Ex Vivo Fluorescence Confocal Microscopy (FCM) Ensures Representative Tissue in Prostate Cancer Biobanking: A Feasibility Study.

BACKGROUND: Biobanking of prostate carcinoma is particularly challenging due to the actual cancer within the organ often without clear margins. Frozen sections are to date the only way to examine the biobank material for its tumor content. We used ex vivo fluorescence confocal microscopy (FCM) to analyze biobank samples prior to cryoasservation. METHODS: 127 punch biopsies were acquired from prostatectomy-specimens from 40 patients. These biopsies were analyzed with a Vivascope 2500-G4 prior to their transfer to the biobank. In difficult cases, larger samples of the prostatectomy specimens were FCM scanned in order to locate tumor foci. After patient acquisition, all samples were taken from the biobank and analyzed. We compared the results of the FCM examinations with the results of conventional histology and measured the DNA content. RESULTS: With upstream FCM, the tumor content of biobank samples could be determined with high confidence. The detection rate of representative biobank samples was increased due to the rapid feedback. The biobank samples were suitable for further molecular analysis. CONCLUSION: FCM allows for the first time lossless microscopic analysis of biobank samples prior to their cryoasservation and guarantees representative tumor and normal tissue for further molecular analysis.

Urethroplasty performed with an autologous urothelium-vegetated collagen fleece to treat urethral stricture in the minipig model.

INTRODUCTION AND OBJECTIVE: Tissue-engineered materials in urethral reconstructive surgeries are a promising field for innovative therapy. Collagen matrices increase stability of cell-based implants and can promote viability and proliferation of urothelial cells. In this study, a collagen type I-based cell carrier (CCC) with stratified multi-layer autologous urothelium was used for urethroplasty after induction of urethral stricture in eight minipigs. MATERIALS AND METHODS: Minipigs underwent surgical procedures to induce urethral stricture by thermocoagulation. Simultaneously, bladder tissue was harvested. Urothelial cells were expanded, labeled with PKH26 and seeded onto CCC in high density. 3 weeks after strictures were induced and verified by urethrography, minipigs underwent urethroplasty using the seeded CCC. Two animals were euthanized after 1, 2, 4, and 24 weeks. Urethras were histologically examined for integration and survival of seeded CCC. In vivo phenotype of multi-layered urothelium matrix constructs was characterized via immunofluorescence staining with pancytokeratin, CK20, p63, E-cadherin and ZO-1. RESULTS: Seeded CCCs showed excellent stability and suturability after manipulation and application. Transplanted cells were detected using positive PKH26 fluorescence up to 6 months after labeling. Urothelium matrix implants integrated well into the host tissue without sign of inflammation. Animals showed no sign of rejection or stricture recurrence (urethrography) at any time during experimental period. Immunofluorescence analysis confirmed epithelial phenotype, junction formation and differentiation after 2 weeks. CONCLUSION: CCC can be suitable for urologic reconstructive surgeries and represents a promising option for clinical application. Longer follow-up results are required to exclude re-occurrence of stricture reformation.

Early sacral neuromodulation ameliorates urinary bladder function and structure in complete spinal cord injury minipigs.

AIMS: To determine the effects of early sacral neuromodulation (SNM) and pudendal neuromodulation (PNM) on lower urinary tract (LUT) function, minipigs with complete spinal cord injury (cSCI) were analyzed. SNM and PNM have been proposed as therapeutic approaches to improve bladder function, for example after cSCI. However, further evidence on efficacy is required before these methods can become clinical practice. METHODS: Eleven adults, female Göttingen minipigs with cSCI at vertebral level T11-T12 were included: SNM (n = 4), PNM (n = 4), and SCI control (SCIC: n = 3). Tissue from six healthy minipigs was used for structural comparisons. Stimulation was started 1 week after cSCI. Awake urodynamics was performed on a weekly basis. After 16 weeks follow-up, samples from the urinary bladder were taken for analyses. RESULTS: SNM improved bladder function with better capacities and lower detrusor pressures at voiding and avoided the emergence of detrusor sphincter dyssynergia (DSD). PNM and untreated SCI minipigs had less favorable outcomes with either DSD or constant urinary retention. Structural results revealed SCI-typical fibrotic alterations in all cSCI minipigs. However, SNM showed a better-balanced distribution of smooth muscle to connective tissue with a trend towards the reduced progression of bladder wall scarring. CONCLUSION: Early SNM led to an avoidance of the emergence of DSD showing a more physiological bladder function during a 4 month follow-up period after cSCI. This study might pave the way for the clinical continuation of early SNM for the treatment of neurogenic LUT dysfunction after SCI.

Extended periprostatic nerve distributions on the prostate surface confirmed using diffusion tensor imaging.

OBJECTIVE: To perform a descriptive microscopic study of prostatectomy specimens from 19 patients which anatomically characterizes the distributions of periprostatic nerve qualities, and to visualize these using diffusion tensor imaging (DTI). MATERIALS AND METHODS: Serial whole-mounted sections were stained for cholinergic (neuronal nitric oxide synthase), adrenergic (tyrosine hydroxylase) and sensory (calcitonin gene-related peptide) nerves. Extracapsular stained nerves were counted by prostate surface sector, and classified by diameter. Stain-related relative density was calculated, and distribution patterns were evaluated. To better visualize the reported neuronal structures and independently confirm our findings, nerve concordance in five male volunteers was investigated using a 3-Tesla magnetic resonance imaging-DTI system. RESULTS: At the base, cholinergic nerves were distributed from the anterolateral to posterior sectors, continuing posterolaterally (mid-section) into the posterolateral-posterior sector toward the apex. Adrenergic nerves were distributed across the anterolateral-posterior sectors at the base, with the course narrowing to the posterolateral-posterior sectors at the mid- and apical levels. Sensory fibres were found posterolaterally posteriorly at the base, continuing posterolaterally over the mid- and apical levels. Although it was not possible to determine the different nerve qualities, DTI confirmed histological findings from the base to the apex. CONCLUSIONS: Different types of nerve fibres were found to vary in distribution. When linked to possible functional aspects of the different nerve types, this morphological evidence may be of importance to further protect function after radical prostatectomy (RP). To our knowledge, this is the first time that DTI has confirmed reported histological findings in nerve-sparing RPs. DTI could be an important tool with which to correlate nerves to tumour for better preoperative planning and to incorporate imaging into treatment.

Minimally invasive prostatic urethral lift (PUL) efficacious in TURP candidates: a multicenter German evaluation after 2 years.

INTRODUCTION: Successful outcomes have been reported for the treatment of lower urinary tract symptoms (LUTS) with the prostatic urethral lift (PUL) in a number of clinical investigations. Our aim was to investigate PUL outcomes in patients treated in a day-to-day clinical setting without the rigid exclusion criteria of clinical studies. MATERIALS AND METHODS: We investigated the outcome of the PUL procedure at five German departments during the initial period when PUL was approved for the clinic (10/2012-06/2014). All candidates for transurethral resection of the prostate (TURP) received PUL information and were given the choice of procedures. The only exclusion criterion was an obstructive median lobe. No patients were excluded because of high post-void residual volume (PVR), prostate size, retention history or LUTS oral therapy. Maximum urinary flow (Qmax), PVR, International Prostate Symptom Score (IPSS) and Quality of Life (QOL) were assessed at baseline, 1, 6, 12, and 24 months after surgery. RESULTS: Of 212 TURP candidates, 86 choose PUL. A mean of 3.8 (2-7) UroLift implants were implanted in patients of 38-85 years with a prostate size of 17-111 ml over 57 (42-90) min under general or local anesthesia. Thirty-eight (38.4%) patients had severe BPH obstruction and would have been denied PUL utilizing previously reported study criteria. Within 1 month 74 (86%) reported substantial symptom relief with significant improvements in Qmax, PVR, IPSS, and QOL (p < 0.001) that was maintained within the follow-up. Sexual function including ejaculation was unchanged or improved. No Clavien-Dindo Grad ≥ 2 was reported postoperatively. Eleven (12.8%) patients were retreated over 2 years. Twelve (86%) of 14 patients presenting with chronic urinary retention were catheter free at last follow-up. CONCLUSION: PUL is a promising surgical technique that may alleviate LUTS, even in patients with severe obstruction.

Combined prostatic urethral lift and remodeling of the prostate and bladder neck: a modified transurethral approach in the treatment of symptomatic lower urinary tract obstruction.

PURPOSE: The aim of the study was to evaluate the feasibility and safety of combining prostatic urethral lift (PUL) and a limited resection of the prostatic middle lobe or bladder neck incision in the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). METHODS: Twenty-eight patients were treated at two tertiary centers and followed prospectively. Patient evaluations included patient characteristics, relief of LUTS symptoms, erectile and ejaculatory function, continence, operative time and adverse events. Patients were followed for a mean of 10.9 months. RESULTS: Patient characteristics were as follows: age 66 years (46-85), prostate volume 39.6 cc (22-66), preoperative IPSS/AUASI 20 (6-35)/QoL 3.9 (1-6)/peak flow 10.5 mL/s (4.0-19)/post-void residual volume (PVR) 123 mL (0-500). Mean operating time was 31 min (9-55). Postoperative complications were minor except for the surgical retreatment of one patient for blood clot retention (Clavien 3b). One patient required catheterization due to urinary retention. Reduction of symptoms (IPSS - 59.6%), increase in QoL (+ 49.0%), increase in flow (+ 111.5%), and reduction of PVR (- 66.8%) were significant. Antegrade ejaculation was always maintained. CONCLUSION: Our data suggest that a combination of PUL and transurethral surgical techniques is feasible, safe, and effective. This approach may be offered to patients with moderate size prostates including those with unfavorable anatomic conditions for PUL. This procedure is still 'minimally invasive' and preserves sexual function. In addition, it may add to a higher functional efficacy compared to PUL alone. STUDY REGISTER NUMBER: DRKS00008970.

Neurogenic bowel dysfunction: Clinical management recommendations of the Neurologic Incontinence Committee of the Fifth International Consultation on Incontinence 2013.

BACKGROUND: Evidence-based guidelines for the management of neurological disease and lower bowel dysfunction have been produced by the International Consultations on Incontinence (ICI). These are comprehensive guidelines, and were developed to have world-wide relevance. AIMS: To update clinical management of neurogenic bowel dysfunction from the recommendations of the 4th ICI, 2009. MATERIALS AND METHODS: A series of evidence reviews and updates were performed by members of the working group. The resulting guidelines were presented at the 2012 meeting of the European Association of Urology for consultation, and modifications applied to deliver evidence based conclusions and recommendations for the scientific report of the 5th edition of the ICI in 2013. RESULTS: The current review is a synthesis of the conclusions and recommendations, including the algorithms for initial and specialized management of neurogenic bowel dysfunction. The pathophysiology is described in terms of spinal cord injury, multiple sclerosis, and Parkinson's disease. Assessment requires detailed history and clinical assessment, general investigations, and specialized testing, if required. Treatment primarily focuses on optimizing stool consistency and regulating bowel evacuation to improve quality of life. Symptom management covers conservative and interventional measures to promote good habits and assist stool evacuation, along with prevention of incontinence. Education is essential to achieving optimal bowel management. DISCUSSION: The review offers a pragmatic approach to management in the context of complex pathophysiology and varied evidence base.

Psychosocial Distress in Bladder Cancer Stratified by Gender, Age, Treatment, and Tumour Stage.

OBJECTIVES: Cancer patients have to cope with anxieties -concerning their prognosis, potential recurrence/progression, and treatment-associated sequelae. Stress-related psychosocial factors influence survival and disease-related mortality in cancer patients. Despite improvements in diagnosis and treatment, bladder cancer (BC) remains characterized by high rates of recurrence and progression. We screened -pre-therapeutically the stress level of BC patients stratified by gender, disease state, treatment, and other factors by -self-administered validated questionnaires to integrate them into psychosocial support as needed. METHODS: A cross-sectional analysis of distress and need of psychosocial care was done in 301 patients undergoing treatment for BC by 2 questionnaires (Distress Thermometer [DT] and Hornheider Screening Instrument). RESULTS: Of the 301 patients, 230 patients underwent transurethral resection for a first -diagnosis, 63 for recurrent disease, 37 had progressive disease, and 25 had advanced metastatic disease and eventually died of BC. The mean stress level in all patients was 4.6. Twenty-eight percent of the patients expressed a need for psychosocial support. In patients with progressive disease, significantly higher stress scores were seen as well as a higher need of psychosocial care (5.4 and 41%). CONCLUSIONS: The median DT-level of 4.6 indicates moderate psychosocial stress in BC patients. From a stress level of 5, the recommendations of a psycho-oncological supervision are pronounced, so that our study showed that early systematic evaluation of psychosocial needs in BC patients is important.

Prostatic urethral lift vs transurethral resection of the prostate: 2-year results of the BPH6 prospective, multicentre, randomized study.

OBJECTIVES: To compare prostatic urethral lift (PUL) with transurethral resection of the prostate (TURP) with regard to symptoms, recovery experience, sexual function, continence, safety, quality of life, sleep and overall patient perception. PATIENTS AND METHODS: A total of 80 patients with lower urinary tract symptoms attributable to benign prostatic hyperplasia (BPH) were enrolled in a prospective, randomized, controlled, non-blinded study conducted at 10 European centres. The BPH6 responder endpoint assessed symptom relief, quality of recovery, erectile function preservation, ejaculatory function preservation, continence preservation and safety. Additional evaluations of patient perspective, quality of life and sleep were prospectively collected, analysed and presented for the first time. RESULTS: Significant improvements in International Prostate Symptom Score (IPSS), IPSS quality of life (QoL), BPH Impact Index (BPHII), and maximum urinary flow rate (Qmax ) were observed in both arms throughout the 2-year follow up. Change in IPSS and Qmax in the TURP arm were superior to the PUL arm. Improvements in IPSS QoL and BPHII score were not statistically different between the study arms. PUL resulted in superior quality of recovery, ejaculatory function preservation and performance on the composite BPH6 index. Ejaculatory function bother scores did not change significantly in either treatment arm. TURP significantly compromised continence function at 2 weeks and 3 months. Only PUL resulted in statistically significant improvement in sleep. CONCLUSION: PUL was compared to TURP in a randomised, controlled study which further characterized both modalities so that care providers and patients can better understand the net benefit when selecting a treatment option.

Collagen cell carriers seeded with human urothelial cells for urethral reconstructive surgery: first results in a xenograft minipig model.

PURPOSE: Urethral strictures are a common disease of the lower urinary tract in men. At present, the use of buccal mucosa is the method of choice for long or recurrent strictures. However, autologous tissue-engineered grafts are still under investigation for reconstructive urological surgery. The aim of this pilot study was to evaluate the use of human urothelial cells (HUC) seeded on bovine collagen type I-based cell carriers (CCC) in an animal model and to evaluate short-term outcome of the surgical procedure. METHODS: Four male Göttingen minipigs were used with immunosuppression (cyclosporine A) for this pilot xenograft study. HUC obtained from human benign ureteral tissue were stained by PKH26 and seeded on a collagen cell carrier (CCC). Seven weeks after urethral stricture induction and protective vesicostomy, cell-seeded CCC was implanted in the urethra with HUC luminal and antiluminal, respectively. After two weeks animals were euthanized, urethrography and histological assessment were performed. RESULTS: Surgery was technically feasible in all minipigs. Stricture was radiologically established 7 weeks after induction. CCC was visible after two weeks and showed good integration without signs of inflammation or rejection. In the final urethrography, no remaining stricture could be detected. Near porcine urothelium, PKH26-positive areas were found even if partially detached from CCC. Although diminished, immunofluorescence with pankeratin, CK20, E-cadherin and ZO-1 showed intact urothelium in several areas on and nearby CCC. CONCLUSION: Finally, this study demonstrates that the HUC-seeded CCC used as a xenograft in minipigs is technically feasible and shows promising results for further studies.

Overactive bladder syndrome and lower urinary tract symptoms after prostate cancer treatment.

PURPOSE OF REVIEW: To assess the contemporary literature on the prevalence, cause and management of lower urinary tract symptoms (LUTS) and bladder overactivity following treatment of prostate cancer with radical surgery, radiotherapy and minimally invasive therapies for localized prostate cancer, including cryotherapy and high-intensity focused ultrasound (HIFU). RECENT FINDINGS: Generally, the highest risk of urinary incontinence is after open radical prostatectomy (7-40%), although not all contemporary studies demonstrate a difference between open and laparoscopic techniques. An increased incidence of bladder overactivity is seen with radiotherapy (as compared to radical prostatectomy). Bladder outlet obstruction is most commonly encountered after radical prostatectomy and radiotherapy combination therapy (up to 26%). It manifests as voiding LUTS or urinary retention, and the risk can accumulate over time. Cryotherapy and HIFU provide effective cancer treatment with lower risks of urinary incontinence, but have fewer published studies and shorter follow-up. Medical treatment options for LUTS include alpha blockers, anticholinergics, and potentially intravesical glycosaminoglycan analogue instillations. Stress urinary incontinence requires surgical correction with artificial urinary sphincter or suburethral slings. SUMMARY: Patients who have undertaken successful prostate cancer treatment have a good prognosis, and commonly present for further interventions to optimise quality of life if bothersome urinary symptoms are experienced. It is important to be vigilant for and treat any adverse urinary consequences.

Emerging techniques in 'truly' minimal-invasive treatment options of benign prostatic obstruction.

PURPOSE OF REVIEW: Benign prostatic enlargement is a common age-related condition, affecting over 50% of men aged more than 60 years. Side effects of medical therapy and significant morbidity of transurethral resection of the prostate and open surgery led to the development of so-called minimally invasive procedures, with the aim to be efficient but with less morbidity and shorter or no hospitalization. For this review, a systematic literature was performed. We report recent results in different treatment options for benign prostate hypoplasia (BPH) and recommend the best minimal-invasive treatment for BPH. RECENT FINDINGS: Within recent years, BPH surgical interventions underwent a shift. Although standard techniques have further improved because of new products and increased business competition, there has been a request from healthcare administration to reduce costs and inpatient treatment. As important, the patients understanding of outcome, fast relief, and recovery might change the common urological outcome measurement. The two main aspects are quality of life and sexuality. SUMMARY: Some of the presented treatments are already established in EAU guidelines, others may be recognized in clinical practice as a suitable alternative treatment to transurethral resection of the prostate and medical therapy. Patients now wish to be more involved in the treatment option decision-making and seem very concerned about side effects and their return to normal life. However, variations in reimbursements allowed in different countries can affect the treatment option.

Obesity and its implications on oncological urological surgery.

PURPOSE OF REVIEW: To review and summarize the contemporary knowledge of the implications of obesity on perioperative outcomes in oncological urologic surgeries. RECENT FINDINGS: In men undergoing radical prostatectomy, obesity seems to confer a higher risk of intraoperative bleeding, biochemical recurrence, urinary incontinence, and postoperative erectile dysfunction. The literature was not consistent regarding the benefits of a minimally invasive approach in overweight and obese patients. Similarly, available data suggest a higher risk of complications in obese patients undergoing radical cystectomy. Obesity does not seem to confer a higher risk of morbidity in patients undergoing radical nephrectomy and nephroureterectomy. However, studies reported conflicting surgical outcomes in obese patients treated with partial nephrectomy. Overweight and obesity status are associated with higher morbidity in patients treated with inguinal lymph node dissection for penile cancer. No data are available regarding the impact of obesity in obese patients treated with retroperitoneal lymph node dissection for testicular cancer. SUMMARY: Although randomized clinical data are lacking and the results of many studies are inconsistent, evidence supports the feasibility and safety of different oncological urological surgeries in obese patients. Nevertheless, obesity is an important comorbidity associated with a higher morbidity rate in most oncological urological surgeries.

Obesity and its implications on nononcological urological surgery.

PURPOSE OF REVIEW: To review and summarize the current literature of the implications of obesity on nononcological urological surgery. We conducted a comprehensive search of the current literature with emphasis on the published literature in the last 18 months. RECENT FINDINGS: Over time, obese patients have become a more common encounter in clinical practice. Obesity represents a considerable operative challenge and has been linked to a higher rate of postoperative complications. Data regarding surgery for incontinence are inconsistent. Nevertheless, the success rates in obese women are high, and complication rates are relatively low with comparable results to nonobese women. In renal surgery, percutaneous nephrolithotomy and minipercutaneous nephrolithotomy are feasible, well tolerated, and effective even in obese patients. However, certain precautions and availability of proper instruments are necessary. SUMMARY: Although randomized clinical data are lacking and the results of many studies are inconsistent, evidence supports the feasibility and safety of different nononcological urological interventions in obese patients. Moreover, the success rates and the overall complication rates seem to be comparable to nonobese patients with some exceptions.

Assessing the reproducibility of high definition urethral pressure profilometry and its correlation with an air-charged system.

INTRODUCTION: Recently, a new urodynamic method for the assessment of stress urinary incontinence called high definition urethral pressure profilometry (HD-UPP) has been introduced. This method combines a novel microtip catheter with advanced signal processing to enable spatial data location and the reconstruction of a pressure image inside the urethra. In order to assess the reproducibility of HD-UPP data, we statistically evaluate HD-UPP datasets and compare them to data from a double balloon air-charged system. MATERIALS AND METHODS: Both catheters are used on sedated female minipigs. Data from the microtip catheter are processed through a signal reconstruction algorithm, urodynamic features are extracted, and compared to the air-charged system. Reproducibility of HD-UPP data is assessed by statistically evaluating consecutive, intra-individual datasets. RESULTS: HD-UPP delivers results in agreement with previous comparisons of microtip and air-charged systems. The average deviation of two consecutive, intra-individual pressure images is very low at 7 cm H2 O. CONCLUSIONS: HD-UPP provides physicians with detailed information on the pressure distribution inside the urethra. Through comparison with an air-charged catheter, it is shown that HD-UPP delivers results in agreement with previous studies on the comparison of microtip and air-charged catheters. It provides excellent reproducibility, as the difference between sequentially measured profiles from the same minipig is significantly lower than the one between profiles from different minipigs.

Precise injection of human mesenchymal stromal cells in the urethral sphincter complex of Göttingen minipigs without unspecific bulking effects.

AIM: To investigate if injection of cells in the urethral sphincter complex causes unspecific bulking effects. METHODS: Human mesenchymal stromal cells were isolated, expanded, and characterized. For transurethral injection, cells were labeled with the fluorescent dye PKH26 and in magnetic resonance imaging associated experiments with superparamagnetic particles. Aliquots of cells in 250 µL solvent were injected under vision in the urethral sphincter of immuno-suppressed Göttingen minipigs. Sphincteric closure pressure was recorded by standard and high-definition urethral pressure profilometry prior to and after cell injection. The animals were sacrificed after surgery or after 3 weeks, 3, 6, or 12 months of follow-up. The localisation of the injected cells was explored by histochemistry. Sham-treated animals served as controls. RESULTS: PKH26-labeled cells survive injections in sphincter tissue samples by Williams cystoscopic injection needle well. In our animal study, the cellular depots were detected in the submucosa or in deeper zones of the sphincter, depending of the length of the injection needle (4-8 mm). Adverse effects associated with injection of cells or solvent such as a noteworthy bleeding, incontinence, or obstruction, were not recorded (n = 96 minipigs). However, a transient infiltration of macrophages was detected 3 weeks after cell injection. Changes in the urethral pressure profiles were not observed in cell-treated (n = 72) compared to sham-treated animals (n = 24). CONCLUSIONS: Injection of small aliquots of cells to investigate cell therapies in minipigs is a feasible and safe procedure, and it does not bias the intrinsic urethral wall pressure.

New laparoscopic approach to the pudendal nerve for neuromodulation based on an anatomic study.

AIMS: The aim was to develop a new laparoscopic technique for placement of a pudendal lead. METHODS: Development of a direct, feasible and reliable minimal-invasive laparoscopic approach to the pudendal nerve (PN). Thirty-one embalmed human specimens were dissected for the relevant anatomic structures of the pelvis. Step-by-step documentation and analysis of the laparoscopic approach in order to locate the PN directly in its course around the medial part of the sacrospinous ligament and test this approach for feasibility. Landmarks for intraoperative navigation towards the PN as well as the possible position of an lead were selected and demonstrated. RESULTS: The visible medial umbilical fold, the intrapelvine part of the internal pudendal artery, the coccygeus muscle and the sacrospinous ligament are the main landmarks. The PN traverses the medial part of the sacrospinous ligament dorsally, medially to the internal pudendal artery. The medial part of the sacrospinous ligament has to be exposed in order to display the nerve. An lead can be placed ventrally on the nerve or around it, depending on the lead type or shape. CONCLUSIONS: A precise and reliable identification of the PN by means of laparoscopy is feasible with an easy four-step approach: (1) identification of the medial umbilical fold; (2) identification of the internal iliac artery; (3) identification of the internal pudendal artery and incision of the coccygeus muscle ('white line', arcuated line); and (4) exposition of the medial part of the sacrospinous ligament to display the PN.

Durable Efficacy and Safety of Long-Term OnabotulinumtoxinA Treatment in Patients with Overactive Bladder Syndrome: Final Results of a 3.5-Year Study.

PURPOSE: These are the final results of the prospective, multicenter, long-term (3.5-year) study of the efficacy/safety of onabotulinumtoxinA for overactive bladder syndrome. MATERIALS AND METHODS: Patients who completed either of 2, 24-week phase 3 trials could enter a 3-year extension and continue treatment with onabotulinumtoxinA 100 U as needed to control overactive bladder symptoms. Data were analyzed by the treatment(s) received (up to 6) and in discrete subgroups that received 1, 2, 3, 4, 5 or 6 treatments (to evaluate the consistency of the response after repeat treatments in the same patient groups). Assessments included the change from baseline in the number of urinary incontinence episodes per day and the proportion of patients who reported improvement/great improvement in urinary symptoms on the TBS (Treatment Benefit Scale) at week 12 as co-primary end points. Other end points were the change from baseline in I-QOL (Incontinence Quality of Life), the number of urgency and micturition episodes per day; duration of effect; the number of adverse events; and the initiation of intermittent catheterization. RESULTS: Consistent mean reductions in urinary incontinence were observed following continued onabotulinumtoxinA treatment, ranging from -3.1 to -3.8 in the overall population and -2.9 to -4.5 in the discrete subgroups. Durable improvements were seen in overactive bladder symptoms and quality of life. A high proportion of patients rated their condition as improved/greatly improved. The median duration of effect was 7.6 months. The most common adverse event was urinary tract infection. The rate of de novo catheterization after the first treatment was 4.0% and it ranged from 0.6% to 1.7% after subsequent treatments. CONCLUSIONS: Long-term onabotulinumtoxinA treatment consistently decreased overactive bladder symptoms and improved quality of life with no new safety signals.

A comparison between an in vitro ureteroscopic stone size estimation and the stone size measurement with the help of a scale on stone baskets.

INTRODUCTION: Endoscopic treatment of ureter stones and renal calculi relies on the surgeon's estimation of the stone size for both lithotripsy and removal of stones or stone fragments. We therefore compared precision and reliability of the endoscopic estimation of stone size by the surgeon with measurements on a scale on a stone basket. MATERIALS AND METHODS: Two surgeons (one high experienced and one low experienced) first estimated, then measured the size of 12 stones differing in size and color using different stone baskets (2.5, 3.0, 4.0 Ch) each via a semirigid renoscope in an artificial ureter under water repeatedly on two different days. All together, we had 288 measurements and 288 estimations. RESULTS: On the whole, the accuracy of the estimation diminished with bigger stones. There is an increasing underestimation with increasing stone size. Factors, which significantly influence the estimation, are the operating surgeon, the color of the stone, the time sequence, and the size of the closed basket, which was held beside the stone. The accuracy of the measurement of the stone baskets is not as good as the estimation. The small 2.5-Ch basket is the most accurate in measuring big stones (>6 mm), the 3.5 Ch in intermediate stones (3-6 mm), the big basket (4.0 Ch) in small stones (<3 mm). CONCLUSION: This first attempt at validation of a scale on stone baskets shows different results for each basket which could be systematically improved. Until now, the estimation of the surgeons is better than the measurement, but it is also influenced by factors like the surgeon or the color of the stone.

Circumferential urinary sphincter surface electromyography: A novel diagnostic method for intrinsic sphincter deficiency.

AIMS: The diagnosis of intrinsic sphincter deficiency (ISD) in patients with stress urinary incontinence (SUI) is not well established. We explored the possibility of applying a new tool: minimally invasive circumferential sphincter surface electromyography (CSS-EMG) to assess the muscular integrity of the urethral sphincter in patients with SUI/ISD. METHODS: CSS-EMG of the urethral sphincter and urodynamic studies were performed in 44 women with SUI. A urethral pressure profile (UPP) was measured in four directions. Maximal urethral closure pressure (MUCP) <40 cm/H2 O or the presence of SUI without urethral hypermobility was used to define ISD. RESULTS: Twenty-one patients had urodynamic SUI, 23 had no SUI and 12 patients had ISD. The mean average rectified value (ARV) of the motor unit action potential (MUAP), an indicator of the strength of urethral rhabdosphincter, was estimated. ARV measured in the 12 o'clock quadrant during maximal contraction was the only CSS-EMG parameter that had significant predictive value for ISD. With an increase in the 12 o'clock ARV value, the likelihood of ISD decreases (Odds Ratio 0.36 95% confidence interval 0.67-0.92). In the ROC curve with ARV measured in the 12 o'clock quadrant during maximal contraction, the explained area was 0.794 (P = 0.02); implying that ARV measured at the 12 o'clock quadrant during maximal contraction was able to predict ISD significantly. CONCLUSIONS: Myogenic changes of the urethral sphincter that contribute to ISD can be assessed with CSS-EMG. This new concept for assessing the functionality of the female urethral sphincter may assist with better understanding of the pathophysiology, the diagnosis and the treatment of SUI.