BCGitis con afectación de aneurisma aortoilíaco: aportación de dos casos y revisión de la literatura / BCGitis with aortoiliac aneurysm involvement: Report of two cases and review of the literature

La BCGitis es una complicación infrecuente del tratamiento intravesical con Bacillus Calmette-Guérin para el cáncer superficial de vejiga de alto grado y el carcinoma in situ. Puede causar afectación vascular. Presentamos 2 casos y una revisión de la literatura de series de casos publicadas en los 10 años previos a la finalización de este trabajo en abril de 2022, que describiesen un caso de aneurisma micótico aortoilíaco tras recibir este tratamiento. De los 51 casos incluidos (49 revisados y 2 originales), el 100% eran hombres, 82% tenían más de 65 años. La mediana del período de latencia fue de 15 meses (RIQ 18). La localización más frecuente fue la aorta abdominal, documentándose rotura en el 45,1%. El síntoma más frecuente fue dolor abdominal o lumbar (61%), seguido de síndrome general (49%). Asoció absceso retroperitoneal un 39,2%. La mortalidad atribuible fue de 13,6%. La BCGitis debería incluirse como diagnóstico diferencial de pacientes que hayan recibido terapia con BCG y presenten afectación vascular, incluso años tras el tratamiento.(AU)

BCGitis is a rare complication after intravesical administration of Bacillus Calmette-Guérin for high-grade superficial bladder cancer and carcinoma in situ. May cause vascular involvement. We present two cases and a review of the literature of the case reports published on the 10 years prior to April of 2022, when this project was finished, which described a case of aortoiliac mycotic aneurysm after receiving this treatment. Of the 51 cases included (49 revised and 2 original), 100% were men, 82% were older than 65 years. The median latency period was 15 months (IQR 18). The most frequent location was the abdominal aorta, rupture occurred in 45.1% of patients. The most frequent symptom was abdominal or lumbar pain (61%), followed by general syndrome (49%). In 39.2% cases, it was associated with retroperitoneal abscesses. Attributable mortality was 13.6%. BCGitis should be included in the differential diagnosis in patients who have received BCG therapy and present vascular involvement, even years after being treated.(AU)

BCGitis with aortoiliac aneurysm involvement: Report of two cases and review of the literature.

BCGitis is a rare complication after intravesical administration of Bacillus Calmette-Guérin for high-grade superficial bladder cancer and carcinoma in situ. May cause vascular involvement. We present 2 cases and a review of the literature of the case reports pubished on the 10 years prior to April of 2022, when this proyect was finished, which described a case of aortoiliac mycotic aneurysm after receiving this treatment. Of the 51 cases included (49 revised and 2 original), 100% were men, 82% were older than 65 years. The median latency period was 15 months (IQR 18). The most frequent location was the abdominal aorta, rupture occurred in 45,1% of patients. The most frequent symptom was abdominal or lumbar pain (61%), followed by general syndrome (49%). In 39,2% cases, it was associated with retroperitoneal abscesess. Attributable mortality was 13,6%. BCGitis should be included in the differential diagnosis in patients who have received BCG therapy and present vascular involvement, even years after being treated.

Protocol of the Comparison of Intravesical Therapy and Surgery as Treatment Options (CISTO) study: a pragmatic, prospective multicenter observational cohort study of recurrent high-grade non-muscle invasive bladder cancer.

BACKGROUND: Bladder cancer poses a significant public health burden, with high recurrence and progression rates in patients with non-muscle-invasive bladder cancer (NMIBC). Current treatment options include bladder-sparing therapies (BST) and radical cystectomy, both with associated risks and benefits. However, evidence supporting optimal management decisions for patients with recurrent high-grade NMIBC remains limited, leading to uncertainty for patients and clinicians. The CISTO (Comparison of Intravesical Therapy and Surgery as Treatment Options) Study aims to address this critical knowledge gap by comparing outcomes between patients undergoing BST and radical cystectomy. METHODS: The CISTO Study is a pragmatic, prospective observational cohort trial across 36 academic and community urology practices in the US. The study will enroll 572 patients with a diagnosis of recurrent high-grade NMIBC who select management with either BST or radical cystectomy. The primary outcome is health-related quality of life (QOL) at 12 months as measured with the EORTC-QLQ-C30. Secondary outcomes include bladder cancer-specific QOL, progression-free survival, cancer-specific survival, and financial toxicity. The study will also assess patient preferences for treatment outcomes. Statistical analyses will employ targeted maximum likelihood estimation (TMLE) to address treatment selection bias and confounding by indication. DISCUSSION: The CISTO Study is powered to detect clinically important differences in QOL and cancer-specific survival between the two treatment approaches. By including a diverse patient population, the study also aims to assess outcomes across the following patient characteristics: age, gender, race, burden of comorbid health conditions, cancer severity, caregiver status, social determinants of health, and rurality. Treatment outcomes may also vary by patient preferences, health literacy, and baseline QOL. The CISTO Study will fill a crucial evidence gap in the management of recurrent high-grade NMIBC, providing evidence-based guidance for patients and clinicians in choosing between BST and radical cystectomy. The CISTO study will provide an evidence-based approach to identifying the right treatment for the right patient at the right time in the challenging clinical setting of recurrent high-grade NMIBC. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03933826. Registered on May 1, 2019.

Safety, Tolerability, and Preliminary Efficacy of TAR-200 in Patients With Muscle-invasive Bladder Cancer Who Refused or Were Unfit for Curative-intent Therapy: A Phase 1 Study.

PURPOSE: Half of patients with muscle-invasive bladder cancer worldwide may not receive curative-intent therapy. Elderly or frail patients are most affected by this unmet need. TAR-200 is a novel, intravesical drug delivery system that provides sustained, local release of gemcitabine into the bladder over a 21-day dosing cycle. The phase 1 TAR-200-103 study evaluated the safety, tolerability, and preliminary efficacy of TAR-200 in patients with muscle-invasive bladder cancer who either refused or were unfit for curative-intent therapy. MATERIALS AND METHODS: Eligible patients had cT2-cT3bN0M0 urothelial carcinoma of the bladder. TAR-200 was inserted for 4 consecutive 21-day cycles over 84 days. The primary end points were safety and tolerability at 84 days. Secondary end points included rates of clinical complete response and partial response as determined by cystoscopy, biopsy, and imaging; duration of response; and overall survival. RESULTS: Median age of the 35 enrolled patients was 84 years, and most were male (24/35, 68.6%). Treatment-emergent adverse events related to TAR-200 occurred in 15 patients. Two patients experienced treatment-emergent adverse events leading to removal of TAR-200. At 3 months, complete response and partial response rates were 31.4% (11/35) and 8.6% (3/35), respectively, yielding an overall response rate of 40.0% (14/35; 95% CI 23.9-57.9). Median overall survival and duration of response were 27.3 months (95% CI 10.1-not estimable) and 14 months (95% CI 10.6-22.7), respectively. Progression-free rate at 12 months was 70.5%. CONCLUSIONS: TAR-200 was generally safe, well tolerated, and had beneficial preliminary efficacy in this elderly and frail cohort with limited treatment options.

Clinical and Preclinical Therapies for Bladder Cancer Following Bacillus Calmette-Guérin Failure.

PURPOSE: Intravesical bacillus Calmette-Guérin is the current first-line treatment for high-grade nonmuscle-invasive bladder cancer; however, a substantial proportion of patients are unresponsive to bacillus Calmette-Guérin treatment. While cystectomy is often recommended in bladder cancer following bacillus Calmette-Guérin failure, there are numerous established therapeutic agents and pre-commercialized trials describing treatments for nonmuscle-invasive bladder cancer following failed bacillus Calmette-Guérin treatment. Our objective in this systematic review is to characterize the efficacy of these therapeutic agents by reporting their corresponding complete response rates and toxicity profiles. MATERIALS AND METHODS: We conducted a systematic review of all available clinical trials evaluating therapies to treat recurring nonmuscle-invasive bladder cancer after previous intravesical bacillus Calmette-Guérin. Bacillus Calmette-Guérin failure patients who had previously failed 1 or more courses of prior bacillus Calmette-Guérin therapy were included. Studies that were not in the English language, included muscle-invasive bladder cancer patient populations, or lacked a post-treatment evaluation of response were excluded. We used PubMed/Medline, the Cochrane Library, and Embase to search for relevant studies. No formal risk of bias assessment was conducted. Complete response rates for 3, 6, 12, and 24 months post-treatment evaluation, progression rates, cystectomy rates, and 12 complications are reported. RESULTS: A total of 70 studies with 73 reports evaluating 27 treatment options were retained for final analysis. These treatments were reported in 5 categories including intravesical chemotherapy, combination therapy, hyperthermia paired with intravesical chemotherapy, immunotherapy, and novel agents, with published years ranging from 1998 to 2021. Single intravesical chemotherapy and the combination of multiple intravesical chemotherapy agents demonstrate varied complete response rates of 10%-83% at 12 months. Limited clinical data evaluating hyperthermia paired with chemotherapy demonstrate 12-month complete response rates of 50%-85%. Despite these reported response rates, progression rates ranged from 0%-18%. Moreover, immunotherapeutic agents demonstrate progression rates of 7% to 22% at a median of 12 months of follow-up. Novel agents displayed a wide range of complete response rates (6% to 91%) at 12 months based on the treatment used. Total grade 3 toxicity rates range from 0%-55% for intravesical chemotherapy and combination intravesical chemotherapy agents, 0%-15% for hyperthermia paired with chemotherapy agents, 12%-13% for immunotherapy agents, and 0%-17% for novel agents. CONCLUSIONS: Bladder-preserving treatments accomplish moderate success in nonmuscle-invasive bladder cancer following bacillus Calmette-Guérin failure. As the majority of available clinical trials are single-armed uncontrolled cohorts and contain a limited number of patients, strength and comparability of the data are limited. In general, intravesical chemotherapy and hyperthermia paired with mitomycin C demonstrate some of the highest complete response rates at 12 and 24 months. Similarly, among the pre-commercialized novel agents, N-803 and gene therapy display promising results and may serve as potential future treatment for nonmuscle-invasive bladder cancer following failed bacillus Calmette-Guérin treatment. In terms of toxicity/complication rates, both commercially available and unavailable treatments showcase low toxicity profiles for bladder cancer following bacillus Calmette-Guérin failure. The comprehensive analysis provided by this systematic review can serve as a reference for treatment decisions and clinical trial design in the bacillus Calmette-Guérin-unresponsive domain.

Low-dose versus standard-dose bacille Calmette-Guérin for non-muscle-invasive bladder cancer: Systematic review and meta-analysis of randomized controlled trials.

PURPOSE: Intravesical BCG (bacille Calmette-Guérin) instillation in patients with non-muscle-invasive bladder cancer decreases the risk for tumor recurrence and progression. After one BCG product was discontinued, a chronic global BCG shortage occurred. We focused on identifying a reduced dose of BCG that could maintain efficacy and reduce adverse effects. MATERIALS AND METHODS: We conducted a comprehensive literature search of PubMed, Embase, the Cochrane Library, CINAHL, Web of Science, and Scopus to identify randomized controlled trials through April 2021. The odds ratios (ORs) and 95% confidence intervals (CIs) for the low and standard doses in nine studies were compared. A low dose was defined as a low volume of BCG compared with the standard BCG dose (Armand Frappier, 120 mg; Connaught, 81 mg; Danish 1331, 120 mg; modified Danish 1331, 120 mg; Tokyo 172, 80 mg). RESULTS: The low-dose group experienced aggravated recurrence (OR, 1.45; 95% CI, 1.09-1.94; p=0.01) but similar progression (OR, 1.11; 95% CI, 0.76-1.62; p=0.59), similar cancer-specific survival (OR, 1.02; 95% CI, 0.60-1.75; p=0.93), similar overall survival (OR, 1.09; 95% CI, 0.76-1.56; p=0.65), favorable adverse effects (OR, 0.41; 95% CI, 0.28-0.62; p<0.0001), and favorable withdrawal (OR, 0.42; 95% CI, 0.25-0.71; p=0.001). CONCLUSIONS: Low-dose BCG had more unfavorable outcomes than did standard-dose BCG in terms of recurrence. Tumor progression, cancer-specific survival, and overall survival were similar between the doses. Low-dose BCG improved adverse effects and withdrawal. In the setting of BCG shortage, low-dose BCG may have strong potential as an alternative.

Improving Rates of Immediate Postoperative Intravesical Chemotherapy with Gemcitabine for Low-Grade Bladder Cancer: An Implementation Analysis.

INTRODUCTION: We sought to demonstrate how an implementation science framework can be used to increase rates of postoperative intravesical chemotherapy with gemcitabine in patients with low-grade, nonmuscle-invasive bladder cancer, thereby improving the quality of cancer care. METHODS: An audit performed at 2 University of Rochester Medical Center hospitals involved in the SWOG S0337 trial identified low usage rates of postoperative intravesical chemotherapy once study accrual closed. The Consolidated Framework for Implementation Research guided an evaluation of barriers to adoption of this evidence-based practice. Methods employed included an online survey of urologists' perceptions of postoperative gemcitabine, face-to-face interviews with key stakeholders and direct observation of utilization processes. Subsequent implementation strategies were mapped to identified barriers; educational training for urologists and support staff and refining workflow processes were critical aspects of the intervention. Repeat usage audits measured practice change at 1 year. RESULTS: The pre-intervention rate of appropriate use of intravesical gemcitabine was 11% at Strong Memorial Hospital and increased to 78% after 4 months and 88% after 12 months. The pre-intervention rate was 37% at Highland Hospital and increased to 82% after 4 months and 94% after 12 months. Over the period audited, 8 patients received gemcitabine who ultimately had nonlow-grade histology. CONCLUSIONS: Implementation science can be used to improve the impact of evidence-based findings in urological practice. The Consolidated Framework for Implementation Research has been used extensively in the literature and was adapted for postoperative intravesical chemotherapy with gemcitabine. This approach is feasible, generalizable, and results in durable practice change.

Intravesical sequential gemcitabine and docetaxel versus bacillus calmette-guerin (BCG) plus interferon in patients with recurrent non-muscle invasive bladder cancer following a single induction course of BCG.

INTRODUCTION: Repeat BCG induction remains an option for select non-muscle invasive bladder cancer (NMIBC) patients who fail initial therapy. Alternative salvage intravesical regimens such as Gemcitabine and Docetaxel (Gem/Doce) have been investigated. We aimed to compare the efficacy BCG plus interferon a-2b (BCG/IFN) and Gem/Doce in patients with recurrent NMIBC after a single prior BCG course. METHODS: The National Phase II BCG/IFN trial database and multi-institutional Gem/Doce database were queried for patients with recurrent NMIBC after one prior BCG induction course, excluding those with BCG unresponsive disease. Stabilized inverse probability treatment weighted survival curves were estimated using the Kaplan-Meier method and compared. Propensity scores were derived from a logistic regression model. The primary outcome was recurrence free survival (RFS); secondary outcomes were high-grade (HG) RFS and risk factors for treatment failure. RESULTS: We identified 197 BCG/IFN and 93 Gem/Doce patients who met study criteria. Patients receiving Gem/Doce were older and more likely to have HG disease, CIS, and persistent disease following induction BCG (all P < 0.01). After propensity score-based weighting, the adjusted 1- and 2-year RFS was 61% and 53% after BCG/IFN versus 68% and 46% after Gem/Doce (P = 0.95). Adjusted 1- and 2-year HG-RFS was 60% and 51% after BCG/IFN versus 63% and 42% after Gem/Doce (P = 0.68). Multivariable Cox regression revealed that Gem/Doce treatment was not associated with an increased risk of failure (HR = 0.97, P = 0.89) as compared to BCG/IFN. CONCLUSION: Patients with recurrent NMIBC after a single induction BCG failure and not deemed BCG unresponsive had similar oncologic outcomes with Gem/Doce and BCG/IFN in a post-hoc analysis. Additional prospective studies are needed.

Impact of bacillus Calmette-Guerin intravesical therapy on the diagnostic efficacy of The Paris System for Reporting Urinary Cytology in patients with high-grade bladder cancer.

BACKGROUND: In high-grade urothelial carcinoma (UC) of the bladder, bacillus Calmette-Guerin (BCG) therapy is a therapeutic mainstay, and urinary cytology is recommended to detect recurrences. However, intravesical BCG instillations can induce morphologic changes in urothelial cells. The authors investigated the impact of BCG therapy on the efficacy of urinary cytology. METHODS: Matched pathology and cytology samples from patients undergoing transurethral resection of the bladder after BCG therapy were assessed. Cytology samples were graded according to The Paris System for Reporting Urinary Cytology. Diagnostic quality criteria were tested for different cutoff definitions, and the results were compared between those obtained <100 versus ≥100 days after the last BCG instillation. In addition, the oncologic outcome of false-positive results was assessed. RESULTS: In total, 389 matched cases from 197 patients who had a history of high-grade UC (HGUC) were identified. Sixty cases (15.7%) were diagnosed as high-grade urothelial bladder cancer. The cytology diagnoses were as follows: non-HGUC, 191 cases (49.1%); atypical urothelial cells, 80 cases (20.6%); suspicious for HGUC, 56 cases (14.4%); and HGUC, 56 cases (14.4%). Interrater reliability was substantial (κ = 0.660). Sensitivity increased from 45% to 75% when cases diagnosed as suspicious for HGUC were also counted as positive. Notably, sensitivity was reduced within the first 100 days after BCG therapy (61.9%) compared with sensitivity at longer intervals (82.1%). Reactive atypia (odds ratio, 4.155; 95% confidence interval, 2.136-8.085; P < .001) and cellular degeneration (odds ratio, 5.050; 95% CI, 2.094-12.175; P < .001) of urothelial cells were associated with false-positive rates, and 44.7% of patients who had a false-positive cytology classification presented with HGUC during follow-up. CONCLUSIONS: BCG therapy has a short-term adverse impact on the efficacy of urinary cytology. After BCG therapy, cases classified as suspicious for HGUC should be considered positive. Importantly, patients with false-positive cytology findings should be closely monitored.

Intravesical gemcitabine for non-muscle invasive bladder cancer: An abridged Cochrane Review.

PURPOSE: To assess the comparative effectiveness and toxicity of intravesical gemcitabine instillation for non-muscle invasive bladder cancer (NMIBC). MATERIALS AND METHODS: We performed a comprehensive literature search on 11 September 2020. We included RCTs in which participants received intravesical gemcitabine for primary or recurrent NMIBC. Two review authors independently assessed the included studies and extracted data for the primary outcomes (time to recurrence, time to progression, grade III to V adverse events) and the secondary outcomes (time to death from bladder cancer, time to death from any cause, grade I or II adverse events, and disease-specific quality of life). We performed statistical analyses using a random-effects model and rated the certainty of the evidence using GRADE. RESULTS: We found seven studies with 1,222 participants. Gemcitabine may reduce the risk of recurrence over time, but may have a similar effect on progression and grade III to V adverse events compared to saline. Gemcitabine may reduce recurrence and progression compared to mitomycin. We are uncertain about the effect of gemcitabine on the grade III to V adverse events compared to mitomycin. Gemcitabine may reduce recurrence and progression compared to giving BCG again in recurrent high-risk NMIBC after BCG treatment. CONCLUSIONS: Based on the findings of this review, gemcitabine may have a favorable impact on recurrence and progression-free survival than saline and mitomycin but we are uncertain about how major adverse events compare. The same is true when comparing gemcitabine to BCG in individuals with high-risk diseases who have previously failed BCG.

Alkalinized lidocaine solution as a first-line local anesthesia protocol for intradetrusor injection of onabotulinum toxin A: Results from a double-blinded randomized controlled trial.

AIMS: Local anesthesia protocols for intradetrusor onabotulinum toxin A (BoNTA) injection lack standardization. We aimed to determine if an alkalinized lidocaine solution is more effective than lidocaine only. METHODS: Patients of both genders aged 18 or above enlisted for intradetrusor BoNTA injection (idiopathic, neurogenic, and bladder pain syndrome) were included in a double-blinded randomized controlled trial after obtaining their informed consent. All participants filled a bladder diary and a urine culture was performed. Subjects were randomized 1:1 to Protocol A (20 ml 2% lidocaine + 10 ml 8.4% sodium bicarbonate) or Protocol B (20 ml 2% lidocaine + 10 ml 0.9% saline solution). A Numeric Rating Scale (0-10) was used to assess the level of pain immediately after the procedure (primary endpoint). Secondary endpoints included pain after 1 h, urinary tract infection, acute urinary retention, and hematuria related to the procedure. RESULTS: A total of 116 patients were randomized. Baseline characteristics (age, sex, indication, and bladder diary parameters) of patients in Group A and B were similar. Pain scores at the end of the procedure were significantly lower with the alkalinized solution (Protocol A and B, respectively, 2.37 ± 0.31 vs. 4.44 ± 0.36, p < .01). No differences were observed 1 h after treatment (Protocol A and B, respectively, 0.54 ± 0.17 vs. 0.69 ± 0.19, p = .487). The only adverse event reported was mild-to-moderate self-limited hematuria in 15.4% of patients. CONCLUSIONS: The use of an alkalinized lidocaine solution has proven to be significantly superior to lidocaine only as local anesthesia before intradetrusor BoNTA injection, suggesting that this may be considered a first-line option.

Comparison of effects of transurethral enucleation of prostate and suprapubic prostatectomy in the treatment of massive prostatic hyperplasia / 中国基层医药

Objective To compare the clinical effects of transurethral prostatectomy (TUERP) and suprapubic prostatectomy(SP) in the treatment of massive prostatic hyperplasia.Methods The clinical data of 40 patients with benign prostatic hyperplasia ( BPH) with a volume range of 80 －150 mL from October 2015 to October 2017 in Shengjing Hospital of China Medical University were retrospectively analyzed .They were divided into two groups :TUERP group(20 cases) and SP group(20 cases).The length and distribution of large prostate were measured.The degree of hemoglobin decrease ,bladder irrigation time,operation time,indwelling catheter time ,maximum urine flow rate ( Qmax), international prostate symptom score ( IPSS), prostate specific antigen ( PSA), residual urine volume (PVR) and the incidence of complications were compared between the two groups before and after operation .Results It was found that the length of the prostatic fossa was less than 5 cm in patients with large prostatic hyperplasia whose volume ranged from 80 to 150 mL.After operation,the degree of hemoglobin decrease ,bladder irrigation time,indwelling catheter time and the incidence of complications in the TUERP group were (7.9 ±2.3)g／L,(42.5 ±3.6)h,(5.3 ± 1.1)d,15%(3／20),respectively,while in the SP group were (14.2 ±4.4)g／L,(62.6 ±6.0)h,(7.8 ±0.8)d and 50%(10／20),respectively,there were statistically significant differences between the two groups (t＝－5.7,－12.8,－8.6,χ2 ＝5.6,all P＜0.05).There were no statistically significant differences in operation time ,Qmax,IPSS,PSA and PVR between the two groups (all P＞0.05).Conclusion After TUERP treatment of large prostate hyperplasia , the improvement of urination and the decrease of PSA is similar to SP ,and the hemostasis effect is good ,the complica－tions are less and the recovery is faster.

Comparison of effects of transurethral enucleation of prostate and suprapubic prostatectomy in the treatment of massive prostatic hyperplasia / 中国基层医药

Objective@#To compare the clinical effects of transurethral prostatectomy(TUERP) and suprapubic prostatectomy(SP) in the treatment of massive prostatic hyperplasia.@*Methods@#The clinical data of 40 patients with benign prostatic hyperplasia(BPH) with a volume range of 80-150 mL from October 2015 to October 2017 in Shengjing Hospital of China Medical University were retrospectively analyzed.They were divided into two groups: TUERP group(20 cases) and SP group(20 cases). The length and distribution of large prostate were measured.The degree of hemoglobin decrease, bladder irrigation time, operation time, indwelling catheter time, maximum urine flow rate(Qmax), international prostate symptom score(IPSS), prostate specific antigen(PSA), residual urine volume(PVR) and the incidence of complications were compared between the two groups before and after operation.@*Results@#It was found that the length of the prostatic fossa was less than 5 cm in patients with large prostatic hyperplasia whose volume ranged from 80 to 150 mL.After operation, the degree of hemoglobin decrease, bladder irrigation time, indwelling catheter time and the incidence of complications in the TUERP group were (7.9±2.3)g/L, (42.5±3.6)h, (5.3±1.1)d, 15%(3/20), respectively, while in the SP group were (14.2±4.4)g/L, (62.6±6.0)h, (7.8±0.8)d and 50%(10/20), respectively, there were statistically significant differences between the two groups(t=-5.7, -12.8, -8.6, χ2=5.6, all P<0.05). There were no statistically significant differences in operation time, Qmax, IPSS, PSA and PVR between the two groups(all P>0.05).@*Conclusion@#After TUERP treatment of large prostate hyperplasia, the improvement of urination and the decrease of PSA is similar to SP, and the hemostasis effect is good, the complications are less and the recovery is faster.

Quadruple immunotherapy of Bacillus Calmette-Guérin, interferon, interleukin-2, and granulocyte-macrophage colony-stimulating factor as salvage therapy for non-muscle-invasive bladder cancer.

BACKGROUND: Bacillus Calmette-Guérin (BCG) is the most effective initial intravesical therapy for high-grade non-muscle invasive bladder cancer, but many patients still fail. Combination intravesical BCG and interferon (IFN) will salvage some patients but results remain suboptimal. OBJECTIVE: We hypothesized that further immunostimulation with intravesical interleukin-2 and subcutaneous granulocyte-macrophage colony-stimulating factor may improve response to intravesical BCG and IFN in patient with prior BCG failure(s). METHODS: A retrospective review was performed. Patients received 6 treatments of quadruple immunotherapy (intravesical solution with one-third dose BCG, 50 million units IFN, and 22 million units interleukin-2, along with a 250-mcg subcutaneous sargramostim injection). Surveillance began 4 to 6 weeks after treatment completion. Patients received maintenance if recurrence-free. Success was defined as no recurrence (bladder or extravesical) and bladder preservation. Analysis was performed by Kaplan-Meier method (P<0.05). RESULTS: Fifty-two patients received treatment with a median recurrence follow-up of 16.3 months and overall follow-up of 41.8 months. All patients had at least 1 prior BCG failure and 13% had 2 or more prior failures. Only 3 patients (6%) were unable to tolerate full induction. Treatment success was 55% at 1 year, and 53% at 2 years. Thirteen patients (25%) underwent cystectomy at a median time of 17.3 months with disease progression to T2 in 1 patient and T3 in 2 patients. No patients had positive surgical margins or positive lymph nodes. CONCLUSIONS: In patients with non-muscle-invasive bladder cancer with prior BCG failure, quadruple immunotherapy demonstrated good treatment success in some patients and warrants further evaluation.

Current progress of intravesical instillation therapy in interstitial cystitis/bladder pain syndrome / 国际外科学杂志

Interstitial cystitis/bladder pain syndrome is a chronic pain syndrome characterised by pain/ discomfort attributed to the bladder,with associated urgency and urinary frequency.Its etiology is unknown and the syndrome probably have different manifestations.There is no specific treatment and multi-treatment often been used to treat interstitial cystitis/bladder pain syndrone.Bladder instillation therapy is often used as an important treatment because the drug is concentrated in the bladder and keeps a higher concentration.But the drug selection and treatment regimen of bladder instillation are not uniform.A number of intravesical agents are reviewed in this paper along with the available evidence for their use.

The Early Histological Effects of Intravesical Instillation of Platelet-Rich Plasma in Cystitis Models.

PURPOSE: To evaluate the early histological effects of the intravesical instillation of platelet-rich plasma (PRP) in rabbit models of interstitial and hemorrhagic cystitis. METHODS: Thirty-six rabbits were classified into 6 groups: saline (S), S+PRP, hydrochloric acid (HCl), HCl+PRP, cyclophosphamide (CyP), and CyP+PRP. At 48 hours after induction, PRP was prepared and intravesically administered to the S+PRP, HCl+PRP, and CyP+PRP groups. Bladder sections were stained with toluidine blue for mast cell counting and with hematoxylin and eosin for histopathology and mitotic index determination. The proliferation index was determined by proliferating cell nuclear antigen (PCNA) immunolabeling. The nonparametric Mann-Whitney U-test was used for statistical analysis. RESULTS: No abnormalities were observed in the S group, whereas increased interstitial edema and increased average mitotic and proliferation indices were observed in the S+PRP group (P=0.023, P=0.004, and P=0.009, respectively). Intense epithelial loss, hemorrhage, and leukocyte infiltration were detected in the HCl and HCl+PRP groups, whereas a significantly increased average mitotic index was observed in the HCl+PRP group (P=0.002). When compared with its CyP counterpart, a significant reduction in hemorrhage and an increase in leukocyte infiltration and mitotic index were observed in the CyP+PRP group (P=0.006, P=0.038, and P=0.002, respectively). In addition, PCNA staining revealed a significantly increased proliferation index in the HCl+PRP and CyP+PRP groups (P=0.032 and P=0.015, respectively). CONCLUSIONS: The intravesical instillation of PRP increased the mitotic index in the saline and cyclophosphamide groups while decreasing macroscopic bleeding.

Intravesical OnabotulinumtoxinA Injection for Overactive Orthotopic Ileal Neobladder: Feasibility and Efficacy.

The efficacy of intravesical onabotulinumtoxinA (BTXA) in the treatment of overactive bladder (OAB) has been well documented. The use of BTXA injection in orthotopic neobladders is yet to be studied. We present 4 cases of patients injected with intravesical BTXA for overactive orthotopic ileal neobladder. We recorded patient demographics, presenting and follow-up symptoms, urodynamic profiles, and Patient Global Impression of Improvement (PGI-I) scores. The 4 patients reported varying degrees of subjective improvements in the symptoms, including urgency, urge incontinence, and pad usage. Mean follow-up duration was 8.3 months (range, 5-14 months). Average PGI-I score was 3 ("a little better") (range, 2-4). To our knowledge, the current study is the first case series examining BTXA injection for orthotopic neobladder overactivity. BTXA injection yielded varying degrees of objective and subjective improvements, without significant complications. Intravesical BTXA injection is feasible and may be considered as a potential treatment alternative for OAB in orthotopic neobladders, although further study is warranted.

Intravesical OnabotulinumtoxinA Injection for Overactive Orthotopic Ileal Neobladder: Feasibility and Efficacy / 대한배뇨장애요실금학회지

The efficacy of intravesical onabotulinumtoxinA (BTXA) in the treatment of overactive bladder (OAB) has been well documented. The use of BTXA injection in orthotopic neobladders is yet to be studied. We present 4 cases of patients injected with intravesical BTXA for overactive orthotopic ileal neobladder. We recorded patient demographics, presenting and follow-up symptoms, urodynamic profiles, and Patient Global Impression of Improvement (PGI-I) scores. The 4 patients reported varying degrees of subjective improvements in the symptoms, including urgency, urge incontinence, and pad usage. Mean follow-up duration was 8.3 months (range, 5-14 months). Average PGI-I score was 3 ("a little better") (range, 2-4). To our knowledge, the current study is the first case series examining BTXA injection for orthotopic neobladder overactivity. BTXA injection yielded varying degrees of objective and subjective improvements, without significant complications. Intravesical BTXA injection is feasible and may be considered as a potential treatment alternative for OAB in orthotopic neobladders, although further study is warranted.