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PURPOSE: The Optilume BPH Catheter System is a novel drug/device combination minimally invasive surgical therapy for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. The PINNACLE study is a prospective, randomized, double-blind, sham-controlled clinical trial evaluating the safety and efficacy of Optilume BPH against a sham surgical procedure. MATERIALS AND METHODS: Eligible patients were men 50 years or older with symptomatic benign prostatic hyperplasia and a prostate size between 20 and 80 g. Subjects were randomized 2:1 to receive treatment with Optilume BPH or a sham surgical procedure. Blinding was maintained for subjects in both arms and evaluating personnel through 1 year postprocedure. Follow-up assessments included the International Prostate Symptom Score, uroflowmetry, and other quality-of-life and sexual function assessments. RESULTS: A total of 148 men were randomized (100 active, 48 sham) at 18 centers in the U.S. and Canada. Subjects randomized to receive Optilume BPH saw a reduction in International Prostate Symptom Score of 11.5±7.8 points at 1 year posttreatment, as compared to a reduction of 8.0±8.3 points at 3 months in the sham arm. Flow rate was dramatically improved after treatment with Optilume BPH, with an improvement of +10.3 mL/s from baseline to 1 year (+125%). CONCLUSIONS: Treatment with Optilume BPH provides immediate and sustained improvements in obstructive symptoms and flow rate while preserving erectile and ejaculatory function. Treatment is well tolerated and can be done in an office or ambulatory setting.
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Síntomas del Sistema Urinario Inferior , Hiperplasia Prostática , Masculino , Humanos , Femenino , Hiperplasia Prostática/terapia , Hiperplasia Prostática/cirugía , Estudios Prospectivos , Erección Peniana , Eyaculación , Método Doble Ciego , Resultado del TratamientoRESUMEN
Penile cancer is a rare and potentially disfiguring disease. There are multiple treatment options for primary penile lesions. Penile sparing approaches offer an attractive option as they can provide several quality of life benefits without detrimental oncologic outcomes. With appropriate diagnostic evaluation and staging, penile sparing techniques provide proper cancer control with improved cosmetic and functional results. Regardless of the chosen treatment modality, a commitment to close follow-up remains a critical component of all treatment considerations. The goal of this review is to provide an overview of the multiple treatment strategies for primary penile tumors with a focus on penile sparing surgical approaches.
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We describe the rare case of a 68-year-old gentleman with the history of a hand-assisted laparoscopic left radical nephrectomy for a T2bN0M1 clear cell renal cell carcinoma (RCC). Seven years after surgery and with clean surveillance imaging for metastasis/recurrence the patient presented with three separate tumors suspicious for malignancy. A bladder lesion was found during workup for hematuria, a stomach lesion during diagnostic endoscopy, and a testicular lesion during self-exam. He underwent transurethral resection of bladder tumor, left inguinal orchiectomy, and upper endoscopic ensnarement. All specimens surprisingly showed RCC by histology and immunostaining. These three sites are rare for RCC metastasis and simultaneous presentation is even rarer, further emphasizing the importance of continuous and careful follow-up in this patient population, despite what could appear as complete remission.
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BACKGROUND: This report details the experience of a multidisciplinary surgical team in the management of stage III and stage IV renal cell carcinoma (RCC) with concomitant inferior vena cava (IVC) tumor thrombus. METHODS: A retrospective inquiry of our vascular database from 2003 to 2012 identified 55 surgical cases of stage III (n = 40) and stage IV (n = 15) RCC presenting with IVC tumor thrombus. Tumor characteristics and IVC tumor thrombus were evaluated by clinical staging and postoperative pathology staging. Patient demographics and surgical reconstruction are detailed. Cancer-specific outcomes consisted of oncologic surveillance with computed tomography or magnetic resonance imaging. A Clavien-Dindo classification of early (<30 days) complications and mortality was recorded, including a review of secondary surgical interventions. RESULTS: According to the Novick classification of IVC tumor thrombus, there were 10 supradiaphragmatic (level IV), 20 intrahepatic (level III), and 25 infrahepatic (level II or I) tumor thrombi. Vena cava reconstruction was completed in 54 patients (98%), with one patient deemed unresectable. Vena cava control required cardiac bypass (n = 10), venovenous bypass (n = 4), or infrahepatic IVC control (n = 40). Reconstruction of the IVC was completed with two prosthetic interposition grafts for one stage IV thrombus and one stage III thrombus; two patch repairs were done for stage III thrombus, and there were 50 primary IVC repairs. All other IVC reconstructions were patent at a mean follow-up of 23 months. A single asymptomatic patient with primary IVC repair had estimated 30% IVC narrowing but no other measurable stenosis as detected by postoperative imaging. Three patients required reoperation (two for surgical site bleeding, one for small bowel fistula). Early surgical complications included Clavien-Dindo grades I (n = 3), II (n = 6), IIIa (n = 2), IIIb (n = 3), and V (n = 2). Regional retroperitoneal or distant recurrent RCC occurred in 26 patients (48%); a single patient demonstrating recurrent IVC tumor thrombus at 8 months required secondary IVC thrombectomy. All patients with tumor invasion of the IVC wall developed recurrent RCC, and no patient survived beyond 5 years. Early mortality was 3.6% (n = 2), with 27 patients (49%) dying within 24 months, resulting in an overall mortality for the cohort of 80% (n = 44) as established on routine regular postoperative surveillance. CONCLUSIONS: A multidisciplinary approach for the management of advanced RCC and IVC tumor thrombus helps optimize outcomes. Primary IVC repairs are possible in most patients, and IVC patency is good. Recurrent tumor thrombus rates are low; however, RCC tumor recurrence and mortality are high, especially among patients with advanced cancer with IVC wall invasion.
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UNLABELLED: What's known on the subject? and What does the study add? Historically, the surgical management of renal tumours with intravascular tumour thrombus has been associated with high morbidity and mortality. In addition, few cases are treated, and typically at tertiary care referral centres, hence little is known and published about the ideal surgical management of such complex cases. The present comprehensive review details how a multidisciplinary surgical approach to renal tumours with intravascular tumour thrombus can optimise patient outcomes. Similarly, we have developed a treatment algorithm in this review that can be used in the surgical planning of such cases. OBJECTIVES: To detail the perioperative and technical considerations essential to the surgical management of renal cell carcinoma (RCC) with inferior vena cava (IVC) tumour thrombus, as historically patients with RCC and IVC tumour thrombus have had an adverse clinical outcome. ⢠Recent surgical and perioperative advances have for the most part optimized the clinical outcome of such patients. MATERIALS AND METHODS: A comprehensive review of the scientific literature was conducted using MEDLINE from 1990 to present using as the keywords 'renal cell carcinoma' and 'IVC tumor thrombus'. ⢠In all, 62 manuscripts were reviewed, 58 of which were in English. Of these, 25 peer-reviewed articles were deemed of scientific merit and were assessed in detail as part of this comprehensive review. ⢠These articles consist of medium to large (≥25 patients) peer-reviewed studies containing contemporary data pertaining to the surgical management of RCC and IVC tumour thrombus. ⢠Many of these studies highlight important surgical techniques and considerations in the management of such patients and report on their respective clinical outcomes. RESULTS: Careful preoperative planning is essential to optimising the outcomes within this patient cohort. High quality and detailed preoperative imaging studies help delineate the proximal extension of the IVC tumour thrombus and possible caval wall direct invasion while determining the potential necessity for intraoperative vascular bypass. ⢠The surgical management of RCC and IVC tumour thrombus (particularly for level III or IV) often requires the commitment of a multidisciplinary surgical team to optimise patient surgical outcomes. ⢠Despite significant improvements in surgical techniques and perioperative care, the 5-year overall survival remains only between 32% and 69%, highlighting the adverse prognosis of such locally advanced tumours. ⢠Important prognostic factors within this patient cohort include pathological stage, nuclear grade, tumour histology, lymph node and distant metastatic status, preoperative performance status, Charlson comorbidity index, and nutritional status. CONCLUSIONS: The multidisciplinary surgical care of RCC and IVC tumour thrombus (particularly high level thrombi) is pivotal to optimising the surgical outcome of such patients. ⢠Similarly, important preoperative, perioperative, and postoperative considerations can improve the surgical outcome of patients.
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Carcinoma de Células Renales/patología , Carcinoma de Células Renales/cirugía , Neoplasias Renales/patología , Neoplasias Renales/cirugía , Células Neoplásicas Circulantes/patología , Vena Cava Inferior/patología , Trombosis de la Vena/cirugía , Anestesia/métodos , Implantación de Prótesis Vascular/métodos , Diagnóstico por Imagen/métodos , Humanos , Estadificación de Neoplasias/métodos , Grupo de Atención al Paciente , Cuidados Preoperatorios/métodos , Resultado del TratamientoRESUMEN
Penile cancer is an uncommon malignancy that has a devastating effect on the patient while also being challenging to diagnose and treat. By implementing preventive measures, we can decrease the incidence of this disease and improve the quality of life of our patients. Early detection plays an important role in disease control and proper diagnostic modalities must be used in order to accurately identify the cancer and its progression. Primary penile lesions should be initially approached when surgically feasible and clinically appropriate with penile preserving surgical techniques. Advances in inguinal lymph node detection and management, has improved the clinical outcome of penile cancer. Advanced penile cancer still portends a poor prognosis and should be approached via a multimodal treatment regimen. In this review, we address the importance of prevention, early detection, and the contemporary management of primary penile lesions, as well as the advances in inguinal lymph node disease detection and surgical treatment, for both localized and advanced disease.