Transcervical Radiofrequency Ablation of Symptomatic Uterine Fibroids: 2-Year Results of the SONATA Pivotal Trial.

Objective: To report 2-year results of sonography-guided transcervical fibroid ablation (TFA) using the Sonata® system in women with symptomatic uterine fibroids. Design: This is a prospective multicenter single-arm interventional trial. Methods: Premenopausal women with up to 10 clinically relevant uterine fibroids, each ranging from 1 to 5 cm in diameter, were treated with sonography-guided TFA on an outpatient basis and returned for regular follow-up visits for 2 years. Assessed outcomes included changes in symptom severity, heath-related quality of life, general health status, work and activity limitations, treatment satisfaction, adverse events, surgical reintervention, and occurrence of pregnancy and associated outcomes. Results: Among 147 enrolled women, 125 (85%) returned for follow-up at 2 years. Compared with baseline, symptom severity decreased from 55 ± 19 to 24 ± 18 (p < 0.001), health-related quality of life increased from 40 ± 21 to 83 ± 19 (p < 0.001), and EuroQol 5-Dimension scores increased from 0.72 ± 0.21 to 0.89 ± 0.14 (p < 0.001). Overall treatment satisfaction at 2 years was 94%. The mean percentage of missed work time, overall work impairment, and activity impairment significantly decreased at follow-up. Through 2 years, surgical reintervention for heavy menstrual bleeding was performed in 5.5% of patients. One singleton pregnancy occurred with a normal peripartum outcome. Conclusions: TFA treatment with the Sonata system provides significant clinical improvement through 2 years postablation, with a low incidence of surgical reintervention. Other favorable outcomes included a rapid return to work and substantial improvements in quality of life, symptom severity, work productivity, and activity levels.

68Ga-PSMA PET/CT vs. mpMRI for locoregional prostate cancer staging: correlation with final histopathology.

BACKGROUND: Prostate-specific membrane antigen (PSMA) positron emission tomography (PET) can be used to locate lesions based on PSMA avidity, however guidelines on its use are limited by its infancy. We aimed to compare multiparametric magnetic resonance imaging (mpMRI) and PSMA PET/CT to prostatectomy histopathology. METHODS: We conducted a chart review from February 2015 to January 2017 of 50 male patients staged for prostate cancer using PSMA PET/CT and mpMRI who then underwent radical prostatectomy. Pre-operative PSMA PET/CT and mpMRI were paired with corresponding histopathology. Correlations, sensitivity, and specificity were used for comparisons. RESULTS: A total of 81 lesions were confirmed by histopathology. Fifty index lesions were detected by histopathology, all of which were detected by PSMA PET/CT (100% detection), and 47 by mpMRI (94% detection). Thirty-one histologically confirmed secondary lesions were detected, 29 of which were detected by PSMA PET/CT (93.5% detection), and 16 by mpMRI (51.6% detection). PSMA had better sensitivity for index lesion localization than mpMRI (81.1 vs. 64.8%). Specificity was similar for PSMA PET/CT and mpMRI (84.6 vs. 82.7%). SUVmax of index lesions ranged from 2.9 to 39.6 (M = 9.27 ± 6.41). Index lesion SUVmax was positively correlated with PSA (rho = 0.48, p < 0.001) and ISUP grade (rho = 0.51, p < 0.001). CONCLUSIONS: PSMA-PET/CT provided superior detection of prostate cancer lesions with better sensitivity than mpMRI. PSMA-PET/CT can be used to enhance locoregional mpMRI to provide improved detection and characterization of lesions.

Efficacy of Punica granatum extract on in-vitro and in-vivo control of Trichomonas vaginalis.

Trichomoniasis vaginalis is now an important worldwide health problem. Metronidazole has so far been used in treatment, but the metronidazole-resistant strains and unpleasant adverse effects have been developed. Treatment of patients with metronidazole refractory vaginal trichomoniasis constitutes a major therapeutic challenge and treatment options are extremely limited. The last 7 years have seen over seven times as many publication indexed by Midline dealing with pomegranate (Punica granatum) than in all the years preceding them, because of this, and the virtual explosion of interest in pomegranate as a medicinal and nutritional product that has followed, this work is accordingly launched. Natural plant extract purified from Pomegranate (Roman) was in-vitro investigated for its efficacy against T. vaginalis on Diamond media. Besides, infection women (18/20) who accepted to be treated with P. granatum juice were completely curedand followed-up for two months. The anti-trichomoniasis vaginalis activity of P. granatum extract (in-vitro and in-vivo) gave very promising results.

Diagnosis of Toxoplasma gondii by ELISA and PCR in mothers and their infants.

Congenital Toxoplasma gondii infection may lead to abortion, stillbirth, neonatal death as well as severe congenital toxoplasmosis in the newborn infants. No doubt, early and proper diagnosis of infection pregnant women or her baby pave the way to effective treatment and minimize complications. In this study; the PCR and ELISA-IgM were used to diagnose active toxoplasmosis. The results revealed that PCR detected very recently infection (23/70 subjects) than ELISA-IgM (18/70 ones). However, the use of both ELISA-IgM and PCR together improved the diagnostic sensitivity and specificity.

A criterion audit of women's awareness of blood transfusion in pregnancy.

BACKGROUND: In the Confidential Enquiry into Maternal Deaths (CEMD) Report, the very high risk of mortality in women who refuse blood transfusions is highlighted. The objectives were to establish current knowledge about, and views of transfusion in our pregnant population and to establish the level of compliance with the set audit standard. METHOD: Questionnaire survey of 228 women, including both high and low risk pregnancies, attending ante-natal clinic between 2-9 May 2000 at the North Staffordshire Maternity Hospital, Stoke on Trent. RESULTS: The response rate was 100%. Only 43% were aware of the possible need for blood transfusion in pregnancy. If a blood transfusion was required, 92% stated that they would accept a blood transfusion in pregnancy. Four percent stated that they would not accept a transfusion because of religious reasons and risk of infection and the remaining four percent did not declare a reason. CONCLUSIONS: This short survey identified that 57% of women were not aware of the possible need for blood transfusion during pregnancy. There is a need for more information to be shared on this subject with all antenatal women. Women who would refuse a transfusion need to be identified at booking and be referred for counselling and a management plan made for pregnancy, labour and delivery.

A longitudinal, patient-centred, integrated curriculum: facilitating community-based education in a rural clinical school.

The Greater Murray Clinical School (GMCS) was founded with two main aims in mind one, to provide a community-based learning environment offering diversified clinical educational experiences, and two, by doing so, to help address the doctor shortage for Australians living in rural and remote areas. The GMCS is a community-orientated and community-based clinical school, which has replaced the typical discipline-based curriculum with a longitudinal, patient-centred one. Students are attached to patients--called "the longitudinal patient"--whom they follow through all stages of their care. They share with patients their experience of illness and disease, their varying care needs, and how these are addressed by different service providers. The philosophy of the course, its implementation and our initial experiences are described.

A crossover randomized trial of transcutaneous electrical nerve stimulation and oxybutynin in patients with detrusor instability.

PURPOSE: Management of idiopathic detrusor instability is difficult in most patients mainly due to the lack of a complete understanding of the pathophysiology. Oxybutynin and transcutaneous electrical nerve stimulation have been used but to our knowledge no direct comparisons have been made. MATERIALS AND METHODS: Patients with frequency, urgency, urge incontinence and proved detrusor instability were studied with urodynamics, quality of life instruments, and frequency and volume charts. Patients were randomized to transcutaneous electrical nerve stimulation or oxybutynin. After 6 weeks of treatment, they were reassessed and after a washout of 2 weeks, they were started on the second arm of treatment and reassessed 6 weeks later. RESULTS: A total of 13 male and 30 female patients were studied. Functional capacity had increased and number of voids daily had decreased significantly compared with before treatment in both arms (p <0.005). There were significant improvements in symptom specific quality of life measures but no changes were found on the global Short Form 36 (SF-36) quality of life questionnaire. The volume to first desire to void and first unstable contraction had increased significantly with oxybutynin but not with transcutaneous electrical nerve stimulation. Of 23 patients 7 were stabilized with treatment, including 2 with oxybutynin only, 2 with either nerve stimulation or oxybutynin and the remaining 3 with only nerve stimulation. Total bladder capacity did not change significantly with either treatment but patients noticed side effects more commonly with oxybutynin. CONCLUSIONS: Both treatments clearly improved subjective parameters. However, only oxybutynin showed significant improvements in objective urodynamic parameters. Transcutaneous electrical nerve stimulation can be used in patients who cannot take oxybutynin. Further studies are needed to show the long-term efficacy and cost analyses of nerve stimulation.

Community based medical education in a rural area: a new direction in undergraduate training.

The Greater Murray Clinical School provides a community based medical education programme for the clinical years at the University of New South Wales. Being a new clinica school in rural Australia allowed the development of a patient-centred longitudinal curriculum. Students follow patients through the health care system, with each exposure stimulating the learning about different aspects of a patient problem. The paper outlines the conceptual approach towards the development and implementation of this novel approach to community based medical education.

Development and evaluation of a micropipette tip washing system.

A tip washing system has been developed for use with disposable polypropylene micropipette tips of different sizes. The primary hardware components of the system are constructed from polyvinyl chloride (PVC) and Plexiglas. The system relies on a low concentration of detergent, gravity or aspirator-assisted feed and flush of minimal volumes of distilled/deionized water, and air or oven drying of the tips. Comparative analyses of new versus washed tips in FAO/IAEA radioimmunoassay (RIA) and enzyme linked immunosorbent assay (ELISA) protocols indicated that disposable polypropylene micropipette tips of various sizes (e.g. 5-300 and 50-1000 microl) can be washed and reused at least ten times without introducing detectable variability into the results of either assay, if the tips are properly washed and dried using this system. Recovery cost of the system can be achieved after approximately eight reuses of 1000 tips, excluding technician time.

The production of nerve growth factor by human bladder smooth muscle cells in vivo and in vitro.

OBJECTIVE: To measure the concentrations of nerve growth factor (NGF) in tissue biopsies taken from subjects with a normal bladder and from patients diagnosed to have idiopathic detrusor instability (associated with a reduction in the density of motor nerves), and to use an in vitro model to study the mechanisms of NGF expression. MATERIALS AND METHODS: Biopsy specimens were obtained during endoscopic and open surgery from patients undergoing routine bladder surgery. The patients were divided into two categories based upon urodynamic characterization. The NGF content in samples from 11 normal bladders and seven idiopathic unstable bladders were measured using an enzyme-linked immunosorbent assay. The mechanisms influencing net NGF production were explored using detrusor cells in vitro. RESULTS: The mean (SEM) NGF content was significantly higher in unstable tissues, at 0.96 (0.05) pg/microg protein, than in the normal bladder, at 0.53 (0.05) pg/microg protein. In the cell model, acetylcholine (10 micromol/L), noradrenaline (1 and 10 micromol/L) and ATP (1 micromol/L) caused a significant increase in net NGF production; acetylcholine at 1 micromol/L had no effect. Direct stimulation of protein kinase C (PKC) by phorbol ester (33 ng/mL) or elevation of cAMP using forskolin (10 micromol/L) increased NGF, suggesting that at least two intracellular pathways (PKC- and PKA-dependent) are involved. The expression of c-Fos was increased by phorbol 12-myristate 13-acetate added before NGF, suggesting that c-Fos may be involved in regulating NGF production. CONCLUSION: These data suggest a role for NGF in the physiology and pathophysiology of the human bladder, and indicate some of the possible mechanisms which might regulate NGF production.

A prospective analysis of 1,930 patients with hematuria to evaluate current diagnostic practice.

PURPOSE: The commonly accepted diagnostic algorithm for hematuria includes excretory urography (IVP) and cystoscopy. Some have suggested that ultrasound of the upper urinary tract is adequate and that cystoscopy is not necessary in younger patients with microscopic hematuria. We ascertain whether a less intensive algorithm could be adopted while retaining diagnostic efficacy. MATERIALS AND METHODS: A total of 1,930 patients were enrolled prospectively in the study at a hematuria clinic between October 1994 and March 1997. Evaluation consisted of basic demographics, history and examination, routine blood tests, urinalysis and cytology. All patients underwent plain abdominal radiography, renal ultrasound, IVP and flexible cystoscopy. RESULTS: A total of 1,194 males and 736 females with a mean age of 58 years (range 17 to 96) were included in the study. Overall, 61% of patients had no basis found for hematuria, 12% had bladder cancer, 13% had urinary tract infection and 2% had stones. Kidney and upper tract tumors were noted in 14 patients (0.7%), including 4 who presented with microscopic hematuria. If only ultrasound or IVP had been performed 4 of these cases would have been missed. Of 982 patients presenting with microscopic hematuria 51 had cancer. Bladder cancer was found in 7 patients younger than 40 years. CONCLUSIONS: Our findings suggest that cystoscopy cannot be safely avoided even in younger patients with microscopic hematuria. Only a combination of ultrasound and IVP detected all upper tract tumors.

The application of ultrastructural studies in the diagnosis of bladder dysfunction in a clinical setting.

PURPOSE: We examine the ultrastructural changes reported to be present in dysfunctional bladders and determine whether they can be used as a predictor of urodynamic diagnosis in a clinical setting. MATERIALS AND METHODS: Subjects who required urodynamic diagnosis and cystoscopy as part of clinical management were recruited for this study. After urodynamic diagnosis cases were classified into 1 of 5 dysfunction groups as normal bladder outflow obstruction, idiopathic sensory urgency, obstruction with detrusor instability and pure detrusor instability. A detrusor muscle biopsy was taken from the lateral wall of the bladder at cystoscopy for subsequent electron microscopy. RESULTS: Of the 27 cases 6 were normal, 9 had bladder outflow obstruction and detrusor instability, 8 had pure detrusor instability and 4 had idiopathic sensory urgency. The obstructed group showed the myohypertrophy pattern previously reported. In contrast to previous reports, abnormal junctions were found in all patients. For each patient the ratios of abnormal-to-normal junctions were calculated. Mean and standard error ratios were 1.1+/-0.1, 2.7+/-0.2, 6.1+/-1.2, 13.3+/-4.4 for normal, idiopathic sensory urgency, obstruction with detrusor instability and pure detrusor instability, respectively (p = 0.0003, 0.0042 and 0.04). CONCLUSIONS: There are distinct morphological changes in the detrusor associated with bladder dysfunction. The ratio of abnormal-to-normal junctions is a novel measurement and can be used to predict urodynamic dysfunction. Ultrastructural studies may be useful as an adjunct in the diagnosis of bladder dysfunction.

Quality of nucleic acids extracted from fresh prostatic tissue obtained from TURP procedures.

PURPOSE: The molecular genetic study of benign prostatic hyperplasia (BPH) requires high quality nucleic acids from BPH tissue. It has been generally assumed, but not experimentally proven, that the diathermy used in trans-urethral resection of the prostate (TURP) damages nucleic acids. MATERIALS AND METHODS: Total RNA, polyA+ RNA and genomic DNA isolated from fresh tissue obtained from TURP procedures were compared with those isolated from tissue obtained from open prostatectomy. RESULTS: On a formaldehyde agarose gel, there was an increase in low molecular weight RNA in the TURP derived samples, in comparison to that in the open prostatectomy derived samples. The 28S and 18S rRNA were present in all TURP specimens and although the two bands were reduced in some samples, there were samples in which the 2 bands were indistinguishable from the open prostatectomy derived samples. Low molecular weight fragments seen in total RNA were reduced greatly in polyA+ RNA and the difference in polyA+ RNA between the TURP and open prostatectomy derived samples was significantly diminished. RT-PCR of two ubiquitously expressed gene transcripts (Galpha11, 256 bp and HPRT, 847 bp) yielded products of similar size and intensity between TURP and open prostatectomy derived samples. Genomic DNA obtained from TURP derived specimens showed no difference in size or enzyme digestibility in comparison to that from open prostatectomy. CONCLUSIONS: Nucleic acids extracted from fresh prostatic tissue derived from TURP procedures can be used as readily as any other fresh tissue for RT-PCR based molecular genetic studies, although polyA+ RNA isolation is recommended if degradation-free RNA is required.

Radiation exposure during fluoroscopy: should we be protecting our thyroids?

BACKGROUND: Recent reports on thyroid cancer among Australian orthopaedic surgeons prompted the present study which sought to evaluate the effectiveness of lead shielding in reducing radiation exposure (RE) to the thyroid region during endo-urological procedures. METHODS: Radiation exposure to the thyroid region of the surgeon and scrubbed nurse was monitored for 20 consecutive operations over a 6-week period by thermoluminescent dosimeters (TLD). A TLD was placed over and underneath a thyroid shield of 0.5 min lead equivalent thickness to monitor the effect of shielding. RESULTS: Eight percutaneous nephrolithotomies, seven retrograde pyelograms and ureteric stentings and five ureteroscopies for calculous disease were monitored. Total exposure time was 63.1 min. For the surgeon, the total cumulative RE over and under the lead shield was 0.46 and 0.02 mSv, respectively, equating to a 23-times reduction in RE if shielding was used. This effectively reduced RE to almost background levels, which was represented by the control TLD exposure (0.01 mSv). CONCLUSION: Although RE without thyroid shields did not exceed current standards set by radiation safety authorities, no threshold level has been set below which thyroid carcinogenesis is unlikely to occur. Because lead shields are easy to wear and can effectively reduce RE to the thyroid region to near-background levels, they should be made easily available and used by all surgeons to avoid the harmful effects of radiation on the thyroid.

Surgeon, don't heal thyself: a study of the health of Australasian urologists.

BACKGROUND: Modern surgical practice is stressful and anxiety-producing. We investigated urologists health and their attitude to their own health care. METHODS: Two hundred and seventy-five Australasian urologists were surveyed to ascertain their attitudes to their physical and psychological health; 205 responses were received. RESULTS: Ten per cent reported serious physical illnesses. Fewer than half had their own general practitioner (GP), and fewer than one-third had seen a doctor in the previous 12 months. A majority had, at some time, prescribed themselves medication, including antibiotics, narcotic and non-narcotic analgesia and benzodiazepams. Nearly all reported that aspects of their urological practice caused them anxiety. More felt that this anxiety was the result of pressures experienced outside the operating theatre than problems directly related to performing surgery. A small number of psychological problems were reported, and fewer than 10 per cent had ever a visited a psychiatrist. It was evident that most Australasian urologists were unwilling to discuss any psychological problems that they may have. Even when a specific problem had been identified, few sought the appropriate care. CONCLUSIONS: It would be advantageous for Australasian urologists and doctors in general to see their GP more regularly, and be more willing to discuss any psychological difficulties that they may experience.

Nephrogenic adenoma of the bladder in renal transplant and non-renal transplant patients: a review of 22 cases.

OBJECTIVES: To review diagnoses of nephrogenic adenoma and in particular to evaluate its association with transitional cell carcinoma (TCC) of the bladder and its relationship to renal transplantation. METHODS: A retrospective review of 22 cases of nephrogenic adenoma (NA) diagnosed between 1989 and 1996 was conducted, 7 of which were in renal transplant patients. Data collected in each case included demographic details, predisposing factors, associated urologic pathology, mode of presentation, cystoscopic finding, management, and follow-up. RESULTS: There was a 3:1 predominance of men. Mean follow-up was 21.4 months (range 3 to 50). Six patients (27%) had one or more recurrences. All 22 patients had some form of previous bladder insult or surgery, including recurrent urine infections, urinary tract instrumentation, placement of ureteric stents, cystodiathermy, and open bladder surgery. Six cases were associated with TCC of the bladder, of which 4 had NA lesions directly over or close to the site of previous fulguration. In 4 patients, there was a temporal relationship between the administration of intravesical doxorubicin hydrochloride or bacille Calmette-Guérin (BCG) and the onset of NA lesions. One case was associated with an inverted papilloma that had not been described before. In 7 renal transplant cases, 3 lesions were found contralateral to the side of the ureterovesical anastomosis. All 22 cases were benign histologically, but one NA was found within a low-grade baldder TCC. Nineteen cases were followed up regularly with no malignant transformation. Three patients were lost to follow-up. CONCLUSIONS: This study has demonstrated an association between NA and bladder cancer. Patients with NA, especially those treated with intravesical chemotherapy or BCG, should have regular cystoscopies. Fulguration or transurethral resection appear to be sufficient treatment. No renal transplant patients had vesical TCC and NA simultaneously. Neither immunosuppression nor ureterovesical anastomosis appeared to be a significant predisposing factor in the transplant patients.

An evaluation of a chest pain diagnostic protocol to exclude acute cardiac ischemia in the emergency department.

BACKGROUND: Although accelerated diagnostic protocols are being increasingly used in emergency departments to diagnose acute cardiac ischemia, there have been no prospective evaluations of a chest pain diagnostic protocol with serial determinations of creatine kinase MB isoenzyme and mandatory exercise electrocardiography (ExECG). METHODS: Prospective cross-sectional study in which chest pain protocol results were compared with final (reference) diagnoses of acute cardiac ischemia (including acute myocardial infarction and unstable angina). Patients in need of hospital admission but at low probability (by a validated algorithm) for acute myocardial infarction were examined for exclusions: known coronary artery disease, cardiac complications, severe comorbidities, or inability to perform exercise testing. A 12-hour diagnostic protocol included serial measurements of creatine kinase MB, ECG, and clinical assessments followed by ExECG for those with negative initial serial testing. Reference diagnoses were established during hospitalization and diagnostic accuracy was assessed. RESULTS: The study group of 317 patients was 54% male and 65% black, and had a mean age of 46.6 years; 9.5% had a final diagnosis of acute cardiac ischemia. For this diagnosis, the protocol had a sensitivity of 90.0% (95% confidence interval, 72.3%-97.4%); specificity, 50.5% (95% confidence interval, 44.6%-56.4%); positive predictive value, 16.0%; and negative predictive value, 98.0%. Creatine kinase MB, serial ECGs, and ExECG each made a contribution to improved sensitivity and accuracy, whereas clinical reassessments were less discriminating, as indicated by protocol's receiver operating characteristic curve. CONCLUSIONS: A chest pain diagnostic protocol achieved high sensitivity and improved specificity over the standard emergency department workup. There were no adverse advents associated with early ExECG.

Advantages of polytetrafluoroethylene arteriovenous loops in the thigh for hemodialysis access.

BACKGROUND: The upper thigh is an alternative but infrequently used site to the forearm for placement of subcutaneous polytetrafluoroethylene (PTFE) arteriovenous conduits in patients requiring hemodialysis for end stage renal failure. This site has the great advantage of easier accessibility for self-cannulation. METHODS: The outcome was reviewed for 74 PTFE loops placed in 61 patients between 1985 and 1991. RESULTS: Mean loop survival time was 99.8 weeks (SD 78.0) when patients with early failure (<1 week), and those patients whose loops functioned adequately until transplantation or death were excluded. Infection occurred in 12 of 74 loops. CONCLUSIONS: Thigh PTFE loops provide satisfactory medium- to long-term vascular access for hemodialysis although, like all other forms of access currently available, they fall short of the ideal for prolonged dialysis.