Use Of Clean Intermittent Catheterization Research Articles

Urinary tract infections and intermittent catheterization among patients with spinal cord injury in Chinese community

We conducted a cross-sectional study using an online questionnaire to investigate the current status of urinary tract infections (UTIs) and the use of clean intermittent catheterization (CIC) in Chinese community-based SCI patients and to explore the risk factors for UTIs in patients using CIC. Our findings suggest that the prevalence of UTIS is higher in Chinese community-based SCI patients compared with patients in medically developed countries. In addition, we found that CIC had the lower incidence of UTIs than urinary indwelling catheter (UIC) and suprapubic catheter (SPC), and that SCI patients with CIC had low rates of use and poor compliance. Further analysis indicated that most of the risk factors for UTIs in CIC patients were associated with irregular use of CIC. Therefore, we call for not only the need to provide stronger caregiver support and financial assistance to improve CIC adherence in Chinese community SCI patients, but also the establishment of a database of Chinese SCI patients in order to enhance the management of bladder emptying methods and further standardize the CIC operation in such patients, thus reducing the risk of UTIs in Chinese community SCI patients.

Importance of Regular Examination and Follow-up in Pediatric Patients with Neurogenic Bladder: 24-Month Follow-up Study Using a Japanese Health Insurance Database.

Data on the long-term management of neurogenic bladder (NGB) are scarce. We evaluated the current status of NGB management in Japanese children over 24-month follow-up using the JMDC database. In this descriptive, observational, retrospective cohort study, patients (≤ 17years) with NGB were included. Patient characteristics and their management status were investigated. A multivariate analysis evaluating the potential risk factors for the development of urinary tract infection (UTI) was performed. The diagnosis of spina bifida, demographics, baseline comorbidities, and early use of clean intermittent catheterization (CIC) and/or overactive bladder (OAB) drugs were used as independent variables. Of 883 eligible children, 39.3% had spina bifida. Over 12/24-month post-index periods, renal urinary tract ultrasound and urinalysis were performed at least once in > 35%/> 45% patients, respectively, while specific tests (urodynamics, cystourethrography, scintigraphy) were performed in substantially fewer (< 11%/< 13%) patients. Over 24months, 21.5% patients used OAB medications (mostly anticholinergics) and 10.8% underwent CIC, alone or with medications; 1.2% patients underwent surgery. Lower UTI (23.3%), urinary incontinence (9.7%), and hydronephrosis (7.0%) were the most common incident complications. Multivariate analysis evaluating risk factors for UTI showed significantly higher odds ratios with point estimates of ≥ 2 for CIC (5.70), presence of spina bifida (2.86), and constipation (2.07). Overall, urodynamic assessments were inadequately performed. Patients with use of CIC and/or having spina bifida and constipation had a higher risk of UTI, suggesting the need for careful follow-up. More guideline-compliant and diligent patient management is necessary in Japanese children with NGB.

A Cost Comparison of Holmium Laser Enucleation of the Prostate with and without Moses™.

Holmium laser enucleation of the prostate (HoLEP) is a size-independent treatment option for the treatment of benign prostatic hyperplasia. HoLEP has been shown to have excellent improvements in prostate symptom scores and maximum flow rates that have been durable for 2 decades. However, the steep learning curve associated with HoLEP has prevented its widespread adoption. New advancements in lasers, specifically the Moses™ pulse-modulation technology, have resulted in improvements in hemostasis and achieving same-day discharges and catheter removals. We aimed to perform a cost-comparison to analyze if Moses-augmented HoLEP (m-HoLEP) resulted in cost-savings. A retrospective review was performed of a single expert surgeon's experience from May 2018 to November 2020, comparing m-HoLEP with HoLEP. Perioperative and postoperative variables were abstracted from the medical record. Univariate and multivariate analyses were performed using SAS® 9.4. Two-sided significance was set at p <0.05. A total of 312 men underwent HoLEP during the study period (192 in m-HoLEP group and 120 in HoLEP group). The m-HoLEP group had more same-day discharges (p <0.001) and emergency department visits (6.3% vs 1.7%, p=0.0071). m-HoLEP resulted in hospital cost savings of $840 for the initial surgical episode (p=0.0297). When factoring in emergency department visits/readmissions, the cost savings decreased to $747 per case (p=0.0574). m-HoLEP was associated with same-day discharge and hospital cost savings of $840 for the initial surgical episode. Further study in other institutions with surgeons of varying experience levels will need to be performed to see if these findings can be replicated.

Современные аспекты консервативной терапии недержания мочи и сохранение функции почек у детей со спинальным дизрафизмом (обзор литературы)

Врожденные дефекты невральной трубки являются одними из самых частых врожденных пороков развития, при которых поражаются несколько органов и систем. В связи с совершенствованием хирургического лечения и коррекции гидроцефалии выживание этих пациентов улучшилось. В настоящее время важной проблемой, влияющей на качество жизни и ее продолжительность, является развитие нейрогенного мочевого пузыря у этих детей. Нейрогенная дисфункция мочевого пузыря вызывает необратимые патологические изменения верхних и нижних мочевыводящих путей. Вторичное поражение стенки мочевого пузыря, развитие пузырно-мочеточникового рефлюкса, гидронефроза, фиброза почек являются основными звеньями патологического процесса, который приводит к почечной недостаточности и смерти. Поэтому раннее активное наблюдение и лечение этих детей важны для сохранения функции почек. Активное применение чистой периодической катетеризации и антихолинергических препаратов при необходимости являются основными консервативными методами урологического ведения детей со spina bifida. Поиск литературы осуществлялся с помощью базы данных PubMed.

PD46-04 TIME-RELATED CHANGES IN PATIENT-REPORTED BLADDER SYMPTOMS AND SATISFACTION AFTER SPINAL CORD INJURY

You have accessJournal of UrologyHealth Services Research: Practice Patterns, Quality of Life and Shared Decision Making IV (PD46)1 Sep 2021PD46-04 TIME-RELATED CHANGES IN PATIENT-REPORTED BLADDER SYMPTOMS AND SATISFACTION AFTER SPINAL CORD INJURY Odinachi Moghalu, John Stoffel, Sean Elliott, Blayne Welk, Sara Lenherr, Chong Zhang, Angela Presson, and Jeremy Myers Odinachi MoghaluOdinachi Moghalu More articles by this author , John StoffelJohn Stoffel More articles by this author , Sean ElliottSean Elliott More articles by this author , Blayne WelkBlayne Welk More articles by this author , Sara LenherrSara Lenherr More articles by this author , Chong ZhangChong Zhang More articles by this author , Angela PressonAngela Presson More articles by this author , and Jeremy MyersJeremy Myers More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002060.04AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Neurogenic lower urinary tract dysfunction is a significant source of concern and morbidity to individuals with spinal cord injury (SCI). Increased time from initial SCI is associated with improvements in bladder symptoms and satisfaction, despite a migration to bladder management strategies with higher morbidity such as indwelling catheters (IDC). We sought to better characterize the relationship between time from injury, bladder symptoms and satisfaction. METHODS: This is a cross-sectional analysis of time-related changes in patient reported bladder symptoms and satisfaction using data from the Neurogenic Bladder Research Group Spinal Cord Injury Registry. Study outcomes included: Neurogenic Bladder Symptom Score (NBSS-total) and its overall quality of life (QoL) question (NBSS-Satisfaction). Multivariable regression was performed to assess associations between time from injury and outcomes, adjusting for: demographics, injury characteristics, bladder management, and psychosocial aspects of health related QoL. Time from injury was categorized as 1-5 (ref.), 6-10, 11-15, 16-20, and >20 yrs. RESULTS: Of 1420 participants, median age at injury was 25.9 yrs. (IQR 19.7–38.8) and median time from injury was 11.6 yrs. (IQR 5.7–22.9). Primary bladder management changed with time from injury. There was a decline in use of clean intermittent catheterization (CIC) (55% 1-5 yrs. vs. 45% >20 yrs., p<0.001), and voiding (21% 1-5 yrs. vs. 17% >20 yrs., p<0.001) with increasing time from injury. Meanwhile, management with IDC (16% 1-5 yrs. vs. 21% >20 yrs.) and surgery (8% 1-5 yrs. vs 18% >20 yrs.) increased as time from injury increased (Figure 1). On multivariable analysis, increased time from injury was associated with less bladder symptoms (lower scores) at >20 yrs. from injury (NBSS-total -3.33, p<0.001) and better satisfaction in participants >10 yrs. from injury (NBSS-satisfaction 11-15 yrs. -0.36, 16-20 yrs. -0.59, >20 yrs. -0.86, p<0.001). CONCLUSIONS: Even in a contemporary population of SCI patients, there is a migration away from CIC, and an increase in IDC usage with time from injury. Despite this, there is a significant decrease in urinary symptoms, and improved QoL, even after adjusting for demographics, injury characteristics, bladder management, and psychosocial aspects of health related QoL. Source of Funding: This work was partially supported through a Patient-Centered Outcomes Research Institute (PCORI) Award (CER14092138). This investigation was supported by the University of Utah Study Design and Biostatistics Center, with funding in part from the National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health, through Grant 5UL1TR001067-05 (formerly 8UL1TR000105 and UL1RR025764) © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e749-e750 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Odinachi Moghalu More articles by this author John Stoffel More articles by this author Sean Elliott More articles by this author Blayne Welk More articles by this author Sara Lenherr More articles by this author Chong Zhang More articles by this author Angela Presson More articles by this author Jeremy Myers More articles by this author Expand All Advertisement Loading ...

Incidence of Urinary Tract Infections in Newborns with Spina Bifida-Is Antibiotic Prophylaxis Necessary?

Urinary tract infections commonly occur in patients with spina bifida and pose a risk of renal scarring. Routine antibiotic prophylaxis has been utilized in newborns with spina bifida to prevent urinary tract infections. We hypothesized that prophylaxis can safely be withheld in newborns with spina bifida until clinical assessment allows for risk stratification. Newborns with myelomeningocele at 9 institutions were prospectively enrolled in the UMPIRE study and managed by a standardized protocol with a strict definition of urinary tract infection. Patient data were collected regarding details of reported urinary tract infection, baseline renal ultrasound findings, vesicoureteral reflux, use of clean intermittent catheterization and circumcision status in boys. Risk ratios and corresponding 95% confidence intervals were calculated using log-binomial models. From February 2015 through August 2019 data were available on 299 newborns (50.5% male). During the first 4 months of life, 48 newborns (16.1%) were treated for urinary tract infection with 23 (7.7%) having positive cultures; however, only 12 (4.0%) met the strict definition of urinary tract infection. Infants with grade 3-4 hydronephrosis had an increased risk of urinary tract infection compared to infants with no hydronephrosis (RR=10.1; 95% CI=2.8, 36.3). Infants on clean intermittent catheterization also had an increased risk of urinary tract infection (RR=3.3; 95% CI=1.0, 10.5). The incidence of a culture positive, symptomatic urinary tract infection among newborns with spina bifida in the first 4 months of life was low. Patients with high grades of hydronephrosis or those on clean intermittent catheterization had a significantly greater incidence of urinary tract infection. Our findings suggest that routine antibiotic prophylaxis may not be necessary for most newborns with spina bifida.

Dificuldades de pacientes e cuidadores na realização do cateterismo intermitente limpo: revisão de escopo

Objetivo: Identificar as principais dificuldades relatadas pelos pacientes e cuidadores no uso do cateterismo intermitente limpo descritas na literatura científica. Métodos: Revisão de escopo com estudos publicados em português, inglês ou espanhol, sem limite de data, em base de dados eletrônicas e bibliotecas digitais, utilizando descritores e palavras-chave. Resultados: Foram identificados 790 estudos, sendo incluídos 34 estudos publicados entre 1984 e 2019. As principais dificuldades relatadas na realização do cateterismo intermitente limpo foram referentes a inserção do cateter, dor, desconforto, trauma uretral, banheiros públicos com instalações inadequadas, dificuldades físicas e falta de acesso aos insumos necessários. Conclusão: Os estudos analisados evidenciam as dificuldades que os pacientes usuários do cateterismo intermitente limpo e seus cuidadores enfrentam no dia a dia, que estão relacionadas à fatores intrínsecos e extrínsecos, institucionais e governamentais e podem diminuir a satisfação e a aderência aos programas de reabilitação vesical, com impacto na qualidade de vida dos pacientes e seus cuidadores. Portanto destaca-se a necessidade de educação em saúde para o adequado ensino da realização do cateterismo intermitente limpo, enfatizando a importância do papel do enfermeiro nesse processo.

Difficulties of patients and caregivers in performing clean intermittent catheterization: scoping review

Objective: To identify the main difficulties reported by patients and caregivers in the use of clean intermittent catheterization described in the scientific literature. Methods: Scoping review with studies published in Portuguese, English or Spanish, without date limit, in electronic databases and digital libraries, using descriptors and keywords. Results: 790 studies were identified, including 34 studies published between 1984 and 2019. The main difficulties reported in performing clean intermittent catheterization were related to catheter insertion, pain, discomfort, urethral trauma, public bathrooms with inadequate facilities, physical difficulties and lack of access to necessary inputs. Conclusion: The studies analyzed show the difficulties that patients who use clean intermittent catheterization and their caregivers face on a daily basis, which are related to intrinsic and extrinsic, institutional and governmental factors and can decrease satisfaction and adherence to rehabilitation programs bladder, with an impact on the quality of life of patients and their caregivers. Therefore, it highlights the need for health education for the proper teaching of performing clean intermittent catheterization, emphasizing the importance of the nurse’s role in this process.

Estimation of renal scarring in children with lower urinary tract dysfunction by utilizing resampling technique and machine learning algorithms

Aim: Classical database methods may be inadequate for large data sets accumulating continuously. Machine learning (ML), one of the main subsets of artificial intelligence, may solve this problem and find the best solution for future problems by gaining experience from the present data in medical studies. A method that may show the correlation between clinical findings and renal scarring (RS) with high accuracy in patients with lower urinary tract dysfunction (LUTD) is needed. In this study, the aim is to establish a model for the prediction of RS in children with LUTD by using ML. Methods: Patients older than three years of age (n=114) who needed urodynamic study were included in the study. There were 47 variables in the data set. Variables such as symptomatic urinary tract infection, vesicoureteral reflux, bladder trabeculation, bladder wall thickness, abnormal DMSA scintigraphy, and the use of clean intermittent catheterization were recorded. Several ML techniques (MLT) were applied to estimate RS. Results: As a result of the comparisons, the highest accuracy rate according to the confusion matrix was obtained by the Extreme Gradient Boosting (XGB) algorithm (91.30%). In the balanced (SMOTE) data set, the highest accuracy rate was obtained by the Artificial Neural Network (ANN) algorithm (90.63%). According to the Receiver Operating Characteristic (ROC), the highest success rate was obtained by the ANN algorithm in the balanced (SMOTE) data set (90.78%). Conclusion: High accuracy rates obtained by MLT may suggest that MLT might provide a faster and accurate evaluation process in the estimation of RS in patients with LUTD.

Urinary function following radical cystectomy and orthotopic neobladder urinary reconstruction.

An orthotopic neobladder urinary diversion aims to minimize the physical and psychological effects of radical cystectomy through avoidance of a stoma and maintenance of urethral voiding. Neobladder function reported in the literature ranges widely due to differences in patient selection and method of assessment. The objective of the study was to characterize functional outcomes of consecutive patients treated at a tertiary care hospital. A historical cohort of patients who underwent radical cystectomy with a neobladder diversion performed at The Ottawa Hospital between January 2006 and December 2014 were reviewed. Outcomes of interest were urinary continence, use of clean intermittent catheterization (CIC), post-void residual volume, and uroflowmetry at three, six, and 12 months following cystectomy. During the study period, 158 neobladder diversions were performed. The mean age of patients was 63.1 years (standard deviation [SD] 8.1), and 81.7% were male. Significant daytime incontinence (>1 pad) three months following surgery was common (65%), but decreased to 8.6% by 12 months. Nighttime incontinence was also common at three months (54%) and improved at 12 months (20%). While no appreciable differences between men and women were observed for continence, more women performed CIC at 12 months post-surgery (59% of women; 9% of men; relative risk [RR] 0.15; 95% confidence interval [CI] 0.07-0.30). Among patients who did not catheterize, uroflowmetry and post-void residual volume parameters were stable between three and 12 months postoperative. Daytime and nighttime incontinence is common in neobladder patients following surgery, but improves considerably with time. Correspondingly, many female neobladder patients at our institution use CIC.

Low‐fidelity simulation for patients and caregivers in the use of lubricants in clean intermittent catheterization

ABSTRACTCan low‐fidelity simulation improve the knowledge and skills of patients undergoing clean intermittent catheterization (CIC) and their caregivers to prevent complications? Patients undergoing CIC are exposed to risks, such as urethral trauma and urinary tract infections. Objective of this paper was to assess the implications of low‐fidelity simulations for patients and caregivers in the use of clean intermittent catheterization in the event of urethral trauma and for its prevention. A quasi‐experimental study carried out between November 2015 and February 2016 in the rehabilitation centre of a university hospital, with patients undergoing CIC and/or their caregivers. Following the ethical precepts, data collection was performed during nursing consultations by means of interviews, structured observation, and a knowledge test applied before and after the low‐fidelity simulation. Patients undergoing CIC and/or caregivers underwent a low‐fidelity simulation of CIC with urethral trauma and then they were guided by the researchers following the protocol established in the department. They then underwent another simulation with the same characteristics. Fifty‐five patients participated in this study, in which most of them (33 [60·0%]) were men, with an average age of 31·7 years. Bleeding was reported by 19 patients (34·5%), of which 18 were men. The performance of low‐fidelity simulations proved to be effective for patients or caregivers in adverse situations, such as bleeding, resistance to the introduction of the catheter and negative urine drainage. The performance of low‐fidelity simulation is easily accessible and shows efficiency when used in teaching‐learning processes of health education and development of skills and competencies.

Health-related quality of life in non-paraplegic (ambulatory) children with myelomeningocele.

Evaluation of the effects of ventriculoperitoenal shunt and incontinence presence on health-related quality of life of ambulatory myelomeningocele patients. The study group included 35 myelomeningocele patients, between 5 and 18years old (mean age=9.6), who were neonatally operated. All patients were ambulatory. The Child Edition of the Child Health and Illness Profile (CHIP-CE) used to evaluate the patient group. Seventeen patients were using clean intermittent catheterization and nine patients had ventriculoperitoneal shunt. The CHIP-CE has five domains, and in satisfaction, resilience and achievement domains, significant lower scores were obtained from our study group. In terms of clean intermittent catheterization use, we got significantly lower scores on satisfaction, resilience and achievement domains (p<0.05). According to the presence of ventriculoperitoneal shunt, we found lower scores in satisfaction, resilience, risk avoidance and achievement domains but the differences were not significant (p>0.05). No significant difference was spotted according to gender and age. Continence problems have important effects on life quality of myelomeningocele patients. Incontinency should always be considered as a major variable in health-related quality of life evaluations.

Risk Factors for Infection Following Third-line Therapy for Overactive Bladder

Sacral neuromodulation and intradetrusor onabotulinum toxinA are FDA approved treatment options for overactive bladder (OAB) and considered third-line therapies according to the American Urological Association (AUA) guidelines. Although each therapy has unique associated risks, infection is a common adverse event shared by both. The purpose of this review is to identify risk factors for infection in third-line therapies for OAB. A PUBMED® and MEDLINE® search was performed for scientific publications on “sacral neuromodulation,” “sacral nerve stimulation,” “onabotulinum toxinA,” “Botox,” “percutaneous tibial nerve stimulation (PTNS)” and “infection,” and “overactive bladder (OAB)” between the years 2003 and 2016. Articles were screened for reports on adverse events and were included in the review if they contained information on infection. We also limited this review to idiopathic OAB in adults. A total of 127 articles were identified (61 in the onabotulinum toxinA and 64 in the sacral neuromodulation (SNM) groups, respectively, and two containing combined data). No articles referencing PTNS and infection were identified; thus, PTNS is not reviewed in this manuscript. Twenty-nine articles met criteria and served as the source information for this article. The primary infection associated with sacral neuromodulation is device-related and ranges between 1.7 and 7.8% in patients implanted for OAB. The most common infection in the onabotulinum toxinA group is a urinary tract infection, with rates ranging from 9.5 to 44%, with the vast majority classified as uncomplicated. Potential risk factors for surgical site infection associated with SNM include patients who are immunocompromised, those with diabetes, or those with a higher BMI. Potential risk factors for urinary tract infection (UTI) associated with onabotulinum toxinA include active medication vs. placebo, urinary retention, and the use of clean intermittent catheterization. Onabotulinum toxinA and SNM are safe and effective third-line therapies for refractory OAB. Onabotulinum toxinA injection is associated with UTIs, and risk factors appear to be the use of active drug vs. placebo, urinary retention, and use of clean intermittent catheterization. In contrast, SNM is associated primarily with surgical site infection. Risk factors identified include diabetes, higher BMI, or immunocompromised status.

Evaluation and Management of Failed Bladder Reconstructions

Bladder reconstructions are commonly performed in patients with neurogenic bladders with a high rate of complications. We seek to help guide the evaluation and management of these complications by reviewing the available data. Augmentation cystoplasty and concomitant procedures such as continent catheterizable channels, bladder neck closure, and bladder neck sling can provide long-term solutions for patients with poorly compliant, high-pressure bladders or refractory detrusor overactivity. While these techniques improve symptoms and protect against upper tract deterioration, patients are exposed to new risks including bladder perforation, increased malignancy rates, urolithiasis, surgical failures, and persistent symptoms. The overall rate of reoperation is high. Evaluation with urodynamics and endoscopy, when indicated, remain critical tools to protect this patient population. Use of clean intermittent catheterization has helped popularize bladder reconstructive surgery, but a strict regimen is required to minimize postoperative risks in the long term. Additionally, various surgical techniques can be utilized to manage complications after bladder reconstruction, and concurrent use of anticholinergics and onabotulinum toxin injections can further mitigate these reconstructive failures. Bladder reconstruction can provide excellent long-term solutions, but patients are at a high risk of long-term complications. Appropriate patient counseling, close follow-up, and timely evaluation are crucial in managing the long-term complications of bladder reconstruction surgery.

MP38-01 LONG-TERM EFFICACY AND SAFETY OF REPEAT ONABOTULINUMTOXINA TREATMENT IN OVERACTIVE BLADDER SYNDROME AND URINARY INCONTINENCE: THIRD INTERIM ANALYSIS, MEDIAN 2.4 YEAR FOLLOW-UP

You have accessJournal of UrologyUrodynamics/Incontinence/Female Urology: Incontinence Therapy II1 Apr 2014MP38-01 LONG-TERM EFFICACY AND SAFETY OF REPEAT ONABOTULINUMTOXINA TREATMENT IN OVERACTIVE BLADDER SYNDROME AND URINARY INCONTINENCE: THIRD INTERIM ANALYSIS, MEDIAN 2.4 YEAR FOLLOW-UP Victor Nitti, Christopher Chapple, David Sussman, Sidney Radomski, Peter Sand, Steven Guard, Christopher Nardo, Jihao Zhou, and Karl-Dietrich Sievert Victor NittiVictor Nitti More articles by this author , Christopher ChappleChristopher Chapple More articles by this author , David SussmanDavid Sussman More articles by this author , Sidney RadomskiSidney Radomski More articles by this author , Peter SandPeter Sand More articles by this author , Steven GuardSteven Guard More articles by this author , Christopher NardoChristopher Nardo More articles by this author , Jihao ZhouJihao Zhou More articles by this author , and Karl-Dietrich SievertKarl-Dietrich Sievert More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2014.02.1258AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES OnabotulinumtoxinA (onabotA) was shown to significantly improve urinary incontinence (UI) and quality of life (QOL) in patients (pts) with overactive bladder (OAB) syndrome and UI who were inadequately managed with an anticholinergic (ACH) in 2 large placebo-controlled, multicenter, phase 3 trials. Less is known about the long-term efficacy/safety of onabotA for OAB. Here we present this third, pre-specified interim analysis of a large, multicenter extension study of the long-term efficacy/safety of onabotA for OAB. METHODS Pts who completed the phase 3 studies could enter a 3 year (y) extension study to receive multiple intra-detrusor onabotA 100U injections. Data integrated across the phase 3 and extension studies were analyzed by onabotA treatment (tx) cycle (up to 5). Assessments included change from study baseline (BL) at week (wk) 12 in OAB symptoms (including co-primary endpoint of UI episodes), proportion of pts with a positive tx response (greatly improved or improved) on the Tx Benefit Scale (TBS; co-primary endpoint), health-related quality of life (HRQOL), duration of effect, adverse events (AEs), and use of clean intermittent catheterization (CIC). RESULTS A total of 829 pts entered the extension study; 544 pts were followed up for ≥2 y. As of 6/13, median follow-up was 126 wk (2.4 y). Discontinuation rates due to AEs/lack of efficacy were low (4.5%/4.9%). At BL, pts reported a mean of 5.55 UI episodes/day. Reductions in UI episodes/day were consistently observed at wk 12 following repeat onabotA 100U tx: reductions were -3.26, -3.70, -3.87, -3.20, and -3.22 (cycles 1-5, respectively). Other OAB symptoms were also consistently reduced over repeated onabotA tx, and improvements in HRQOL consistently exceeded clinically relevant minimally important differences. High proportions of onabotA-treated pts continued to report positive TBS responses with repeat onabotA (74.0, 80.9, 80.4, 79.4, and 86.1% in cycles 1-5). Median duration of effect was 24.0, 31.6, 27.9, 24.3, and 23.9 wks (cycles 1- 5). Urinary tract infection was the most common AE in each tx cycle (27.5, 26.5, 27.4, 19.9, and 18.2%), and no change in AE profile over time was observed. CIC rates were 4.6, 4.0, 4.3, 4.6, and 2.9% (cycles 1-5). CONCLUSIONS Continued follow-up in this long-term study revealed sustained improvements in OAB symptoms, pt perception of improvement in their condition, and HRQOL, with no new safety signals observed with repeated onabotA 100U tx in OAB pts with UI inadequately managed with an ACH. © 2014FiguresReferencesRelatedDetails Volume 191Issue 4SApril 2014Page: e400-e401 Advertisement Copyright & Permissions© 2014MetricsAuthor Information Victor Nitti More articles by this author Christopher Chapple More articles by this author David Sussman More articles by this author Sidney Radomski More articles by this author Peter Sand More articles by this author Steven Guard More articles by this author Christopher Nardo More articles by this author Jihao Zhou More articles by this author Karl-Dietrich Sievert More articles by this author Expand All Advertisement Advertisement PDF DownloadLoading ...

MP76-05 REDUCTION IN URINARY INCONTINENCE AND IMPROVEMENT IN QUALITY OF LIFE WITH ONABOTULINUMTOXINA IN OVERACTIVE BLADDER PATIENTS IS UNAFFECTED BY THE USE OF CLEAN INTERMITTENT CATHETERIZATION OR THE PRESENCE OF URINARY TRACT INFECTION

You have accessJournal of UrologyUrodynamics/Incontinence/Female Urology: Non-neurogenic Voiding Dysfunction1 Apr 2014MP76-05 REDUCTION IN URINARY INCONTINENCE AND IMPROVEMENT IN QUALITY OF LIFE WITH ONABOTULINUMTOXINA IN OVERACTIVE BLADDER PATIENTS IS UNAFFECTED BY THE USE OF CLEAN INTERMITTENT CATHETERIZATION OR THE PRESENCE OF URINARY TRACT INFECTION David Sussman, Jennifer Gruenenfelder, Heinrich Schulte-Baukloh, Steven Guard, Yan Zheng, and Karel Everaert David SussmanDavid Sussman More articles by this author , Jennifer GruenenfelderJennifer Gruenenfelder More articles by this author , Heinrich Schulte-BauklohHeinrich Schulte-Baukloh More articles by this author , Steven GuardSteven Guard More articles by this author , Yan ZhengYan Zheng More articles by this author , and Karel EveraertKarel Everaert More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2014.02.2398AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES OnabotulinumtoxinA (onabotA) 100U significantly reduced urinary incontinence (UI) and improved quality of life (QOL) in overactive bladder (OAB) patients who were inadequately managed by anticholinergics in two phase 3 trials. An analysis of the pooled phase 3 trials assessed the efficacy and QOL outcomes by the use of clean intermittent catheterization (CIC) and the presence of urinary tract infection (UTI). METHODS OAB patients who were inadequately managed by anticholinergics received 20 cystoscopic intradetrusor injections (0.5 mL/injection) of onabotA 100U (n=557) or placebo (n=548), sparing the trigone. The proportion of patients with a positive response (condition ‘greatly improved’ or ‘improved’) on the treatment benefit scale (TBS), incontinence-quality of life (I-QOL) total score, and King’s Health Questionnaire (KHQ) domains of role limitations, social limitations, physical limitations, and incontinence impact were assessed by CIC use/non-use and UTI status (presence/absence) during the first 12 weeks of treatment. Change from baseline at week 12 in UI episodes/day was assessed by UTI status. Minimally important differences (MIDs, which reflect clinical relevance) were +10 and -5 points for I-QOL and KHQ, respectively. RESULTS CIC use was reported in 44 patients in onabotA group vs 8 in placebo; 99 patients in onabotA vs 30 in placebo had UTI. Regardless of CIC use, the perception of treatment benefit was greater with onabotA vs placebo (63.6% vs 25.0% with CIC; 61.6% vs 28.0% without CIC) and QOL improvements above MID were seen with onabotA vs placebo in I-QOL total score and KHQ role and social limitations, physical limitations and incontinence impact domains. At week 12, regardless of UTI status, onabotA reduced UI episodes/day from baseline vs placebo (-3.01 vs -1.19 episodes/day with UTI; -2.76 vs -0.93 without UTI) and increased the proportion of positive TBS responders vs placebo (52.5% vs 33.3% with UTI, and 63.8% vs 27.6% without UTI). QOL improvements above MID were noted with onabotA vs placebo regardless of UTI status, including improvements in I-QOL total score and all evaluated KHQ domain scores. CONCLUSIONS In OAB patients who were inadequately managed by anticholinergics, the perception of treatment benefit and QOL improvements with onabotA were unaffected by CIC use. In addition, onabotA reduced UI and improved perception of treatment benefit and QOL regardless of UTI status. © 2014FiguresReferencesRelatedDetails Volume 191Issue 4SApril 2014Page: e883-e884 Advertisement Copyright & Permissions© 2014MetricsAuthor Information David Sussman More articles by this author Jennifer Gruenenfelder More articles by this author Heinrich Schulte-Baukloh More articles by this author Steven Guard More articles by this author Yan Zheng More articles by this author Karel Everaert More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

MP5-12 CHRONIC URINARY RETENTION AFTER RADICAL CYSTECTOMY AND ORTHOTOPIC NEOBLADDER IN WOMEN: RISK FACTORS AND RELATION TO TIME

You have accessJournal of UrologyUrinary Diversion: Bladder Reconstruction, Augmentation, Substitution, Diversion1 Apr 2014MP5-12 CHRONIC URINARY RETENTION AFTER RADICAL CYSTECTOMY AND ORTHOTOPIC NEOBLADDER IN WOMEN: RISK FACTORS AND RELATION TO TIME Bedeir Ali-El-Dein, Mohamed Zahran, Diaa-Eddin Taha, and Atallah A. Shaaban Bedeir Ali-El-DeinBedeir Ali-El-Dein More articles by this author , Mohamed ZahranMohamed Zahran More articles by this author , Diaa-Eddin TahaDiaa-Eddin Taha More articles by this author , and Atallah A. ShaabanAtallah A. Shaaban More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2014.02.395AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Chronic urinary retention (CUR) is one of the major functional problems in women after radical cystectomy (RC) and orthotopic neobladder (ONB). The objective of this study is to investigate the relation of CUR to time elapsed after RC and to study the possible risk factors. METHODS We retrospectively analyzed the records of 342 women for whom RC and ONS were performed between January 1995 and January 2013. Patients’ demographics, oncological and functional outcomes were assessed. Patients with available follow-up data for more than one year postoperatively with no evidence of oncological failure were included in the study. The primary outcome is the development of CUR and the use of clean intermittent catheterization (CIC) during follow-up. The incidence, correlation with time and risk factors for CUR were investigated. The presence of diabetes mellitus (DM), surgical modifications to prevent CUR, patient age, body mass index, tumor stage, type of the pouch and presence of Bilharziasis were studied as risk factors for CUR. The surgical modifications included preservation of the round ligaments and their use to suspend the vaginal stump, back support of the pouch by omentum, preservation of the peritoneum covering of the anterior rectal wall and suspension of the pouch near its doom to the back of the rectus muscle. RESULTS A total of 185 women with a median follow up of 62 months (range from 6-218) met the inclusion criteria. CUR developed in 41 patients (22%) with a median onset of 45 months. The incidence of CUR increased with time, where 7 (17%), 9 (22%), 13 (31.5%) and 12 patients (29% ) complained of CUR and started CIC in the first, second, 2-5 years and after five years of follow-up, respectively. On univariate analysis, CUR was of a higher incidence among diabetic women (p = 0.02). In addition, modifications to prevent CUR were associated with a lower incidence of CUR (p = 0.008). CUR was not dependent on patient age, body mass index, tumor stage, type of pouch or presence of Bilharziasis. Using multivariate analysis, surgical modifications to prevent CUR was the only independent and significant predictor that decreased incidence of CUR (p = 0.006). CONCLUSIONS The incidence of CUR after RC and ONB in women increases with time even after five years of follow-up. On univariate analysis, DM and surgical modifications to prevent CUR significantly affect the incidence of CUR. On multivariate analysis, surgical modification is the single factor which attained independent and significant association with CUR. EAU © 2014FiguresReferencesRelatedDetails Volume 191Issue 4SApril 2014Page: e86 Advertisement Copyright & Permissions© 2014MetricsAuthor Information Bedeir Ali-El-Dein More articles by this author Mohamed Zahran More articles by this author Diaa-Eddin Taha More articles by this author Atallah A. Shaaban More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

1367 ONABOTULINUMTOXINA IN PATIENTS WITH OVERACTIVE BLADDER AND URINARY INCONTINENCE: CONSISTENT EFFECT OVER REPEAT TREATMENT

You have accessJournal of UrologyUrodynamics/Incontinence/Female Urology: Incontinence, Evaluation & Therapy (III)1 Apr 20131367 ONABOTULINUMTOXINA IN PATIENTS WITH OVERACTIVE BLADDER AND URINARY INCONTINENCE: CONSISTENT EFFECT OVER REPEAT TREATMENT Victor W. Nitti, Karl-Dietrich Sievert, David Sussman, Sidney B. Radomski, Peter Sand, Catherine Thompson, Christopher Nardo, Jihao Zhou, Denise Globe, Cornelia Haag-Molkenteller, and Christopher Chapple Victor W. NittiVictor W. Nitti New York, NY More articles by this author , Karl-Dietrich SievertKarl-Dietrich Sievert Tuebingen, Germany More articles by this author , David SussmanDavid Sussman Newark, NJ More articles by this author , Sidney B. RadomskiSidney B. Radomski Toronto, Canada More articles by this author , Peter SandPeter Sand Chicago, IL More articles by this author , Catherine ThompsonCatherine Thompson Marlow, United Kingdom More articles by this author , Christopher NardoChristopher Nardo Irvine, CA More articles by this author , Jihao ZhouJihao Zhou Irvine, CA More articles by this author , Denise GlobeDenise Globe Irvine, CA More articles by this author , Cornelia Haag-MolkentellerCornelia Haag-Molkenteller Irvine, CA More articles by this author , and Christopher ChappleChristopher Chapple Sheffield, United Kingdom More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2013.02.2721AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES OnabotulinumtoxinA (onabotA) 100U was confirmed to be effective in 2 placebo-controlled pivotal studies for the treatment (tx) of patients (pts) with idiopathic overactive bladder (OAB) syndrome and urinary incontinence (UI) who were inadequately managed with anticholinergic (ACH) therapy. This is the first report of a pre-specified interim analysis of the extension trial, with evaluation of efficacy and safety over repeated onabotA tx. METHODS On completion of the pivotal studies, pts could enter a 3-year extension study and receive multiple tx of intradetrusor onabotA. Data were integrated across studies; pts receiving ≥1 onabotA tx in the evaluation period were analyzed by onabotA tx cycle (up to 5 cycles). Change from baseline (BL; before any tx) at week (wk) 12 in OAB symptoms, proportion of pts with a positive tx response (greatly improved or improved) on the tx benefit scale (TBS), duration of effect (Kaplan-Meier analysis of time to pts' request for re-tx), and health-related quality of life (HRQOL) were assessed. Adverse events (AEs) and use of clean intermittent catheterization (CIC) due to elevated post void residual urine (PVR) were also evaluated. RESULTS A total of 825, 558, 253, 113, and 47 pts received 1, 2, 3, 4, and 5 onabotA 100U tx, respectively, in this ongoing study. UI episodes/day were consistently reduced compared to BL; reductions at wk 12 were −3.25, −3.70, −3.49, −2.79, and −2.55 in onabotA 100U tx cycles 1 through 5. Continued reductions vs BL were also seen in other OAB symptoms over repeated tx cycles. A high proportion of pts reported a positive tx response on TBS during each tx cycle (73.9, 78.9, 77.3, 72.9, and 77.1% at wk 12 in onabotA 100U cycles 1 through 5). A consistent duration of effect was observed; median time to request for re-tx was 24.0, 25.7, and 24.1 wks for cycles 1, 2, and 3 (too few pts had yet requested re-tx in cycles 4 and 5 for an accurate estimate). Large improvements from BL in HRQOL that exceeded the minimally important difference were seen following each onabotA tx. The most common AE in each tx cycle was uncomplicated urinary tract infection (26.9, 24.2, 24.5, 20.4, and 14.9%). The proportion of pts requiring CIC due to elevated PVR was 4.6, 4.1, 4.7, 5.3, and 2.1% in onabotA 100U cycles 1 through 5. No change in the AE profile was observed. CONCLUSIONS Repeated onabotA tx in OAB pts with UI inadequately managed with ACHs showed sustained improvements in OAB symptoms, pt perception of improvement in their condition, and HRQOL. A consistent safety profile was also seen, with no new safety signals. © 2013 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 189Issue 4SApril 2013Page: e559-e560 Peer Review Report Advertisement Copyright & Permissions© 2013 by American Urological Association Education and Research, Inc.MetricsAuthor Information Victor W. Nitti New York, NY More articles by this author Karl-Dietrich Sievert Tuebingen, Germany More articles by this author David Sussman Newark, NJ More articles by this author Sidney B. Radomski Toronto, Canada More articles by this author Peter Sand Chicago, IL More articles by this author Catherine Thompson Marlow, United Kingdom More articles by this author Christopher Nardo Irvine, CA More articles by this author Jihao Zhou Irvine, CA More articles by this author Denise Globe Irvine, CA More articles by this author Cornelia Haag-Molkenteller Irvine, CA More articles by this author Christopher Chapple Sheffield, United Kingdom More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Orthotopic bladder replacement in women: Focus on functional results of a retrospective, single-centre study

Objective. The aim of this study was to investigate the functional and oncological outcomes of orthotopic neobladders in women with urothelial cancer. Material and methods. From 1993 to 2007, 61 women underwent radical cystectomy and orthotopic ileal neobladder using the hemi-Kock pouch or Skinner T pouch. Sixteen of them were excluded owing to a lack of available follow-up data. Finally, 39 women with diagnosed TCC were included in this retrospective study. Demographic data, functional outcome including micturition characteristics such as voided volume, continence situation, use of clean intermittent catheterization (CIC), residual urine volume and recurrence rate were collected 3, 6 and >12 months after surgery. Results. Tumours were non-muscle-invasive in 13 patients (pT1; 32.8%) with isolated carcinoma in situ (after failure of bacillus Calmette–Guérin) in five patients (13.0%) and muscle-invasive in 19 patients (pT2–3; 49.0%), extensive superficial bladder cancer was shown in one patient (2.6%), and remaining dysplasia after transurethral resection of the bladder for T1 G2 in one patient (2.6%). Median follow-up was 37 (range 3–165) months. Day-time (71.4%) and night-time (67.8%) continence (0–1 pad/24 h) 3 months postoperatively increased to 83.8% on long-term follow-up. Clean intermittent self-catheterization was required by 20%. At a mean follow-up of 39.5 (8–86) months, two women experienced local recurrence (septum rectovaginale, pelvic floor), urethral recurrence was seen in 5.2% and distant metastasis (pulmonary, peritoneal carcinosis) also in 5.2%. Conclusions. Orthotopic bladder replacement is an efficient option in appropriately selected women undergoing radical cystectomy, with encouraging functional outcome and low urethral recurrence rates, similar to published literature in men.

Intermittent catheterization and recurrent urinary tract infection in spinal cord injury.

To study the association of recurrent symptomatic urinary tract infections (UTIs) with the long-term use of clean intermittent catheterization (CIC) for the management of neurogenic bladder in patients with spinal cord injury (SCI). Retrospective study of 61 SCI patients with neurogenic bladder managed by CIC. Subjects were selected from 210 SCI patients seen at the Yale Urology Medical Group between 2000 and 2010. Medical UTI prophylaxis (PRx) with oral antimicrobials or methenamine/ascorbic acid was used to identify patients with recurrent UTI. The number of positive cultures (≥10(3) cfu/mL) within a year prior to starting PRx was used to confirm the recurrence of UTI. Fifty-one male and 10 female subjects were managed with CIC. Forty-one (67%) subjects were placed on medical PRx for symptomatic recurrent UTI. Seventeen (28%) subjects had at least 3 positive cultures within the year prior to starting PRx. Fifteen of 20 (75%) subjects not on PRx had no complaints of UTI symptoms in the final year of follow-up. Recurrent symptomatic UTIs remain a major complication of long-term CIC in SCI patients. Although CIC is believed to have the fewest number of complications, many SCI patients managed with long-term CIC are started on medical PRx early in the course of management. Future studies are needed to determine the efficacy of routine UTI PRx in these patients as well as determine what factors influence why many patients on CIC experience frequent infections and others do not.