The Role of Prostate Specific Antigen Monitoring after Holmium Laser Enucleation of the Prostate.

PURPOSE: Prostate specific antigen screening for prostate cancer has recently been challenged due to poor sensitivity. In addition to prostate cancer, a number of conditions elevate prostate specific antigen, of which benign prostatic hyperplasia is most common. The objective of this study was to assess the positive predictive value of prostate specific antigen and prostate specific antigen density for prostate cancer risk following holmium laser enucleation of the prostate. MATERIALS AND METHODS: We queried an institutional review board approved database of holmium laser enucleation of the prostate performed at Indiana University from 1999 to 2018 to identify 1,147 patients with prostate specific antigen data available after holmium laser enucleation. A total of 55 biopsies after enucleation were recorded. Demographics, prostate specific antigen, prostate volume and oncologic details were analyzed. The primary outcome was biopsy proven prostate cancer. RESULTS: A total of 55 patients underwent transrectal ultrasound prostate biopsy for cause after holmium laser enucleation of the prostate. Cancer was identified in more than 90% of biopsied cases. Men with prostate specific antigen above 1 ng/ml at biopsy had a 94% probability of cancer detection and an 80% risk of clinically significant disease. Prostate specific antigen density above 0.1 ng/ml2 was associated with a 95% risk of cancer and an 88% risk of clinically significant cancer. Prostate specific antigen greater than 5.8 ng/ml or prostate specific antigen density greater than 0.17 ng/ml2 was universally associated with biopsy proven cancer. CONCLUSIONS: Prostate specific antigen and prostate specific antigen density have high positive predictive value for prostate cancer risk after holmium laser enucleation of the prostate. Thresholds for biopsy should be lower than in patients who do not undergo holmium laser enucleation. Those who undergo that procedure and have prostate specific antigen above 1 ng/ml or prostate specific antigen density above 0.1 ng/ml2 are at higher risk for harboring clinically significant disease and should undergo biopsy. Referring physicians should be aware of these significant risk shifts.

Use of flexible cystoscopy at time of artificial urinary sphincter placement.

INTRODUCTION: Artificial urinary sphincters (AUS) are used to treat significant urinary incontinence. Flexible cystoscopy at the time of AUS placement provides relevant intraoperative feedback including confirmation that the AUS is functioning, visualization of coaptation, and evaluation for urethral injury. Current guidelines for placement of an AUS do not include flexible cystoscopy. The objective was to evaluate whether flexible cystoscopy at time of AUS placement changed cuff size at the time of surgery. MATERIALS AND METHODS: A retrospective cohort study was performed to evaluate all patients undergoing AUS placement by a single surgeon between March 2013 and March 2017. The primary endpoint of the study was change in cuff size based on cystoscopy. RESULTS: A total of 109 AUS were placed in 96 patients. In five (4.6%) cases flexible cystoscopy identified a lack of coaptation of the urethra despite appropriate sizing which resulted in down-sizing of the cuff. Five patients were identified as having a bladder neck contracture that was previously unrecognized as clinic cystoscopy was performed by the referring urologist and was reportedly normal. Three patients developed postoperative infections, two of these patients had a history of multiple AUS placement and revisions and the third patient had a history of cystectomy and neobladder. CONCLUSIONS: Flexible cystoscopy at time of AUS placement changed the cuff size in nearly 5% of cases. Flexible cystoscopy at time of AUS placement provides valuable feedback and should be recommended for low volume prosthetic surgeons.

A novel technique for direct visualization of reservoir placement for penoscrotal inflatable penile prostheses using a single incision.

INTRODUCTION: We aim to present a modified technique and outcomes of a novel method allowing for direct visualization of the reservoir placement during a penoscrotal inflatable penile prosthesis (IPP). METHODS: Out of165 patients who underwent IPP placement from August 2012 to March 2015, 157 underwent a modified technique and comprised the cohort of this study. A Deaver's retractor was placed lateral to the penis and over the pubic bone to allow for direct visualization of the tissues overlying the lower abdomen. After dissecting through the superficial layers, the Deaver's was slowly advanced, allowing for visualization of the fascia, which was incised. Using blunt dissection, a space for the reservoir was created between the bladder and the pubic bone. The reservoir was then placed safely into this space and the Deaver's retractor was removed. RESULTS: The causes of ED in the study cohort included postprostatectomy ED (n = 107), organic impotence (n = 40), Peyronie's disease (n = 3), ED following cystoprostatectomy (n = 2), ED due to spinal cord injury (n = 2), ED resulting from priapism (n = 2), and ED after pelvic injury (n = 1); all of which were refractory to medical management. The median age of study population was 66 years and the mean (standard deviation) operative time was 72.8 (14.7) min. Eighty percent of the procedures were performed on outpatient basis. Complication rates were low (<5%), with four infections, one proximal pump migration, one scrotal hematoma, and one urinary tract infection. CONCLUSION: The modified technique for placement of the IPP's spherical reservoir under direct visualization through a penoscrotal incision is quick, safe, and effective.

Changing USA national trends for adrenalectomy: the influence of surgeon and technique.

OBJECTIVE: To explain differences over time between operative approach and surgeon type for adrenal surgery in the USA. PATIENTS AND METHODS: A retrospective cohort analysis was performed on all patients undergoing adrenalectomy between 2002 and 2011 using the Nationwide Inpatient Sample. Patients undergoing concurrent nephrectomy were excluded. Surgeon specialty was only available for 2003-2009. Descriptive analyses and multivariable logistic regression models were used to assess variables associated with minimally invasive surgery (MIS) and urologist-performed procedures. RESULTS: In all, 58,948 adrenalectomies were identified. A MIS approach was used in 20% of these operations. There was a 4% increase in MIS throughout the study period (P < 0.001). Cases performed at teaching hospitals were more likely to be MIS (odds ratio [OR] 1.47, P < 0.001). We were able to identify surgical specialty in 23,746 cases, of which 60% were performed by urologists. Cases performed in the Midwest compared with Northeast were at increased adjusted odds of being performed by urologists (OR 1.38, P = 0.11). Despite most cases being performed by urologists, adrenalectomy by urologists showed a 15% annual decrease over the analysed period (P < 0.001). CONCLUSIONS: The use of a MIS technique to perform adrenalectomy is increasing at a slower rate compared with most other surgical extirpative procedures. Further investigation to explain the decreased performance of adrenalectomy by urologists is warranted.

The Mulcahy Salvage: Past and Present Innovations.

INTRODUCTION: Inflatable penile implants are a mainstay for the surgical correction of erectile dysfunction. For the last 40 years they have provided reliable outcomes with durable patient satisfaction. Infection of the implant continues to remain the primary surgical concern, despite the advent of antibiotic-coated devices and improved skin preparation solutions. METHODS: In this article, we review and evaluate the published literature for important contributions surrounding the various salvage techniques and washout strategies. In addition, the role of biofilm in prosthetic infection will be discussed. RESULTS: First described by Mulcahy for instances of device infection, the salvage or rescue procedure was established to avoid complete removal and staged replacement. This approach, with its avoidance of difficult revision surgery, penile shortening and patient discomfort, has produced success as high as 84%. CONCLUSION: Mulcahy's innovative approach at salvage or rescue reimplantation has proven to be a highly successful approach to this difficult surgical problem. Without question, the report of the long-term results of his salvage patients has directly influenced a generation of prosthetic surgeons.

Ventral onlay buccal mucosa urethroplasty: a 10-year experience.

OBJECTIVE: To report our experience, and to evaluate the long-term outcomes and complication profiles of ventral onlay buccal mucosal graft urethroplasty (BMU) after prior urological intervention. METHODS: We retrospectively reviewed 114 consecutive patients between February 2001 and April 2009 who underwent buccal mucosal graft urethroplasty for recurrent anterior urethral stricture disease. Seven patients were excluded for incomplete data. The remaining 107 patients comprised the study cohort. The mean follow-up time was 39.3 months (range 6.6-127.3 months). All patients had prior urological attempts at operative management. RESULTS: The mean stricture length was 3.14 cm (range 1.0-8.0 cm). Indications for buccal mucosal graft urethroplasty included: lichen sclerosis (2.8%), iatrogenic (24.3%), infection (4.7%) and perineal trauma/straddle injury (20.6%). Of these patients, 78 had bulbo-membranous stricture disease, 20 had penile involvement and nine were multifocal strictures. The average number of prior urological procedures was 2.83 (range 1-9). The overall graft failure rate was 6.5%. Importantly, the re-operation rate was 20.6%, primarily for stricture recurrence (18), meatal stenosis (3) and urethral diverticulum. The mean time to complication was 10.8 months. CONCLUSIONS: Ventral onlay buccal mucosal graft urethroplasty offers satisfactory results in the setting of recurrent and complicated urethral stricture disease. Graft failures and complications generally occur within the first year after surgery. Bulbar strictures enjoy greater graft patency and lower complication rates than other stricture locations. In particular, guarded expectations should be given for stricture length >4 cm and multifocal disease.

Long-term Renal Preservation and Complication Profile With Ileal Ureter Creation.

OBJECTIVE: To examine long-term ileal ureter replacement results at over 32 years at our institution. Long segment or proximal ureteral strictures pose a challenging reconstructive problem. Ureteroureterostomy, psoas hitch, Boari flap, buccal ureteroplasty, and autotransplantation are common reconstructive techniques. We show that ileal ureter remains a lasting option. METHODS: We performed a retrospective review of patients undergoing open ileal ureter creation from 1989-2021. Patient demographics, operative history, and complications were examined. All patients were followed for changes in renal function. Demographic data were analyzed and Cox proportional hazard models were performed. RESULTS: One hundred and fifty-eight patients were identified with median follow-up time of 40 months. Eighty-one percent had a unilateral ileal ureter creation. Fifty percent were female, median age was 53.3. Twenty-seven percent of patients had radiation-induced strictures. Preoperatively, 56.3% of patients were chronic kidney disease stage 1-2 and 43.7% were stage 3-5. Post-operatively, 54% were stage 1-2 and 46% were stage 3-5. Cox proportional hazard models demonstrated no significant correlation between worsening renal function and stricture cause, bilateral repair, complications, or sex (biologically male or female). Seventy-seven percent had no 30-day complications. Clavien complications included grade 1 (18), grade 2 (4), grade 3 (9), and grade 4 (5). Long-term complications included worsening renal function (3%), incisional hernia (8.2%), and small bowel obstruction (6.9%). Five (3.1%) patients ultimately required dialysis and 5 (3.1%) patients developed metabolic acidosis. CONCLUSION: Ileal ureteral reconstruction is often a last resort for patients with complex ureteral injuries. Clinicians can be reassured by our long-term data that ileal ureteral creation is a safe treatment with good preservation of renal function and low risk of hemodialysis and metabolic acidosis.

Ileal Ureter Utilization in Patients With Previous Urinary Diversions.

OBJECTIVE: To evaluate a subset of patients who develop strictures requiring Ileal Ureter (IU) in the setting of prior urinary diversion or augmentation (ileal conduits, neobladders, continent urinary diversions). To our knowledge, there are no prior studies on patients with IU substitution into established lower urinary tract reconstructions. METHODS: A retrospective review of patients (18 years) undergoing IU creation from 1989 to 2021 was performed. A total of 160 patients were identified. In total, 19 (12%) patients had IUs into diversions. We examined demographics, stricture cause, diversion type, renal function, and postoperative complications. RESULTS: Nineteen patients were identified. Sixteen were male. Mean age was 57.7(SD 17.0) years. Diversions included continent urinary reservoirs (4), neobladders (5), ileal conduits (7), and bladder augmentations with Monti channels (3). Fifteen had unilateral surgery, and 4 had bilateral "reverse 7" IU creation. Average length of stay was 7.6 days (SD 2.9). Average follow-up was 32.9 months (SD 27). Mean preoperative creatinine was 1.5 (SD 0.4); mean postoperative creatinine at most recent follow-up was 1.6 (SD 0.7). There was no significant difference between pre- and postoperative creatinine (P = .18). One patient had a ventriculoperitoneal Shunt infection resulting ventriculoperitoneal shunt externalization, 1 had Clostridium difficile infection potentially causing an entero-neobladder fistula, 2 with ileus, 1 urine leak, and 1 wound infection. None required renal replacement therapy. CONCLUSION: Patients with urinary diversions and prior bowel reconstructive surgeries with subsequent ureteral strictures are a challenging cohort of patients. In properly selected patients, ureteral reconstruction with ileum is feasible and preserves renal function with minimal long-term complications.

A comparison of robotic, laparoscopic and open partial nephrectomy.

INTRODUCTION: Comparison of treatments for partial nephrectomy is limited by case selection. We compared robotic (RPN), laparoscopic (LPN), and open partial nephrectomy (OPN), controlling for tumor size, patient age, sex, and nephrometry score. METHODS: RPN, LPN, and OPN procedures between March 2003 and March 2010 were reviewed. All RPN and LPN were included, and 2 OPN were matched for each RPN in tumor size (±0.5cm), patient age (±10 y), sex, and nephrometry score. Perioperative outcomes were compared. RESULTS: Ninety-six partial nephrectomy procedures were reviewed: 27 RPN, 15 LPN, and 54 OPN. RPN, LPN, and OPN had similar median tumor size (2.4, 2.2, and 2.3cm, respectively), nephrometry score (6.0 each), and preoperative glomerular filtration rate (71.5, 84.6, and 77.0 mL/min/1.73m(2), respectively). Blood loss was higher for OPN (250 mL) than for RPN or LPN (100 mL), P < 0.001. Operative time was shorter in OPN (147 min) than in RPN (190 min) or LPN (195 min), P < .001. Median warm ischemia time was shorter for OPN (12.0 min) than for RPN (25.0 min) or LPN (29.5 min), P Kt; .05. Cold ischemia time for OPN was 25.0 min. A 10% glomerular filtration rate decline occurred in 10 RPN, 5 LPN, and 29 OPN cases (P < .252). Median hospital stay for LPN and RPN was 2.0 d versus 3.0 d for OPN (P < .001). Urine leak occurred in 1 RPN and 3 OPN cases. Postoperative complications occurred in 4 RPN (3 were Clavien grade 2 or less), 1 LPN (grade 1), and 7 OPN (6 were grade 2 or less) cases. CONCLUSION: Renal function preservation and complications are similar for each treatment modality. OPN offers faster operative and ischemia times at the expense of greater blood loss and hospital stay.

Sarcoidosis: A rare cause of penile edema.

Reports of penile sarcoidosis are rare in the literature. We describe the case of a male who presented with several months of distal penile swelling and progressive inability to retract the foreskin. Firm, non-tender subcutaneous nodules were palpated near the base of the penis. The patient ultimately underwent penile skin resection, partial scrotal resection, and split thickness skin graft to the penis after failing multiple conservative treatments. Pathology revealed non-caseating granulomatous lesions which in addition to CT chest findings of bilateral hilar adenopathy suggested a diagnosis of penile sarcoidosis.

The role of urethral ligation after AUS failure and end stage urethra.

PURPOSE: To provide our single-center experience with an approach to refractory stress urinary incontinence (SUI) with permanent urethral ligation (PUL) and suprapubic tube (SPT) placement, in hopes of contributing to the limited body of research surrounding this surgical treatment option for patients with end-stage urethra (ESU). METHODS: All patients undergoing PUL with SPT placement from 01/01/2018 to 04/30/2022 were identified from an institutional database. Institutional Review Board exempt status was granted for the conduct of this study. Patients were seen postoperatively at 1 month and 1 year. If there were any concerns of incontinence, an antegrade urethrogram via the SPT was performed. Descriptive statistics were used to evaluate patients. RESULTS: Seven patients underwent PUL with SPT in our timeframe and were included in the study. All patients previously had an AUS placed, and two patients had a urethral sling previously placed. The median follow-up time was 21 months, ranging between 2 and 48 months. Complications included bladder spasms (43%) and continued leakage per urethra (14%). Of the 7 patients, 6 have reported continence through their urethra at their most recent follow-up. CONCLUSION: This initial data suggest that PUL with SPT placement may be a viable surgical approach to treating refractory SUI, especially for patients with ESU who wish to avoid the morbidity associated with more formal supravesical diversion. Further study of this technique and longer follow-up is required to determine its long-term efficacy and tolerability for patients.

Definitive surgical therapy for refractory radiation cystitis: Evaluating effectiveness, tolerability, and extent of surgical approach.

INTRODUCTION AND OBJECTIVE: The management of severe symptoms secondary to radiation changes to the bladder can be difficult. Many patients often endure costly procedures, hospitalizations, transfusions, and physician visits for intractable symptoms. Our aim was to evaluate the short-term efficacy and feasibility of urinary diversion in patients with severe, debilitating symptoms related to radiation cystitis by focusing on perioperative data examining surgical feasibility and assess for any improvement in the number of procedures, transfusions, hospitalizations, and office visits required. METHODS: With IRB approval, we queried our institutional database for patients with a diagnosis code of radiation cystitis who underwent urinary diversion with or without bladder removal from 2011 to 2018. We reviewed institutional and regional record to assess pre, peri and postoperative outcomes, including rates of surgical procedures, hospitalizations, transfusions and clinic visits, in the year before and after treatment. Non-parametric statistics and linear regression were used. RESULTS: Of the 286 patients with radiation cystitis, 45 patients underwent definitive urinary diversion - 31 with concomitant cystectomy and 14 with diversion alone. Analysis of perioperative variables such as estimated blood loss, surgical time, post-operative hospital stay or complication rates were similar to our experience with cystectomy in non-radiated patients. With a mean follow up of 14.6 months, we found that the number of procedures, hospitalizations and transfusions objectively improved following radical surgery. Office visits, however, did not seem to be impacted by performing urinary diversion. There were no significant differences in post-operative benefits between patients that received a concomitant cystectomy and those that only underwent diversion. CONCLUSION: Patients suffering from severe refractory symptomatic radiation cystitis may be best treated with a radical surgical approach. Definitive urinary diversion with or without cystectomy can lower burden of disease by reducing the need for additional procedures, hospitalizations, and blood transfusions on short term follow-up.

Impact of obesity on male urethral sling outcomes.

BACKGROUND: The impact of obesity on AdVance male urethral sling outcomes has been poorly evaluated. Anecdotally, male urethral sling placement can be more challenging due to body habitus in obese patients. The objective of this study was to evaluate the impact of obesity on surgical complexity using operative time as a surrogate and secondarily to evaluate the impact on postoperative pad use. METHODS: A retrospective cohort analysis was performed using all men who underwent AdVance male urethral sling placement at a single institution between 2013 and 2019. Descriptive statistics comparing obese and non-obese patients were performed. RESULTS: A total of 62 patients were identified with median (IQR) follow up of 14 (4-33) months. Of these, 40 were non-obese and 22 (35.5%) were obese. When excluding patients who underwent concurrent surgery, the mean operative times for the non-obese versus obese cohorts were 61.8 min versus 73.7 min (p = 0.020). No Clavien 3-5 grade complications were noted. At follow up, 47.5% of the non-obese cohort and 63.6% of the obese cohort reported using one or more pads daily (p = 0.290). Four of the five patients with a history of radiation were among the patients wearing pads following male urethral sling placement. CONCLUSION: Obese men undergoing AdVance male urethral sling placement required increased operative time, potentially related to operative complexity, and a higher proportion of obese compared with non-obese patients required postoperative pads for continued urinary incontinence. Further research is required to better delineate the full impact of obesity on male urethral sling outcomes.

Robotic and open partial nephrectomy for intermediate and high complexity tumors: a matched-pairs comparison of surgical outcomes at a single institution.

Objective: To compare peri-operative factors and renal function following open partial nephrectomy (OPN) and robotic partial nephrectomy (RPN) for intermediate and high complexity tumors when controlling for tumor and patient complexity.Methods: A retrospective review of 222 patients undergoing partial nephrectomy was performed. Patients with intermediate (nephrometry score NS 7-9) or high (NS 10-12) complexity tumors were matched 2:1 for RPN:OPN using NS, Charlson Comorbidity Index (CCI), and BMI. Patient demographics, peri-operative values, renal function, and complication rates were analyzed and compared.Results: Seventy-four OPN patients were matched to 148 RPN patients with no difference in patient demographics. Estimated blood loss in OPN patients was significantly higher (368.5 vs 210.5 mL, p < 0.001) as was transfusion rate (17% vs 1.6%, p < 0.001). Warm ischemia time was longer in OPN (25.5 vs 19.7 min, p = 0.001) while operative time was reduced (200.5 vs 226.5 min, p = 0.010). RPN patients had significantly shorter hospitalizations (5.3 vs 3.0 days, p < 0.001). GFR decrease after one month was not statistically significant (12.9 vs 6.6 ml/min, p = 0.130). Clavien III-V complications incidence was higher for OPN compared to RPN although not significantly (20.3% vs 10.8%, p = 0.055).Conclusion: When matching for tumor and patient complexity, RPN patients had fewer high grade post-operative complications, decreased blood loss, and shorter hospitalizations. RPN is a safe option for patients with intermediate and high complexity tumors.

Use of ileum as ureteral replacement in urological reconstruction.

PURPOSE: We reviewed indications and outcomes in patients undergoing ileal ureter replacement for ureteral reconstruction. MATERIALS AND METHODS: Between December 1989 and September 2007, 105 patients underwent ileal ureter replacement, of whom 14 were excluded from study due to incomplete data. The remaining 91 patients (99 renal units) comprised the study cohort. RESULTS: Mean patient age was 46.8 years and mean followup was 36.0 months. Indications for an ileal ureter were stricture following genitourinary surgery in 29 cases (31.9%), radiation induced stricture in 17 (18.7%), nonurological surgery iatrogenic injury in 16 (17.6%) and retroperitoneal fibrosis in 11 (12.1%). Only 4 patients (4.4%) had primary ureteral cancer. Long-term complications included anastomotic stricture in 3 patients (3.3%) and fistula in 6 (6.6%). Serum creatinine decreased or remained stable in 68 patients (74.7%) and hyperchloremic metabolic acidosis developed in 3. No patient complained of excessive urinary mucous production. CONCLUSIONS: In 68.1% of patients indications for an ileal ureter included radiation induced stricture or iatrogenic injury. The ileal ureter is a reasonable option for long-term ureteral reconstruction with preserved renal function in carefully selected patients.

An Uncommon Case of a Traumatic Corporal Cutaneous Fistula.

Penetrating perineal trauma is an unusual urologic injury. Even less common is a delayed presentation. Herein we present the case of a patient with delayed development of a corporal cutaneous fistula 3 months following perineal trauma.

The Use of Full Thickness Skin Graft Phalloplasty During Adult Acquired Buried Penis Repair.

OBJECTIVE: To evaluate the feasibility and outcomes of full thickness penile skin grafting (FTSG) for phalloplasty during acquired buried penis repair. MATERIALS AND METHODS: A retrospective cohort study of patients undergoing complex genital reconstruction for buried penis between January 2013 and April 2018 was performed. Patients undergoing FTSG were identified. All patients underwent escutcheonectomy, scrotoplasty, and penile skin grafting by a single Urologist (MM) and Plastic surgeon (JS). Escutcheon tissue was used for the FTSG. The primary outcome was graft take and the secondary outcome was recurrence requiring surgical revision. RESULTS: Thirteen patients were identified for inclusion in the study with average age of 43.4 and average BMI of 42. Median (range) follow-up for the cohort was 8 (3-44) months. Surgical indication was lymphedema in 6 (46.2%), morbid obesity in 6 (46.2%), and hidradenitis suppurativa in one (7.7%). Seven required concurrent urethromeatoplasty for meatal stenosis and fossa navicularis strictures. All grafts were successful. Two patients developed postoperative wound infections requiring antibiotics. One patient redeveloped lymphedema of the scrotum and required complete revision surgery although the FTSG remained intact. No patients had reburying of the penis. Minor outpatient surgical revision was performed for 2 patients for scarring and edema of the glans. CONCLUSION: Full thickness skin grafts provide a useful option for penile reconstruction during surgical management of buried penis. Patients had excellent graft acceptance and minimal wound complications. Further research and comparative cohorts are warranted to fully determine the role of FTSG in genital reconstruction.

Anti-angiogenic gene therapy for metastatic renal cell carcinoma produces tumor growth suppression in an athymic nude mouse model.

PURPOSE: We investigated the anti-angiogenic and antitumor properties of 2 adenoviral vectors expressing the endostatin-angiostatin fusion protein Ad-EndoAngio and the soluble, endothelium specific tyrosine kinase receptor Ad-Tie2 in a mouse renal cell carcinoma xenograft model. MATERIALS AND METHODS: A total of 29 bilateral subcutaneous renal cell carcinomas were induced in athymic nude mice. On days 2 and 10 following tumor establishment the mice were intratumorally injected with an adenoviral vector in the right flank only. Seven treatment groups were randomly assigned, including the control group of 7 mice, the Ad-GFP control group of 7, the Ad-Tie2 group of 9, the Ad-EndoAngio group of 8, the Ad-GFP plus Ad-Tie2 group of 7, the Ad-GFP plus Ad-EndoAngio group of 9 and the Ad-EndoAngio plus Ad-Tie2 group of 8. Tumor volume was measured biweekly for 60 days. Additionally, each treatment group was administered fluorescent rhodamine conjugated bovine serum albumin dye for vascular imaging. After establishing skin windows overlying the tumors dual photon optical imaging was used to qualitatively assess the tumor vasculature. RESULTS: Tumors treated with Ad-EndoAngio, Ad-GFP plus Ad-EndoAngio and Ad-EndoAngio plus Ad-Tie2 demonstrated 82%, 83% and 87% growth reduction, respectively, compared to controls (p <0.001). Furthermore, in vivo imaging revealed a decrease in the number of blood vessels, lumen diameter and flow velocity in these treatment groups. CONCLUSIONS: Adenoviral vectors expressing endostatin-angiostatin fusion protein have effective anti-angiogenic action against human renal cell carcinoma cells as well as potential as a novel treatment for metastatic renal cell carcinoma.