Combined thoracoscopic and laparoscopic approach to remove a large retroperitoneal compound paraganglioma: A case report.

BACKGROUND: Paragangliomas (PGLs) are rare catecholamine-secreting neuroendocrine tumors, which often present with secondary hypertension. The most common location is the retroperitoneal space. For the first time, we report a rare case of large retroperitoneal compound PGL, and we have innovatively applied a new surgical plan to completely remove the tumor. CASE SUMMARY: A 55-year-old middle-aged man was admitted to the hospital for fluctuating blood pressure for more than 1 year with intermittent headache. He suffered dozens of attacks every day. Blood and urine catecholamines were elevated, somatostatin receptor imaging was positive, and the diagnosis of PGL was clear. The imaging examination revealed a large tumor on the right front of the mediastinal spine at the level of T10-L1 (the posterior space of the right phrenic foot). For the first time in our department, a combined thoracoscopic and laparoscopic operation was used to detect and remove large tumors. CONCLUSION: This is the first reported case of using a thoracoscopic and laparoscopic approach simultaneously to remove a large retroperitoneal compound PGL, which may provide a new surgical approach for similar cases.

Everolimus versus sirolimus for angiomyolipoma associated with tuberous sclerosis complex: a multi-institutional retrospective study in China.

PURPOSE: To evaluate the efficacy and safety of everolimus and sirolimus in patients with tuberous sclerosis complex-associated angiomyolipomas (TSC-AML). MATERIALS AND METHODS: We performed a multi-institutional retrospective study of TSC-AML patients treated with oral everolimus 10 mg or sirolimus 2 mg per day for at least 3 months. Angiomyolipoma volume was estimated using orthogonal measurements by MRI or CT. Adverse events (AEs) were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events. All analyses were performed using SPSS 19.0 software. RESULTS: Response rates were high in both groups. With the prolonged medication durations, the therapeutic efficacy of both agents became more significant. The TSC-AML volume reduction after 6 and 12 months was more pronounced in patients with everolimus than those with sirolimus. More than half of the patients treated with everolimus had ≥ 50% reduction, and approximately 80% of them had ≥ 30% reduction, which was higher than that in patients treated with sirolimus. Regarding safety, there was no significant difference in the incidence of AEs between the two groups. CONCLUSIONS: Both everolimus and sirolimus are excellent therapeutic options for TSC-AML. However, everolimus has a better therapeutic efficacy than sirolimus, particularly in reducing TSC-AML volume. Everolimus is therefore recommended as the first choice of therapy for TSC-AML.

Sum of High-Risk Gene Mutation (SHGM): A Novel Attempt to Assist Differential Diagnosis for Adrenocortical Carcinoma with Benign Adenoma, Based on Detection of Mutations of Nine Target Genes.

There has been no research on applying gene detection to differential diagnosis of adrenocortical carcinoma (ACC). We attempted to explore a novel auxiliary method for differential diagnosis between ACC with benign adrenocortical adenoma (ACA), based on mutations of target genes in tissues. Nine genes were chosen as target genes, including TP53, CTNNB1, ARMC5, PRKAR1A, ZNRF3, RB1, APC, MEN1, and RPL22. Exons sequencing of target genes were performed in 98 cases of tissue samples by FastTarget technology, including 41 ACC tissues, 32 ACA tissues, and 25 normal adrenal gland tissues. Significant mutations were detected and identified, and the clinical information was collected, for further comparative analysis and application to assist differential diagnosis of ACC. We identified 132 significant gene mutations and 227 significant mutation sites in 37 ACC tissues, much more than ACA and normal adrenal gland tissues. Mutation rates of 6 genes in ACC tissues were obviously higher than ACA tissues, including ZNRF3, ARMC5, TP53, APC, RB1, and PRKAR1A, regarded as high-risk genes. The sum of mutated high-risk genes detected in each sample was denominated sum of high-risk gene mutation (SHGM), and the rates of SHGM > 0 and SHGM > 1 in ACC tissues were 73.0% and 62.2%, respectively, both obviously higher than those in ACA tissues, with significant statistic differences. Especially for 8 cases of ACC with diameter < 5 cm, SHGM > 0 and SHGM > 1 were found in 6 samples (75%) and 4 samples (50%), respectively. However, no relevance was found between SHGM and clinical characteristics of ACC. We identified 6 high-risk genes in ACC tissues, with significantly higher mutation rates than ACA or normal adrenal gland tissues. The sum of mutated high-risk genes detected in ACC tissues was denominated SHGM, which was potential to assist the differential diagnosis of ACC with ACA, especially for the small-size ACC.

Giant multilocular prostatic cystadenoma in a 16-year-old male with difficulty in defecation: case report and literature review.

Giant multilocular prostatic cystadenoma is a rare benign tumor that originates from the prostate gland. It usually is between the rectum and the bladder, and is composed of predominantly cystic enlarged prostatic glands in a fibrous stroma and spreads extensively in the pelvis. The mass usually causes a series of obstructive symptoms by compressing adjacent organs. Here we report a case of a giant multilocular prostatic cystadenoma in a 16-year-old patient, who is the youngest case reported up to now, complaining of difficulty in defecation.

Intraoperative Vaginal Perforation During Various Mid-Urethral Sling Procedures Treating Female Stress Urinary Incontinence.

BACKGROUND: Incidence of intraoperative vaginal perforation is generally considered to be low but varies among different procedures. Vaginal perforation could not only prolong the surgeries and aggravate surgical trauma but also result in postoperative discomfort or even a second surgery. METHOD: Vaginal perforation, vaginal epithelial perforation, vaginal wall perforation, vaginal penetration, urinary incontinence were searched in PubMed, Cochrane, Embase database to identify the qualified clinical trial and relevant literature sources were also searched. RESULTS: A total of 9223 cases of from 33 trials from literatures and 387 cases from our own trail were analyzed, which provided detailed data on intraoperative vaginal perforation. Incidence of intraoperative vaginal perforation during mid-urethral sling surgery treating stress urinary incontinence was generally low, which was 1.56%. Incidence of intraoperative vaginal perforation during transobturator (TOR) procedure was higher than that during retropubic (RPR) procedure, which were 2.11% and 0.89% respectively. Incidence of intraoperative vaginal perforation during outside-to-inside TOR procedure like TOT and MONARC was higher than that during inside-to-outside TOR procedure like TVT-O, which were 2.74% and 1.52%, respectively. Incidence of intraoperative vaginal perforation during single-incision surgery like H-type TVT-SECUR reached 1.97%, while no report on U-type TVT-SECUR surgeries. CONCLUSION: The incidence of intraoperative vaginal during mid-urethral sling procedures for female stress urinary incontinence is fairly high. Vaginal perforation was more common in trans-obturator route (TOR) than retropubic route (RPR). In TOR route, it was less frequent in inside-to-outside procedure than outside-to-inside procedure. Surgery proficiency could also have an impact on this complication.

Is Prophylactic Steroid Treatment Mandatory for Subclinical Cushing Syndrome After Unilateral Laparoscopic Adrenalectomy?

OBJECTIVE: This study aimed to provide rational guidelines for patients with subclinical Cushing syndrome (SCS), who are undergoing laparoscopic adrenalectomy, in order to avoid the risk of overtreatment. METHODS: A total of 59 patients diagnosed with SCS caused by unilateral adrenal adenoma, who underwent laparoscopic adrenalectomy from 2010 to 2017, were included into the study. These patients did not receive prophylactic steroid treatment. After discharge, patients with adrenal insufficiency (AI) were treated with glucocorticoid. Then, cortisol levels were reevaluated at three months after surgery by morning serum cortisol. RESULTS: No severe perioperative complications occurred. After unilateral laparoscopic adrenalectomy, no patient developed AI and was readmitted. In the first week after surgery, 10 patients (16.9%) received steroid therapy at the clinic because of mild symptoms of AI. The probability of developing AI was greater in patients with 1-mg dexamethasone midnight suppression test (1 mg-DST) >5 µg/dL than patients with mg-DST ranging within 1.8 to 5.0 µg/dL (P=0.042). The initial dose of hydrocortisone was 20.00±6.67 mg/d (range, 10 to 30), and the duration of treatment was 6.90±3.51 weeks (range, 3 to 12 wk). At three months after surgery, morning cortisol was >5 µg/dL in all patients. CONCLUSIONS: After laparoscopic adrenalectomy, the probability of AI is small in patients with adrenal SCS, and the symptoms of AI were mild. Meanwhile, the HPA axis rapidly recovered. Therefore, prophylactic steroid treatment is not mandatory. Given that AI is more frequent in patients with higher cut-offs of 1 mg-DST, a more precise definition of SCS is necessary to better manage these patients.

Open adrenalectomy versus laparoscopic adrenalectomy for adrenocortical carcinoma: a retrospective comparative study on short-term oncologic prognosis.

PURPOSE: Open adrenalectomy (OA) remains the gold standard of surgical therapy for adrenocortical carcinoma, while the role of laparoscopic approach is controversial. We aim to explore the influence of surgical approaches on the oncologic prognosis of adrenocortical carcinoma by comparing the short-term outcomes of patients undergoing OA with those undergoing laparoscopic adrenalectomy (LA). PATIENTS AND METHODS: We retrospectively analyzed the baseline characteristics, perioperative data and short-term prognosis of 42 patients diagnosed with stage I-III adrenocortical carcinoma, receiving OA (n=22) and LA (n=20) as primary therapy. The primary end point was the first recurrence. RESULTS: OA group had larger mean maximum diameter of tumor (10.1±3.6 versus 6.3±2.2 cm) and lesser benefits in operative time, bleeding loss and postoperative hospital stay than laparoscopic group. Mean disease-free survival (DFS) of OA was 44.8±35.1 months, which was longer than 17.5±10.4 months of LA, and the rate of 2-year DFS after primary surgery in the open group was higher than in the laparoscopic group (61.1% versus 21.4%, respectively). Rates of 1- and 3-year DFS showed no significant difference. All patients undergoing LA (11/11) showed local recurrent lesions at the first time of recurrence, while 5 of 13 patients undergoing OA did not show local recurrence (P=0.03). CONCLUSION: OA for adrenocortical carcinoma is superior to laparoscopic approach in terms of DFS and rate of 2-year DFS, in spite of the larger maximum diameter of tumors and lesser benefit during perioperation. After LA, patients are more likely to show local recurrent lesions at the first time of relapse.

Comparison of Partial and Radical Laparascopic Nephrectomy: Long-Term Outcomes for Clinical T1b Renal Cell Carcinoma.

PURPOSE: To compare the long-term clinical and oncologic outcomes in patients treated with laparoscopic partial nephrectomy (LPN) and laparoscopic radial nephrectomy (LRN) for clinical T1b renal cell carcinoma. MATERIALS AND METHODS: We retrospectively reviewed the records of all patients who underwent LPN or LRN for a single clinical T1b tumor between January 2005 and January 2012, an actual follow-up of 2-year or greater was available in 39 and 160 after LPN and LRN, respectively. Survival was calculated using the Kaplan-Meier method. Multivariable Cox regression analysis was done to assess predictors of survival. RESULTS: The two cohorts of patients were similar in age, sex, body-mass index and preoperative eGFR. There were no differences in tumors size (4.97 vs 5.29cm, P = .08), and pathological stage distribution between the two cohorts. The median follow-up after LPN and LRN were 67 (range: 18-118) and 70 (19-120) months, respectively. For LPN versus LRN, 5-years overall and cancer specific survival rates were 93.33% vs 85.69% and 96.00% vs 91.35%, respectively. For LPN versus LRN, 10-years overall and cancer specific survival rates were 85.56% vs73.41% and 88.00% vs 82.85%, respectively. On multivariate analysis, patients' age, ASA score and pathological stage were the major factors affecting overall survival, and patients' age and pathological stage were associated with cancer specific survival. The percent decrease in glomerular filtration rate was significantly lower in the LRN group at early and last followup. CONCLUSION: LPN is an effective treatment option in appropriately selected patients with cT1b RCC. It provides 5-year, 10-year overall survival and cancer specific survival comparable to those of LRN as well as better preservation of renal function than LRN. Overall survival and cancer specific survival are associated with nonmodifiable factors but not by the choice of operative technique.

Subclinical left ventricular systolic dysfunction detected by two-dimensional speckle tracking echocardiography in patients with pheochromocytoma and paraganglioma and preserved ejection fraction.

BACKGROUND: Excessive catecholamine leads to pressure overload and left ventricular (LV) remodeling. The goal of this study was to explore subclinical LV systolic dysfunction and the mechanism of preserved left ventricular ejection fraction (LVEF) in patients with pheochromocytoma and paraganglioma using two-dimensional speckle tracking echocardiography. METHODS: A total of 48 patients with pheochromocytoma and paraganglioma and preserved LVEF and 38 age- and gender-matched volunteers were studied. Echocardiographic parameters including LVEF, and global peak longitudinal and circumferential strains were measured. The correlation between echocardiographic parameters and blood pressure as well as biochemical parameters was analyzed. RESULTS: LVEF was similar between patients with pheochromocytoma and paraganglioma and controls. The amplitude of LV longitudinal strain was decreased, and the amplitude of LV circumferential strain was increased in the pheochromocytoma and paraganglioma group (P = .003 and P = .009). LV mass index and blood pressure were positively correlated with 24-hour urinary norepinephrine (r = .696, P < .0001; r = .470, P = .0007). The amplitude of LV longitudinal strain reduced with increase in blood pressure, 24-hour urinary norepinephrine and LV mass index (r = -.305, P = .035; r = -.506, P = .0002; r = -.680, P < .0001). CONCLUSIONS: This study revealed that excessive norepinephrine in pheochromocytoma and paraganglioma was associated with increased blood pressure and LV mass. The LV longitudinal strain was decreasing with increase in blood pressure and LV mass index. The enhanced LV circumferential strain might be the mechanism of compensation to maintain the normal LVEF in these patients.

Adrenalectomy was recommended for patients with subclinical Cushing's syndrome due to adrenal incidentaloma.

OBJECTIVE: To assess whether adrenalectomy may improve biochemical and metabolic impairment for patients with subclinical Cushing syndrome (SCS) due to adrenal incidentaloma (AI) compared with conservative management. METHODS: A total of 87 patients with SCS due to AI in Peking Union Medical College Hospital between September 2011 and January 2016 have been treated. Forty-eight patients underwent laparoscopic adrenalectomy (operative group), whereas 39 were managed conservatively (control group). RESULTS: The duration of follow-up was 32.5 ± 10.6 months in operative group, and 30.1 ± 13.1 months in control group, respectively. In the operative group, laboratory corticosteroid parameters normalized in all patients but not in the control group. In the operative group, BP of hypertensive patients improved or normalized (22 of 48); to the contrary, in the control group, cure or improvement was never achieved among the patients with hypertension, whereas a worsening was observed in 5 patients (P= 0.004). No significant difference was found in glycemic control and blood lipid change between the two groups. However, a decrease in triglyceridaemia and HBA1c was found in operative group compared with the control group (P= 0.011 and P= 0.017, respectively). Substitutive corticosteroid treatment was administered in 3 patients due to postoperative adrenal insufficiency during hospital stay, and the duration of treatment was 9 weeks, 10 weeks and 12 weeks, respectively. CONCLUSIONS: Laparoscopic adrenalectomy should be performed for patients with SCS due to AI.

Effectiveness and safety of laparoscopic enucleation combined with selective arterial embolization for renal angiomyolipoma.

OBJECTIVE: This study aims to investigate the clinical value of laparoscopic enucleation combined with selective arterial embolization for the treatment of renal angiomyolipoma. METHODS: Data of patients who underwent laparoscopic nephron-sparing surgery for renal angiomyolipoma between July 2013 and November 2014 in our center were analyzed. RESULTS: Before surgery, 19 patients underwent selective arterial embolization, while 24 patients did not receive this treatment. Intraoperative blood loss was 46.4 ± 20.6 ml in the embolization group and 89.5 ± 30.4 ml in the non-embolization group (P= 0.000). Operation time was 90.3 ± 21.1 minutes in the embolization group and 131.7 ± 18.6 minutes in the non-embolization group (P= 0.000). Warm ischemia time was 9.5 ± 5.7 minutes in the embolization group and 24.2 ± 4.8 minutes in the non-embolization group (P= 0.001). Hospitalization time was 7.7 ± 1.1 days in the embolization group and 6.3 ± 1.3 days in the non-embolization group (P= 0.000). No serious complications occurred in patients in the embolization group, while one patient developed urinary leakage and another patient had angiomyolipoma in the operation area in the non-embolization group. Three months after the operation, serum creatinine level was 70.1 ± 13.7 µ mol/L in the embolization group and 84.2 ± 9.1 µ mol/L in the non-embolization group (P= 0.000). No tumor recurrence occurred in patients in both groups. CONCLUSION: Compared with laparoscopic partial nephrectomy alone, tumor enucleation combined with selective arterial embolization can reduce blood loss and shorten warm ischemia time.

Preliminary Application of WCX Magnetic Bead-Based Matrix-Assisted Laser Desorption Ionization Time-of-Flight Mass Spectrometry in Analyzing the Urine of Renal Clear Cell Carcinoma.

Objective To evaluate the application of weak cation exchange (WCX) magnetic bead-based Matrix-Assisted Laser Desorption Ionization Time-of-Flight Mass Spectrometry (MALDI-TOF MS) in detecting differentially expressed proteins in the urine of renal clear cell carcinoma (RCCC) and its value in the early diagnosis of RCCC.Methods Eleven newly diagnosed patients (10 males and 1 female, aged 46-78, mean 63 years) of renal clear cell carcinoma by biopsy and 10 healthy volunteers (all males, aged 25-32, mean 29.7 years) were enrolled in this study. Urine samples of the RCCC patients and healthy controls were collected in the morning. Weak cation exchange (WCX) bead-based MALDI-TOF MS technique was applied in detecting differential protein peaks in the urine of RCCC. ClinProTools2.2 software was utilized to determine the characteristic proteins in the urine of RCCC patients for the predictive model of RCCC. Results The technique identified 160 protein peaks in the urine that were different between RCCC patients and health controls; and among them, there was one peak (molecular weight of 2221.71 Da) with statistical significance (P=0.0304). With genetic algorithms and the support vector machine, we screened out 13 characteristic protein peaks for the predictive model. Conclusions The application of WCX magnetic bead-based MALDI-TOF MS in detecting differentially expressed proteins in urine may have potential value for the early diagnosis of RCCC.

Case report of renal pelvis squamous cell carcinoma with tumor embolus in autosomal dominant polycystic kidney disease.

INTRODUCTION: Autosomal dominant polycystic kidney disease (ADPKD) is a multisystem hereditary disease characterized by formation of cysts in the ductal organs. Renal pelvis malignancy in ADPKD is very rare and sporadically reported in the previous literature. Here, we report the first case of renal pelvis squamous cell carcinoma with tumor embolus in a 35-year-old ADPKD patient. The patient presented with 3 months of persistent backache and intermittent fever, and was initially diagnosed as intracystic hemorrhage with inferior vena cava thrombosis formation. As a result, he received anticoagulation therapy in a local hospital. However, his backache got worsened during the therapy, and he lost 10 kg of his body weight from the onset of illness. In our hospital, computed tomography demonstrated a heterogeneous right renal mass as well as emboli in the inferior vena cava and bilateral renal veins. Positron emission tomography computed tomography and biopsy were also performed, but the results were equivocal. Considering the patient's willingness and the potential malignancy, we performed thoracoabdominal nephrectomy and embolectomy, and histological examination made the diagnosis of renal pelvis squamous cell carcinoma. After adjuvant chemotherapy including paclitaxel and carboplatin, the patient obtained improved physical status and was disease free at the 6-month follow-up. Although rare, renal pelvis squamous cell carcinoma should be considered in the differential diagnosis of renal mass in ADPKD patients. CONCLUSION: Our case suggested surgery combined with adjuvant chemotherapy might be effective treatments in such a condition.

The Clinical Characteristics of Metanephric Adenoma: A Case Report and Literature Review.

We describe the clinical presentation, diagnosis, treatment, and follow-up data of a 39-year-old woman with asymptomatic right kidney tumor, which was later histopathologically diagnosed as metanephric adenoma (MA). Macroscopically, the tumor had integrity tegument with homogeneous and gray cutting surface. Microscopically, the tumor cells were formed in adenoid or papillary pattern and contained psammoma bodies, without distinctive atypia. Immunohistochemistry results showed they were negative for creatine kinase 7, epithelial membrane antigen, and renal cell carcinoma, and positive for AE1/AE3, vimentin, and Wilms Tumor 1. Pathological diagnosis was MA. The 48 months' follow-up information was available without recurrence.According to this case and literature review, we figured that it is difficult to make a definite diagnosis of MA only by image examination. Nephron-sparing surgery is eligible to treat MA. Long-term active surveillance is necessary because of the uncertainty of the biological behavior and cellular origin of MA.

IgG4-related inflammatory pseudotumor of the kidney mimicking renal cell carcinoma: A case report.

IgG4-related disease is a recently recognized clinical entity. It is characterized by diffuse organ swelling or mass formation, a dense lymphoplasmacytic infiltrate rich in IgG4-positive plasma cells with fibrosis and typically an increased serum IgG4 concentration, which may affect various organs. An 80-year-old woman with an otherwise unremarkable previous medical history was revealed to have a renal mass that was indicative of renal malignant carcinoma, for which a radical nephrectomy was performed. The mass was diagnosed as an IgG4-related inflammatory pseudotumor, which was histopathologically confirmed. The patient is currently well without evidence of IgG4-related disease at 3 months post-surgery, and did not require any additional therapy.

Comparison of clinicopathological features in metastatic upper tract urothelial carcinoma and urothelial bladder cancer.

PURPOSE: To compare the characteristics of primary tumors, sites distribution of metastases and the metastasis-free interval (MFI) between metastatic upper tract urothelial carcinoma (UTUC) and urothelial bladder cancer (UBC), and evaluate the clinicopathological factors associated with MFI. METHODS: We retrospectively reviewed 153 metastatic urothelial carcinoma patients consecutively registered at our hospital from 1997 to 2015, including 71 UTUC and 82 UBC, with a median follow-up of 18.3 months. MFI indicators were assessed by univariate and multivariate logistic regression analysis. RESULTS: There were significant differences in median age at metastatic disease (p = 0.016), gender (p = 0.018), primary tumor size (p = 0.003), growth pattern (p < 0.001), grade (p < 0.001) and stage (p < 0.001) between metastatic UTUC and UBC. The median MFI of UTUC was dramatically shorter than that of UBC (6.1 vs. 17.4 months, p < 0.001). Univariate analysis revealed pathological stage was the only factor associated with the MFI of UTUC. Multivariate analysis showed that primary tumor grade was an independent inferior predictor for the MFI of UBC (HR 6.384, 95% CI 3.21-12.69, p < 0.001), while recurrence was an independent favorable factor for the MFI of UBC (HR 0.384, 95% CI 0.18-0.82, p = 0.014). CONCLUSIONS: Compared to metastatic UBC, the primary tumors of metastatic UTUC were more invasive and the MFI was significantly shorter. Pathological stage was the only factor associated with the MFI in UTUC, while primary tumor grade and recurrence were independent factors for the MFI of UBC.

Clinicopathologic Comparison of Urothelial Bladder Carcinoma in Young and Elder Patients.

Bladder cancer (BC) is a common aggressive malignancy and Urothelial bladder cancer (UBC) consists of the majority of BC. There is uncertainty regarding the clinicopathologic characteristics of UBCs in younger patients. To investigate the clinicopathologic features of young patients with UBCs. A total of 2825 pathological records of UBC patients, including 42 young patients (≤ 30 years old) and 2783 elder patients (> 30 years old), were retrospectively studied. The stage distribution classified was statistically significant (Χ (2) = 12.25, P = 0.02) between young and old patients; superficial tumors was far more in young patients than in old patients. More young patients tended to be low- and moderate-grade UBCs (Χ (2) = 6.75, P = 0.009). Young patients with superficial UBCs also showed lower recurrence rate, compared to elder patients (Χ (2) = 5.77, P = 0.02). For 5-year survival rate, young patients (93.8%) showed better than elder patients (85.1%) (Χ (2) = 4.01, P = 0.045). Patients younger than 30 years old with UBCs had low-grade and low-stage tumors and exhibited better prognosis than elder patients.

An analysis of treatment preferences and sexual quality of life outcomes in female partners of Chinese men with erectile dysfunction.

The impact of erectile dysfunction is distressing to both males and their female partners, but less attention has been paid to identify female partners' preferred treatment and sexual quality of life outcomes. The present analysis explores female partners' treatment preference for erectile dysfunction in Chinese Men. This was a phase 4, randomized, open-label, multicenter, crossover study in Chinese men with erectile dysfunction who were naïve to phosphodiesterase type 5 inhibitor treatments. Eligible patients were randomized to sequential 20-mg tadalafil/100-mg sildenafil or 100-mg sildenafil/20-mg tadalafil for 8 weeks each. Of 418 patients, female partners of 64 patients agreed to enter the study; of 64 patients who entered the study with female partners, 63 were randomized, and 62 completed the study. Baseline demographics and disease characteristics were comparable between treatment groups. Significantly more couples preferred tadalafil compared with sildenafil overall (75.4% vs 24.6%; P < 0.001), and irrespective of erectile dysfunction severity at baseline (P ≤ 0.005). Significant improvements in sexual quality of life scores were reported at endpoint (Visit 8) in male patients and female partners in both tadalafil and sildenafil treatment groups (P < 0.001). Significantly higher mean changes from baseline were observed for male patients in the tadalafil group compared with the sildenafil group for the erectile function (P = 0.013) and overall satisfaction (P = 0.019) International Index for Erectile Function domains and the spontaneity domain (P < 0.001) of the Psychological and Interpersonal Relationship Scale. No major safety concerns were reported during the study. Though both treatments were effective, safe, and tolerable, more couples preferred tadalafil compared with sildenafil.