Efficacy of RestoreX after prostatectomy: open-label phase of a randomized controlled trial.

OBJECTIVE: To report open-label phase data from a recent randomized controlled trial (RCT), after previous data from that study showed improved penile length and erectile function among post-prostatectomy men treated with Restorex penile traction therapy (RxPTT). MATERIALS AND METHODS: An RCT (NCT05244486) was performed to evaluate RxPTT vs no treatment (Tx) for 5 months, which was followed by a 3-month open-label phase. Men were stratified based on as-treated data: Group 1 = No Tx; Group 2 = No Tx → Tx; Group 3 = Tx → No Tx; Group 4 = Tx. Assessments included stretched penile length and standardized (International Index of Erectile Function [IIEF]) and non-standardized questionnaires. RESULTS: A total of 82 men were enrolled (mean age 58.6 years) with 9-month data available in 45 of the men. Baseline characteristics were similar among the cohorts. Comparing Group 1 and Group 4 (respectively), notable differences included: IIEF Erectile Function domain (IIEF-EF) score (-8 vs -0.5; P = 0.16), penile length (-0.1 vs +1.7 cm; P < 0.01), intracavernosal injection use (86% vs 14%; P < 0.01), Sexual Encounter Profile (SEP) Question 2 (50% vs 100%; P < 0.01), SEP Question 3 (33% vs 100%; P < 0.01). Men who crossed over to Tx (Group 2) failed to achieve equivalent improvements in length (+0.5 cm) or sexual function (IIEF-EF score -6) compared to men treated early (Groups 3 and 4). Those who crossed over to no treatment after initial treatment (Group 3) experienced preserved length (+1.8 cm), and erectile function (IIEF-EF score +0) despite therapy discontinuation. CONCLUSIONS: Use of RxPTT beginning 1 month post-prostatectomy results in improved penile length and erectile function, with benefits maintained after discontinuing therapy. If confirmed, these results represent the first postoperative therapy shown in a RCT to improve erectile function post-prostatectomy. External validation is warranted.

Efficacy of a Novel Penile Traction Device in Improving Penile Length and Erectile Function Post Prostatectomy: Results from a Single-Center Randomized, Controlled Trial.

PURPOSE: RestoreX is a novel penile traction therapy device, with randomized, controlled data demonstrating improvements in penile length and erectile function after 30 to 90 minutes of daily use in men with Peyronie's disease. We sought to determine if similar improvements could be achieved post prostatectomy. MATERIALS AND METHODS: Men post prostatectomy were randomly assigned to control or one of 2 penile traction therapy protocols for 6 months, followed by a 3-month open-label phase. The current study presents data from the randomized phase. The primary outcome was changes in stretched penile length; secondary outcomes were changes in International Index of Erectile Function (IIEF) scores, adverse events, satisfaction and subjective measures. RESULTS: In all, 82 men (mean age 58.6 years) were randomized, with 6-month data available in 25 controls and 30 penile traction therapy cases. At 6 months, penile traction therapy achieved greater improvements/preservation of penile length (+1.6 vs +0.3 cm, p <0.01), erectile function (IIEF-Erectile Function +0 vs -6.5, p=0.03), intercourse satisfaction (IIEF-Intercourse Satisfaction +1 vs -3.5, p <0.01) and overall sexual satisfaction (IIEF-Overall Sexual Satisfaction 0 vs -3, p <0.01). Erectogenic therapy use was lower in penile traction therapy men (phosphodiesterase-5 inhibitors 86% vs 94%, p=0.44; intracavernosal injections 19% vs 50%, p <0.05). More penile traction therapy men reported satisfaction or improvement in penile length than controls. Adverse events were transient and mild; 87% would choose to repeat therapy, and 93% would recommend it to others. CONCLUSIONS: The use of a novel penile traction therapy device results in significant improvements in objective and subjective penile length post prostatectomy and measures of erectile function, intercourse satisfaction and overall sexual satisfaction. External validation is warranted.

The Impact of Upper Tract Urothelial Carcinoma Diagnostic Modality on Intravesical Recurrence after Radical Nephroureterectomy: A Single Institution Series and Updated Meta-Analysis.

PURPOSE: Diagnostic ureteroscopic biopsy for upper tract urothelial carcinoma (UTUC) has been hypothesized to increase intravesical recurrence of urothelial carcinoma after radical nephroureterectomy (RNU). Moreover, the impact of ureteroscopy without biopsy or percutaneous biopsy on intravesical recurrence remains unknown. Herein, we compared post-RNU intravesical recurrences across UTUC diagnostic modalities. MATERIALS AND METHODS: Patients undergoing RNU at our institution between 1995 and 2019 were categorized by UTUC diagnostic modality: 1) no ureteroscopy or percutaneous biopsy; 2) percutaneous biopsy; 3) ureteroscopy without biopsy; 4) ureteroscopic biopsy. Intravesical recurrences were compared using Kaplan-Meier analyses and Cox-proportional hazard models. Results of group 4 vs 1 were pooled with the literature using a fixed effects meta-analysis. RESULTS: In a cohort of 834 RNU patients, 210 (25.2%) had undergone no ureteroscopy, 57 (6.6%) percutaneous biopsy, 125 (15.0%) ureteroscopy without biopsy, and 442 (53.0%) ureteroscopic biopsy. Two-year intravesical recurrence rates were 15.0%, 12.7%, 18.4%, and 21.9% for groups 1 through 4, respectively (p=0.09). Multivariable analysis found that group 4 had increased intravesical recurrences (HR 1.40, p=0.04) relative to group 1 while group 2 (HR 1.07, p=0.87) and group 3 (HR 1.15, p=0.54) did not. Group 4 remained associated with intravesical recurrence on subset analyses accounting for post-RNU surveillance cystoscopy frequency. On meta-analysis including 11 other series, ureteroscopic biopsy was associated with intravesical recurrence (HR 1.47, p <0.01). CONCLUSIONS: Ureteroscopic biopsy before RNU, but not percutaneous biopsy or ureteroscopy without biopsy, was associated with increased intravesical recurrence. Clinical trials of intravesical chemotherapy after ureteroscopic biopsy are warranted to reduce intravesical recurrences.

Outcomes of a Novel Penile Traction Device in Men with Peyronie's Disease: A Randomized, Single-Blind, Controlled Trial.

PURPOSE: Current penile traction therapy devices have significant limitations, including the need to use them for 3 to 8 hours per day. Given these issues, the novel RestoreX® penile traction therapy device was developed in cooperation with Mayo Clinic. MATERIALS AND METHODS: We performed a randomized, controlled, single-blind, intent to treat trial (ClinicalTrials.gov NCT03389854) in men with Peyronie's disease who were assigned to the penile traction therapy device for 30 to 90 minutes per day or to no therapy for 3 months. Study inclusion criteria were curvature 30 degrees or greater with no study exclusions due to complex curvature, hourglass deformity, prior Peyronie's disease therapy or surgery, or calcification. The primary outcome was safety and secondary outcomes were penile length and curvature, and questionnaire responses. RESULTS: A total of 110 men were randomized 3:1 to the penile traction therapy group or the control group. The cohorts were well matched with a mean age of 58.4 years, a 49.7-month Peyronie's disease history and 59.3 degree curvature. Overall penile traction therapy was well tolerated with only transient and mild adverse events reported. At 3 months men undergoing penile traction therapy demonstrated significant improvements over controls in penile length (1.5 vs 0 cm, p <0.001), curvature (-11.7 vs 1.3 degrees, p <0.01) and erectile function (4.3 vs -0.7, p = 0.01) according to the International Index of Erectile Function-Erectile Function among men with erectile dysfunction. Overall 77% of the men on penile traction therapy experienced improved curvature (mean -17.2 degrees in 28.2% of responders) while 94% achieved increased length (1.6 cm in 10.9%). Counter bending and the white line indicator improved efficacy, validating key device innovations. Of men who had previously used other penile traction therapy devices 100% preferred the RestoreX device. CONCLUSIONS: Penile traction therapy with the RestoreX device for 30 to 90 minutes per day was safe, and resulted in significant and clinically meaningful improvements in penile curvature and length in men with Peyronie's disease, and in erectile function in men with erectile dysfunction and Peyronie's disease with no significant adverse events. To our knowledge these data represent the only reported improvements for any device used less than 3 to 8 hours per day.

Efficacy of Combined Collagenase Clostridium histolyticum and RestoreX Penile Traction Therapy in Men with Peyronie's Disease.

BACKGROUND: Previous studies of penile traction therapy (PTT) devices have demonstrated limited/no efficacy when combined with intralesional therapies for Peyronie's disease (PD). Recently, randomized data have demonstrated the efficacy of a novel PTT device, RestoreX, developed in cooperation with the Mayo Clinic, in men with PD. AIM: To assess the safety and efficacy of treatment with the RestoreX device plus collagenase Clostridium histolyticum (CCH) compared with CCH alone and CCH with other PTT devices. METHODS: A prospective registry has been maintained of all men undergoing CCH injections for PD between March 2014 and January 2019. Assessments were performed at baseline, during each series, and after completion of treatment. Those completing therapy (8 injections or sooner if satisfied) were categorized into group 1 (CCH alone), group 2 (CCH plus any PTT device other than RestoreX), or group 3 (CCH plus RestoreX). OUTCOMES: Changes in penile length, curvature, and subjective perception and the occurrence of adverse events. RESULTS: Of 287 men with data on PTT use, 113 had completed therapy with all objective data available and compose the current cohort. Baseline demographic and pathophysiological variables were similar among the 3 groups except penile length and previous PD medications. Following treatment, group 3 demonstrated significantly greater improvements in curvature (mean, 20.3°/31% for group 1, 19.2°/30% for group 2, and 33.8°/49% for group 3), length (-0.7 cm/-4%, -0.4 cm/-2%, and +1.9 cm/+17%, respectively), and subjectively estimated curvature improvement (44%, 32%, and 63% respectively), despite shorter daily PTT use (0.9 vs 1.9 hours/day). Group 3 was more likely than the other groups to experience ≥20°, ≥20%, and ≥50% curvature improvements, ≥1 cm length gain, and ≥20% length improvement. All results were statistically significant for group 3 versus groups 1 and 2, but not between groups 1 and 2, even after controlling for baseline features and isolating a subset of ≥3 hours/day PTT use (group 2). Group 3 was 6.9 times more likely to achieve ≥20° curvature improvement, and 3.5 times more likely to achieve ≥50% curvature improvement, and 10.7 times more likely to experience ≥20% length improvement. Adverse events were similar among the 3 groups. CLINICAL IMPLICATIONS: Use of the RestoreX device enhances mean curvature outcomes by 71% and increases penile length in men with PD receiving CCH therapy. STRENGTHS & LIMITATIONS: Study strengths include a prospective registry, consistent assessments, the largest single-site series with complete posttreatment outcomes reported to date, the largest PTT series reported to date, and a true-to-life clinical design. Limitations include the nonrandomized methodology and single-site setting. CONCLUSION: The combination of RestoreX and CCH is associated with significantly greater curvature and length improvements compared with CCH alone or CCH with other PTT devices. Alom M, Sharma KL, Toussi A, et al. Efficacy of Combined Collagenase Clostridium histolyticum and RestoreX Penile Traction Therapy in Men with Peyronie's Disease. J Sex Med 2019;16:891-900.

Percutaneous resection of metastatic renal cell carcinoma.

INTRODUCTION: Metastasis-directed therapy of small solitary foci of metastatic renal cell carcinoma has been associated with improved survival. Percutaneous resection of tumors in the upper tract urinary system has been widely used for treatment of localized urothelial carcinoma, however, its role in renal cell carcinoma has not been described. Herein, we present the first case of patient undergoing percutaneous resection of renal cell carcinoma in the contralateral renal pelvis. MATERIALS AND METHODS: This is a case report describing the diagnosis, management and surgical approach to renal cell carcinoma recurrence in the contralateral renal pelvis. RESULTS: Our patient was a 75-year-old male with a history of renal cell carcinoma status post radical nephrectomy who developed a solitary 2 cm recurrence in the contralateral renal pelvis, which was found after he presented with gross hematuria. He underwent successful percutaneous resection of this recurrence with final pathology showing clear cell renal cell carcinoma. CONCLUSION: We present the first case of renal cell carcinoma recurrence in the contralateral renal pelvis treated with percutaneous resection.

Standardizing the Definition of Biochemical Recurrence after Radical Prostatectomy-What Prostate Specific Antigen Cut Point Best Predicts a Durable Increase and Subsequent Systemic Progression?

PURPOSE: Multiple definitions of biochemical recurrence for prostate cancer exist after radical prostatectomy, and variation continues in prostate cancer outcome reporting and secondary treatment initiation. We reviewed long-term prostatectomy outcomes to assess the most appropriate prostate specific antigen cut point that predicts future disease progression. MATERIALS AND METHODS: We identified 13,512 patients with cT1-2N0M0 prostate cancer who underwent radical prostatectomy between 1987 and 2010. Single prostate specific antigen cut points of 0.2, 0.3, 0.4 and 0.5 ng/ml or greater, as well as confirmatory prostate specific antigen value definitions of 0.2 ng/ml or greater followed by prostate specific antigen greater than 0.2 ng/ml and 0.4 ng/ml or greater followed by prostate specific antigen greater than 0.4 ng/ml were tested. Continued prostate specific antigen increase after a designated cut point definition was estimated using cumulative incidence. The strength of association between biochemical recurrence definitions and subsequent systemic progression were analyzed using Cox proportional hazard models and the O'Quigley event based R(2) test. RESULTS: At a median postoperative followup of 9.1 years (IQR 4.9-14.3) a detectable prostate specific antigen developed in 5,041 patients and systemic progression developed in 512. After reaching the prostate specific antigen cut point of 0.2, 0.3 and 0.4 ng/ml, the percentage of patients experiencing a continued prostate specific antigen increase over 5 years was 61%, 67% and 74%, respectively, plateauing at 0.4 ng/ml. The strongest association between biochemical recurrence and systemic progression occurred using a single prostate specific antigen cut point of 0.4 ng/ml or greater (HR 36, R(2) 0.92). CONCLUSIONS: A prostate specific antigen cut point of 0.4 ng/ml or greater reflects the threshold at which a prostate specific antigen increase becomes durable and shows the strongest correlation with subsequent systemic progression. Consideration should be given to using a prostate specific antigen of 0.4 ng/ml or greater as the standard biochemical recurrence definition after radical prostatectomy.

Buried Penis Reconstruction in the Management of Localized Penile Cancer.

INTRODUCTION: The objective of this article is to describe surgical techniques for the management of localized penile cancer concurrent with adult acquired buried penis. Penile cancer, while rare, invariably impacts quality of life as the primary surgical management ranges from local excision to total penectomy. Penile cancer has recently been linked to adult acquired buried penis (AABP) with the hypothesis that chronic inflammation of the penis contributes to risk of penile malignancy. Buried penis reconstruction is now a well-described procedure involving escutcheonectomy and split thickness skin grafting which has been shown to improve quality of life in individuals with adult acquired buried penis. TECHNICAL CONSIDERATIONS: This report describes a patient with AABP requiring partial penectomy and inguinal node dissection who also underwent adult acquired buried penis repair during his procedure. A review of cases of buried penis cases was carried out and four other cases of penile cancer were identified who were managed with penile preserving procedures. CONCLUSIONS: This combination of surgical techniques strives to improve quality of life and facilitate cancer surveillance without compromising oncologic outcomes.

Initial Experience with da Vinci Single-port Robot-assisted Radical Prostatectomies.

BACKGROUND: Single-port robotic surgery is being adopted for various surgical procedures. There have been interest in and clinical use of single-port robot-assisted radical prostatectomy (spRARP), but little reported data on feasibility and early outcomes. OBJECTIVE: To describe our institution's initial experience with spRARP utilizing the da Vinci single-port (SP) robotic system. DESIGN, SETTING, AND PARTICIPANTS: A retrospective review of the initial experience of three high-volume robotic prostate surgeons performing an spRARP utilizing the da Vinci SP robotic system was carried out. SURGICAL PROCEDURE: An spRARP using the da Vinci SP robotic system was performed following the traditional retropubic or Retzius-sparing approach. MEASUREMENTS: Patient demographics, operative time, blood loss, postoperative hospital stay, complications, and catheter duration were obtained and analyzed. RESULTS AND LIMITATIONS: In a cohort of 49 patients undergoing spRARP, median age was 62yr and prostate-specific antigen 6.4. Of the patients, 35 (71%) had cT1c disease on presentation, 92% had Gleason grade group ≥2 disease, and 85% were pT2 on final pathology. Median operative time was 161min. Median blood loss was 200ml. Seven Retzius-sparing cases were performed. Four Clavien 2 complications occurred (complication rate 8.1%). Median hospital stay was 1d and median catheter duration 7d. Operative time was <200min for all three surgeons by their third case. CONCLUSIONS: The da Vinci SP system spRARP is safe and feasible, with acceptable operative time and blood loss. Further research is needed to establish noninferiority to the da Vinci Xi and Si systems, and impact of spRARP on patient-assessed cosmesis and pain. PATIENT SUMMARY: Robotic prostatectomy using a purpose-built da Vinci single-port robotic system is safe and feasible, and warrants further study to determine whether it can improve patient outcomes.

Percutaneous Image-guided Core Needle Biopsy for Upper Tract Urothelial Carcinoma.

OBJECTIVE: To better understand the safety and diagnostic yield of percutaneous core-needle biopsy (PCNB) for upper tract urothelial carcinoma (UTUC). METHODS: Of 444 patients undergoing radical nephroureterectomy (RNU) for UTUC between 2009 and 2017 at our institution, 42 who had PCNB prior to RNU were identified for analysis. Endpoints included safety, diagnostic yield, and concordance with RNU pathology. PCNB specimens were deemed histologically concordant with RNU specimens for cases when cytologic evaluation of biopsy specimen and corresponding pathologic evaluation of RNU specimen both made a histologic diagnosis of urothelial carcinoma. RESULTS: Median tumor size was 3.8 cm (1.2-10.2 cm). All lesions arose from the pelvicalyceal system. CT-guidance was utilized in 52% (n = 22), and ultrasound-guidance in 48% (n = 20). Relative to RNU pathology, 95% of PCNBs demonstrated histologic concordance. Histologic grade was provided in 69% (n = 29) of PCNBs, with a 90% (n = 26) concordance with surgical pathology. Grades 1-2 and 3 complications occurred in 14.3% (n = 6) and 2.4% (n = 1), respectively. At a median follow-up of 28.2 months (range, 1.2-97.1 months) after biopsy, no cases of radiographic tract seeding were identified. CONCLUSION: In our cohort of 42 patients undergoing RNU for UTUC, PCNB appeared a safe diagnostic tool with high histologic yield and grade concordance. With greater than 2 years of follow-up, no cases of tract seeding were identified.

Ureteroscopic Stone Extraction in Cross-Fused Renal Ectopia.

Background: Urinary stone disease in cross-fused renal ectopia is rare and the aberrant anatomy poses challenges to treatment options. The available literature on treatment modalities remains limited. In this study, we present a case of ureteral stone in a cross-fused renal ectopia managed through retrograde approach. Case Presentation: We present a case of a 69-year-old woman with an obstructing ureteral stone in a cross-fused renal ectopia managed with ureteroscopic stone extraction. With the use of a ureteral access sheath, holmium laser, and Nitonol basket, the stone was fragmented and removed through retrograde access. The stone composition was 100% calcium oxalate monohydrate and her 24-hour urine collection was only significant for low volume. Conclusion: With special modifications and attention to the individual patient's anatomy, retrograde approach with the use of an access sheath is safe and effective for treatment of ureteral stones in patients with cross-fused renal ectopia.

A Case of Prenatally Diagnosed Wilms Tumor Managed With Laparoscopic Nephrectomy.

We present a case of prenatally diagnosed Wilms tumor, with subsequent operative approach and management. The patient was referred to our institution with an abnormal prenatal renal ultrasound. Computed tomography scan after delivery showed a multifocal enhancing left renal mass. The patient underwent an uncomplicated left laparoscopic radical nephrectomy and retroperitoneal lymph node sampling using a novel hidden incision endoscopic surgery technique. Final pathology revealed favorable histology stage II Wilms tumor. The patient underwent adjuvant chemotherapy with vincristine and dactinomycin based on the EE4A regimen. We highlight the diagnostic pathway, perioperative management, surgical approach, and early postoperative follow-up in this case report.

Small Renal Masses in Close Proximity to the Collecting System and Renal Sinus Are Enriched for Malignancy and High Fuhrman Grade and Should Be Considered for Early Intervention.

INTRODUCTION: Recent reports show a correlation between renal tumor radiographic characteristics and pathologic features. We hypothesize that a more central location within the relatively hypoxic renal medulla might confer a more aggressive tumor phenotype. To test this, radiographic tumor characteristics were compared with tumor grade and histology. MATERIALS AND METHODS: We retrospectively reviewed renal masses <4 cm in diameter that underwent resection between 2008 and 2013. Tumor location was recorded using standard R.E.N.A.L. Nephrometry Score. Multivariate logistic regression was performed to compare independent anatomic features with incidence of malignancy and high nuclear grade. RESULTS: A total of 334 renal tumors had information available for analysis. Univariate analysis showed that increasing endophycity and proximity to the collecting system (<4 mm) were predictors of malignancy and high-grade features. In multivariate analysis, proximity to the collecting system <4 mm remained the as the only anatomical variable predictive of malignancy (odds ratio [OR], 3.58; 95% confidence interval [CI], 1.06-12.05; P = .04) and high nuclear grade (OR, 2.81; 95% CI, 1.44-5.51; P = .003). CONCLUSION: Malignancy and high tumor grade occur with much greater frequency when tumors are located deep in the kidney, in close proximity to the collecting system and renal sinus. Ninety-six percent of small renal masses in this region were cancers and nearly half were Fuhrman Grade 3 or 4, suggesting that these small centrally located tumors should be targeted for early intervention.

Risk Factors and Microbial Distribution of Urinary Tract Infections Following Radical Cystectomy.

OBJECTIVE: To evaluate clinicopathologic features associated with the risk of urinary tract infection (UTI) after radical cystectomy (RC), and determine the underlying organisms responsible for these events. MATERIALS AND METHODS: We reviewed 1248 patients treated with RC for bladder cancer from 2000 to 2010 at Mayo Clinic. UTIs diagnosed within 90 days of surgery were recorded. Multivariable logistic regression analysis was performed to evaluate the association of clinicopathologic features with postoperative UTI. RESULTS: UTI was diagnosed in 129 (10.3%) patients within 90 days of RC. Median time to UTI was 22.5 days (interquartile range 14,42). On multivariable analysis, factors associated with a significantly increased UTI risk were diabetes (odds ratio [OR] 2.27; P < .001), receipt of a perioperative blood transfusion (OR 1.58; P = .03), continent urinary diversion (OR 2.17;P < .001), and development of a urine leak (OR 3.42;P < .001). Culture-specific infection data were available for 88 of the patients, with a total of 113 UTIs diagnosed among this cohort. Of these, 36.8% of UTIs were polymicrobial. Drug-resistant Staphylococcus aureus and Enterococcus were isolated in 45.0% and 12.8% of infections, respectively. Fungal elements were present in 27 (23.9%) cultures, and were the sole organism in 15 (13.3%). No significant differences in microbial distribution or timing of infections were detected between patients who underwent conduit vs continent diversion. CONCLUSION: We found that diabetes, perioperative blood transfusion, continent diversion, and urine leak were associated with UTI risk following RC. Multiple organisms, drug resistance, and fungal elements were commonly identified, supporting the use of initial broad-spectrum coverage, including consideration of antifungal therapy, upon diagnosis of UTI after RC.

Forgetting heart break: a fascinating case of transient left ventricular apical ballooning syndrome associated with dissociative amnesia.

Transient left ventricular apical ballooning syndrome (TLVABS), also known as takotsubo cardiomyopathy, is characterized by transient left ventricular dysfunction, electrocardiographic changes, and release of myocardial enzymes that mimic acute myocardial infarction in patients without angiographic evidence of coronary artery disease. Most patients are post-menopausal women and an emotional or physiologic stressor frequently precedes the presentation. Psychogenic or dissociative amnesia is a memory disorder characterized by sudden retrograde memory loss with inability to recall personal information said to occur for a period of time ranging from hours to years after a stressful event. Interestingly, the mechanism of both disorders has been linked to plasma elevation in catecholamines. Here we present the case of a 66-year-old female diagnosed with both TLVABS and dissociative amnesia following the sudden unexpected death of her sister. To our knowledge, this is surprisingly the first report of the co-occurrence of TLVABS and dissociative amnesia, two processes with a potential shared underlying etiology.