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PubMed1988

Intravesical chemotherapy: combination with dimethyl sulfoxide does not enhance cytotoxicity in vitro.

There is evidence that dimethyl sulfoxide (DMSO) can increase the anticancer activity of chemotherapeutic drugs. As DMSO is instilled into the bladder for interstitial cystitis, it could be readily adopted in clinical practice if it was found to enhance the effectiveness of the drugs used for intravesical chemotherapy. The purpose of this study was to investigate, using a human bladder cancer cell line, the hypothesis that DMSO enhances the activity of these agents. However, the addition of 4% DMSO to the four drugs most frequently used for intravesical chemotherapy (adriamycin, epodyl, mitomycin-c, thiotepa) did not increase tumour cell kill in vitro.

Administration, Intravesical↗
PubMed1994

A randomized trial of early intravesical instillation of epirubicin in superficial bladder cancer. The Nagoya University Urological Oncology Group.

A total of 135 patients with superficial bladder cancer diagnosed as totally resectable were entered into a randomized multicenter trial to investigate the efficacy of early intravesical epirubicin instillation after resection in comparison with transurethral resection (TUR) alone. Epirubicin (40 mg/40 ml saline) was given within 24 h of TUR and once during the 1st week, weekly for 4 weeks and then monthly for 11 months. In all, 122 patients (90.4%) were eligible and 119 (88.1%) were evaluable. The interval to initial recurrence was significantly longer (P = 0.02) in the epirubicin group (36 months; 95% confidence interval, 32-40 months) than in the group receiving TUR alone (28 months; 95% confidence interval, 24-32 months). The recurrence rate per year in the epirubicin group was less than that in the TUR-alone group (0.13 versus 0.29 annual recurrences). Disease progression was observed in only one patient in the epirubicin-instillation group. The main toxicity encountered was bladder irritation (13.8%). These results demonstrate that early intravesical epirubicin instillation is efficacious in preventing local recurrence.

Administration, Intravesical↗
PubMed1996

Eosinophilic cystitis induced by mitomycin-C.

Eosinophilic cystitis is an unusual form of cystitis which is characterized by irritative voiding symptoms and haematuria. In the report herein two adult cases of eosinophilic cystitis treated with intravesical Mitomycin-C instillations for prophylaxis of bladder carcinoma are presented and the literature is reviewed.

Administration, Intravesical↗
PubMed2004

Effect of intravesical instillation on performance of uCYT+ test.

OBJECTIVES: To assess the influence of intravesical instillation of epirubicin or bacille Calmette-Guérin (BCG) in patients with bladder cancer on the clinical performance of the uCyt+ test, which traces the three monoclonal antibodies M344, LDQ 10, and 19A211 in urothelial cells. METHODS: A total of 267 patients with a mean age of 70.5 years (range 35 to 87) were included in this prospective study. All patients were being followed up after complete transurethral resection of superficial urothelial cancer. All patients received a single instillation of 80 mg epirubicin within 24 hours of transurethral resection and 163 underwent subsequent cycles of chemotherapy with epirubicin or immunotherapy with BCG. This was because of multifocality, high-recurrence, or high-grade urothelial cancer. At the next control, all patients underwent urinary cytology, with the uCyt+ test performed on liquid-based cytology (ThinPrep), subsequent cystoscopy, and evaluation of any suspicious lesion by biopsy. Patients who underwent intravesical BCG therapy underwent random bladder cold biopsy after every instillation series. RESULTS: Of the 267 patients, 8 could not be evaluated by uCyt+ because of insufficient cells. Of the remaining 259 patients under assessment, 86 had proven urothelial cancer. In the 101 patients under assessment with only a single intravesical instillation of epirubicin (group 1), the overall sensitivity for cytology and the uCyt+ test was 44.7% and 76.6%, respectively. Cytology had a specificity of 90.7% and uCyt+ of 64.8%. The negative predictive value for cytology and uCyt+ was 65.3% and 76.1%, respectively. Of the 158 patients under evaluation who were treated with long-term intravesical therapy (group 2), the overall sensitivity and specificity for cytology and the uCyt+ test was 37.8% and 84.6% and 94.9% and 70.6%, respectively. The negative predictive value for cytology and the uCyt+ test was 83.1% and 93.3%, respectively. Statistical analysis showed no statistically significant difference between the overall sensitivity (P = 0.512) and specificity (P = 0.558) for the uCyt+ test in the two groups of patients. CONCLUSIONS: The sensitivity and specificity of the uCyt+ test are not significantly affected by intravesical long-term treatment with epirubicin or BCG.

Administration, Intravesical↗
PubMed1987

5-year experience with intravesical therapy of carcinoma in situ: an inquiry into the risks of "conservative" management.

Recent reports of disease progression in patients being treated with intravesical agents for carcinoma in situ of the bladder led us to examine our 5-year experience with 26 consecutive patients with carcinoma in situ treated with intravesical therapy for this lesion. Nine patients with isolated carcinoma in situ and 17 with carcinoma in situ associated with papillary lesions were treated intravesically with a variety of agents in a closely monitored program for a mean of 22 months. All patients wished to exhaust conservative options before accepting cystectomy. Of 26 patients treated 9 (35 per cent) have no evidence of disease with a functional bladder after 27 months, 13 (50 per cent) are treatment failures and 4 (15 per cent) maintain an equivocal status to date. Successful treatment results with each drug were 6 of 24 thiotepa, 0 of 7 mitomycin, 0 of 6 doxorubicin and 3 of 8 bacillus Calmette-Guerin. Treatment failure was associated with disease progression to muscle invasion, adjacent organ invasion or metastases in 7 patients (27 per cent). Significant reduction in bladder capacity after prolonged therapy occurred in 3 patients. Our results suggest that persistent, intensive, "conservative" intravesical therapy in the face of recurrent or persistent disease is associated with substantial patient risk.

Administration, Intravesical↗
PubMed2000

Intravesical treatment of overactive bladder.

Intravesical agents for overactive bladder have mostly been used in patients with neurogenic bladder disorders. The patients have usually had severe detrusor hyperreflexia (DH) plus a disorder of bladder emptying, and because of residual urine have been performing intermittent self-catheterization. Intravesical medication has therefore been appropriate. Strategies for treating DH have been either to lessen the parasympathetic efferent activity or to de-afferent the bladder. Two types of treatment have been used: intravesical medications that block pelvic nerve-detrusor smooth muscle cholinergic transmission, or agents that block the afferent arm of the reflex that causes detrusor contraction. Intravesical oxybutynin is thought to have some local anesthetic effect, although its main mode of action is to block cholinergic transmission. It has been demonstrated to be effective in resistant DH. Intravesical atropine has been demonstrated to increase bladder capacity but its usefulness in the clinical management of DH has yet to be demonstrated. Local anesthetics can increase bladder capacity, but the effect is short-lived. Longer-acting agents may have a selective neurotoxic effect on capsaicin-sensitive bladder afferents. Many patients worldwide have now been treated with intravesical capsaicin. Resiniferatoxin (RTX) is an ultrapotent capsaicin analog that has the significant advantage of being a nonirritant. Intravesical agents appear to be attractive alternatives to oral medication and hold the exciting possibility of selectively targeting end organs implicated in pathophysiologic responses.

Administration, Intravesical↗
PubMed1999

Mycotic vascular infections of large arteries with Mycobacterium bovis after intravesical bacillus Calmette-Guérin therapy: case report.

Disseminated infection after intravesical bacille Calmette-Guérin instillation for bladder cancer is a rare but potential complication. Vascular infection is an additional serious complication but is seldom reported. We present the first report of a small series of patients with vascular infections after intravesical bacille Calmette-Guérin instillation, and we review the related literature.

Administration, Intravesical↗
PubMed1996

Intravesical capsaicin in neurologic impaired patients with detrusor hyperreflexia.

Capsaicin is known to be neurotoxic for C-fiber afferents. We investigated the intravesical application of capsaicin in the treatment of detrusor hyperreflexia (DH) in seven patients (ages 23-52) with neurologic impairment. The patients were evaluated with both ice-water cystometry and formal video-urodynamic studies. Four biweekly courses of intravesical capsaicin treatment were administered using increasing concentrations (100 microM, 500 microM, 1 mM, and 2 mM). Treatment effect was monitored using a bladder diary and urodynamic evaluation one month after capsaicin treatment. Prior to treatment, six of the seven patients demonstrated a positive ice-water test and DH. Two patients were not able to complete the study due to discomfort attributed to capsaicin. Five of the seven patients completed the four courses of increasingly concentrated capsaicin. Three patients noted symptomatic improvement while two did not. The mean urodynamic bladder capacity significantly increased from 124 +/- 39 ml pre-capsaicin to 231 +/- 62 ml one month post-capsaicin in the three patients with symptomatic improvement (p < 0.05). Urodynamic testing revealed that one of the six patients with a positive ice-water test lost that response after intravesical capsaicin. Intravesical capsaicin is a novel and promising treatment for detrusor hyperreflexia in neurologically impaired patients.

Administration, Intravesical↗
PubMed2004

Intravesical vanilloids and neurogenic incontinence: ten years experience.

INTRODUCTION: In this study we critically review our '10-year' experience with intravesical vanilloids (capsaicin and resiniferatoxin) in the treatment of neurogenic incontinence, addressing the issue of their introduction into daily clinical practice. MATERIALS AND METHODS: From July 1992 to June 2001, 54 patients suffering from detrusor hyperreflexia, due to spinal cord injuries, received intravesical instillation of capsaicin, and from January 1995 to June 2001, 47 patients received intravesical instillation of resiniferatoxin (RTX) in order to treat bladder dysfunction and symptoms. All patients presented detrusor hyperreflexia refractory to oral and/or intravesical oxibutynin and they displayed high-voiding pressure associated with frequent urine leakage. Capsaicin was used at a concentration of 10 mM; RTX was tested in two different concentrations: 10 nM and 10 microM. The outcome was considered according to simple parameters: (i) the number of patients who reported an improvement in clinical status (patient dry between clean intermittent catheterization) and urodynamic status (a bladder capacity 50% higher than pretreatment capacity, lasting more than 3 months after the instillation); (ii) the number of patients who continued intravesical therapy; (iii) the number of instillations they received; (iv) the length of the interval between 2 consecutive instillations, and (v) alternative therapies when vanilloids failed. RESULTS: The topical intravesical instillation of capsaicin produced an improvement in symptoms and urodynamic parameters, in 29 patients (53.7%) after 3 months. In these 29 patients only 7 (24.13%) continued to received capsaicin in June 2001. The mean follow-up was 32.28 +/- 14.20 (range 8-52) months, the mean number of instillations was 6.14 +/- 2.54 (range 2-10) and the mean interval between the 2 consecutive instillations was 7.14 +/- 2.60 (range 4-12) months. The topical intravesical instillation of RTX produced an improvement in symptoms and urodynamic parameters in 73.33% of patients (a total of 45 patients) who received 10 microM. 18 of them (54.54%) continued to received RTX in June 2001. The mean follow-up was 27.88 +/- 10.95 (range 11-49) months, the mean number of instillations was 4.33 +/- 1.60 (range 2-8). The mean interval between 2 consecutive instillations was 9.61 +/- 2.99 (ranged 4-16) months. CONCLUSION: The results obtained using RTX seem to be very promising with regard to efficacy and tolerance, particularly in comparison with capsaicin. Even if the number of patients who received capsaicin and RTX remains small, the intravesical vanilloid receptor agonist RTX could offer an attractive alternative to oral medications in the treatment of neurogenic incontinence.

Administration, Intravesical↗
PubMed1990

[Intravesical bacillus Calmette-Guerin instillation therapy in superficial bladder cancers--clinical study on prognostic factors].

Intravesical instillation of Tokyo 172 strain bacillus Calmette-Guerin (BCG) was performed on 137 patients with superficial bladder cancer (Ta and T1) after transurethral tumor resection as a prophylaxis against tumor recurrence. The recurrence rate of tumors was compared with that of historical controls and was estimated by the person-years method. There were statistically significant decreases in recurrent tumors following BCG therapy. To clarify the efficacy of intravesical BCG therapy, prognostic significance of several factors were evaluated in 90 patients with initial bladder cancer treated with TUR and BCG instillation, and compared to those of controls. Prophylactic effects were statistically better for those with multiple tumors, grade 3 lesions or Ta lesions than for control patients. No correlation between purified protein derivative responsiveness and favorable results could detected. There were no marked side effects or fatal complications of BCG therapy during the observation periods. Our results suggest that BCG is able to change the biological behavior of superficial bladder cancers with multiple, high grade or low stage lesions. The intravesical BCG instillation seems to be effective and safe as a prophylaxis against the recurrence of superficial bladder tumors.

Administration, Intravesical↗
PubMed1989

[Intravesical BCG vaccine in bladder cancer].

We present a preliminary report on intravesical BCG instillation in four patients. The indications are prevention of new superficial tumors and treatment of carsinoma in situ. 120 mg Connaught BCG-vaccine in 50 cc saline is instillated weekly for a total of six treatments. Follow-up was performed every three months and included cystoscopy and urine cytology. The prophylactic effect is encouraging, even in patients who have previously not responded to intravesical chemotherapy. There were no serious complications and the common side effects of fever and dysuria did not delay or interrupt treatment.

Administration, Intravesical↗
PubMed1992

The 4th study of prophylactic intravesical chemotherapy with adriamycin in the treatment of superficial bladder cancer: the experience of the Japanese Urological Cancer Research Group for Adriamycin.

A multicentric randomised trial was conducted for the purpose of investigating the efficacy of intravesical chemoprophylaxis of superficial bladder cancers. A total of 443 patients (number of evaluable patients, 284) were registered from July 1987 to December 1989 and randomised into 3 groups. Group A received 21 intravesical instillations of Adriamycin (ADM) at 20 mg/40 ml physiological saline for 2 years after undergoing transurethral resection (TUR); group B was given the same dose as group A but received 6 intravesical instillations for 2 weeks before undergoing TUR; and group C served as a control and underwent TUR only. Better prophylactic effects were obtained in group A. The overall non-recurrence rates calculated for groups A and B differed significantly (P less than 0.05) on day 240, and those determined for groups A and C were also significantly different (P less than 0.01) on day 480. No benefit was obtained using intravesical instillation prior to TUR (group B). The major side effects encountered were pollakisuria and miction pain, which occurred in 32% of the patients in group A and in 52% of those in group B.

Administration, Intravesical↗
PubMed2001

[Phase I study of amrubicin hydrochroride (SM-5887) for superficial bladder cancer in intravesical chemotherapy].

A phase I study of intravesical chemotherapy with amrubicin hydrochloride for superficial bladder cancer was conducted. Amrubicin was dissolved in 30 ml of physiological saline and injected intravesically on 6 consecutive days. The drug solution was retained for 2 hours. The starting dose was 60 mg/day, and the dose was escalated to 150 mg/day in 30 mg/day increments. Fifteen patients were entered into this study, of whom 14 were eligible and assessable for toxicity, and 13 were assessable for efficacy. The incidence and severity of cystic irritabilities such as micturition pain, pollakisuria and hematuria were related to the doses of amrubicin. At 150 mg/day, one of three patients experienced grade 3 micturition pain and pollakisuria. The dose-limiting toxicities, therefore, were micturition pain and pollakisuria, and the maximal tolerated dose was estimated to be 150 mg/day, considering that none of the three patients could retain the drug solution for 2 hours. One complete response and four partial responses were obtained in 13 assessable patients, and the overall response rate was 38.5%. A breakdown according to the doses was as follows. One PR of 3 patients were achieved at 60 and 90 mg/day, respectively 2 PRs of 5 patients at 120 mg/day, and one CR of 2 patients at 150 mg/day.

Administration, Intravesical↗
PubMed1995

[Intravesical instillation of epirubicin hydrochloride in superficial bladder tumor--prophylactic and therapeutic instillation for carcinoma in situ].

Between May 1990 and May 1993 we performed intravesical instillation of epirubicin hydrochloride (EPI) to 52 patients with superficial bladder tumor after transurethral resection. Indications of these instillations were classified into 3 groups. Group 1 was for carcinoma in situ (CIS) or the CIS other than the original tumor, group 2 was for multiple tumors, and group 3 was for pT1G3 tumor. Intravesical instillations of the drug were given weekly for 10 weeks and close follow-up examinations were performed routinely. Group 1 was treated for CIS, whereas group 2 and group 3 were prophylactic instillations. The disease-free rate in group 1 was 67%, and that in group 2 and group 3 was 77% at 12 months, and 42% at 24 months according to the Kaplan-Meier method. The major side effects of the instillations were bladder irritation, hematuria and pyuria. However, we experienced 5 patients with severe side effects; 2 of atrophic bladder and 3 of hemorrhagic cystitis. Although this study was conducted retrospectively, these findings suggest that intravesical instillations of EPI can be as effective as other drugs, such as mitomycin C, and doxorubicin, by adding the maintenance instillation or by elevating the drug density and shortening the instillation time.

Administration, Intravesical↗
PubMed1992

[Prophylactic intravesical instillation therapy in patients with superficial bladder cancer--results of a randomized prospective study].

A randomized prospective study was conducted for the purpose of investigating the efficacy of intravesical chemoprophylaxis of superficial bladder cancers. Eligible patients were randomized into three groups: 1) adriamycin (ADM) group; intravesical instillation with 50 mg of ADM dissolved in 100 ml physiological saline, 2) mitomycin C (MMC) group; intravesical instillation with 30 mg of MMC dissolved in 100 ml of physiological saline, 3) control group; transurethral resection or transurethral coagulation only. The characteristic features of our protocol consisted of frequent (six times) instillations of the drugs within two weeks after transurethral resection, followed by instillations on two consecutive days at four-week intervals for two years. Furthermore, large quantities (100 ml) of instillation fluid containing relatively low concentrations of the drugs (500 micrograms/ml for ADM or 300 micrograms/ml for MMC) were employed. One hundred and forty-four patients have been submitted to the study; 110 patients were fully evaluable for recurrence and 34 patients were eliminated as non-evaluable patients. The cumulative five-year non-recurrence rates of the patients with multiple tumors were 32% in the MMC group, 25% in the ADM group and 7% in the control group. The cumulative non-recurrence rates of the ADM and MMC groups were significantly higher than that of the control group. It is considered that this instillation therapy with ADM and MMC is useful for preventing the recurrence of superficial bladder cancers.

Administration, Intravesical↗
PubMed2004

[Intravesical Bacillus Calmette-Guerin (BCG: Tokyo 172 strain) instillation for carcinoma in situ of the bladder: results with 6 successive instillations of 40 mg BCG].

We performed a study to evaluate the usefulness of intravesical Bacillus Calmette-Guerin (BCG: Tokyo 172 strain) instillation on carcinoma in situ (CIS) of the bladder. Between 1998 and 2003, 43 patients were treated for CIS of the bladder with a median follow-up period of 45 months (range: 12 to 69 months). The patients (35 males and 8 females) ranged in age from 45 to 89 years (average: 67.5 years). They underwent intravesical instillation of 40 mg of BCG once a week for 6 weeks. A complete response (CR) was achieved in 83.7% of the patients. Among these patients, 97.2% and 70.7% remained recurrence-free during follow up for one year and three years, respectively. The median duration of CR was 31.5 months. Although total cystectomy was performed on 1 patient, none of the patients died of bladder cancer. Adverse effects included bladder irritability in 48.8%, pyuria in 46.5%, gross hematuria in 18.6%, and fever (temperature over 37.5 degrees C) in 9.3%. No clinically significant side effects were observed. These results indicate that intravesical instillation of BCG at a dose of 40 mg given 6 times was as effective as the routine dose of 80 mg, and could decrease systemic adverse effects such as high fever.

Administration, Intravesical↗
PubMed1998

Possible factors affecting response to intravesical bacillus Calmette-Guérin (Tokyo 172 strain) therapy for carcinoma in situ of the bladder: a multivariate analysis.

To evaluate clinicopathological factors affecting response to intravesical instillation therapy with the bacillus Calmette-Guérin (BCG) Tokyo 172 strain for carcinoma in situ (CIS) of the bladder, we reviewed data for 84 patients treated between 1985 and 1996. Median follow-up was 56 months. The patients comprised three groups: primary (only the in situ lesion, 31 patients), subsequent (found after treatment of a gross neoplasm, 20), and concomitant (found together with a gross neoplasm, 33). A complete response was found in 62 (74%) of the 84 patients. Intravesical BCG therapy eradicated tumour cells in 74% of the primary group, 70% of the subsequent group, and 76% of the concomitant group. Multivariate logistic regression analysis revealed that the presence of gross haematuria and patient age were significantly associated with a complete response to the intravesical BCG therapy (p<0.05). On the other hand, gender, irritative bladder symptoms, type of extent of CIS, histological grade of CIS, BCG dose, and number of times BCG was given did not exert any significant influence. The 5-year recurrence rate was 33% for the 62 patients for whom a complete response was once achieved. Patients aged 60 or older had a higher probability of recurrence than those less than 60 years of age (p<0.05). Disease progression was found in 13% of the 84 patients and total cystectomy was performed in 19%. The present finding that patient age is related to the response to intravesical BCG therapy may point to a role for the reduced host immunocompetence in elderly individuals.

Administration, Intravesical↗