Intravesical onabotulinumtoxinA Injection Research Articles

Intravesical OnabotulinumtoxinA Injection for Overactive Bladder Patients with Frailty, Medical Comorbidities or Prior Lower Urinary Tract Surgery.

Overactive bladder (OAB) symptoms increase with age and involve several comorbidities. OnabotulinumtoxinA (BoNT-A) intravesical injection is a treatment choice for patients who are intolerant of or refractory to antimuscarinics. However, the increased risk of urinary tract infection and elevated post-void residual (PVR) volume post-treatment require resolution. Male sex, baseline PVR > 100 mL, and comorbidities are independent risk factors of adverse events (AEs) such as acute urinary retention (AUR). Intravesical BoNT-A injection is safe and effective for OAB patients with frailty, medical comorbidities such as Parkinson’s disease (PD), chronic cerebrovascular accidents (CVA), dementia, or diabetes, or a history of prior lower urinary tract surgery (prostate or transvaginal sling surgery). Post-treatment, 60% of frail elderly patients had a PVR volume > 150 mL and 11% had AUR. Although intravesical BoNT-A injection is safe for PD patients, CVA patients had higher strain voiding rates. Diabetic patients were at increased risk of large PVR urine volume and general weakness post-treatment. Treatment results were similar between patients with and without a history of prostate or transvaginal sling surgery. Possible AEs and bladder management strategies should be conveyed to patients before treatment. Careful patient selection is important, and therapeutic safety and efficacy should be carefully balanced.

Efficacy and Safety of Intravesical OnabotulinumtoxinA Injection in Patients with Detrusor Hyperactivity and Impaired Contractility.

We investigated the efficacy and safety of intravesical onabotulinumtoxinA injection in patients with detrusor hyperactivity and impaired contractility (DHIC). Twenty-one patients with urodynamically proven DHIC and 21 age-matched patients with overactive bladder (OAB) with urodynamic detrusor overactivity were treated with intravesical injections of 100 U of onabotulinumtoxinA. The overactive bladder symptom score, urgency severity score, patient perception of bladder condition, global response assessment, voiding diary, and procedure-related adverse events (AE) at baseline, two weeks, one, three, and six months after treatment were assessed. The results showed that the subjective symptom scores improved significantly in both groups, and the scores did not differ between the groups. The decrease in urgency episodes and urgency urinary incontinence were noted in OAB patients but not in DHIC patients. Although the incidence of AEs was comparable between the groups, the therapeutic efficacy lasted for a mean of 4.9 ± 4.8 months in DHIC patients and 7.2 ± 3.3 months in OAB patients (p = 0.03). We concluded that the efficacy of intravesical onabotulinumtoxinA injection for DHIC patients was limited and short-term. Nevertheless, AEs did not increase in DHIC. Intravesical onabotulinumtoxinA might not be a good indication in patients with DHIC and high post-voiding residual urine. Physicians should inform patients of the potential benefits and risks of onabotulinumtoxinA injection for treatment of DHIC.

Factors Associated with Therapeutic Efficacy of Intravesical OnabotulinumtoxinA Injection for Overactive Bladder Syndrome

ObjectivesTo analyze the predictors of therapeutic efficacy after intravesical botulinum toxin A injection for overactive bladder syndrome (OAB) refractory to antimuscarinic therapy.MethodsAll consecutively OAB patients, who visited the urologic outpatient clinics of a medical center and refractory to antimuscarinic treatment, were prospectively enrolled. All enrolled patients received intravesical injection of 100 U onabotulinumtoxinA (Botox). The Global Response Assessment (GRA) score ≥ 2 at 3 months after Botox injection was defined as a successful treatment, otherwise failed.ResultsOverall, 89 patients received intravesical injection. Eighty patients, including 42 men and 38 women, had received follow-up at 3 months. The overall success rate was 63.8%. The global response assessment, urgency severity score, urgency, urgency urinary incontinence and frequency episodes, and functional bladder capacity improved after treatment. However, post-void residual volume (PVR) increased, and voiding efficiency (VE) decreased after treatment. Female gender (odds ratio = 3.75) was the only independent factor associated with the success. Female gender (coefficient = 0.74), low baseline overactive bladder symptoms score (coefficient = -0.12) and the presence of OAB-wet (coefficient = 0.79) were independent factors associated with therapeutic efficacy (i.e., GRA score). VE (odds ratio = 0.062) was the only predictor for a large PVR at 3 months. The optimum cutoff value of VE was <87% with the area under the ROC curve being 0.64 (sensitivity = 63.8%, specificity = 57.1%).ConclusionsThe therapeutic effects of Botox can persist till 6 months after treatment. Female gender, low overactive bladder symptoms score and OAB-wet are associated better therapeutic efficacy, and low baseline VE is associated with large PVR. These findings can serve as an initial guide or assist in consultation regarding the treatment of OAB patients with Botox injection.Trial RegistrationClinicalTrials.gov NCT01657409

Practical Aspects of Botulinum Toxin-A Treatment in Patients With Overactive Bladder Syndrome.

Intravesical onabotulinumtoxinA (BoNT-A) injection is an effective treatment for overactive bladder syndrome (OAB) that is refractory to antimuscarinics. An injectable dose of 100 U has been suggested to achieve the optimal balance of benefit and safety in patients with OAB. BoNT-A (total volume of 10 mL) was administered as evenly distributed intradetrusor injections (5 U) across 20 sites approximately 1 cm apart (0.5 mL per site) using a flexible or rigid cystoscope. Treatment with BoNT-A was generally well tolerated by most patients, and most treatment-related adverse events were localized to the urinary tract. The prevalence of OAB increases with age, and elderly patients are more vulnerable to complications. The short-term efficacy of intravesical BoNT-A injection for refractory OAB with no treatment-related complications in the elderly population has been documented. Frail elderly patients can experience the same treatment results, such as significantly improved urgent urinary incontinence and quality of life, as young and nonfrail elderly patients with 100-U BoNT-A injections. However, increased risk of larger postvoid residual (PVR) urine and lower long-term success rates were noted in frail elderly patients; around 11% had acute urinary retention, while 60% had PVR urine volume >150 mL after treatment. In addition, intravesical injection of BoNT-A effectively decreased urgency symptoms in elderly patients with OAB and central nervous system lesions. The adverse effects were acceptable, while the long-term effects were comparable to those in patients with OAB without central nervous system lesions. Nonetheless, the possibility of longstanding urinary retention and chronic catheterization in this vulnerable population requires careful evaluation before treatment with intravesical BoNT-A. In conclusion, the current findings indicate that intravesical BoNT-A is an effective and safe treatment for OAB in elderly patients.

Reduction of urgency severity is the most important factor in the subjective therapeutic outcome of intravesical onabotulinumtoxina injection for overactive bladder

Reduction of urgency severity is the most important factor in the subjective therapeutic outcome of intravesical onabotulinumtoxina injection for overactive bladder

The outcome of intravesical onabotulinum toxin injections for salvage therapy of refractory detrusor overactivity following augmentation enterocystoplasty

Objective: The objective of this article is to assess the effect of intravesical onabotulinum toxin A (OBTX-A) injections in patients with persistent/refractory symptomatic detrusor overactivity (DO) and urge urinary incontinence (UUI) following previous augmentation enterocystoplasty. Patients and methods: We conducted a retrospective review of all patients with previous augmentation enterocystoplasty having intravesical OBTX-A for persistent/refractory DO and UUI. Information on demographics, original diagnosis, date and technique of enterocystoplasty, dose of OBTX-A and symptomatic outcomes was recorded. Results: Fifteen patients (three men) with mean age 42 years were studied. Eight out of 15 (53%) reported complete continence or significant improvement, while the remaining seven (47%) noticed no difference in their symptoms. Urodynamics were repeated in these seven patients and persistent DO was confirmed. Four out of five (80%) NDO patients who received 300 U of OBTX-A reported a favourable outcome, whereas a favourable response was noted in only four out of 10 IDO (40%) when smaller amounts of OBTX-A (100 U or 200 U) were used. Conclusions: Intravesical OBTX-A injections completely resolved or significantly improved persistent/recurrent symptoms of DO in 53% of patients with a previous augmentation enterocystoplasty. The success rate was higher for those receiving the higher dose of 300 U and/or those with NDO.

Reduction of urgency severity is the most important factor in the subjective therapeutic outcome of intravesical onabotulinumtoxinA injection for overactive bladder.

This study investigated the relationship between the subjective outcome assessment and objective parameters after intravesical onabotulinumtoxinA injection in patients with overactive bladder (OAB). A total of 77 consecutive patients with urodynamically confirmed detrusor overactivity were treated with intravesical 100 U of onabotulinumtoxinA in 20 divided injections (5 U in 0.5 ml normal saline each) at different sites sparing the trigone. The primary end-point was the change in the Global Response Assessment (GRA) 3 months after treatment. All patients were monitored monthly after treatment for up to 6 months. Patients were divided into successful and failed treatment groups according to change in their GRA (≥2 and ≤1, respectively) at 3 months. The changes in voiding diary variables, Urgency Severity Score (USS), Overactive Bladder Symptom Score (OABSS), maximal bladder capacity (MBC), post-void residual (PVR) volume, and voiding efficiency (VE) were compared between groups at each time point. Overall, USS, OABSS, and MBC improved after treatment. Three months after BoNT-A injection, 49 (64%) patients reported an improvement in the GRA of 2 (n = 30) or 3 (n = 19). Patients with GRA ≥ 2 had significant improvements in OABSS at 3 months, and USS, OABSS, urgency urinary incontinence (UUI), and urgency episodes at 6 months compared with patients with GRA ≤ 1. No significant difference in MBC, PVR, or VE was noted between groups at 3 or 6 months. Subjectively successful treatment outcomes of intravesical onabotulinumtoxinA injection for OAB patients were associated with improvement in OAB symptoms but not increased bladder capacity. Neurourol. Urodynam. 36:338-343, 2017. © 2015 Wiley Periodicals, Inc.

Long-Term Efficacy and Safety of Repeated Intravescial OnabotulinumtoxinA Injections Plus Hydrodistention in the Treatment of Interstitial Cystitis/Bladder Pain Syndrome.

Intravesical onabotulinumtoxinA (BoNT-A) injection can relieve symptoms of interstitial cystitis/bladder pain syndrome (IC/BPS), but lacks sustainability. Repeated injections have been shown to provide a superior outcome to a single injection, but data on long-term efficacy and safety is limited. In this prospective study, we enrolled patients with refractory IC/BPS, and treated them with 100 U of BoNT-A injection plus hydrodistention followed by repeated injections every six months for up to two years or until the patient wished to discontinue. A “top-up” dose was offered after the fourth injection. Of these 104 participants, 56.7% completed four BoNT-A injections and 34% voluntarily received the fifth injection due to exacerbated IC symptoms. With a follow-up period of up to 79 months, O’Leary-Sant symptom and problem indexes (ICSI, ICPI, OSS), pain visual analogue scale (VAS) functional bladder capacity, frequency episodes, and global response assessment (GRA) all showed significant improvement (p < 0.0001). Those who received repeated injections had a better success rate during the long-term follow-up period. The incidence of adverse events did not rise with the increasing number of BoNT-A injections. A higher pre-treatment ICSI and ICPI score was predictive for successful response to repeated intravesical BoNT-A injections plus hydrodistention.

Intravesical botulinum toxin-A injections reduce bladder pain of interstitial cystitis/bladder pain syndrome refractory to conventional treatment - A prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial.

Intravesical onabotulinumtoxinA (BoNT-A) injection is a beneficial treatment for interstitial cystitis/bladder pain syndrome (IC/BPS), yet its therapeutic efficacy remains to be validated. This study tests efficacy and safety of intravesical BoNT-A injections for treatment of IC/BPS. A multicenter, randomized, double-blind, placebo-controlled trial in patients with IC/BPS refractory to conventional treatment. Patients were randomized in a 2:1 ratio to hydrodistention plus suburothelial injections of BoNT-A 100 U (Botox group) or the equivalent amount of normal saline (N/S group). The primary endpoint was a decrease in pain assessed using a visual analog scale (VAS) at week 8 after treatment. Secondary endpoints included voiding diary and urodynamic variables. The Wilcoxon sign rank and rank sum tests were used for statistical analyses. A total of 60 patients (8 males, 52 females, age 50.8 ± 13.9 years) including 40 in the Botox and 20 in the N/S groups were enrolled. At week 8, a significantly greater reduction of pain was observed in the Botox group compared to the N/S group (-2.6 ± 2.8 vs. -0.9 ± 2.2, P = 0.021). The other variables did not differ significantly between groups except for cystometric bladder capacity, which was increased significantly in the Botox group. The overall success rates were 63% (26/40) in the Botox group and 15% (3/20) in the N/S group (P = 0.028). Adverse events did not differ between the groups. Intravesical injections of 100 U of BoNT-A effectively reduced bladder pain symptoms in patients with IC/BPS. The adverse events were acceptable. Neurourol. Urodynam. 35:609-614, 2016. © 2015 Wiley Periodicals, Inc.

MP81-03 PREDICTIVE FACTORS FOR A SUCCESSFUL ONABOTULINUMTOXINA INJECTION TREATMENT FOR REFRACTORY INTERSTITIAL CYSTITIS/BLADDER PAIN SYNDROME

You have accessJournal of UrologyUrodynamics/Incontinence/Female Urology: Female Urology1 Apr 2015MP81-03 PREDICTIVE FACTORS FOR A SUCCESSFUL ONABOTULINUMTOXINA INJECTION TREATMENT FOR REFRACTORY INTERSTITIAL CYSTITIS/BLADDER PAIN SYNDROME Yuh-Chen Kuo, Dong-Ling Tang, and Hann-Chorng Kuo Yuh-Chen KuoYuh-Chen Kuo More articles by this author , Dong-Ling TangDong-Ling Tang More articles by this author , and Hann-Chorng KuoHann-Chorng Kuo More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2015.02.2881AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Although intravesical injection of onabotulinumtoxinA (BoNT-A) has been proved to be promising in treating patients with interstitial cystitis/bladder pain syndrome (IC/BPS), what kind of patients may benefit from this treatment modality remains unclear. We conducted this study to find out the predictors for a successful treatment outcome. METHODS Patients with IC/BPS who failed conventional treatments were prospectively enrolled. They underwent intravesical injection of 100 U of BoNT-A immediately followed by cystoscopic hydrodistention under intravenous general anesthesia. Variables such as O'Leary-Sant symptom and problem indexes (ICSI and ICPI), bladder pain visual analogue scale (VAS), functional bladder capacity (FBC), daily urinary frequency, nocturia and urodynamic parameters were measured at baseline and 6 months after treatment. Global response assessment (GRA) was obtained to evaluate the treatment outcome 6 months after therapy. GRA≥2 was defined as a successful result. Univariate and multivariate logistic regression analyses were used to identify variables predicting treatment success at 6 months after BoNT-A injection. RESULTS A total of 101 patients (13 men and 88 women) were enrolled in our study. Significant improvements could be observed in mean ICSI, ICPI, OSS (ICSI+ICPI), pain VAS, FBC, frequency, nocturia and GRA at 6 months after BoNT-A injections (Table 1). The successful rate at 6 month after BoNT-A injection was 46/101 (45.54%). In addition, univariate logistic regression revealed significant relationships between the treatment outcome and baseline ICSI, ICPI, OSS, FBC, frequency and urodynamic parameter FD (all p<0.05). However, multivariate logistic regression model showed the baseline ICSI score (odds ratio = 0.770, 95% confidence interval = 0.601-0.989) was the only predictive factor for a treatment outcome. ICSI≥12 was the most predictive cutoff value for treatment failure, with a ROC area of 0.70 (sensitivity = 69.1%, specificity = 60.9%). CONCLUSIONS The baseline ICSI is an independent predictor for BoNT-A injection in treating patients with refractory IC/PBS. The finding could serve as an initial guide or assist in consultation regarding the treatment of IC/BPS patients with BoNT-A. Table 1. Univariate and multivariate logistic regressions of baseline variables for a successful treatment outcome at 6 months after BoNT-A injection Variables Treatment outcome Univariate Multivariate Successful (N = 46) Failed (N = 55) OR (95% CI) p Value OR (95% CI) p Value ICSI 11.15±3.47 13.33±3.07 0.811 (0.709-0.928) 0.002 0.770 (0.601-0.989) 0.040 ICPI 10.76±3.34 11.98±2.65 0.869 (0.756-0.999) 0.048 1.106 (0.853-1.435) 0.447 FBC (mL) 151.96±82.75 109.55±63.09 1.008 (1.002-1.014) 0.007 1.003 (0.996-1.010) 0.389 Frequency 13.37±5.02 17.07±9.04 0.922 (0.861-0.989) 0.023 1.011 (0.904-1.053) 0.531 FD (mL) 191.12±68.71 154.17±73.74 1.007 (1.001-1.014) 0.021 1.005 (0.998-1.012) 0.171 ICSI:OιLeary-Sant symptom index; ICPI: OιLeary-Sant problem index; FBC: functional bladder capacity; FD: first desire to void © 2015 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 193Issue 4SApril 2015Page: e1028-e1029 Advertisement Copyright & Permissions© 2015 by American Urological Association Education and Research, Inc.MetricsAuthor Information Yuh-Chen Kuo More articles by this author Dong-Ling Tang More articles by this author Hann-Chorng Kuo More articles by this author Expand All Advertisement Advertisement PDF DownloadLoading ...

Urinary retention rates after intravesical onabotulinumtoxinA injection for idiopathic overactive bladder in clinical practice and predictors of this outcome.

The purpose of this study was to find the rate of urinary retention in clinical practice after treatment with onabotulinumtoxinA (BTN/A) for refractory overactive bladder (OAB) symptoms and determine factors that predict this outcome. This is a retrospective study of BTN/A for treatment of non-neurogenic, refractory OAB symptoms. Patients were analyzed with respect to their first and second BTN/A injections. The primary outcome measure was postoperative urinary retention. Statistical significance was assessed with multivariate logistic regression. Based on inclusion and exclusion criteria, the study population was 160. Mean age was 64 ± 13.2 years and 24% of the patients were men. The rate of urinary retention was 35% (n = 56). For the first BTN/A treatment, multivariate analysis revealed that preoperative PVR (post-void residual volume) (OR 1.27, 95% CI 1.13-1.43, P < 0.001) and preoperative bladder capacity (OR 1.05, 95% CI 1.01-1.08, P = 0.005) were associated with postoperative urinary retention. In patients with a preoperative PVR of ≥100 ml, 94% (n = 17) went into urinary retention. For those who underwent a second BTN/A treatment, preoperative PVR, BTN/A units injected and retention after the first BTN/A were associated with an increased rate of postoperative retention. Increased preoperative PVR was associated with urinary retention. The retention rate is higher than that reported in recent clinical trials. The inclusion of patients with a preoperative PVR ≥100 ml and a lower threshold to initiate clean intermittent catheterization contributed to this high rate of retention.

578 The efficacy of intravesical onabotulinumtoxin-A injection in the treatment of interstitial cystitis/bladder pain syndrome: A randomized, double-blind, placebo controlled study

578 The efficacy of intravesical onabotulinumtoxin-A injection in the treatment of interstitial cystitis/bladder pain syndrome: A randomized, double-blind, placebo controlled study

Increased Risk of Large Post-Void Residual Urine and Decreased Long-Term Success Rate After Intravesical OnabotulinumtoxinA Injection for Refractory Idiopathic Detrusor Overactivity

Increased Risk of Large Post-Void Residual Urine and Decreased Long-Term Success Rate After Intravesical OnabotulinumtoxinA Injection for Refractory Idiopathic Detrusor Overactivity

Down Regulation of Vascular Endothelial Growth Factor Is Associated With Decreased Inflammation After Intravesical OnabotulinumtoxinA Injections Combined With Hydrodistention for Patients With Interstitial Cystitis—Clinical Results and Immunohistochemistry Analysis

To measure the expression of vascular endothelial growth factor (VEGF) in bladder tissue and improvement of clinical symptoms and inflammatory biomarkers after repeated onabotulinumtoxinA injections in patients with interstitial cystitis/bladder pain syndrome (IC/BPS). Twenty-one patients with IC/BPS received 4 sets of intravesical 100-U onabotulinumtoxinA injections combined with hydrodistention. Assessments at baseline and 6 months after each treatment included O'Leary-Sant Symptom Score, bladder pain visual analog scale, functional bladder capacity (FBC), grade of glomerulations under cystoscopic hydrodistention, and urodynamic parameters. The bladder specimens at baseline and at the fourth treatment were investigated by western blotting for the expression of VEGF, Bcl-2-associated X protein (Bax), and phospho-p38 (p-p38), and immunohistochemistry staining for apoptotic and mast cell activity. Six women with genuine stress urinary incontinence served as controls for comparison. The measured immunohistochemical parameters were significantly higher in patients with IC/BPS than the controls. Statistically significant decrease in the expression of VEGF was noted in patients treated with repeated onabotulinumtoxinA injections compared with baseline (0.83 ± 0.28 vs 1.00; P = .016). The apoptotic cell count (0.86 ± 1.00 vs 1.76 ± 1.69; P = .026) and mast cell activity (1.81 ± 2.29 vs 5.82 ± 4.97; P = .009) were also reduced. Significant increases in FBC and global response assessment score were also observed after onabotulinumtoxinA treatment; however, except for mast cell activity, VEGF expression and apoptotic cell count were still significantly higher than the controls. Increased VEGF was associated with bladder inflammation and smaller FBC in patients with IC/BPS and decreased after repeated onabotulinumtoxinA injections and hydrodistention, suggesting VEGF plays an important role in the pathogenesis of IC/BPS.

Diabetes mellitus does not affect the efficacy and safety of intravesical onabotulinumtoxina injection in patients with refractory detrusor overactivity

To investigate the efficacy and safety of intravesical onabotulinumtoxinA injection in patients with diabetes mellitus (DM) and refractory detrusor overactivity (DO). Forty-eight type 2 DM patients with refractory DO received intravesical 100 U onabotulinumtoxinA injection. Another 48 age-matched patients were randomly selected from a non-diabetic group as controls. Video-urodynamic studies were performed at baseline and were repeated 3 months after treatment. The treatment outcomes were graded on the basis of changes in the Patient's Perception of Bladder Condition (PPBC) and a PPBC decrease of 2 or more points was considered successful. Treatment-related adverse events including acute urinary retention, large post-voiding residual (PVR) volumes, straining to void, urinary tract infection, hematuria, and general weakness were recorded. The mean ages of the diabetic and non-diabetic patients were 73.1 ± 8.8 and 72.0 ± 9.3 (P = 0.552), respectively. The changes of urodynamic parameters were comparable between the two groups. Similar successful results were noted at the 6-month follow-up (DM, 56% vs. non-DM, 61%, P = 0.128). Diabetic patients had a significantly greater incidence of large PVR volumes (DM, 60.4% vs. non-DM, 33.3%; P = 0.007) and general weakness (DM, 10.4% vs. non-DM, 0%; P = 0.03) after treatment. Baseline urodynamic parameters in diabetic patients did not predict the occurrence of adverse events. No major complication was noted in either group. Intravesical onabotulinumtoxinA injection is a safe and effective treatment for DM patients with refractory DO. Patients with DM should be informed of the increased risk of large PVR before initiation of treatment.

Repeated intravesical onabotulinumtoxinA injections are effective in treatment of refractory interstitial cystitis/bladder pain syndrome

To evaluate the efficacy and safety of repeated intravesical onabotulinumtoxinA (BoNT-A) injections for treatment of interstitial cystitis/bladder pain syndrome (IC/BPS). Patients confirmed to have IC/BPS and refractory to conventional treatments were treated with intravesical injections of 100 U of BoNT-A plus hydrodistention every 6 months for up to four times. Primary end-point was 6 months after the fourth BoNT-A injection. Measured parameters included O'Leary-Sant symptom score (OSS) including symptom and problem indexes (ICSI/ICPI), visual analogue score (VAS) for pain, voiding diary variables, urodynamic parameters, maximal bladder capacity (MBC), glomerulation grade, and global response assessment (GRA). Multiple measurements and Wilcoxon rank-sum test were used for comparison between groups. In overall patients, GRA, OSS, ICSI and ICPI scores, VAS, functional bladder capacity (FBC) and cystometric bladder capacity (CBC) all showed significant improvement. The glomerulation grade decreased (1.77 ± 1.06 vs. 1.19 ± 1.05, p = 0.026), but MBC remained unchanged. Among 31 patients, 19 (61%) had a GRA ≥ 2 and 12 (39%) had a GRA < 2 at end-point. Patients with a GRA ≥ 2 had significantly greater changes in OSS, ICPI, VAS, FBC and CBC than patients with a GRA < 2. Extended study revealed that persistent symptomatic improvement lasted 6-12 months in seven, 13-22 months in six and 23-51 months in six after the fourth BoNT-A injection. Five women who had GRA < 2 were found to have Hunner's ulcer. Lack of control is the main limitation. Four repeated intravesical BoNT-A injections were safe and effective for symptom and pain relief and increased bladder capacity for treatment of IC/BPS.

Increased Risk of Large Post-Void Residual Urine and Decreased Long-Term Success Rate After Intravesical OnabotulinumtoxinA Injection for Refractory Idiopathic Detrusor Overactivity

Increased Risk of Large Post-Void Residual Urine and Decreased Long-Term Success Rate After Intravesical OnabotulinumtoxinA Injection for Refractory Idiopathic Detrusor Overactivity

Protein expression profiling in interstitial cystitis/painful bladder syndrome: A pilot study of proteins associated with inflammation, apoptosis, and angiogenesis

ObjectiveProtein arrays are rapidly becoming a powerful means to detect proteins, monitor their expression levels, and investigate protein interactions and functions. We used this technology and demonstrated its application in identifying potential biomarkers for the diagnosis and treatment of interstitial cystitis/painful bladder syndrome (IC/PBS). Materials and MethodsTo compare the expression profiles of 40 proteins related to inflammation, 30 proteins related to apoptosis, and 20 proteins related to angiogenesis, we performed a protein array assay using bladder tissues of three normal and six IC/PBS patients and urine samples at the baseline and after three repeated intravesical onabotulinumtoxinA injections. Different protein expression levels were determined using the Image J process. After the onabotulinumtoxinA injections, urine samples of IC/PBS the patient were analyzed using angiogenesis proteins, and results were compared with the untreated baseline data. ResultsOf all inflammatory antigens, 15 were slightly promoted in the IC/PBS patients' bladder tissues. Moreover, 80% of proapoptotic proteins and 10% of antiapoptotic proteins on the protein array increased. We also found that several angiogenesis cytokines decreased in the urine of the IC/PBS patients after the onabotulinumtoxinA injections. ConclusionOur results indicate that several signal transduction pathways are involved in the pathophysiology of IC/PBS and provide valuable information on the signal networks of different pathways in IC/PBS, including inflammation, apoptosis, and angiogenesis. This is a powerful database to further investigate molecular mechanisms of IC/PBS.

Increased Risk of Large Post-Void Residual Urine and Decreased Long-Term Success Rate After Intravesical OnabotulinumtoxinA Injection for Refractory Idiopathic Detrusor Overactivity

Intravesical injection of onabotulinumtoxinA is effective for idiopathic detrusor overactivity refractory to antimuscarinics. However, safety is a major concern, especially in elderly individuals. We investigated the efficacy and safety of intravesical onabotulinumtoxinA injection for refractory idiopathic detrusor overactivity in the frail elderly population. A total of 166 patients with urodynamic idiopathic detrusor overactivity refractory to previous antimuscarinics for more than 3 months received 1 intravesical 100 U onabotulinumtoxinA injection from 2004 to 2009. Frail elderly was defined as age greater than 65 years and 3 or more of certain criteria, including unintentional weight loss, self-reported exhaustion, weakness, slow walking speed and/or low physical activity. Treatment results were assessed by the Patient Perception of Bladder Condition, voiding diary, urodynamic parameters and Kaplan-Meier estimates of survival plots. We evaluated 61 frail elderly patients, 63 who were elderly without frailty and 42 younger than 65 years. Large post-void residual urine volume (greater than 150 ml) after onabotulinumtoxinA injection was significantly higher in the frail elderly group than in the other groups (60.7% vs 39.7% and 35.7%, respectively, p = 0.018). Urinary retention developed in 7 frail elderly patients (11.5%), 4 (6.3%) who were elderly without frailty and 1 younger patient (2.4%) (p = 0.203). Recovery duration was significantly longer in frail elderly patients. The cumulative success rate was significantly lower in the frail elderly group than in the other 2 groups (p = 0.009). Although safety and efficacy were similar between elderly patients without frailty and younger patients, an increased risk of large post-void residual urine volume and a lower long-term success rate in frail elderly patients were noted after intravesical onabotulinumtoxinA injection for refractory idiopathic detrusor overactivity.

Intravesical OnabotulinumtoxinA Injections for Refractory Painful Bladder Syndrome

Background: Bladder pain associated with interstitial cystitis and painful bladder syndrome (IC/PBS) is frequently excruciating and intractable. The use of onabotulinumtoxinA (BoNT-A) for relief of this type of bladder pain has not been well described. Objectives: To evaluate the efficacy and safety of intravesical BoNT-A injection for treatment of IC/PBS refractory to conventional treatment. Study Design: Prospective, non-randomized study. Setting: A tertiary medical center in Taiwan. Methods: Sixty-seven patients with characteristic IC/PBS were enrolled. Intravesical injection of 100U of BoNT-A immediately followed by cystoscopic hydrodistention under intravenous general anesthesia. Changes of the urodynamic parameters, O’Leary-Sant Interstitial Cystitis Symptom Index (ICSI) and Interstitial Cystitis Problem Index (ICPI), visual analog score (VAS) for pain, functional bladder capacity, and global response assessment (GRA) were evaluated at baseline and 6 months after BoNT-A injection. Adverse events that occurred after this procedure were also assessed. Results: Significant improvement was shown after intravesical injection of 100 U of BoNT-A. Baseline and 6 months after injection scores were: ICSI and ICPI (23.6 ± 5.9 versus 15.2 ± 8.5, P = 0.000), VAS (5.3 ± 2.2 versus 3.3 ± 2.4, P = 0.000), functional bladder capacity (136 ± 77.6 versus 180 ± 78.2, P = 0.000) and GRA (0.3 ± 0.8 versus 1.4 ± 1.0, P = 0.000). Limitations: This study lacks a placebo control group so the placebo effect cannot be eliminated. This study also does not provide information about the efficacy of this treatment after 6 months. Conclusion: Intravesical onabotulinumtoxinA injection appears to be a safe and effective therapeutic option for analgesia and increased bladder capacity for patients with IC/PBS. Institutional Review: This study was approved by the Institutional Review Board of the Buddhist Tzu-chi General Hospital. Key words: Botulinum toxin, interstitial cystitis/painful bladder syndrome, intravesical treatment, bladder pain