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PubMed1987

Monitoring intravesical bacillus Calmette-Guerin treatment of superficial bladder carcinoma by postoperative urinary cytology.

We studied 51 patients with superficial bladder carcinoma who had been treated with transurethral resection of all gross tumor followed by intravesical bacillus Calmette-Guerin weekly for 6 weeks. Within 72 hours of either the first or second quarterly cystoscopic surveillance examination after bacillus Calmette-Guerin therapy, a conventional cytology study was obtained. Of these patients 8 (15.7 per cent) had positive, 9 (17.6 per cent) suspicious and 34 (66.7 per cent) negative postoperative cytology studies. Subsequent tumor recurrence was defined as a positive biopsy or visible papillary tumors on cystoscopic examination. All 8 patients with a positive postoperative cytology study had tumor recurrence at a median interval of 4 months. Of the 9 patients with a suspicious study 7 (77.8 per cent) had recurrent tumor at a median interval of 7 months and 2 (22.2 per cent) had no evidence of disease at 16 and 19 months, respectively. Of the 34 patients with a negative postoperative cytology study 13 (38.2 per cent) had tumor recurrence after a median interval of 4 months and 21 (67.8 per cent) had no evidence of disease after a median of 25 months. The tumor recurrence rate in patients with a positive or suspicious postoperative cytology study was significantly greater than that of patients with a negative study (p equals 0.001, Fisher's exact test). Postoperative cytology appears to be a significant prognostic indicator following transurethral resection and intravesical bacillus Calmette-Guerin treatment of superficial bladder carcinoma.

Administration, Intravesical↗

PubMed2003

Evaluation of DD23 as a marker for detection of recurrent transitional cell carcinoma of the bladder in patients with a history of bladder cancer.

OBJECTIVES: To determine whether DD23 increases the sensitivity of urinary-based detection of transitional cell carcinoma (TCC) recurrence. The murine monoclonal antibody DD23 recognizes a 185-kDa tumor-associated antigen that is expressed in human bladder cancer cells in vitro and in vivo but is not detected in normal urothelium. METHODS: Using alcohol-fixed urinary cytology, matched voided urine and bladder wash specimens were evaluated for the contribution of DD23 antigen expression in the detection of recurrent TCC. The selected patient population had a history of bladder cancer, and urine cytology analysis was performed in a single commercial reference laboratory. DD23 antigen expression in a cohort of 81 patients was compared with urine cytology findings, and the sensitivity and specificity for each urine-based test was determined. The presence of recurrent disease was determined by positive pathologic biopsy. RESULTS: The 81-patient cohort produced 151 urine specimens for which both biopsy and cytology information were obtained. Of these specimens, 64 were confirmed by a tissue diagnosis for TCC recurrence. These biopsy-proven recurrences were used as the dependent variable to assess the accuracy of cytology testing. For the detection of TCC, the DD23 antigen had a sensitivity of 70.3% and a specificity of 59.8%. Combined with cytopathologic findings, DD23 enhanced the sensitivity for the detection of TCC from 43.8% (cytology alone) to 78.1%. For low-grade TCC (n = 20) DD23 enhanced the sensitivity from 20.0% (cytology alone) to 55.0%. For high-grade TCC (n = 25), DD23 enhanced the sensitivity from 64.0% (cytology alone) to 76.0%. In patients with a prior history of intravesical treatment, DD23 had a sensitivity of 94.7% and a specificity of 33.3% compared with a sensitivity of 52.6% and a specificity of 83.3% for cytology. CONCLUSIONS: DD23 antigen expression can be used as an adjunct to cytopathologic evaluation to enhance the sensitivity of urinary cytology detection of TCC. In addition, DD23 does not appear to lose sensitivity in patients with a prior history of bladder cancer treated with intravesical agents.

Administration, Intravesical↗

PubMed1998

Intravesical bacillus Calmette-Guérin treatment for Stage T1 grade 3 transitional cell carcinoma of the bladder.

OBJECTIVES: To retrospectively analyze intravesical bacillus Calmette-Guerin (BCG) treatment for Stage T1 grade 3 (T1G3) transitional cell carcinoma (TCC) of the bladder. METHODS: Between 1984 and 1995, 78 patients with Stage T1 grade 3 tumor were treated by transurethral resection of all visible tumors and adjuvant BCG intravesical instillations. Median follow-up was 56 months (range 12 to 141). RESULTS: After an initial induction course, 52 patients (67%) were tumor-free. Twenty-two patients (28%) had recurrent tumor after a median of 7 months (range 5 to 62). Progression occurred in 6 patients (7.7%) after a median of 18 months (range 5 to 56). CONCLUSIONS: Intravesical BCG appears to be an effective treatment for patients with Stage T1 grade 3 TCC. Patients whose tumors recur after an initial induction course may benefit from a second course of BCG. Intravesical BCG treatment may lower the tumor progression rate. Late recurrence, beyond 2 years, warrants long-term follow-up.

Adjuvants, Immunologic↗

PubMed2004

Double-blind randomized controlled trial assessing the safety and efficacy of intravesical agents for ureteral stent symptoms after extracorporeal shockwave lithotripsy.

BACKGROUND AND PURPOSE: Ureteral stents are a significant source of pain and discomfort for many urologic patients. A novel approach to addressing this problem is the intravesical instillation of a selected pharmacologic agent after stent insertion. The purpose of this study was to assess the safety and efficacy of intravesical instillation of various agents in reducing ureteral stent-associated discomfort in patients requiring a stent after extracorporeal shockwave lithotripsy (SWL). PATIENTS AND METHODS: In this double-blind prospective trial, 42 patients were randomized to receive intravesical instillation of one of three agents (oxybutynin, alkalinized lidocaine, or ketorolac) or a control solution (0.9% sodium chloride) immediately after stent insertion at time of SWL. The four groups of patients were demographically similar. Preoperative, intraoperative, and postoperative data were collected prospectively and analyzed statistically. The primary outcome measure was reduction in ureteral stent symptoms, and the secondary outcome measure was the safety of intravesical instillation of each agent through assessment of drug-related adverse events. RESULTS: There were no intraoperative or postoperative complications, nor were there any serious side effects attributable to any of the intravesically instilled agents. There was a statistically significant decrease in stent-related discomfort at the 1-hour time point in the group of patients who received intravesical ketorolac compared with the control group. CONCLUSIONS: Intravesical instillation represents a novel approach to the problem of ureteral stent-related discomfort. From our results, ketorolac appears to be the most effective intravesical agent in reducing stent-related patient discomfort, and we have established that intravesical instillation of ketorolac is safe in humans.

Administration, Intravesical↗

PubMed1998

Results of transurethral resection plus adjuvant intravesical chemotherapy for superficial bladder cancer.

BACKGROUND: We analyzed the results of conservative therapy for superficial bladder cancer to determine the risk factors for recurrence and progression. METHODS: Between May 1984 and February 1997, 111 patients with primary superficial bladder cancer were treated by a transurethral resection with or without intravesical instillation of chemotherapy, or for patients with concomitant carcinoma in situ (CIS), bacillus Calmette-Guérin. We examined the relationship between tumor stage, grade, incidence of concomitant CIS and recurrence-free survival according to pathologic findings and the drugs instilled. RESULTS: The incidence of concomitant CIS in pT1, grade 3 tumors was significantly higher than that in pTa, grade 1 tumors (42% vs. 3%, P= 0.006). The 5-year recurrence-free survival rate of all patients was 73%. There was no significant difference in recurrence-free survival and pathologic stage, tumor grade, presence of concomitant CIS, or drugs used for instillation. However, the recurrence-free survival in patients with > or = 5 tumors was significantly lower than in patients with less than 5 tumors. Of the 111 patients, only 3 patients demonstrated disease progression and underwent a radical cystectomy, while 1 patient with a pT1b, grade 3 tumor developed a tumor in the ureter. No patient died of bladder cancer. CONCLUSION: Our results indicate that the prognosis of superficial bladder cancer patients with a high-stage, high-grade (pT1, grade 3) tumor is favorable when treated by a transurethral resection and intravesical instillation. Bacillus Calmette-Guérin therapy is useful to prevent the recurrence of tumors with concomitant CIS.

Administration, Intravesical↗

PubMed2000

Diagnostic value of intravesical lidocaine for overactive bladder.

PURPOSE: To determine the diagnostic use of intravesical lidocaine, we evaluated its effects on the overactive bladder in patients with brain lesions, spinal lesions, benign prostatic hyperplasia (BPH) and idiopathic overactive bladder. MATERIALS AND METHODS: Cystometry was performed before and 15 minutes after intravesical instillation of 20 ml. 4% lidocaine in 57 patients with an overactive detrusor in the storage phase. RESULTS: The percentage increase in bladder capacity for patients with spinal lesions was 136%, compared to 56%, 29% and 41% for patients with brain lesions, BPH and idiopathic bladder overactivity, respectively (significant difference p <0.01 to 0.05). Of the patients with an increase of 50% or more 55% had brain lesions, 80% spinal lesions, 23% BPH and 31% idiopathic bladder overactivity. The incidence of the disappearance of detrusor contractions in patients with spinal lesions was greater than that in the others. CONCLUSIONS: These results suggest that intravesical instillation of 4% lidocaine is useful for identification of overactive bladder attributable to spinal or other lesions.

Administration, Intravesical↗

PubMed2003

[Reiter syndrome after intravesical Bacillus Calmette-Guerin (BCG) immunotherapy: a case report].

A 56-year-old man who had previously undergone transurethral resection and intra-arterial chemotherapy for bladder cancer developed irritable bladder, bilateral conjunctivitis and arthritis including the knees, ankles and sacroiliac joints after starting intravesical Calmette-Guerin bacillus (BCG) immunotherapy. These symptoms were in agreement with the features of Reiter syndrome. One month after cessation of the intravesical BCG immunotherapy and initiation of the treatment with a non-steroidal anti-inflammatory drug (NSAID), he was not complaining of symptoms. Reiter syndrome is an uncommon complication after intravesical BCG immunotherapy. Nevertheless, since the prolonged arthritis has a possibility to cause joint deformity, we must pay serious attention to this side effect.

Administration, Intravesical↗

PubMed1995

[Intravesical instillation of pirarubicin for a patient with bladder cancer and chronic renal failure: a case report].

The patient was a 71-year-old woman. Two years ago right nephrectomy was performed by a general surgeon at the diagnosis of right renal cell carcinoma. However, the pathological report was transitional cell carcinoma (TCC) of the right renal pelvis, Grade II. She developed chronic renal failure and received hemodialysis once a week. The recurrence of bladder tumor was recognized and she was transferred to our hospital. Transurethral resection of bladder tumor (TUR-Bt) and right ureterectomy with a bladder cuff were performed. Also intravesical instillation of pirarubicin was done after the operation. No side effects or elevation of serum pirarubicin level were observed.

Administration, Intravesical↗

PubMed1997

BCG update: intravesical therapy.

BCG is currently the most active immunotherapy agent for intravesical use and is considered the first-line treatment for patients with aggressive T1 G3 and Tis superficial tumors of the bladder. Its main drawback, toxicity, is being addressed by several prospective studies that try to find the lowest active dose and optimal schedule, as well as by studies investigating the efficacy of antigenic bacterial fractions, devoid of the toxicity of the living bacilli. Efforts to improve the efficacy by combination with chemotherapy and biomodulating natural remedies are also under way. In this review we discuss: (1) the indications, limits and contraindications of BCG; (2) the efficacy; (3) the strains; (4) route of administration; (5) dose; (6) schedule; (7) the problem of toxicity, and (8) how to improve BCG therapy.

Adjuvants, Immunologic↗

PubMed1994

Treatment of cyclophosphamide-induced hemorrhagic cystitis with prostaglandins.

OBJECTIVE: To report a case of cyclophosphamide-induced hemorrhagic cystitis, discuss prevention, and review treatment options, particularly the use of intravesicular prostaglandins. DATA SOURCES: Literature obtained through a computerized search, with subsequent bibliography scanning. Information on the individual case was obtained from the patient's medical record and the Pharmacy Clinical Research Specialist. CASE SUMMARY: A 29-year-old woman who had a postallogeneic bone marrow transplantation was hospitalized because of graft-versus-host disease. During hospitalization, she developed a cyclophosphamide-induced hematuria that, despite hydration and transfusions of blood products, progressed to refractory hemorrhagic cystitis. A response was prompted ultimately by a regimen consisting of continuous bladder irrigation and intermittent intravesical instillation of carboprost. DISCUSSION: The best treatment for hemorrhagic cystitis remains prevention. Therapies for established cystitis are varied; the choice depends on the degree of hematuria present. Therapies are often temporary or ineffective, and themselves cause significant morbidity. One promising treatment option involves the intravesicular administration of prostaglandins. Reports in the literature discuss a variety of products, dosages, and treatment schedules that have been used with some success. The available data on this technique are presented. CONCLUSIONS: Prostaglandins appear to be effective in resolving established hemorrhagic cystitis; however, their place in therapy remains unclear. Before this class can be employed routinely, several basic issues remain. These include optimal dosage, dosing schedule, duration of treatment, and comparative efficacy with other agents.

Administration, Intravesical↗

PubMed1994

Comparison of the prophylactic usefulness of epirubicin and doxorubicin in the treatment of superficial bladder cancer by intravesical instillation: a multicenter randomized trial. Kobe University Urological Oncology Group.

A multicentric randomized trial was conducted for the purpose of investigating the prophylactic efficacy of intravesical epirubicin instillation following transurethral resection of superficial bladder cancer in comparison with the efficacy of doxorubicin. The patients were centrally randomized into 2 groups and received 19 intravesical instillations of epirubicin or doxorubicin at 30 mg/30 ml physiological saline twice a week for 4 weeks and then once monthly for 11 months. A total of 150 patients with Ta and T1 superficial bladder cancer were entered in the trial, and 114 were evaluable. The nonrecurrence rates determined for each group at 1 and 2 years by the Kaplan-Meier method were 92.8% and 88.6%, respectively, for the epirubicin group and 86.4% and 81.7%, respectively, for the doxorubicin group. The differences between the two groups were not statistically significant. The main side effects encountered in this study were symptoms of bladder irritation such as micturitional pain, pollakisuria, and hematuria. The respective frequencies of those symptoms were 10%, 15.0%, and 5.0% in the epirubicin group and 14.8%, 14.8%, and 0 in the doxorubicin group. These results suggest that epirubicin is a useful drug, comparable with doxorubicin, for intravesical instillation chemotherapy in the prophylactic treatment of superficial bladder cancer.

Administration, Intravesical↗

PubMed1992

Adriamycin absorption after Nd:YAG laser coagulation compared to electrosurgical resection of the bladder wall.

The toxicity of intravesical drugs used for the treatment of bladder cancer is increased by systemic absorption. Therefore, treatment is often delayed several weeks after transurethral resection until sufficient healing occurs. Since a neodymium:YAG laser causes tissue injury by thermal coagulation, we investigated differences in bladder permeability after laser treatment compared to TUR. Comparable 2.5 cm in diameter areas of tissue injury were created in the bladder of mongrel dogs either by Nd:YAG laser coagulation or transurethral electrocautery resection (TUR). Subsequently, 30 mg. of adriamycin were instilled intravesically. A control group consisted of animals receiving adriamycin alone. Blood was taken at 10, 30, 60, and 120 minutes after instillation and the serum concentration of adriamycin measured quantitatively by high performance liquid chromatography (HPLC) with fluorescence detection. The maximum serum ADM concentration during 120 minutes for the control group was 28.0 +/- 12.9 ng/ml compared to 38.9 +/- 4.8 for the laser group and 102.9 +/- 29.9 for TUR. The area under the curve was 35.1 +/- 10.2 ng x hours/ml for control, 43.5 +/- 3.9 for laser and 127.7 +/- 49.9 for TUR. Using a two-tailed Student's t test, the difference between the TUR and the laser group was significant (p less than 0.01). There was no difference between laser and control. These results suggest that laser treatment has minimal effect on the absorption of drugs from the bladder. The clinical practice of delaying intravesical therapy after TUR is verified but a similar policy may not be necessary after laser treatment.

Administration, Intravesical↗

PubMed1990

Clinical and pathological findings in prostates following intravesical bacillus Calmette-Guerin instillations.

The prostates of 36 patients who were treated with intravesical bacillus Calmette-Guerin were evaluated by digital rectal examination and transrectal ultrasonography. When abnormal palpatory and/or ultrasonographic findings were detected, core needle biopsies from the suspicious areas were performed. Of the 36 patients 20 underwent biopsies of the prostate. Pathological findings revealed typical granulomas in 8 patients (3 caseating and 5 noncaseating multifocal granulomas). Nonspecific chronic prostatitis was noted in 4 patients and benign prostatic hyperplasia was noted in 8. The number of bacillus Calmette-Guerin instillations ranged from 6 to 19. The interval from initiation of therapy to biopsy ranged from 1.5 to 14.5 months. Caseating granulomas were found during the early course of bacillus Calmette-Guerin instillations (1.5 to 3.0 months), whereas noncaseating granulomas were detected at later stages (4 to 14.5 months). These findings present a high incidence of granuloma formation in patients treated with intravesical bacillus Calmette-Guerin. The duration of therapy is a determinant factor in the induction of granuloma type.

Administration, Intravesical↗

PubMed1988

Nephrogenic adenoma in patients with transitional cell carcinoma of the bladder receiving intravesical thiotepa.

Nephrogenic adenoma is a rare, benign lesion of the urothelium that generally occurs after open surgery or other bladder trauma. We present 2 recently treated patients with nephrogenic adenomas, both of whom had been treated previously with transurethral resection and intravesical thiotepa for histologically proved transitional cell carcinoma of the bladder. The occurrence of nephrogenic adenoma after transurethral resection alone is extremely rare and suggests a possible adjuvant role of the intravesical thiotepa. With the increasing use of such local chemotherapeutic agents, the incidence of nephrogenic adenoma in such patients may be increasing.

Administration, Intravesical↗

PubMed1992

The effect of intravesical Marcain instillation on hyperreflexic detrusor contractions.

Thirty-six patients with suprasacral spinal injury were treated with intravesical local anaesthetic instillation. Eighteen of 32 patients (56%) were converted from an 'ice water positive' hyperreflexic state to an 'ice water negative' state by bupivacaine hydrochloride. Four patients treated with lignocaine hydrochloride showed no benefit. Intravesical local anaesthetic instillation is suggested as a possible treatment for selected cases of detrusor hyperreflexia in patients on intermittent catheterisation.

Administration, Intravesical↗

PubMed2005

Phase I trial of intravesical Suramin in recurrent superficial transitional cell bladder carcinoma.

Suramin is an antitrypanosomal agent with antineoplastic activity, but with serious systemic side effects. We administered Suramin intravesically to determine a concentration with low toxicity but with evidence of a pharmacodynamic effect, to recommend a dose level for phase II trials. This was an open-labelled, non-randomized dose-escalation phase I study. In all, 12 patients with a history of recurrent superficial bladder cancer were grouped into four dose levels (10-150 mg ml(-1) in 60 ml saline). Six catheter instillations at weekly intervals were used. Cystoscopy and biopsy were performed before and 3 months after the start of treatment. Suramin was assayed using high-performance liquid chromatography, vascular endothelial growth factor (VEGF) using ELISA (enzyme-linked immunosorbent assay), and urinary protein profile using surface-enhanced laser desorption ionisation mass spectroscopy (SELDI). Minimal systemic absorption of Suramin was found at the highest dose of 150 mg ml(-1). Urinary VEGF was affected by Suramin at doses above 50 mg ml(-1), corresponding to the estimated threshold of saturation of Suramin binding to urine albumin. SELDI showed a specific disappearance of urinary protein peaks during treatment. Intravesical Suramin shows lack of toxicity and low systemic absorption. The results of this phase I trial support expanded clinical trials of efficacy at a dose of 100 mg ml(-1) intravesically.

Administration, Intravesical↗

PubMed2000

The absorption of pirarubicin instilled intravesically immediately after transurethral resection of superficial bladder cancer.

OBJECTIVES: To assess the validity of the prophylactic use of pirarubicin ([2'R]-4-O-tetrahydropyranyl-doxorubicin) immediately after transurethral resection of bladder tumour (TURBT), using pharmacodynamic studies. PATIENTS AND METHODS: The study included 20 consecutive patients with superficial bladder cancer. Pirarubicin (30 mg/50 mL or 30 mg/100 mL, 10 patients each) was instilled immediately after TURBT and retained in the bladder for 1 h. Blood samples were obtained before and at 15, 30, 60 and 120 min after the instillation. After retaining the drug for 1 h all the intravesical fluid was collected and assayed for pirarubicin. RESULTS: The plasma pirarubicin concentration in those receiving either dose was below detectable levels at any time after instillation. The mean recovery rate of pirarubicin in the drained fluid was 73%. CONCLUSION: The intravesical instillation of pirarubicin immediately after TURBT caused no detectable plasma concentration and few systemic side-effects.

Absorption↗

PubMed2002

Recurrence and progression in stage T1G3 bladder tumour with intravesical bacille Calmette-Guérin (Danish 1331 strain).

OBJECTIVE: To report recurrence and progression rates in patients with T1G3 superficial bladder carcinoma treated with intravesical bacille Calmette-Guérin (BCG, Danish 1331 strain) after complete transurethral resection. PATIENTS AND METHODS: Data from the records of 111 patients with T1G3 bladder carcinoma treated between January 1991 and December 1999 were analysed for recurrence, progression, salvage therapy and survival. RESULTS: Of the 111 patients with T1G3 bladder tumours, 69 had intravesical BCG therapy, 20 radical cystectomy and 22 only transurethral resection (TUR). Of the 69 patients receiving BCG therapy 37 (54%) had no recurrence, and 24 (35%) had a recurrence that was not muscle-invasive (Ta/T1) and were treated with TUR only. The remaining eight (12%) progressed to muscle invasion and had salvage cystectomy. During the follow-up six patients died, four from disease and three from other causes, while the remaining 63 are alive and well. Of the other 42 patients, 15 are alive after radical cystectomy and 18 after TUR. CONCLUSION: This series further confirms the benefits of intravesical BCG (Danish 1331) in an adjuvant setting; furthermore, this treatment facilitates bladder preservation by reducing recurrences and delaying the progression in many patients.

Adjuvants, Immunologic↗