The PINNACLE Study: A Double-blind, Randomized, Sham-controlled Study Evaluating the Optilume BPH Catheter System for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia.

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.

Will adherence to new guidance lead to missed cancer diagnoses? Evaluation of limiting symptomatic mammograms to over forties.

Within the United Kingdom, a recent change in "Best Practice Guidance" has suggested that mammograms for symptomatic breast patients, with a clinically benign examination, should be limited to those over 40 years . This has led to anxiety over missing cancer diagnoses in the 35-39 year-old age group. This study aimed to assess the impact of the new guidance upon a NHS Breast unit with a particular focus on safety. Two cancer data bases (BASO and SOMERSET) were used to identify thirty-three patients aged 35-39 years diagnosed with breast cancer between January 2007 and June 2011. Case notes were retrieved and retrospectively analyzed for trends during clinical (P1-P5) and radiological assessment (using Royal College Radiologists Breast Group classification-M1-5, U1-5). Sensitivity and false-negative rates for each modality were calculated. Sensitivities of clinical examination, mammography, and ultrasound for detecting malignancy were 72.7%, 78.8%, and 93.9%, respectively. Within the clinically benign group (P1 and P2), mammography and ultrasound showed sensitivities of detecting malignancy of 55.5% and 88.9%, respectively, with three extra cancers being identified by ultrasound when mammography was graded less than M3 (indeterminate lesion-requiring biopsy). Importantly, no cancers would have been missed if the new guidance had been adhered to. This study has shown that mammography has no additional diagnostic benefit as first-line imaging in symptomatic breast patients aged 35-39 years. It has confirmed that implementation of the new Best Practice Guidance is safe, when used in the setting of triple assessment, to ensure cancer diagnoses are not missed.

Practical multidisciplinary framework for the assessment and management of patients with unexplained chronic aerodigestive symptoms.

OBJECTIVE: Patients experiencing unexplained chronic throat symptoms (UCTS) are frequently referred to gastroenterology and otolaryngology outpatient departments for investigation. Often despite extensive investigations, an identifiable structural abnormality to account for the symptoms is not found. The objective of this article is to provide a concise appraisal of the evidence-base for current approaches to the assessment and management of UCTS, their clinical outcomes, and related healthcare utilisation. DESIGN: This multidisciplinary review critically examines the current understanding of aetiological theories and pathophysiological drivers in UCTS and summarises the evidence base underpinning various diagnostic and management approaches. RESULTS: The evidence gathered from the review suggests that single-specialty approaches to UCTS inadequately capture the substantial heterogeneity and pervasive overlaps among clinical features and biopsychosocial factors and suggests a more unified approach is needed. CONCLUSION: Drawing on contemporary insights from the gastrointestinal literature for disorders of gut-brain interaction, this article proposes a refreshed interdisciplinary approach characterised by a positive diagnosis framework and patient-centred therapeutic model. The overarching aim of this approach is to improve patient outcomes and foster collaborative research efforts.

Cochlear implantation under local anaesthesia - Our experience and a validated patient satisfaction questionnaire.

OBJECTIVES: Cochlear implantation (CI) under local anaesthetic (LA) has previously been shown to be a successful and safe option for a specific group of patients (e.g. elderly and significant co-morbidity). We aim to discuss our practice and obtain qualitative information about patient experience from our cohort of patients at the Yorkshire Auditory Implant Service (YAIS). METHODS: Retrospective chart review to include demographics, co-morbidities and physiological parameters were recorded and used to calculate P-POSSUM (Portsmouth Physiological and Operative Severity Score for the enumeration of Mortality and Morbidity) scores. The Iowa Satisfaction with Anaesthesia Scale (ISAS) questionnaire was distributed to all patients who received CI under LA and subsequently analysed. RESULTS: Seven patients received CI under LA at YAIS. This included five males and two females. The mean age was 79 years (range 26 -93). The mean P-POSSUM mortality and morbidity for this cohort was 2.4 and 34.9%, respectively. The average ISAS score was +1.72 (where range of -3 is completely dissatisfied and +3 is completely satisfied). DISCUSSION: We discuss our cohort and show that patients receiving CI have a favourable experience when LA is used. CI under LA is a viable and safe option for more elderly patients and those who are deemed at high risk of morbidity or mortality associated with a general anaesthetic. CONCLUSIONS: The data regarding validated patient experience obtained from this study can be used to help counsel patients that may be offered CI under LA.

Inside implant criteria or not? - Detection of non-organic hearing loss during cochlear implant assessment.

OBJECTIVES: The diagnosis of non-organic hearing loss (NOHL) is a difficult but important issue during the assessment process for cochlear implantation (CI). We aim to identify the key factors in identifying patients with NOHL during CI assessment and present our local screening protocol for NOHL. METHODS: A retrospective review of patients referred to the Yorkshire Auditory Implant Service (YAIS) between 2003 and 2015 who were subsequently diagnosed with NOHL during the assessment. Patient demographic data, audiological and functional assessments were assessed. RESULTS: Thirty-two patients were included in the study. Mean age was 43 years (range 14-82 years). Male to female ratio was 1:1.7. Indicators of possible NOHL included a sudden deterioration in hearing (n = 21; 66%), mismatches in observed behaviour and either pure-tone audiogram (PTA) (n = 27; 84%) or functional testing (n = 20; 80%) and stapedial reflexes below reported audiological thresholds (n = 12; 46%). A mismatch in functional hearing and PTA was seen in 72% of patients. Patients with suspected NOHL were referred for further objective testing. All 23 patients who underwent objective testing had better hearing levels compared to reported hearing thresholds thus placing them outside of implant criteria. Five candidates were found to have normal hearing thresholds. DISCUSSION: NOHL can present a significant challenge to the implant team, particularly in the subgroup with a pre-existing organic hearing loss with non-organic overlay. We discuss the common features in this cohort of patients. CONCLUSIONS: To facilitate the identification of patients with NOHL, the YAIS has developed a screening protocol.

Renal Bleeding Due to Extramedullary Hematopoiesis in a Patient With Chronic Myelogenous Leukemia.

Chronic myelogenous leukemia (CML) is a myeloproliferative disorder that normally presents in middle-aged adults. Renal infiltration and extramedullary hematopoiesis in renal tissue has been rarely reported. This case report presents a patient with CML and renal insufficiency who developed gross hematuria. Efforts at controlling the hematuria led to a cascade of events propelled by the underlying disorder that ultimately led to a radical nephrectomy, multiorgan failure, and prolonged hospitalization. We suggest that management of gross hematuria in clinically stable patients with CML, suspected of having extramedullary hematopoiesis, should prioritize treatment of the myeloproliferative disorder over efforts to control bleeding.

Investigating the value of fine needle aspiration cytology in thyroid cancer.

BACKGROUND: Current guidance recommends the use of fine needle aspiration cytology (FNAC) as an essential investigation in patients presenting with a thyroid lump. Current literature suggests that the sensitivity of FNAC in thyroid nodules ranges between 80-90%. However, only very few studies have looked specifically at the sensitivity of FNAC in solely thyroid cancer patients. AIMS: The aim of our study was to investigate the value of FNAC as a first-line investigation in patients with thyroid cancer. We aimed specifically to assess the sensitivity of FNAC within this group. MATERIALS AND METHODS: Patients diagnosed with thyroid cancer between 2000-08 were identified from a local histopathology database. Sixty-seven case notes were retrieved, retrospectively reviewed and analyzed. Analysis included results of FNAC, ultrasound scanning and final histopathological diagnosis. RESULTS: Analysis of the 56 patients who underwent FNAC revealed that a cytological grading of thy3 or greater was only given to 31 cases (55.3%). CONCLUSION: In this study, FNAC findings of thy3 or greater were reported only in 55.3% of proven thyroid cancer cases. This study highlights the greater diagnostic difficulties of thyroid cancer compared to other thyroid nodules. Our findings suggest that clinicians must interpret the results of this initial investigation with caution and consider the routine use of ultrasound scanning to help guide FNAC.

Use of hydrophilic-coated urethral catheters in management of acute urinary retention.

OBJECTIVES: Acute urinary retention (AUR) is a painful subacute emergency that is frequency seen in the general practice of urology. Urethral catheterization to drain the bladder can usually be performed successfully, safely, and with minimal discomfort using standard balloon retention catheters. In a small percentage of cases, however, abnormal urethral anatomy precludes passage of catheters of any size. In these situations, the urologist has a variety of more invasive and complex tools available for draining the bladder. With the introduction of hydrophilic catheters and their prominent use in children receiving intermittent catheterization, we have developed a protocol extrapolating our knowledge in children to the older male in AUR in whom a traditional catheter could not be placed. METHODS: A total of 44 men in AUR in whom placement of a traditional catheter had failed were recruited into our study in an attempt to avoid more invasive bedside maneuvers or surgical intervention. A hydrophilic catheter that had been modified to allow the throughput of a wire was used to attempt bladder catheterization. RESULTS: Of the 44 men, 34 (72%) had successful placement of the hydrophilic catheter, relieving their discomfort and AUR. Of the 34 successful catheterizations, 30 (88%) resulted in successful placement of an indwelling Council catheter after removal of the hydrophilic catheter. Long-term drainage was accomplished in 30 (68%) of the 44 men in whom initial catheter placement for AUR had failed. CONCLUSIONS: We propose that the hydrophilic catheter should be a part of the urologist's armamentarium whenever treating men with AUR.

Squamous cell carcinoma in a female urethral diverticulum.

A 38-year-old woman was found to have a squamous cell carcinoma in a urethral diverticulum after a simple diverticulectomy. The aggressiveness of this histologic subtype of carcinoma, along with this patient's long life expectancy, supported the choice of aggressive therapy. Only nine other cases have been reported. A brief review of the published reports on the presentation, diagnosis, options for treatment, and outcomes is included.