Initiation Of Clean Intermittent Catheterization Research Articles

Assessing the Utility of Tamsulosin in Delaying Progression to Clean Intermittent Catheterization and End-stage Renal Disease in Patients With Posterior Urethral Valves: Are We Postponing the Inevitable?

To assess whether tamsulosin may aid emptying of the lower urinary tract in posterior urethral valves patients, mitigating the likelihood of progressing to clean intermittent catheterization (CIC) or need for renal replacement therapy. We reviewed a prospective institutional database containing posterior urethral valves patients treated between January 2000 and January 2022. After assessing baseline characteristics, Kaplan-Meier survival curves and log-rank tests were generated to assess differences in clinically significant outcomes (progression to CIC, dialysis, or kidney transplantation) between those prescribed tamsulosin and those who were not. A total of 179 patients were included. Fifty-nine patients received tamsulosin prior to initiation of CIC (group 1), and 120 did not (group 2). The baseline characteristics were similar between the two groups, except for anticholinergic use (tamsulosin group - 35/59 vs no tamsulosin - 32/120, P<.001). The median age at tamsulosin initiation was 26.0 months (IQR 15.5-48.6) and the median time from initiation of tamsulosin to progression to CIC was 52.6 months (IQR 10.1-69.3). Kaplan-Meier survival curves showed that patients on tamsulosin were less likely to progress to CIC (P=.021), however, there was no difference in progression to dialysis or kidney transplantation. A Cox-regression analysis controlling for baseline characteristics, including age, anticholinergic use, vesicoureteral reflux severity, and CKD stage at 1-year of life, showed a consistent effect of tamsulosin in delaying progression to CIC (HR 0.444 95%CI 0.218-0.902, P=.025). While tamsulosin may delay CIC, it does not appear to delay progression to end-stage renal disease. Additional studies exploring specific patient factors are required to determine the timing and subset who may benefit the most from tamsulosin.

MP53-13 DOES THE PRESENCE OF PRESSURE "POP-OFFS" IMPACT VOIDING EFFICIENCY AND BLADDER OUTCOMES IN POSTERIOR URETHRAL VALVES?

You have accessJournal of UrologyCME1 Apr 2023MP53-13 DOES THE PRESENCE OF PRESSURE "POP-OFFS" IMPACT VOIDING EFFICIENCY AND BLADDER OUTCOMES IN POSTERIOR URETHRAL VALVES? Adree Khondker, Priyank Yadav, Jin Kyu Kim, Michael Chua, Natasha Brownrigg, Juliane Richter, Joana Dos Santos, Armando Lorenzo, and Mandy Rickard Adree KhondkerAdree Khondker More articles by this author , Priyank YadavPriyank Yadav More articles by this author , Jin Kyu KimJin Kyu Kim More articles by this author , Michael ChuaMichael Chua More articles by this author , Natasha BrownriggNatasha Brownrigg More articles by this author , Juliane RichterJuliane Richter More articles by this author , Joana Dos SantosJoana Dos Santos More articles by this author , Armando LorenzoArmando Lorenzo More articles by this author , and Mandy RickardMandy Rickard More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003301.13AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The protective role of pressure pop-offs, consisting of vesicoureteral reflux (VUR) and ipsilateral kidney dysplasia, in posterior urethral valve (PUV) is controversial. While there has been significant emphasis on exploring the non-significant association between “pop-offs” and kidney function, there is paucity of data on the impact of this mechanism on bladder function. Here, we analyzed this association by examining the role of pressure pop-offs on long-term bladder outcomes in PUV patients. METHODS: A retrospective chart review was conducted for toilet-trained children with PUV managed at our institution between 2000 and 2022, only excluding cases without recorded uroflowmetry studies. Patients were stratified by the presence of pressure pop-offs (high-grade VUR+ipsilateral kidney dysplasia). Outcomes included uroflowmetry parameters and initiation of clean-intermittent catheterization (CIC). Survival analysis was conducted to calculate hazard ratios (HR). RESULTS: We identified a total of 101 patients who met study inclusion criteria, with a median follow-up of 114 months (IQR 67, 169). The median age of first and last uroflowmetry was 57 months (IQR 48, 82) and 120 months (IQR 89, 160), respectively. Patients with pressure pop-offs had similar flow velocity, post-void residuals, and bladder voiding efficiency to other PUV patients at last follow-up uroflowmetry. On survival analysis, patients with pressure pop-offs had no significant difference in risk of requiring CIC compared to patients without pop-offs (HR 1.92, p=0.06). Kidney dysplasia was independently associated with increased risk of CIC (HR 3.16, p=0.02) while VUR was not (HR 1.85, p=0.07). CONCLUSIONS: We show that boys with pressure pop-offs are not at higher risk of poorer voiding and intermittent catheterization than others with PUV. By extension, VURD syndrome does not confer protection against poorer bladder function. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e717 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Adree Khondker More articles by this author Priyank Yadav More articles by this author Jin Kyu Kim More articles by this author Michael Chua More articles by this author Natasha Brownrigg More articles by this author Juliane Richter More articles by this author Joana Dos Santos More articles by this author Armando Lorenzo More articles by this author Mandy Rickard More articles by this author Expand All Advertisement PDF downloadLoading ...

Does VURD syndrome impact voiding efficiency in posterior urethral valves?

There is debate regarding the effect of VURD syndrome, consisting of vesicoureteral reflux (VUR) and ipsilateral kidney dysplasia, on long-term outcomes in boys with posterior urethral valve (PUV). Here, we assessed whether VURD syndrome played a "protective" role on long-term bladder outcomes and voiding efficiency in boys with PUV. A retrospective chart review was conducted for toilet-trained children with PUV managed at our institution between 2000 and 2022, only excluding cases without recorded uroflowmetry studies. Patients were stratified by VUR status and by the presence of VURD syndrome (high-grade VUR+ipsilateral kidney dysplasia). Outcomes included initial and final uroflowmetry parameters, and initiation of clean-intermittent catheterization (CIC). We identified a total of 101 patients who met study inclusion criteria, with an overall median follow-up of 114 months (IQR 67, 169). The median age of first and last uroflowmetry was 57 months (IQR 48, 82) and 120 months (IQR 89, 160), respectively. Patients with VURD syndrome had similar flow velocity, post-void residuals, and bladder voiding efficiency to other PUV patients at last follow-up uroflowmetry. On survival analysis, patients with VURD syndrome had no significant difference in risk of requiring CIC compared to patients without pop-offs (p=0.06). Like more contemporary studies on pressure pop-offs, we show that this population is not at higher risk of poorer voiding and intermittent catheterization than others. VURD syndrome does not confer protection against poorer bladder function. Instead, our study suggests an independent association between kidney dysplasia and bladder outcomes which requires further attention. Among boys with PUV, VURD syndrome was not associated with significantly different uroflowmetry findings or rates of CIC by last follow-up.

Renal outcomes of children born with posterior urethral valves at a tertiary center: A 15-year retrospective review.

Posterior urethral valves (PUVs) is a congenital condition in which an obstruction in the urethra prevents drainage of urine from the bladder in males, with up to 60% of children diagnosed developing chronic kidney disease (CKD). The primary aim of this study was to identify novel factors that may predict development of CKD and end-stage real disease (ESRD ) in children with PUVs to potentially address modifiable factors and delay progression. The secondary aim was to compare rates of catheterization and incontinence between our patients and other case series to provide information to parents about long-term bladder outcomes. A single-center, retrospective cohort study was performed of all children referred to our multidisciplinary clinic for PUV diagnosis between 2005 and 2019. Univariable associations of different variables with the composite outcome CKD or ESRD were evaluated. Thirty of 46 patients (65%) developed CKD, with the majority (40%) being stage 2 CKD (n=12). Seven of 30 patients (23%) developed ESRD requiring renal replacement therapy. Fourteen of 26 (30%) required clean intermittent catheterization (CIC) initiation, with a median CIC initiation age of 4.3 years. Creatinine nadir post-valve ablation, oligohydramnios, and initiation of CIC are significant predictors of CKD development. This review reiterates that children born with PUVs have a high morbidity rate, with a high proportion developing CKD. Using a multidisciplinary approach to PUV patient care allows for better family education, early intervention of bladder dysfunction, and possibly better long-term preservation of renal function.

Comparison of outcomes of prenatal versus postnatal presentation of posterior urethral valves: a systematic review and meta-analysis.

To determine through a comprehensive systematic review and meta-analysis the differences in the outcomes of prenatally versus postnatally diagnosed posterior urethral valves (PUV) to ascertain if prenatal detection of PUV has superior outcomes. We conducted a systematic review and meta-analysis in March 2022 (PROSPERO ID - CRD42021243546) and included all studies that reported outcomes of prenatally and postnatally diagnosed PUV. However, for meta-analysis, only those studies that described both groups were included. The main outcomes of interest included progression of chronic kidney disease (CKD), need for renal replacement therapy (RRT) and renal transplant, and bladder dysfunction as determined by initiation of clean intermittent catheterization (CIC). Time to event analyses were completed when possible. The systematic review included 49 studies (3820 patients). The pooled effect estimates for progression to CKD (OR 0.75 [95% CI 0.43, 1.31]), need for RRT (OR 1.39 [95% CI 0.64, 2.99]) and need for renal transplant (OR 1.64 [95% CI 0.61, 4.42]) between prenatal and postnatal groups was not different. CICs rates were as high as 32% in the prenatal group and 22% in the postnatal group. Most studies had a moderate or serious risk of bias. The existing comparative literature on prenatal versus postnatal presentation of PUV is very heterogeneous. The diagnostic and treatment protocols have not been reported in majority of the studies. The outcome variables are also reported inconsistently. Based on the current evidence, prenatal diagnosis of PUV does not appear to improve the long-term outcomes of these patients.

MP11-19 THE ART OF INTRODUCING CLEAN INTERMITTENT CATHETERIZATION: HOW FAMILIES RESPOND &amp; ADAPT. A QUALITATIVE STUDY

You have accessJournal of UrologyCME1 May 2022MP11-19 THE ART OF INTRODUCING CLEAN INTERMITTENT CATHETERIZATION: HOW FAMILIES RESPOND & ADAPT. A QUALITATIVE STUDY Stuart B. Bauer, Rachel Saunders, Saafia Masoom, Lillian Hayes, Diane Price, Paige Sable, Kennary Choung, and Ashley Shimmel Stuart B. BauerStuart B. Bauer More articles by this author , Rachel SaundersRachel Saunders More articles by this author , Saafia MasoomSaafia Masoom More articles by this author , Lillian HayesLillian Hayes More articles by this author , Diane PriceDiane Price More articles by this author , Paige SablePaige Sable More articles by this author , Kennary ChoungKennary Choung More articles by this author , and Ashley ShimmelAshley Shimmel More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002533.19AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Irrespective of etiology, clean intermittent catheterization (CIC) is well-accepted for the management of bladder dysfunction in children; it helps to preserve kidney function & aids in achieving continence. Despite emphasis on CIC techniques, there is limited research on how families respond & adapt. The objective of this study was to explore families’ lived experiences when beginning CIC & to determine what optimized or hindered this process. METHODS: A phenomenological approach using semi-structured interviews was conducted with patients & families between Aug 2018 & Oct 2019. Interview questions were validated for acceptability with a pilot sample. Purposive sampling identified eligible patients with bladder dysfunction on CIC. Interviews were grouped by patient age: caregivers of children <12 years (Group 1), patients 12-18 years & their caregivers, interviewed separately (Group 2), & patients >18 years (Group 3). Reasons for CIC (neurogenic, anatomic, functional voiding disorders) were recorded for all. Interview questions focused on initiation of CIC, specifically which aspects of training or education acted as facilitators or barriers to implementation. Two coders reviewed transcripts independently with explicit coding and met to resolve differences between them. Emerging themes were identified to ascertain convergence, divergence, or variation in response. This allowed creation of a code book used for closed coding. Dedoose (a web-based qualitative coding program) was used to create code reports & allow for thematic analysis. RESULTS: 52 interviews were conducted: Group 1 (14 families, 14 interviews), Group 2 (10 families, 20 interviews), & Group 3 (16 families, 18 interviews including 2 parents interviewed separately). From these interviews, 6 themes emerged. Caregivers believed that learning & implementing CIC was easier when: (1) the child was young & a male, (2) information about CIC as a possibility was provided well in advance of formal teaching, (3) there was an adjustment period before starting, (4) all potential caregivers were present at teaching sessions, (5) the healthcare team offered guidance to balance employment obligations with CIC requirements, & (6) the healthcare team was sensitive, engaged, & accessible during its initiation. CONCLUSIONS: Healthcare providers should seriously consider engaging patients & caregivers in these strategies when introducing CIC as families would benefit from a well-structured educational plan & guidance prior to & following its implementation. Source of Funding: None © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e164 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Stuart B. Bauer More articles by this author Rachel Saunders More articles by this author Saafia Masoom More articles by this author Lillian Hayes More articles by this author Diane Price More articles by this author Paige Sable More articles by this author Kennary Choung More articles by this author Ashley Shimmel More articles by this author Expand All Advertisement PDF DownloadLoading ...

The Importance of Early Diagnosis and Management of Pediatric Neurogenic Bladder Dysfunction.

Neurogenic bladder dysfunction is a major source of urologic morbidity in children, especially in those with spina bifida (SB). Complications from progression of bladder dysfunction can include urinary tract infections (UTIs), urinary incontinence, upper tract deterioration, and renal dysfunction or failure. In these children, there has been a recent trend toward proactive rather than expectant management of neurogenic bladder. However, there is a lack of consensus on how to best achieve the three main goals of neurogenic bladder management: 1) preserving kidney function, 2) achieving continence (if desired by the family/individual), and 3) achieving social and functional urologic independence (if appropriate). Hence, our objective was to perform a narrative literature review to evaluate the approaches to diagnosis and management of pediatric neurogenic bladder dysfunction, with special focus on children with SB. The approach strategies vary across a spectrum, with a proactive strategy on one end of the spectrum and an expectant strategy at the other end. The proactive management strategy is characterized by early and frequent labs, imaging, and urodynamic (UDS) evaluation, with early initiation of clean intermittent catheterization (CIC) and proceeding with pharmacotherapy, or surgery if indicated. The expectant management strategy prioritizes surveillance labs and imaging prior to proceeding with invasive assessments and interventions such as UDS or pharmacotherapy. Both treatment strategies are currently utilized and data have historically been inconclusive in demonstrating efficacy of one regimen over the other. We performed a narrative literature evaluating proactive and expectant treatment strategies as they relate to diagnostics and management of Spina Bifida. From the available literature and our practice, a proactive strategy favors greater benefit in preventative management and may decrease risk of renal dysfunction compared with expectant management.

Risk Factors for Renal Function Impairment in Childen with Meningomyelocele; a Single Center Study

Introduction: Chronic kidney disease and its complications are among the most frequent cause of morbidity and mortality in patients with meningomyelocele. Objective: In this study, we aimed to determine the risk factors leading to chronic kidney disease progression in these patients. Material and Method: Fifty patients with meningomyelocele were analyzed retrospectively. Age, gender, followup period, serum creatinine, glomerular filtration rate, vesicoureteral reflux (VUR), initial urodynamic findings and initiation time of clean intermittent catheterization (CIC) were noted. The progression of Chronic kidney disease (CKD) was evaluated by DMSA renal scintigraphy, changes in serum creatinine (Screa), and glomerular filtration rate (GFR). Results: 30 of the 50 patients were included in the study. VUR was detected in 63% of the patients, and scar was detected in 83% by renal scintigraphy. The median value of Screa was 0.5 mg/dl in admission, while the median Screa was 1.02 mg/dl (min-max: 0.27-5) at the last visit and the difference was statistically significant (p=0.001). A statistically significant was found between CKD progression and GFR in admission (p=0.001), CIC onset age (p=0.03), degree of VUR (p=0.046), presence of renal scar (p=0.002). It was shown that delay in admission (p=0.011; OR 1.36; CI 1.07-1.73) and low GFR in admission (p=0.036 OR 0.915 CI 0.842-0.994) were the most important risk factors. Conclusion: In our study, it was shown that delay in neurogenic bladder treatment, delay in the initiation of CIC, and low GFR at admission were important risk factors for the progression of CKD in children with meningomyelocele. Therefore, we aimed to emphasize the importance of regular follow-up of these children in Pediatric Nephrology Clinics from the neonatal period.

Urodynamic and imaging findings in infants with myelomeningocele may predict need for future augmentation cystoplasty

Urologic issues are persistent and important causes of morbidity and mortality in patients with myelomeningocele. Classically, patients with elevated bladder pressures despite adherence to clean intermittent catheterization (CIC) and pharmacotherapy undergo augmentation cystoplasty (AC). Currently, there is little understanding of which infants are more likely to require AC later. In this context, the authors studied whether unfavorable urodynamic or imaging findings in patients with myelomeningocele during infancy could predict future AC. The authors hypothesized that infants born with elevated bladder pressures, vesicoureteral reflux (VUR), and/or hydronephrosis would be more likely to undergo AC. The authors retrospectively identified patients with myelomeningocele at their institution who were followed-up since infancy (<1 year of age), with a minimum of eight continuous years of follow-up. Standard care protocol included cystometrogram, voiding cystourethrogram (VCUG), and renal ultrasound during infancy. The primary outcome was AC for elevated bladder pressures despite attempts at more conservative management with medical therapy and CIC. Specifically, the authors evaluated for differences in augmentation rates based on gender, level of lesion, presence of detrusor leak point pressure (DLPP) or end-fill pressure (EFP) greater than 40cmH2O, presence of hydronephrosis, VUR, initiation of CIC, and initiation of antimuscarinics in infancy. The authors excluded patients who underwent surgical intervention for urinary incontinence. A total of 97 patients met the inclusion criteria. The median follow-up time was 13.8 years. Augmentation cystoplasty was performed for 17 patients (17.5%) at a median age of 114 months (9.5 years). Detrusor leak point pressure/EFP was greater than 40cmH2O in 34.0% (33/97) of infant cystometrogram studies, while 30.9% (30/97) had VUR on infant VCUG and 20.6% (20/97) had hydronephrosis on infant renal ultrasound. Patients with DLPP/EFP greater than 40cmH2O or VUR during infancy were more likely to undergo AC (P=0.02 and P=0.03, respectively). Binomial logistic regression revealed that DLPP/EFP greater than 40cmH2O (odds ratio [OR]: 4.28, 95% confidence interval [CI]: 1.34-13.62) and VUR (OR: 3.73, 95% CI: 1.18-11.77) were independent risk factors for future AC. Infants with myelomeningocele and elevated bladder pressures and VUR should be closely monitored by urodynamic testing and imaging studies. Parents can be counseled regarding the potentially higher risk for future AC in these patients. Nonetheless, the majority of high-risk infants will safely avoid AC with conservative management.

The fallow mitrofanoff

Treatment of severe congenital dysfunctional bladders often requires bladder drainage to maintain low bladder pressure, thus preserving renal function. Although clean intermittent catheterization is the ideal choice, this can be especially challenging in the younger pediatric population or in children with neurological impairment. Alternatives such as incontinent vesicostomy, long-term suprapubic catheterization, or button cystostomy exist, but these are rarely very long-term options. The objective of this study is to report the authors' experience with children who underwent a 'fallow' Mitrofanoff, meaning an appendicovesicostomy in which an indwelling catheter was placed for several months or years, allowing for bladder emptying several times a day, until the child was ready for clean intermittent catheterization (CIC). All patients who underwent a Mitrofanoff appendicovesicostomy with or without concomitant bladder augmentation, for whom there was a significant delay (≥6 months) between surgery and implementation of CIC, were reviewed. In all these cases, the child showed obvious opposition to CIC. An indwelling catheter was left in place, with a stopper allowing for bladder emptying 5-6 times a day as would happen with CIC. The catheter was changed once a week until CIC was implemented. Complications including febrile urinary tract infections (fUTIs) during the fallow period and complications including leakage or stenosis during the CIC period were noted. The series includes 10 patients (7 boys and 3 girls), aged a median 41±34 months (range: 23-144) at the time of the appendicovesicostomy (6 posterior urethral valves and 4 non-neurogenic neurogenic bladders). All underwent classic appendicovesicostomies. The delay before full implementation of CIC was a median 29.5±24 months (range: 6-72). During the fallow period, 3 patients presented fUTIs. The catheter was closed, allowing for bladder drainage 4-6 times a day. There were no episodes of leakage from the Mitrofanoff or stomal stenosisduring the fallow period or CIC period. Mean follow-up since the appendicovesicostomy is 66±33 months and since initiation of CIC is 26±26 months (range: 4-94). For children who require bladder drainage, an appendicovesicostomy can be performed even if CIC is not initiated immediatelyand be used as a suprapubic catheter or button cystostomy. When the child is ready, CIC can be initiated without need for further surgery and without risk for the conduit. The limitations of this study include its retrospective natureand the low number of patients. A Mitrofanoff appendicovesicostomy can be performed in a child requiring long-term bladder drainage and in whom classic CIC is not possible, even if CIC is not initiated immediately.

Bladder changes after catheterizable channel creation in adults with cerebral palsy who are in chronic urinary retention

Cerebral palsy (CP) is characterized by motor impairments as a result of brain injury during development. Patients can have neurogenic bladder dysfunction and are often unable to catheterize through their native urethra. Catheterizable channel (CC) creation can facilitate clean intermittent catheterization (CIC). We have observed that patients with large capacity, low-pressure bladders can develop de novo neurogenic detrusor overactivity (NDO) postoperatively. We sought to better characterize this finding. We reviewed the charts of patients 17 years or older with CP seen between 2006 and 2017. Patients undergoing creation of any type of CC without augmentation cystoplasty, due to adequate storage on pre-operative urodynamics (UDS), were included. Pre- and post-operative UDS were reviewed. Frequency of incontinence and use of anticholinergics or intravesical injections of onabotulinum toxin A (Btx) were reviewed. Eight patients with CP underwent CC creation without augmentation. Preoperatively, six of eight patients were in chronic retention with two others performing CIC. Following CC creation, patients in retention required additional NDO management with anticholinergics, mirabegron, or onabotulinumtoxin A. Among those with complete UDS data, 67% demonstrated lower maximum cystometric capacity postoperatively. Median follow-up was 25 months. CC creation facilitates CIC in adults with CP who are in chronic retention due to pseudodyssynergia. Despite preoperative UDS suggesting an adequate capacity, low-pressure bladder, such patients often manifest de novo NDO and worsening incontinence upon initiation of CIC after surgery. These findings should be considered when determining whether to perform augmentation at the time of CC in adults with CP.

Expectant use of CIC in newborns with spinal dysraphism: Report of clinical outcomes.

Report urologic outcomes among newborns with spinal dysraphism managed within an expectant clean intermittent catheterization (CIC) program. Newborns were followed clinically and with serial ultrasound (US). Urodynamics (UD) and dimercaptosuccinic acid (DMSA) renal scan were obtained at 3-6months, 1 year, 3 years, then as needed. Patients with initial evaluation after 6months were excluded. Median follow-up was 3.2 years. 11/102 began catheterization for continence (median 4.0 years) and 47/102 did not start CIC. Of these, 2/58 developed a DMSA abnormality. 44/102 began CIC early, often for elevated storage pressures and febrile urinary tract infection (UTI). Of these, 20/44 developed a DMSA abnormality including 9 who had abnormality detected prior to starting CIC. Being on CIC or starting immediately upon recognition of new hydronephrosis, reflux, elevated filling pressures, or febrile UTI was associated with lower chance of DMSA abnormalities (4/17, 24%) compared to delaying CIC (16/27, 60%) (p= 0.03). CIC can be deferred until continence in select infants with a low risk of significant DMSA abnormality. However, immediate initiation of CIC upon recognition of risk factors is recommended as this was associated with fewer DMSA abnormalities than delaying CIC. Recommendations for expectantly-managed patients include close follow-up, serial US and UD, and prompt initiation of CIC upon recognition of new hydronephrosis, reflux, elevated storage pressures, or febrile UTIs.

Intratrigonal OnabotulinumtoxinA Improves Bladder Symptoms and Quality of Life in Patients with Bladder Pain Syndrome/Interstitial Cystitis: A Pilot, Single Center, Randomized, Double-Blind, Placebo Controlled Trial

We compared the efficacy and safety of trigonal injections of onabotulinumtoxinA and saline in patients with bladder pain syndrome/interstitial cystitis. This phase II study enrolled women who had had bladder pain syndrome/interstitial cystitis for more than 6 months and pain for 4 months or longer on a visual analogue scale of 0 to 10, which were refractory to common treatment. OnabotulinumtoxinA 100 U in 10 or saline as placebo in 9 was administered as 10 trigonal injections of 1 ml. The primary study end point was the change from baseline pain intensity reported at week 12. Additional end points included O'Leary-Sant scores, micturition frequency, quality of life at week 4, 8 and 12, and the treatment benefit scale at week 12. Safety assessments included urinary tract infection, post-void residual urine and the initiation of clean intermittent catheterization. At week 12 onabotulinumtoxinA had significantly reduced pain compared with saline (mean ± SD -3.8 ± 2.5 vs -1.6 ± 2.1, p <0.05). The proportion of patients who achieved a 50% or greater reduction in the pain visual analog scale was 60% for onabotulinumtoxinA vs 22% for placebo. OnabotulinumtoxinA significantly improved O'Leary-Sant scores and quality of life over placebo at weeks 4, 8 and 12. Important numerical reductions in voiding frequency were also observed with the toxin. OnabotulinumtoxinA was well tolerated. Urinary tract infections developed in 3 patients who received onabotulinumtoxinA vs 2 who received saline. Mean post-void residual urine at week 12 was 5 ± 13 ml for onabotulinumtoxinA vs 0 ml with saline. This study had the limitations inherent to a single center trial with a small number of patients enrolled. OnabotulinumtoxinA 100 U caused significant and clinically relevant improvements in bladder pain and quality of life in patients with bladder pain syndrome/interstitial cystitis refractory to common therapy. It was also well tolerated.

Association between clean intermittent catheterization and urinary tract infection in infants and toddlers with spina bifida

The primary goal of urologic management in children with spina bifida is to reduce the risk of urinary tract infection (UTI) and associated renal injury. While clean intermittent catheterization (CIC) has been the mainstay of treatment, recent studies have suggested that this approach is not without risk. The objective of this study was to examine the association between alternative bladder management strategies and UTI in infants and toddlers with spina bifida. A retrospective cohort study was conducted on spina bifida patients, aged 0-3 years, seen in a multidisciplinary spinal defects clinic between 2008 and 2013. Inclusion criteria included: a primary diagnosis of meningocele, myelomeningocele, or lipomyelomeningocele. Patients were excluded if they had: <1 year of follow-up, urologic surgery prior to initial evaluation, or incomplete data for analysis. Bivariate analyses were performed using Chi-squared or Fisher's exact tests. Multivariate analyses were performed using logistic regression. A total of 107 patients meeting study criteria were identified. The majority of patients had lumbar lesions (74.8%) and ventriculoperitoneal (VP) shunts (72.9%). Initial bladder management was by CIC in 39.3% of patients and spontaneous voiding in 60.8% of patients. Median age at follow-up was 2.5 years. During the study period, 23.4% of patients switched from spontaneous voiding to CIC. Patients managed with CIC were more likely to have UTIs at final follow-up than those managed with voiding (35.7% vs. 18.5%; P=0.045). Patients with vesicoureteral reflux (VUR) were also more likely to have UTIs (54.5% vs. 17.9%; P=0.015). Patients who switched from spontaneous voiding to CIC over the study period were more likely to be evaluated with urodynamics (72.0% vs. 31.8%; P<0.0001) than those managed with voiding alone. Patients who switched to CIC were also more likely to have VUR (16% vs. 0%; P=0.09) and UTIs (24% vs. 15%; P=0.06) than those managed with voiding alone; however, these differences were not statistically significant. In the present series, infants and toddlers with spina bifida who were initially managed with spontaneous voiding had a lower risk of UTI than those managed with CIC. Patients who switched to CIC after a period of initial observation with voiding did not have a significantly different risk of UTI compared with those managed with CIC alone. These findings suggest that early initiation of CIC may not be warranted in all infants with spina bifida. Further studies are needed to more clearly define optimal indications for initiation of CIC in these patients.

The Association of Urinary Nerve Growth Factor Levels With Bladder Outlet Obstruction in Women

Nerve growth factor (NGF) has been proposed as a urinary biomarker and previously shown to be elevated in male patients with bladder outlet obstruction (BOO) and other lower urinary tract symptoms. No published studies have examined NGF as a potential urinary biomarker in women with BOO. The aims of this prospective study were to evaluate NGF levels in urine from women with anatomic BOO resulting from pelvic organ prolapse (POP) and/or previous incontinence surgery and to measure the effect associated with surgical or conservative management. From January to September 2012, all female patients referred for evaluation and management of BOO from POP or previous incontinence surgery were screened for enrollment. Inclusion criteria included elevated postvoid residual, valsalva voiding on urodynamics, or urinary peak flow (Qmax) of 12 mL/s or less. A control group of 10 asymptomatic age-matched female volunteers was also recruited. In all subjects, urinary NGF and creatinine (Cr) levels were measured and normalized to the urinary Cr concentrations (NGF/Cr). Urinary NGF levels were measured at 1 month and 3 months after either surgical correction or initiation of clean intermittent catheterization. A total of 10 female patients with anatomic BOO (mean [SD] age of 66.2 [3.88] years) and 10 female control subjects (mean [SD] age of 62 [7] years) were recruited. Nine patients had POP. Six patients had undergone a previous anti-incontinence procedure. Five patients had both POP and undergone a previous anti-incontinence procedure. The urinary NGF/Cr levels in the study patients with BOO (mean [SE] 20.8 [4.31] pg/mg) were significantly higher (P = 0.0001) than the levels in the age-matched control group (5.6 [0.65] pg/mg). After treatment, the urinary NGF/Cr level significantly decreased to 6.50 (0.57) pg/mg (P = 0.01) CONCLUSIONS: In this study, female patients with anatomic BOO resulting from POP and/or previous incontinence surgery had significantly higher urinary NGF/Cr levels when compared with age-matched controls. After treatment, the urinary NGF/Cr levels significantly decreased.

Commentary to ‘Early clean intermittent catheterization may not prevent dimercaptosuccinic acid renal scan abnormalities in children with spinal dysraphism’

The authors aimed to address a clinically relevant issue: do we prevent new renal scarring by early administration of clean intermittent catheterization (CIC) in patients with spina bifida? In 2006, Peter Dik and co-workers presented their results of the concept of prophylactic initiation of CIC combined with antimuscarinic therapy in myelodysplastic newborns. Out of 144 children, five patients had pre-existing renal abnormalities, 69 had an overactive sphincter, 27 had reflux, and six had renal scarring. Five of the six patients with renal scarring were put on CIC and antimuscarinic therapy several months after birth. This study provided prima facie evidence that early initiation of CIC and antimuscarinics has the potential to prevent new renal scars [1]. In the presented study, postnatal CIC combined with antimuscarinics was performed in 17 out of 100 patients. A dimercaptosuccinic acid (DMSA) scan was only carried out if a pathology was found or suspected. These 17 patients were compared with a markedly larger group of 83 patients in whom CIC was initiated at a median age of 5 years. Moreover, only the latest DMSA scan was reviewed. Although the authors are to be congratulated on a wellthought-out and well-written manuscript, the study has several limitations which may not support the conclusions drawn by the authors. First, this is a small retrospective series and, more importantly, there is not uniformity in the groups. Second, there is a wide range of different indications for a DMSA scan in this study (different renal size, symptomatic urinary tract infection [UTI], Vesicoureteral reflux (VUR), increase of hydronephrosis, refusal of CIC, or per provider discretion); third, 192 out of the 292 patients did not receive a DMSA scan. Taken together, there is a considerable selection bias which should be taken into account when drawing conclusions from the present data. There may be a non-negligible bias when comparing the group of patients born after 2007 (group 1) with those born

Response to the commentary ‘Early clean intermittent catheterization may not prevent dimercaptosuccinic acid renal scan abnormalities in children with spinal dysraphism’

We agree that the ideal study to address the value of early clean intermittent catheterization (CIC) would only be possible if myelodysplastic patients were followed prospectively with specific guidelines regarding imaging. As a result, we are advocating for dimercaptosuccinic acid (DMSA) scans as a baseline during the first year of life, at 5 years of age, and if there are clinical changes. Selection bias and the retrospective nature of this study are valid concerns that we realize prevent an absolute statement on when to initiate CIC. In fact, we were quite surprised to find a higher likelihood of renal scarring in patients who started early CIC versus CIC later in life since this was contrary to our initial hypothesis. Nevertheless, given the limitations, we can only propose that early CIC may not prevent renal scarring. There have been several studies looking at the early initiation of CIC or prophylactic CIC to prevent upper tract changes or prevent the need for further surgery. The 2006 study by Dik et al. addressed the value of early CIC as well. However, out of their population of 144 patients, only 10 DMSA scans were performed based on suspicion of ultrasound determined renal abnormalities. Of these, six scans

Early clean intermittent catheterization may not prevent dimercaptosuccinic acid renal scan abnormalities in children with spinal dysraphism

ObjectivesTo determine whether early initiation of clean intermittent catheterization is associated with increased renal preservation in children with spinal dysraphism based on dimercaptosuccinic acid (DMSA) renal scans. MethodsA retrospective review was performed of 100 patients from a pediatric spinal defects clinic from June 2007 to October 2011 who were followed with routine studies including DMSA scans, voiding cystourethrograms, renal/bladder ultrasounds, and urodynamics. DMSA scans were reviewed for evidence of renal cortical loss as defined by presence of scarring or difference in differential function greater than 15%. Multivariate analysis was performed for risk factors for upper tract damage. ResultsRenal cortical loss on DMSA scan was found in 43/100 (43%) of patients. CIC was started at birth in 17/100 (17%) of patients with the rest starting at a median age of 5 years (IQR 3–9). Upon multivariate regression analysis, age at DMSA scan (OR 1.21; 95% CI 1.08–1.36), history of VUR (OR 8.64; 95% CI 2.52–29.57), history of hydronephrosis (OR 3.44; 95% CI 1.12–10.5), and CIC from birth (OR 9.26; 95% CI 1.99–43.18) were statistically significant predictors of kidney damage. ConclusionEarly initiation of CIC may not reduce the incidence of DMSA abnormalities in pediatric patients with spinal dysraphism.

1717 CONSISTENT AND PERSISTENT LONG-TERM EFFICACY AFTER REPEAT ONABOTULINUMTOXINA DETRUSOR INJECTIONS IN PATIENTS WITH NEUROGENIC DETRUSOR OVERACTIVITY

You have accessJournal of UrologyUrodynamics/Incontinence/Female Urology: Neurogenic Voiding Dysfunction1 Apr 20131717 CONSISTENT AND PERSISTENT LONG-TERM EFFICACY AFTER REPEAT ONABOTULINUMTOXINA DETRUSOR INJECTIONS IN PATIENTS WITH NEUROGENIC DETRUSOR OVERACTIVITY Michael Kennelly, Brenda Jenkins, Jihao Zhou, and Roger Dmochowski Michael KennellyMichael Kennelly Charlotte, NC More articles by this author , Brenda JenkinsBrenda Jenkins Irvine, CA More articles by this author , Jihao ZhouJihao Zhou Irvine, CA More articles by this author , and Roger DmochowskiRoger Dmochowski Nashville, TN More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2013.02.2963AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES OnabotulinumtoxinA (onabotA) has been shown to be well tolerated and provide sustained efficacy in patients (pts) with UI due to neurogenic detrusor overactivity (NDO). However, many previous long-term studies were from single centers with few pts. Here we present an additional analysis of the large cohort of patients (with multiple sclerosis or spinal cord injury) treated in the long-term extension study of the two onabotA phase 3 pivotal studies, including over 100 pts receiving at least 5 onabotA injections administered via cystoscopy, avoiding the trigone. METHODS The 3 year extension study allowed pts who completed the pivotal trials to continue receiving the same dose (200U or 300U) of intradetrusor onabotA as in the pivotal studies (until approval of the 200U dose for treatment of UI due to NDO, after which the protocol was amended so all pts receive 200U). Pts who received placebo during the pivotal studies received onabotA (reported here as treatment 1). Data were integrated across the pivotal and extension studies and analyzed by onabotA treatment cycle. Change from study baseline (BL) in daily UI episodes and volume/void at 6 wks after each treatment were assessed, as were adverse events (AEs) and initiation of clean intermittent catheterization (CIC). RESULTS A total of 387, 348, 283, 195, 108, 59, and 40 pts received 1, 2, 3, 4, 5, 6, and 7 onabotA treatments. Repeat onabotA treatment consistently reduced the number of daily UI episodes from BL; at week 6, mean changes from BL ranged from -3.1 to -4.4 for onabotA 200U and -3.0 to -3.7 for onabotA 300U across treatment cycles 1-7 (Figure). Volume/void was ∼150 mL at BL and increased to ∼300mL following onabotA treatment across all cycles. Only 10 pts discontinued due to AEs. Most common AEs were urinary tract infections and urinary retention. No new safety signals were observed over repeat treatment. Risk of denovo CIC was highest after the first treatment and was greatly reduced after subsequent treatments. CONCLUSIONS Consistent and persistent improvements in UI episodes and volume per void were observed, with no new safety signals identified, after repeat onabotA treatment (up to 7 treatment cycles). © 2013 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 189Issue 4SApril 2013Page: e706-e707 Advertisement Copyright & Permissions© 2013 by American Urological Association Education and Research, Inc.MetricsAuthor Information Michael Kennelly Charlotte, NC More articles by this author Brenda Jenkins Irvine, CA More articles by this author Jihao Zhou Irvine, CA More articles by this author Roger Dmochowski Nashville, TN More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Renal Cortical Deterioration in Children With Spinal Dysraphism: Analysis of Risk Factors

Background/Objective: Because hydronephrosis and reflux are reversible, we believe cortical loss represents true renal deterioration in children with spinal dysraphism. Our goal was to better define risk factors for cortical loss.Methods: After institutional review board approval, we reviewed the medical records of 272 children with spinal dysraphism. The following factors were evaluated: age, sex, renal and bladder imaging, urodynamic parameters, medications, catheterization program, continence, infections, and surgical history. Renal cortical loss was defined by scarring or a differential function greater than 15% using a nuclear scan. Univariate and multivariate logistic regression models were fitted to test the associations of specific variables with cortical loss.Results: Renal cortical loss was found in 41% of children with high-grade reflux vs 2% of children without reflux. Univariate analysis showed only high-grade reflux and female sex to be independent risk factors. Controlling for age and sex, reflux and initiation of catheterization after 1 year of age are significant risk factors. High bladder pressure and hydronephrosis in the absence of reflux were not associated with cortical loss. Multivariate analysis showed that girls with reflux have a 55-fold increased risk of cortical loss.Conclusion: By limiting the definition of renal deterioration to cortical loss, we identified relevant risk factors: reflux, female sex, and delayed initiation of clean intermittent catheterization. We have also discounted other suspected risk factors: hydronephrosis and elevated bladder pressure. Rather than continuing our focus on hydronephrosis and urodynamics, we believe more research and management debate should be afforded to females with reflux.