Complications of Synthetic Midurethral Slings: Is There a Relevant Discrepancy Between Observational Data and Clinical Trials?

CONTEXT: The complications of synthetic midurethral slings (MUSs) in women with stress urinary incontinence (SUI) have become a globally debated issue. OBJECTIVE: To systematically review the short- and long-term complications of mesh slings reported in observational data compared with clinical trial data, to determine whether the complication rates from clinical trials reflects "real-world" observational data. EVIDENCE ACQUISITION: PubMed and Cochrane Library were searched. Methods as detailed in Preferred Reporting Items for Systematic Reviews and Meta-analyses and Cochrane Handbook for Systematic Reviews of Interventions were followed. EVIDENCE SYNTHESIS: Thirty registries/databases including 709 335 MUS procedures (1-22 yr of follow-up) were identified. MUS procedures were associated with intraoperative bladder perforation in 0.86-3.6%, urethral perforation in 0-0.1%, vascular injury in 0.04-0.1%, voiding lower urinary tract symptoms (LUTS) in 1.47-3.5%, vaginal exposure in 0.2-1.9%, and reoperation in up to 9% of cases. Forty-three randomised clinical trials were identified, including 6284 women who underwent MUS procedures and 2177 women who underwent other interventions (1-10 yr of follow-up). MUS procedures were associated with urinary tract perforation in 2.58%, vaginal injury in 1.43%, de novo voiding LUTS in 4.37%, de novo storage LUTS in 5.41%, mesh extrusion/exposure (vaginal/urinary tract) in 2.54%, dyspareunia in 2.26%, pain (pelvic/suprapubic/perineal) in 2.83%, and reoperation for complications required in 1.82% of cases. Meta-analyses of the randomised controlled trials revealed that retropubic MUSs were associated with more events of urinary tract perforation (risk ratio [RR] 9.81, 95% confidence interval [CI] 5.05-19.04, high certainty of evidence [COE]) and voiding LUTS (RR 1.57, 95% CI 1.19-2.07, high COE) than transobturator MUSs. MUSs were associated with more events of pain than mini-slings (RR 1.72, 95% CI 1.04-2.87, moderate COE). CONCLUSIONS: Short- and long-term data on complications of polypropylene mesh used for female SUI are fairly comparable when using outcome data from well-designed clinical trials or from less structured prospective or retrospective registries. Comparisons have to be made with caution since the two systems of data collection are inherently incomparable. This knowledge should be incorporated in the discussion on how to implement polypropylene mesh for female stress incontinence. PATIENT SUMMARY: In order to know whether mesh tapes used for treating stress incontinence work well and are safe, high-quality information is important. It appears that well-designed clinical studies give similar results to large registration databases. These data should be interpreted with caution in view of the different ways the information was collected. These results will help physicians and patients understand the risks of mesh tapes.

Sepsis rates after template prostate biopsy with single-dose prophylactic antibiotic.

Introduction: Urosepsis is a significant risk associated with prostate biopsy. Resistance of microorganisms to antibiotics is a challenging issue for clinicians in everyday practice. In the current study, we investigated the rates of sepsis and hospital admissions following transperineal (TP) prostate biopsies using a single dose of gentamicin. Material and methods: Data for consecutive patients who underwent TP prostate biopsies (March 2019-March 2020) were included. Patients received a single-dose of prophylactic gentamicin 120 mg IV and had skin preparation with antiseptic povidone-iodine or chlorhexidine solution prior to the procedure. Patient's electronic records were reviewed for rates of sepsis and readmission to hospital within 7 days following TP prostate biopsy. Results: A total of 365 consecutive patients were included in the study. After exclusion of non-eligible patients, 280 patients were included in final analysis. The median age was 67 years (32-83), the median prostate-specific antigen (PSA) level was 8.5 ng/ml (0.2-58), and the median prostate size was 44 cc (10-188). Approximately 58% of patients had one or more comorbidities in the form of diabetes mellitus (DM), hypertension, asthma, chronic kidney disease, or ischemic heart disease. Adenocarcinoma was found in 71.7% of patients. None of the 280 patients developed sepsis. Urinary tract infection (UTI) occurred in 2.8% of patients with E.coli, none of them required hospital readmission. Conclusions: Our single centre experience showed a 0% sepsis rate after TP prostate biopsy with single prophylactic dose of gentamicin. Future randomized controlled trials (RCTs) should explore the possibility of performing these procedures without antibiotic prophylaxis in order to reduce the unnecessary use of antibiotics.

Is There Outcome Reporting Heterogeneity in Trials That Aim to Assess the Effectiveness of Surgical Treatments for Stress Urinary Incontinence in Women?

CONTEXT: Inconsistent reporting of effectiveness outcomes in surgical trials of stress urinary incontinence (SUI) has hindered direct comparisons of various surgical treatments for SUI. OBJECTIVE: To systematically review the verbatim outcome names, outcome definitions, and tools used to measure the outcomes in surgical trials of SUI in women. EVIDENCE ACQUISITION: Trials of women with SUI who have undergone surgical interventions were included. We conducted a systematic review (SR) on outcomes reported in randomized controlled trials of surgical management published in 2014-2019, covering the following databases: MEDLINE, EMBASE, CENTRAL, and CDSR. Verbatim outcome names extracted from the included studies were categorized and then grouped into domains using the Williamson-Clarke (W/C) outcome taxonomy. A matrix was also created to visualize and quantify the dimensions of outcome reporting heterogeneity in SUI trials. EVIDENCE SYNTHESIS: A total of 844 verbatim outcome names were extracted, of which, 514 varied terms were reduced to 71 standardized outcome names. They were further categorized into 11 domains from the W/C taxonomy. There were 7.24 different terms on average to describe each outcome, and the four outcomes with the most heterogeneity evident in terms used to describe them were "urinary retention", "reoperation", "subjective cure rate" and "quality of life". Each of them had ≥20 different terms. Only 28% of the outcome definitions were reported and a variety of measuring tools was noted, particularly in subjective outcomes. High heterogeneity was found in the outcome names, outcome definitions, choice and number of measuring instruments of the outcomes, and choice and number of outcomes reported across studies. CONCLUSIONS: This SR provides objective evidence of heterogeneity in outcome reporting in SUI surgical trials. Our categorization of outcomes highlights the difficulties in summarizing the current evidence base. A core outcome set, developed using the methods advocated by the Core Outcome Measures in Effectiveness Trials (COMET) and COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) initiatives, is required. PATIENT SUMMARY: In this research, we have highlighted the diversity in outcomes reporting in stress urinary incontinence (SUI) surgical trials and have categorized the outcomes. We support the development of a core outcome set for SUI, which will promote future clinical researchers to measure the same outcome in the same way in all trials. This will, in turn, help researchers summarize the evidence more effectively and aid decision making for patients and doctors.

Ciprofloxacin: single versus multiple doses in transrectal ultrasound guided prostate biopsy.

INTRODUCTION: There is rising concern regarding overuse of fluoroquinolones due to severe musculoskeletal and neurological side effects, and development of resistant microorganisms. In June 2019, the European Commission recommended fluoroquinolones should not be used routinely for prophylaxis in urological surgical procedures. Methods to reduce unnecessary exposure to fluroquinolones should be investigated.The aim of this article was to determine differences in hospital admission secondary to sepsis following transrectal ultrasound (TRUS) guided prostate biopsies between patients who received single vs. multiple doses of fluoroquinolones. MATERIAL AND METHODS: A retrospective analysis (June 2017-September 2018) of 200 consecutive TRUS biopsies at a single centre was undertaken. Group 1 (n = 100) received 750 mg ciprofloxacin 1-hr before their procedure followed by 3 days of ciprofloxacin 250 mg BD. Group 2 (n = 100) received a single dose of 750 mg ciprofloxacin 1-hr before the procedure. Midstream urine (MSU) culture results were examined pre-biopsy and 7 days post-biopsy. Data was also gathered on readmission rates to hospital as a result of urosepsis. RESULTS: A total of 1% of patients in each group required hospital admission secondary to Escherichia coli sepsis. A further 4% (n = 4) in Group 1 developed a urinary tract infection requiring antibiotic treatment post biopsy compared with 1% (n = 1) in Group 2. There was no statistically significant difference in development of infectious complications post-biopsy between the two groups (p >0.05). CONCLUSIONS: A single prophylactic dose of 750 mg of ciprofloxacin 1-hour pre-biopsy is as effective as multiple doses for TRUS guided prostate biopsy. Avoiding an unnecessary and prolonged course of fluoroquinolones has advantages in reducing potential side effects and development of resistant pathogens.

Female neurogenic stress urinary incontinence.

PURPOSE OF REVIEW: The aim of this article is to look into recent updates on the management of neurogenic stress urinary incontinence (NSUI) in adult females. RECENT FINDINGS: Recently, a small number of studies have investigated different surgical modalities in treatment of NSUI in adult females including artificial urinary sphincter (AUS), suburethral tapes (SUT) and adjustable slings and urethral bulking agents. Up to 70% of neurogenic patients who received AUS implants are continent and have not required surgical revision over a 20-year follow-up period. However, the risk for explantation of AUS may be twice as high in neurogenic patients compared with nonneurogenic patients. SUT have success and improvement in quality of life rates of up to 52 and 68%, respectively. However, complications may be as high as 24%. Early data on adjustable slings may suggest up to 80% continence with low complication rates. SUMMARY: AUS can provide satisfactory continence levels with acceptable rates of revision and explantation. SUT are effective but more than half of patients may require additional procedures. Adjustable slings could be a promising option. Further high-quality studies with careful attention to methodology and standardization of both definitions used and outcome reporting are required to help us reach safe conclusions.

Complications of Urethral Bulking Agents for Stress Urinary Incontinence: An Extensive Review Including Case Reports.

OBJECTIVES: Stress urinary incontinence in women is a common problem that significantly impacts quality of life. Periurethral injection of urethral bulking agents (UBAs) is a simple, noninvasive, and cost-effective treatment. However, complications associated with UBA are often underappreciated. Objective of this review was to get a complete overview of all published complications of UBA. METHODS: An extensive search of the scientific literature was conducted to quantitatively summarize the complications and their treatments of 8 UBAs. A total of 117 articles (original articles and case reports) were included in the final analysis. Complication incidence, treatment incidence, and follow-up time were extracted when mentioned. Statistical analysis of complication incidence of each UBA was calculated if possible. RESULTS: A total of 2095 complications in 6462 treated patients were reported in 79 studies. Sixty-seven (3%) were considered serious implying operative correction (Clavien grade III); of these, 46 (69%) required incision and drainage, and 21 (31%) required a more invasive procedure. In 38 case reports and small case series, 49 patients were treated for 110 complications. Of these 110 complications, 41 (37%) can be classified as Clavien grade III. CONCLUSIONS: This extensive review shows that various UBAs have different complication rates, with certain UBAs being more prone to serious complications. Based on available publications, most UBAs have a good safety profile, with low complication rates. However, although the majority of UBA complications are transient and require no or noninvasive treatment, serious complications may require invasive intervention and treatment.

A novel algorithm for the non-invasive detection of bladder outlet obstruction in men with lower urinary tract symptoms.

OBJECTIVE: To determine the ability of bladder wall thickness (BWT) in combination with non-invasive variables to distinguish patients with bladder outlet obstruction (BOO). PATIENTS AND METHODS: Patients completed the International Prostate Symptom Score (IPSS) questionnaire and prostate size was measured by transrectal ultrasonography (US). Pressure-flow studies were performed to determine the urodynamic diagnosis. BWT was measured at 250-mL bladder filling using transabdominal US. Recursive partition analysis (RPA) recursively partitions data for relating independent variable(s) to a dependent variable creating a tree of partitions. It finds a set of cuts of the dependent variable(s) that best predict the independent variable, by searching all possible cuts until the desired fit is reached. RPA was used to test the ability of the combined data of BWT, maximum urinary flow rate (Qmax), post-void residual urine volume (PVR), IPSS, and prostate size to predict BOO. RESULTS: In all, 72 patients were included in the final analysis. The median BWT, voided volumes, PVR, mean Qmax, and IPSS were significantly higher in patients who had an Abrams/Griffiths (A/G) number of >40 (55 patients) compared to those with an A/G number of ≤40 (17 patients). RPA revealed that the combination of BWT and Qmax gave a correct classification in 61 of the 72 patients (85%), with 92% sensitivity and 65% specificity, 87% positive predictive value, and 76% negative predictive value (NPV) for BOO (area under the curve 0.85). The positive diagnostic likelihood ratio of this reclassification fit was 2.6. CONCLUSIONS: It was possible to combine BWT with Qmax to create a new algorithm that could be used as a screening tool for BOO in men with lower urinary tract symptoms.

Single session vs two sessions of flexible ureterosopy (FURS) for dusting of renal pelvic stones 2-3 cm in diameter: Does stone size or hardness play a role in number of sessions to be applied?"

OBJECTIVE: To evaluate the stone hardness in predicting the need for single or two sessions of retrograde intrarenal surgery (RIRS) for renal pelvis stones of 2-3 cm in size. MATERIAL AND METHODS: Ninety-six patients (64 male and 32 female) with only renal stones (2.5±0.3 cm) underwent RIRS using flexible 7.5 Fr ureteroscope (FURS). The stone hardness was evaluated by preoperative non-contrast computed tomography (NCCT). The patients were divided into two groups based on stone hardness: Group I (n=54) (hard stones - Hounsfield Unit (HU) >1000) and group II (n=42) (not hard stone - HU <1000). The stone-free rate, the operative time, any intra or postoperative complications and the need for second sessions of RIRS were evaluated. RESULTS: All stones were successfully accessed. Intraoperative complications were not reported. The initial stone-free rate was 40% in Group I and 95% in Group II after a single session (p=0.01). A second session FURS was needed in 32 cases of Group I (40%) where postoperative CT showed significant residual stone fragments of 6±2 mm, and stone-free rate up to 100 percent. On the contrary only 2 cases from Group II underwent second session FURS (p=0.01). The operative times were 75±15 minutes in Group I and 55±13 minutes in Group II (p<0.01). Six patients (4 in group I and 2 in group II) had postoperative high-grade fever (Clavien Grade II). CONCLUSION: Stone hardness had a significant impact on the decision of performing single versus two sessions of FURS for renal pelvic stones of 2-3 cm rather than the stone size alone.

Pathophysiology and Contributing Factors in Postprostatectomy Incontinence: A Review.

CONTEXT: The incidence and awareness of postprostatectomy incontinence (PPI) has increased during the past few years, probably because of an increase in prostate cancer surgery. Many theories have been postulated to explain the pathophysiology of PPI. OBJECTIVE: The current review scrutinizes various pathophysiologic mechanisms underlying the occurrence of PPI. EVIDENCE ACQUISITION: A search was conducted on PubMed and EMBASE for publications on PPI. The primary search returned 2518 publications. Animal and basic research studies, letters, publications on prostatectomy for benign reasons, pathology of prostatic carcinoma, radiotherapy and hormone therapy of prostatic carcinoma, and review articles were all used as criteria for exclusion from the study. A total of 128 publications were selected for final analysis. EVIDENCE SYNTHESIS: Neuromuscular anatomic elements and pelvic support are known to influence PPI as evidenced by multiple publications. A number of non-anatomic and surgical elements have been postulated as contributing factors to PPI. Biological factors and preoperative parameters include: functional bladder changes, age, body mass index (BMI), pre-existing lower urinary tract symptoms (LUTS), prostate size, and oncologic factors. Multiple studies reported the impact of specific anatomic/surgical factors, including fibrosis, shorter membranous urethral length (MUL), anastomotic stricture, damage to the neurovascular bundle, and extensive dissection, all of which have a negative impact on the continence status of patients following radical prostatectomy (RP). Investigation of the impact of techniques to spare the bladder neck and additional procedures to reconstruct the posterior or anterior support structures (eg, the Rocco stitch) on continence status is ongoing. CONCLUSIONS: Anatomic support and pelvic innervation appear to be important factors in the etiology of PPI. Biological/preoperative factors including greater age at time of surgery, pre-existing LUTS, high BMI, shorter MUL, and functional bladder changes have a negative impact on continence after RP. Extensive dissection during surgery, damage to the neurovascular bundle, and postoperative fibrosis also have a substantial negative impact on the continence status of men undergoing RP. Sparing of the bladder neck and anterior fixation of the bladder-urethra anastomosis are associated with better continence rates. There is still debate about whether posterior pelvic reconstruction leads to better postoperative continence rates. PATIENT SUMMARY: Radical prostatectomy is an oncologic procedure and thus requires removal of the entire prostate gland and seminal vesicles, ideally with negative surgical margins. This sometimes results in urinary incontinence. The factors contributing to urinary incontinence are explained in this article.

Decline in artificial urinary sphincter survival in modern practice-do we treat a different patient?

AIM: Over the past few years, we have been doing an increasing number of revisions for artificial urinary sphincters (AUS) at our center. The study aims to investigate reason for this change in our practice. METHODS: Demographics and surgical outcomes of patients who received AUS in 2003-2014 at our center were retrospectively evaluated, and patients were contacted to check the current status of their AUS. The outcomes of the study were: percentage of revisions and explanation, survival, and the risk factors associated with these events. RESULTS: A total of 102 patients (72 years (30-87)) underwent 214 procedures: 99 primary implants, 11 secondary implants, 84 revisions, and 20 explantations-median follow-up was 54 months (5-146). The 5-years and 10-years revision-free survival for AUS were 47% and 23%, respectively. The 5 and 10 years explantation-free survival were 77% and 72%, respectively. The median time to revision for AUS implanted in 2010-2014 was shorter than in AUS implanted in 2003-2009 (6 vs. 13.5 months, P = 0.08). The percentage of AUS that were preceded by urethral surgery for incontinence was significantly higher in AUS implanted in 2010-2014 than in those implanted in 2003-2009 (19% vs. 63%, P = 0.001). The percentage of patients with AUS who received radiotherapy in the past 5 years was higher than in 2003-2009 (53% vs. 30%, P = 0.09). CONCLUSIONS: In modern urological practice, more exposure to RT and previous surgeries for incontinence are associated with increased risk for revision with decline in AUS survival.

Urethroplasty for treatment of long anterior urethral stricture: buccal mucosa graft versus penile skin graft-does the stricture length matter?

PURPOSE: To investigate the surgical outcomes of dorsal onlay urethroplasty (DOU) using buccal mucosa graft (BMG) or penile skin graft (PSG) and to assess the effect of stricture length in men with anterior urethral strictures. METHODS: A prospective cohort included men with anterior urethral strictures between 2008 and 2015. Patients underwent DOU using PSG or BMG. Patients had urethrography and uroflowmetry at 0, 3, 6, 12 months, and urethroscopy when needed. Student's t test, Mann-Whitney U tests, and Pearson's Chi-square test were used for analysis. RESULTS: Sixty-nine patients (43 ± 14 year) were included, 31 received BMG, and 38 received PSG. Mean stricture length was 8 ± 3 cm, mean operative time was 145 ± 31 min, and mean follow-up was 56 ± 10 mo. Success rate was 87 % (90 % BMG vs. 84 % PSG, p = 0.4). Mean operative time was significantly shorter in PSG group (136 ± 29 min vs. 256 ± 58 min, p = 0.0005). Complications of grade I developed in 36 % (wound infection = 10 %, postvoiding dribbling = 18.8 %). Thirty of 69 patients (43 %) had strictures ≥8 cm, and 39 (57 %) had strictures <8 cm-success rate was equal for both subgroups (87 %). Mean blood loss, mean operative time, and incidence of postvoid dribbling were significantly lower in strictures <8 cm. CONCLUSION: BMG and PSG have comparable success rates in treatment of long anterior urethral strictures. Operative time is significantly longer in BMG. Long-segment strictures are associated with longer operative time, more blood loss, and more occurrence of postvoid dribbling. However, the length of the stricture has no influence on the success rate and functional outcomes of DOU.

Surgical treatment of neurogenic stress urinary incontinence: A systematic review of quality assessment and surgical outcomes.

BACKGROUND: There are many opinions but little firm knowledge about the optimal treatment of neurogenic stress urinary incontinence (NSUI). OBJECTIVE: To scrutinize the quality and surgical outcomes of the available treatment modalities in the published literature. EVIDENCE ACQUISITION: A systematic review of the published literature from Pub Med and Web of Science was undertaken for studies describing surgical treatment of NSUI between 1990 and 2013. A checklist of criteria of methodological and reporting quality of interventions in urological publications was applied to assess quality of the retrieved publications. Surgical outcomes of success, failure, and reoperation were calculated. Statistical analyses included one-way ANOVA and post-hoc tests to determine significant differences between groups. EVIDENCE SYNTHESIS: Thirty studies were identified with Level 3 evidence. The quality of reporting was 43-81%, with significantly higher quality noted in studies published after 2002 (64% vs. 45%, P < 0.0001). None of the studies followed a randomized controlled trial (RCT) design. Three primary surgical procedures were used in 29 of 30 studies: artificial urinary sphincter (AUS), urethral slings, and urethral bulking agents. One study used a ProACT device. AUS was considered more successful than urethral bulking agents (77 ± 15% vs. 27 ± 20%, P = 0.002). Urethral bulking agents reported higher failures than urethral sling procedures (49 ± 16% vs. 21 ± 19%, P = 0.016) and AUS (21 ± 19% vs. 10 ± 11%, P < 0.002). CONCLUSIONS: The quality of evidence obtained from non-RCTs is modest. Surgeries for NSUI have relatively high success rates but also high complication rates in this highly heterogeneous population. More studies using modern techniques are required to update our knowledge.

Subpubic cartilaginous pseudocyst: orthopedic feature with urological consequences.

Introduction. Masses arising from structures adjacent to the female urethra can cause obstructive urinary symptoms. Subpubic cartilaginous pseudocyst is a rare degenerative lesion of pubic symphysis that may cause these symptoms. Materials and Methods. A 61-year- and 57-year-old women presented with symptoms of difficult micturition and dyspareunia. Physical examination revealed a painless smooth, rounded, firm, and cystic mass, at the anterior vaginal wall of about 4 cm width. The mass caused inward deviation of the external urethral meatus. Cystoscopy and MRI were done. Results. Cystoscopy of case 1 (61 y) demonstrated anterior external urethral compression with normal urethral mucosa. Cystoscopy was not possible in case 2 (57 y) because the urethra could not be entered under local anesthesia. MRI showed almost the same findings in both cases: midline, rounded, and cystic mass ~3 × 3 × 4 cm, anterosuperior to the urethra, and posteroinferior to the pubic symphysis, with normal features of the urinary bladder. Open surgical excision of theses lesions was performed in both patients. Histopathologic assessment of the specimen obtained from both patients showed degenerated hyaline with areas of fibrinous and mucoid degeneration, a picture suggestive of cartilaginous subpubic pseudocyst. After 11-month and 4-month followup of patients numbers 1 and 2, respectively, there is no evidence of local recurrence of the lesion, either clinically or radiologically and both patients void empty. Conclusions. Subpubic cartilaginous pseudocysts are rare benign lesions with only 13 cases were reported in the literature. Patients present with a spectrum of gynecological and/or urological manifestations. Sizable lesions severely compressing the urethra need surgical excision to restore the voiding function.

Noninvasive 2-dimensional monitoring of strain in the detrusor muscle in patients with lower urinary tract symptoms using ultrasound strain imaging.

PURPOSE: Pressure flow studies and filling cystometry are currently the standard diagnostic urodynamic tests for lower urinary tract symptoms. A noninvasive ultrasound based method for 2-dimensional monitoring of deformation (or strain) in the detrusor muscle may provide insight into detrusor muscle structural and dynamic properties related to pressure in physiological and disease conditions. MATERIALS AND METHODS: In a male patient population with lower urinary tract symptoms, strain in the detrusor muscle (perpendicular to the bladder wall) was estimated based on 2-dimensional radio frequency ultrasound imaging. The estimated strain was correlated to detrusor pressure and urinary flow rate using Spearman's correlation coefficient. RESULTS: Twenty men (mean ± SD age 66 ± 6 years) with lower urinary tract symptoms were included in the study. Ultrasound data acquisition was successful in 13 patients. In 7 patients data acquisition failed due to out-of-plane motion of the bladder wall during voiding or as a result of patient movement during acquisition. The estimated strain correlated positively with detrusor pressure in the 5 patients with an isovolumetric detrusor contraction (Spearman's 0.70-0.99, p <0.05). Of 8 patients with urinary voiding during detrusor muscle contraction this correlation was significantly positive in 5 patients (Spearman's 0.52-0.81, p <0.05). CONCLUSIONS: In 13 of 20 patients with lower urinary tract symptoms we demonstrated that strain in the detrusor muscle can be estimated using ultrasound imaging. The estimated strain correlated positively with the detrusor pressure. Optimal results were obtained in the pre-voiding phase, suggesting that ultrasound strain imaging can possibly be used to monitor detrusor muscle activity in real time.

Tissue engineered tubular construct for urinary diversion in a preclinical porcine model.

PURPOSE: The ileal conduit has been considered the gold standard urinary diversion for patients with bladder cancer and pediatric patients. Complications are mainly related to the use of gastrointestinal tissue. Tissue engineering may be the technical platform on which to develop alternatives to gastrointestinal tissue. We developed a collagen-polymer conduit and evaluated its applicability for urinary diversion in pigs. MATERIALS AND METHODS: Tubular constructs 12 cm long and 15 mm in diameter were prepared from bovine type I collagen and Vypro® II synthetic polymer mesh. Characterized tubes were sterilized, seeded with and without primary porcine bladder urothelial cells, and implanted as an incontinent urostomy using the right ureter in 10 female Landrace pigs. At 1 month the newly formed tissue structure was functionally and microscopically evaluated by loopogram and immunohistochemistry, respectively. RESULTS: The survival rate was 80% with 1 related and 1 unrelated death. By 1 month the collagen was resorbed and a retroperitoneal tunnel had formed that withstood 40 cm H(2)O water pressure. In 5 cases the tunnel functioned as a urostomy. Histological analysis revealed a moderate immune response, neovascularization and urothelial cells in the construct lumen. The polymer mesh provoked fibroblast deposition and tissue contraction. No major differences were observed between cellular and acellular constructs. CONCLUSIONS: After implanting the tubular constructs a retroperitoneal tunnel was formed that functioned as a urinary conduit in most cases. Improved large tubular scaffolds may generate alternatives to gastrointestinal tissue for urinary diversion.

Feasibility of noninvasive near-infrared spectroscopy to diagnose detrusor overactivity.

INTRODUCTION: Near-infrared spectroscopy (NIRS) is an optical technology able to detect the hemodynamic changes in biological tissues. Our objective was to determine the feasibility of applying NIRS in the noninvasive diagnosis of detrusor overactivity (DO). PATIENTS AND METHODS: Comparative analysis was performed on 39 involuntary detrusor contractions (IDC) from 23 filling cystometries with simultaneous noninvasive NIRS of the bladder in 14 patients with DO. Motion artifacts were checked for via surface EMG of the abdominal muscles. RESULTS: Thirty-nine IDC were obtained. The median amplitude of rise in detrusor pressure at DO was 48 cm H(2)O (range: 5-219). The median filling volume at DO was 148 ml (range: 9-531). NIRS curves demonstrated apparently significant deviations from baseline in 35 of 39 (90%) DO episodes. All onsets of NIRS deviations occurred within the time period of the IDC with a mean delay of 3 s (range: 0-9). CONCLUSION: NIRS can be a potential tool for the noninvasive diagnosis of DO.

Non-invasive techniques in the diagnosis of bladder storage disorders.

AIMS: To review clinical studies thus have been conducted to develop non-invasive diagnostic tools in the storage phase of the micturition cycle. METHODS: Pub Med and Web of Science searches were carried out. The search covered the published data of non-invasive diagnostic techniques for detrusor overactivity (DO) and/or low compliance bladder in patients with urinary storage symptoms. The patho-physiological and clinical relevance of these methods were addressed. Diagnostic accuracy of these techniques was scrutinized. RESULTS: Eighteen studies were included in the review. Ultrasonography and biomarkers were the most investigated techniques in the diagnosis of storage disorders. Assessment of diagnostic accuracy was possible in four studies. The heterogeneity in data reporting was too high to conduct a meta-analysis. Ultrasonographic parameters and cut-off values have been developed to define DO; such as bladder wall thickness (BWT), detrusor wall thickness and bladder weight. The likelihood ratio of vaginal ultrasonography in measurement of BWT was good. Guidelines are currently developing to standardize the methodologies applied in these techniques. Laboratory biomarkers of DO are gaining more attention recently, but their specificity for DO should be carefully defined. Near infrared spectroscopy (NIRS) is potential non-invasive diagnostic method that is able to detect the DO episodes in real time. However, a solution needs to be found for motion artifacts in this technique. CONCLUSION: Non-invasive diagnostic techniques for storage disorders show limited progress with some limitations. Yet these techniques still cannot replace the standard filling cystometry in standard clinical practice.

Near-infrared spectroscopy: a novel, noninvasive, diagnostic method for detrusor overactivity in patients with overactive bladder symptoms--a preliminary and experimental study.

BACKGROUND: Near-infrared spectroscopy (NIRS) is an optical technology. It detects the hemodynamic changes in tissues via noninvasive measurement of changes in the concentration of tissue chromophores such as oxyhemoglobin (O(2)Hb) and deoxyhemoglobin (HHb). Involuntary bladder contractions may cause changes detectable by NIRS. OBJECTIVE: To address the accuracy and reproducibility of NIRS to detect the hemodynamic effects of detrusor overactivity (DO). DESIGN, SETTING, AND PARTICIPANTS: A prospective cohort study was carried out on 41 patients with overactive bladder symptoms. MEASUREMENTS: Forty-one patients underwent one or more filling cystometries with simultaneous NIRS of the bladder. The separated graphs representing both tests were presented to three urodynamicists on two occasions, 3 wk apart. The graphs showed curves with and without DO episodes with the bladder sensations marked. Thirteen of 47 graphs (28%) with DO and 16 of 58 graphs (28%) without DO were excluded due to motion artifacts. The urodynamicists marked pressure changes suggestive of DO on the cystometry curves. For NIRS curves they marked definite deviations from baseline. The sensitivity and specificity of NIRS for DO were determined. The inter- and intraobserver agreements were determined. RESULTS AND LIMITATIONS: Valid data from 33 of 41 patients (80%) were included in the analysis. The interobserver agreement to trace the effect of DO on NIRS curves was "substantial" (κ(f)>0.6). The sensitivity of the Hb(sum) (O(2)Hb+HHb) curves for DO was 62-97% with a specificity of 62-79% (area under the curve [AUC]: 0.80-0.82; p<0.001). O(2)Hb curves had 79-85% sensitivity and 82-91% specificity for DO (AUC: 0.80-0.85; p<0.001). The sensitivity and specificity of the HHb curves for DO were 71-82% and 77-82%, respectively (AUC: 0.73-0.84; p<0.001). These values represent the performance of NIRS in the data sample that is not contaminated with motion artifacts; they are not representative of a general clinical setting. CONCLUSION: NIRS is a potential noninvasive, reproducible, diagnostic method to detect DO.