PNL procedures were completed in one session, mean number of RIRS sessions was higher (1.22 ± 0.05). Mean duration of the procedure was slightly higher in RIRS group and based on Clavien scoring system, despite a higher risk of Hb drop noted in patients treated with PNL, all complication rates were found to be similar in both groups. CONCLUSION: Our results demonstrate that of the available minimally invasive treatment alternatives, both PNL and RIRS could be safe and effective alternatives for renal stone removal in patients with HSK.