Variation between hospitals and reviewers in detection of adverse events identified through medical record review in Korea.

OBJECTIVES: This study utilized the method of medical record review to determine characteristics of adverse events that occurred in the inpatient units of hospitals in Korea as well as the variations in adverse events between institutions. DESIGN: A two-stage retrospective medical record review was conducted. The first stage was a nurse review, where two nurses reviewed medical records of discharged patients to determine if screening criteria had been met. In the second stage, two physicians independently reviewed medical records of patients identified in the first stage, to determine whether an adverse event had occurred. SETTING: Inpatient units of six hospitals. PARTICIPANTS: Medical records of 2 596 patients randomly selected were reviewed in the first stage review. INTERVENTION(S): N/A. MAIN OUTCOME MEASURE(S): Adverse events. RESULTS: A total of 277 patients (10.7%) were confirmed to have had one or more adverse event(s), and a total of 336 adverse events were identified. Physician reviewers agreed about whether an adverse event had occurred for 141 patients (5.4%). The incidence rate of adverse events was at least 1.3% and a maximum of 19.4% for each hospital. Most preventability scores were less than four points (non-preventable), and there were large variations between reviewers and institutions. CONCLUSIONS: Given the level of variation in the identified adverse events, further studies that include more medical institutions in their investigations are needed, and a third-party committee should be involved to address the reliability issues regarding the occurrence and characteristics of the adverse events.

Urinary urgency outcomes after propiverine treatment for an overactive bladder: the 'Propiverine study on overactive bladder including urgency data'.

OBJECTIVE: To investigate the effects of a daily regimen of propiverine 20 mg in patients with an overactive bladder (OAB), focused on improving urgency, as the clinical efficacy of treatment for OAB should be measured in terms of urgency, the cornerstone symptom of OAB. PATIENTS AND METHODS: Eligible patients aged > or = 18 years with symptoms of OAB were enrolled in this multicentre, prospective, parallel, double-blind, placebo-controlled trial. Of 264 patients (mean age 52.2 years), 221 who had efficacy data available from baseline and at least one on-treatment visit with >75% compliance with medication were analysed (142 in the propiverine group and 79 in the placebo group). All patients were randomized to receive a placebo or 20 mg propiverine once daily in a 12-week study. They completed a 3-day voiding diary before visits during the study period, including the severity of urgency associated with every voiding, using the Indevus Urgency Severity Scale and the Urgency Perception Score. The patients' overall self-evaluation of treatment benefits at the end of the study, and safety data, were also collected. RESULTS: The daily urgency episodes reduced significantly from baseline to 12 weeks on propiverine treatment, compared with placebo (-46.0% vs -31.3%, P = 0.005). Secondary endpoints, including sum of urgency severity per 24 h, urgency severity per void, and daytime voiding frequency, were also improved significantly in the propiverine group. Overall, of those patients treated with propiverine, 38.7% rated their treatment as providing 'much benefit', compared with 15.2% of the placebo group (P = 0.025). Adverse events reported by 32 (22.5%) and 10 (12.7%) patients in the propiverine and placebo group were all tolerable. However, this is a short-term study using only one fixed regimen. CONCLUSIONS: Propiverine 20 mg once-daily could be an effective treatment for patients with OAB, by improving urgency.

Efficacy and Safety of X-incision with Inversed Morcellation in Holmium Laser Enucleation of the Prostate: Comparison to Conventional Morcellation.

BACKGROUND: Three-quarters of aged men experience lower urinary tract symptoms with benign prostate hypertrophy (BPH). Transurethral resection of the prostate (TURP) and holmium laser enucleation of the prostate (HoLEP) are standard endosurgical procedures in patients with BPH. Previous studies reported better results in patients undergoing HoLEP than in those undergoing TURP. METHODS: This study compared the efficiency and safety of conventional morcellation and morcellation performed after X-incision during enucleation, a newly added technique in HoLEP. Overall, 174 patients were selected as the final study population. The populations were stratified with respect to resected volumes. A t-test were used to compare the conventional morcellation and X-incision procedure groups. RESULTS: In morcellation times and rates, there were significant differences in stratified resected mass (g) between the groups. The results also showed a decreased incidence of bladder injury as a surgical complication. CONCLUSION: We believe morcellation performed after X-incision procedure during enucleation is efficient and safe for older adults with BPH.

Application of the modified clavien classification system to 402 cases of holmium laser enucleation of the prostate for benign prostatic hyperplasia.

PURPOSE: We attempted to evaluate the perioperative complications of holmium laser enucleation of the prostate (HoLEP) for benign prostatic hyperplasia by using the modified Clavien classification system (MCCS). MATERIALS AND METHODS: Targeting 402 patients who underwent HoLEP for benign prostatic hyperplasia performed by a single surgeon between July 2008 and January 2011, we investigated complications that occurred during and within 1 month after surgery and classified them into grade I to grade V on the basis of the MCCS. If two or more complications occurred in one patient, each complication was graded and counted. RESULTS: The mean age, prostate volume, operation time, hospital stay, and average follow-up period of 402 patients who underwent HoLEP were 68.8 years (range, 52-84 years), 53.2 g (range, 23-228 g), 58.2 minutes (range, 20-230 minutes), 4.5 days (range, 2-7 days), and 9 months (range, 4-27 months), respectively; 78 complications occurred in 71 of the patients (morbidity rate, 17.6%). In MCCS grade I, complications occurred in 54 cases (69.2%); in grade II, complications occurred in 19 cases (24.3%); in grade III, complications occurred in 4 cases (5.1%); and in grade IV, 1 patient required intensive care unit care because of cerebral infarction (1.2%). There were no grade V complications. CONCLUSIONS: The HoLEP-based MCCS complications classification was performed very quickly. However, MCCS, when compared with other measures of endoscopic prostate surgery experiences, including HoLEP, exposed the lack of accuracy in low grade classification and the inability to include late complications.

Analysis of female voiding dysfunction: a prospective, multi-center study.

PURPOSE: Female voiding dysfunction lacks clear definitions or objective data even to this day due to the relatively low prevalence and complex etiologies of voiding dysfunction in women compared to men. The prevalence varies widely from 2.7 to 23 % (Nitti et al. in J Urol 161(5):1535-1540, 1999; Rees et al. in Br J Urol 47(7):853-860, 1975; Groutz et al. in Neurourol Urodyn 19(3):213-220, 2000; Farrar et al. in Br J Urol 47(7):815-822, 1975; Massey and Abrams in Br J Urol 61(1):36-39, 1988; Chassagne et al. in Urology 51(3):408-411, 1998). Diagnostic criteria and management of female voiding dysfunction have not yet been established. We performed a prospective, multi-center study at nine hospitals to investigate the characteristics and prevalence of female voiding dysfunction. MATERIALS AND METHODS: A total of 1,415 women visited urology clinics in nine hospitals from September to December 2005. Among them, 792 patients presented with lower urinary tract symptoms (LUTS). We analyzed their urinary symptoms with an International Prostate Symptom Score (IPSS) and obtained objective data using uroflowmetry, residual urine volume, and urinalysis. The authors hereby define female voiding dysfunction as maximum flow rate (Q max) of 15 ml/s or less, which may be due to either bladder outlet obstruction (BOO) or bladder dysfunction caused by detrusor underactivity. BOO was defined as Q max <15 ml/s with detrusor pressure >20 cmH2O at Q max, and detrusor underactivity was defined as Q max <15 ml/s with detrusor pressure <20 cmH2O at Q max on pressure flow studies. RESULTS: Hundred and two patients (12.8 %) from a total of 792 LUTS patients complained of voiding difficulty. Mean total IPSS score, mean IPSS subscores for voiding and storage symptom was 19.5 ± 7.9, 12.0 ± 5.0, and 8.4 ± 3.4, respectively. Among the seven categories of IPSS, incomplete emptying was the most common symptom followed by weak stream. Eighty-nine patients (87.2 %) from a total of 102 voiding dysfunction patients showed BOO, while 13 patients (12.8 %) showed detrusor underactivity. Concomitant diseases observed with voiding dysfunctions were overactive bladder (32 patients), stress urinary incontinence (25), detrusor underactivity (13), previous stress urinary incontinence surgery (12), pelvic organ prolapse (4), and anatomical obstruction (3 patients). CONCLUSION: The prevalence of voiding difficulty in female urology patients who visit urologic office clinic was 7.2 and 12.8 % in female LUTS patients. Voiding symptoms were more common than storage symptoms, while functional BOO was more prevalent than detrusor underactivity in female voiding difficulty patients. We may expect alpha blockers to be an effective treatment option in female voiding difficulty due to functional BOO.

Holmium laser enucleation of the prostate: modified morcellation technique and results.

PURPOSE: We developed an inverse technique for tissue morcellation by modifying the conventional upward technique and then examined its safety and efficiency. MATERIALS AND METHODS: From July 2008 to December 2010, a total of 389 consecutive patients treated with holmium laser enucleation of the prostate (HoLEP) were enrolled in this study. For tissue morcellation, we used an upward technique for an initial series of 84 patients and an inverse technique for a consecutive series of 305 patients. We compared efficiency and safety between the inverse technique and the upward technique. RESULTS: There were no significant differences in mean age or prostate volume between the two groups. The mean morcellation efficiency was higher in the inverse technique group. The incidence of severe bladder injury was significantly higher in the upward technique group. Regarding the site of bladder injury, 7 and 4 cases of bladder injury occurred in the bladder dome and posterior wall, respectively, in the upward technique group. In the inverse technique group, however, the site of bladder injury was limited to the trigone. We divided our clinical series of patients into the upward technique group and three inverse technique groups on the basis of the timing. The mean morcellation efficiency was significantly higher in all three inverse technique groups than in the upward technique group. However, there was no significant difference in mean morcellation efficiency between the three inverse technique groups. CONCLUSIONS: In conclusion, the inverse technique might be a more effective, safer, and more excellent method of morcellation than the conventional upward technique.

Are there risk factors for persistent urge urinary incontinence after the transobturator tape (TOT) procedure in mixed urinary incontinence?

PURPOSE: We wanted to identify factors predicting persistent urge urinary incontinence (UUI) after the transobturator tape (TOT) procedure in patients with mixed urinary incontinence (MUI). MATERIALS AND METHODS: Of 293 patients who underwent a TOT procedure from May 2007 to August 2010, 175 MUI patients had at least one 6-month follow-up visit. Preoperative evaluations including history taking, physical examination, urinalysis, urine culture, uroflowmetry, postvoid residual (PVR), urodynamic studies (UDS), and symptom questionnaire were performed. After the operation, surgical outcome and patient satisfaction were assessed by symptom questionnaire, uroflowmetry, PVR, and stress test. Statistical analysis was carried out to determine the possible factors influencing persistent UUI after the TOT procedure. RESULTS: Of 175 patients with MUI, 51 (29.1%) had persistent UUI after the TOT procedure. In a univariate analysis, age (p=0.012) and previous anticholinergic use (p=0.040) were found to be associated with persistent UUI. However, only age (adjusted odds ratio, 3.317; 95% confidence interval, 1.015-12.060; p=0.036) was an independent risk factor in the multivariate analysis. CONCLUSIONS: Our findings suggested that women who are older than 65 years may have an increased likelihood of persistent UUI after a TOT procedure. Clinicians should consider the possibility of persistent postoperative UUI in elderly women with mixed incontinence.

Holmium laser enucleation of the prostate for benign prostatic hyperplasia: effectiveness, safety, and overcoming of the learning curve.

PURPOSE: To examine the efficacy and safety of holmium laser enucleation of the prostate (HoLEP) for the surgical treatment of benign prostatic hyperplasia and to estimate the time to overcome the learning curve. MATERIALS AND METHODS: From May 2008 to October 2009, 164 consecutive patients treated with HoLEP were enrolled in this study. International Prostate Symptom Score (IPSS), peak urinary flow rate (Qmax), and postvoid residual urine (PVR) were documented preoperatively and at 6 weeks and 3, 6, 12, and 18 months postoperatively. The 164 study subjects were divided into 3 groups (group 1 the first 50 patients treated, group 2 the second 50, and group 3 the third 64), and perioperative data and complications were analyzed in these groups to determine the learning curve. In addition, the inverse and upward techniques were compared in terms of the effects and the stability of morcellation. RESULTS: The mean patient age was 69 years, and the average operation time was 62 minutes (range, 20-208 minutes). Mean prostate volume was 54.2 ml and mean resected tissue weight was 18.6 g. Postoperatively, IPSS and PVR decreased and Qmax increased significantly. Postoperative complications were transient incontinence (8.5%), urinary retention (4.3%), hematuria (3.0%), urinary tract infection (1.2%), and urethral stricture (0.6%), and intraoperative complications were minor capsular perforation (4%) and bladder injury (8%). CONCLUSIONS: HoLEP was found to be effective and safe regardless of prostate size. We recommend that a systematic educational program be established to reduce the learning curve.

Acute Urinary Retention due to Aseptic Meningitis: Meningitis-Retention Syndrome.

Acute urinary retention in aseptic meningitis is rarely encountered, and the diagnosis of aseptic meningitis may be less than straightforward, because its symptoms and neurological signs are occasionally mild or absent. We report a case in which acute urinary retention provided an appropriate indication for the diagnosis of aseptic meningitis as the cause of an undiagnosed fever.

Differential alternative splicing of human transglutaminase 4 in benign prostate hyperplasia and prostate cancer.

Transglutaminase 4 is a member of enzyme family that catalyzes calcium-dependent posttranslational modification of proteins. Although transglutaminase 4 has been shown to have prostate-restricted expression pattern, little is known about the biological function of transglutaminase 4 in human. To gain insight into its role in prostate, we analyzed the expression status of human transglutaminase 4 in benign prostate hyperplasia (BPH) and prostate cancer (PCa). Unexpectedly, RT-PCR and nucleotide sequence analysis showed four alternative splicing variants of transglutaminase 4: transglutaminase 4-L, -M (-M1 and -M2) and -S. The difference between transglutaminase 4-M1 and -M2 is attributed to splicing sites, but not nucleotide size. The deduced amino acid sequences showed that transglutaminase 4-L, -M1 and -M2 have correct open reading frames, whereas transglutaminase 4-S has a truncated reading frame. RT-PCR analysis of clinical samples revealed that transglutaminase 4-M and -S were detected in all tested prostate tissue (80 BPH and 48 PCa). Interestingly, transglutaminase 4-L was found in 56% of BPH (45 out of 80) and only in 15% of PCa (7 out of 48). However, transglutaminase 4-L expression did not correlate with serum prostate-specific antigen (PSA) level, prostate volumes or PSA densities. These results will provide a clue to future investigation aiming at delineating physiological and pathological roles of human transglutaminase 4.

Comparison of anxiety between patients with mixed incontinence and those with stress urinary incontinence.

OBJECTIVE: Some authors insist that patients with mixed incontinence (MI) suffer from more anxiety than those with pure stress urinary incontinence (SUI) due to the added emotional stress caused by various symptoms of an overactive bladder. We objectively evaluated and compared the degree of anxiety between the two groups. MATERIAL AND METHODS: Among 172 patients who presented with urinary incontinence, 118 showed MI and 54 SUI. They were surveyed regarding their anxiety using the Beck Anxiety Inventory (BAI) questionnaire. RESULTS: The mean BAI score was 12.0+/-8.8 in the MI group and 7.8+/-5.2 in the SUI group and this difference was statistically significant (p<0.05). CONCLUSIONS: This study provides objective evidence that patients with MI have a higher degree of anxiety than those with pure SUI. Therefore, we suggest that doctors should pay more attention to anxiety symptoms when caring for patients with MI.

Combination treatment with propiverine hydrochloride plus doxazosin controlled release gastrointestinal therapeutic system formulation for overactive bladder and coexisting benign prostatic obstruction: a prospective, randomized, controlled multicenter study.

PURPOSE: We evaluated the efficacy and safety of a therapeutic modality involving propiverine combined with doxazosin in patients with overactive bladder (OAB) and benign prostatic obstruction. MATERIALS AND METHODS: Men 50 years or older with OAB symptoms and urodynamically proven bladder outlet obstruction (Abrams-Griffith score greater than 20) were randomized (1:2) into 2 groups, namely group 1-doxazosin controlled release gastrointestinal therapeutic system formulation (4 mg once daily) only and group 2-propiverine hydrochloride (20 mg once daily) plus doxazosin controlled release gastrointestinal therapeutic system formulation for an 8-week treatment regimen. RESULTS: A total of 211 men, including 69 in group 1 and 142 in group 2, were treated and 198 (93.8%) completed the 8 weeks of treatment. Significant improvements were noted in each group after treatment in urinary frequency, maximum flow rate, average micturition volume and International Prostate Symptom Score. Compared with group 1 improvement rates with regard to urinary frequency (23.5% vs 14.3%, p = 0.004), average micturition volume (32.3% vs 19.2%, p = 0.004), and storage (41.3% vs 32.6%, p = 0.029) and urgency (p = 0.019) International Prostate Symptom Score symptoms were more significant in group 2. Post-void residual urine was found to be significantly increased only in group 2 but this was not accompanied by urinary retention. Patient satisfaction rates were found to be significantly higher in group 2 than in group 1 (p = 0.002). Overall adverse event rates were higher in group 2 (p = 0.002), although discontinuation rates and discontinuation rates due to adverse events were not different between the 2 groups. CONCLUSIONS: This study reveals that combination therapy consisting of alpha1-adrenoceptor antagonists with antimuscarinics represents an effective and relatively safe treatment modality in select patients with OAB coexisting with benign prostatic obstruction.