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PubMed2002

After a decade of intravesical vanilloid therapy: still more questions than answers.

Vanilloid sensitivity is a functional signature of a subset of unmyelinated fibres innervating the urinary bladder. The role that these nerves have in the physiological control of storage and voiding is unclear. However, after the bladder has been disconnected by spinal injury from the pontine micturition centre, vanilloid-sensitive fibres assume a central role in the reflex emptying of the bladder that occurs at low volumes. Intravesical vanilloid (capsaicin or resiniferatoxin) administration is beneficial in this disorder by "desensitising" these nerves. Resiniferatoxin is superior to capsaicin in terms of its tolerability profile. Investigators are moving rapidly to identify the mechanisms by which desensitisation to vanilloids occurs. Vanilloids induce lasting, but fully reversible, changes in gene expression, including downregulation of the vanilloid receptor subtype 1. It is hoped that application of gene chip technologies will address the global profile of vanilloid-induced changes in gene expression and their relative contribution to desensitisation. Drugs that target signalling mechanisms that bring about these changes in gene expression have obvious therapeutic potential.

Administration, Intravesical↗
PubMed2000

Sensitivity of BCG to modern antibiotics.

The viability of bacillus Calmette-Guérin (BCG) in intravesical instillation therapy has been demonstrated to be crucial for the prevention of bladder tumour recurrence. The aim of the present study was to determine the effects of modern antibacterial chemotherapeutics on BCG viability, particularly cycloserine, which has been recommended in the treatment of BCG-induced sepsis. The minimal inhibitory concentrations (MICs) of 32 antibacterial drugs potentially effective against the Connaught BCG strain were measured in vitro by the radiometric BACTEC 460TB method. The MICs were compared with the drug concentrations achievable in blood and urine. Susceptibility testing of cycloserine was performed with three different strains (Connaught, Tice and RIVM), using the modified proportion method, as defined in the German guidelines for anti-tuberculosis drug testing. The Connaught BCG strain was highly susceptible to fluoroquinolones, but was resistant to beta-lactams, macrolides (except clarithromycin), and some aminoglycosides. It was also sensitive to doxycycline and gentamicin at dosages that typically occur in the urine of patients after a normal dose. Connaught BCG was susceptible to all the tuberculostatic drugs tested, except for pyrazinamide. All the BCG strains analysed were resistant to cycloserine. During intravesical BCG instillation therapy, simultaneous administration of fluoroquinolones, doxycycline or gentamicin should be avoided. In cases of severe systemic complications, or if one of the antituberculosis drugs is not tolerated, fluoroquinolones may be used. Cycloserine is no longer recommended for the early treatment of BCG sepsis.

Administration, Intravesical↗
PubMed1991

Combined intravesical chemotherapy with mitomycin C and local bladder microwave-induced hyperthermia as a preoperative therapy for superficial bladder tumors. A preliminary clinical study.

Twelve patients suffering from superficial transitional cell carcinoma of the bladder underwent treatment combining simultaneous mitomycin C topical instillation and local endocavitary hyperthermia as a preoperative adjunct to transurethral resection in a preliminary clinical study. A specifically designed system to deliver and monitor local bladder hyperthermia was used. The feasibility, the subjective tolerance and the side effects of the combined treatment were the main target of our investigation. Endoscopic and histologic features, assessed before, during and after this combined approach, showed selective damage to neoplastic areas with minimal changes in the normal urothelium. Local intravesical concurrent chemotherapy and hyperthermia administration is found to be a safe and well-tolerated approach for superficial bladder tumor treatment. The preliminary results encourage further studies to define the limits and prospects of this regimen, in both superficial bladder tumor ablation and prophylaxis of recurrences.

Administration, Intravesical↗
PubMed1992

Optimal BCG treatment of superficial bladder cancer as defined by American trials.

Immunotherapy provides an effective alternative approach to chemotherapy in the management of superficial bladder cancer. The first widely used immunotherapy, bacillus Calmette-Guérin (BCG), eradicates residual tumour bacillus Calmette-Guérin (BCG), eradicates residual tumour in one half of patients with carcinoma in situ. Unlike chemotherapy, induction of immunity against transitional cell carcinoma has the potential of protecting patients from tumours which have not yet developed. Controlled trials suggest that BCG immunotherapy reduces disease progression, decreases the need for cystectomy and prolongs survival. While the optimal BCG treatment schedule remains unknown and may in fact vary from one patient to another, data clearly suggest that a single 6-week induction course is suboptimal. In 150 randomized patients with CIS treated with 120 mg Connaught BCG, Southwest Oncology Group (SWOG) investigators found that just 3 additional weekly treatments at week 12 increased complete response from 70 to 82% (p less than 0.05). Intravesical BCG is clearly superior to oral BCG, and controlled studies have demonstrated that percutaneous administration is not necessary. While evidence suggests that BCG is the best available treatment for superficial bladder cancer and 95% of patients have no significant toxicity, serious and even fatal toxicity can occur. Sepsis can occur with intravenous absorption and often appears to result from hypersensitivity. Limited clinical and animal model experience suggests that cycloserine improves survival over treatment with isoniazid and rifampicin, but optimal treatment of BCG sepsis is isoniazid 300 mg, rifampicin 600 mg, and prednisolone 40 mg daily.

Administration, Intravesical↗
PubMed1998

Electromotive drug administration and hydrodistention for the treatment of interstitial cystitis.

Thirteen patients with interstitial cystitis diagnosed by the NIH criteria were treated with intravesical electromotive administration of lidocaine and dexamethasone followed by cystodistention. After a mean follow-up of 10 (range 3-22) months, 8/13 (62%) of the patients reported complete resolution of bladder symptoms lasting an average 4.5 (range 0.75-17) months. Partial or short-term improvement of bladder symptoms was observed in three patients, while two patients reported aggravation of pain for several days after therapy. A significant increase in bladder capacity, to an average 166% of the pretreatment capacity, was observed in all patients. Whenever symptoms recurred after initially effective therapy, retreatments were performed with equal efficacy in 11 patients. This promising new therapeutic approach, performed on an outpatient basis, may become first-line treatment for patients with interstitial cystitis.

Administration, Intravesical↗
PubMed1993

Urodynamic effects of intravesical instillation of atropine and phentolamine in patients with detrusor hyperactivity.

The effects of intravesical instillation of atropine (10(-6) M) and phentolamine (10(-6) M) on urodynamic parameters were investigated in patients with detrusor hyperactivity of neurogenic or non-neurogenic origin. A modified cystometric technique with slow intermittent filling was used. The reproducibility of the investigative procedure was first verified in 17 patients. Eighteen patients, 12 with detrusor hyperreflexia and 6 with detrusor instability, were then investigated with atropine and 17 patients, 11 with detrusor hyperreflexia and 6 with detrusor instability, were investigated with phentolamine. In individual patients clinically relevant improvements, such as an increased bladder capacity and a decreased detrusor pressure, were found. Five/12 neurogenic and 1/6 non-neurogenic patients responded to instillation of atropine. Five/11 neurogenic but none of the non-neurogenic patients responded to phentolamine. In the neurogenic group phentolamine caused an increase of the bladder capacity from 247 +/- 57 ml. to 378 +/- 57 ml. (p < 0.05). It is suggested that the different sensitivities to intravesical drug administration in patients with detrusor hyperreflexia and detrusor instability can be explained by pathophysiological differences and concluded that intravesical instillation of drugs may be of therapeutic value in selected groups of patients.

Administration, Intravesical↗
PubMed1994

[Severe self-limiting hypersensitivity reaction after immunotherapy with intravesical BCG].

We present the case of a 67-years-old patient diagnosed of superficial vesical transitional carcinoma which, under immunotherapy with intravesical BCG, developed a severe hypersensitivity reaction with spontaneous resolution. We describe several adverse reactions after the administration of intravesical BCG, as well as its diagnostic and therapeutic problems, especially in the cases of hypersensitivity.

Administration, Intravesical↗
PubMed1999

Perivesical fat necrosis after adjuvant intravesical chemotherapy.

OBJECTIVE: To document the presence of extensive transmural and perivesical fat necrosis in a series of radical cystectomies, and associate the surgical and pathological findings with the administration of intravesical chemotherapy. PATIENTS AND METHODS: The study comprised 12 patients with pT2+ transitional cell tumours who were referred to the West Middlesex University Hospital and who proceeded to primary radical cystectomy between November 1996 and April 1998. The association between the presence of widespread transmural and extravesical necrosis and the administration of a single dose of intravesical epirubicin or mitomycin C in the 24 h after the initial transurethral resection of bladder tumour (TURBT) was analysed using the two-tailed Fisher's exact test. RESULTS: The association between the presence of transmural and extravesical fat necrosis and administration of intravesical chemotherapy was highly significant (P=0.015). CONCLUSIONS: The depth and extent of the mural muscle necrosis and perivesical fac necrosis in patients receiving intravesical chemotherapy within 24 h of TURBT is remarkable and more florid than the usual muscle necrosis seen after TURBT. Clinically, the necrotic tissue makes the cystectomy significantly more difficult technically, and may even mimic extravesical spread of malignant disease. This was not borne out by the histology of the specimens, which showed no extravesical spread of the tumour. Surgeons should be aware of the possibility that such operative findings might be the result of intravesical chemotherapy.

Administration, Intravesical↗
PubMedDate not supplied

[Changes in prostate specific antigen levels during intravesical instillations with Calmette-Guerin bacillus: relationship with transurethral resection of the prostate].

OBJECTIVES: To evaluate variations on the serum PSA levels during and after administration of intravesical BCG and its relationship with previous transurethral resection of the prostate (TURP). METHODS: PSA serum concentration variations were studied after each instillation, at 1 month and at 3 months in 24 patients with superficial bladder cancer and/or CIS under weekly BCG instillations treatment. Three patients had undergone TURP. RESULTS: A raise in PSA was observed in 87.5% of the cases during BCG instillations, although the increase was only significative in patients who had undergone TURP. PSA values descended at one and three months. CONCLUSIONS: Endovesical BCG administration produces an increase on serum PSA levels. This variation is higher in patients with history of TURP.

Adjuvants, Immunologic↗
PubMed1992

Regional chemotherapy for bladder neoplasms using continuous intravesical infusion of doxorubicin: impact of concomitant administration of dimethyl sulfoxide on drug absorption and antitumor activity.

BACKGROUND: One objective of regional chemotherapy is to achieve the therapeutic drug levels in local tissues and primary nodal drainage fields, while minimizing systemic drug toxicity. The composition of the drug-delivery vehicle may influence local drug absorption and thereby modulate both tissue drug levels and systemic toxicity. PURPOSE: We evaluated the effect of dimethyl sulfoxide (DMSO) as a drug-delivery vehicle on regional and systemic levels of doxorubicin (DOX) and on the cytotoxicity of DOX following continuous intravesical administration in an invasive rat transitional cell bladder carcinoma model. METHODS: F344 rats received continuous intravesical DOX infusion for a 7-day period using a regional drug administration system. A constant dose of DOX was administered in one of three DMSO concentrations (0%, 10%, or 50%) to groups of animals (N = 20 per group). These concentrations corresponded to target urinary concentrations of 0%, 0.1%, and 0.5%, respectively. DOX levels in urine, serum, muscle, liver, bladder wall, and retroperitoneal lymph nodes were measured using a fluorescence assay on experimental days 0, 2, 4, 6, and 8 (N = four animals/group per day). In vitro assays evaluated the effect of DMSO concentration on the cytotoxicity of DOX against six transitional cell carcinoma cell lines. A final experiment on rats with established bladder tumors compared the cytoreductive effect of continuous intravesical infusion of DOX in 50% DMSO with that of DOX alone and with that in a sham-treated control group; there were 20 rats in each group. RESULTS: Mean and peak tissue and serum levels of DOX increased as a direct function of DMSO concentration. Compared with the results in controls, mean concentrations of DOX in the bladder were increased 7.1-fold and 12.1-fold in the groups given 10% and 50% DMSO, respectively. Average drug concentrations in the lymph nodes were increased 9.6-fold and 9.3-fold in the groups given 10% and 50% DMSO, respectively. In vitro, DMSO synergistically enhanced the cytotoxicity of DOX in two of the six cell lines studied. Solubilizing the test agent in 5% DMSO reduced the IC50 (drug concentration required to reduce cell viability to 50% of control values) to an average of 56% +/- 41% (+/- SD) of control values; 10% DMSO further decreased the average IC50 to 20% +/- 18% (+/- SD) of control values. The mean bladder tumor weight of animals treated with the combination of DOX and DMSO was 0.52 g. This compared with a mean tumor-bearing bladder weight of 2.69 g in the control group (P = .012) and 0.80 g in the group treated with DOX alone (P = .0544). CONCLUSIONS: These results suggest that the use of DMSO as a solvent vehicle for DOX improves drug absorption while simultaneously potentiating DOX cytotoxicity. The use of DMSO as a drug carrier merits further evaluation as a way of enhancing the efficacy of regional chemotherapy regimens.

Administration, Intravesical↗
PubMed1992

Intravesical instillations of 4-epi-doxorubicin (epirubicin) in the prophylactic treatment of superficial bladder cancer: results of a controlled prospective study.

A controlled prospective study in 65 patients was done to evaluate the efficacy of intravesical epirubicin administration as prophylactic treatment in regard to the pattern of tumor recurrences after complete endoscopic resection of superficial transitional cell carcinoma of the bladder. Intravesical instillations of the drug were given weekly for 6 consecutive weeks and to the responders an intermittent maintenance therapy was administered for the first 2 years after each followup examination. Of the patients treated prophylactically with epirubicin 37% had recurrence within a total of 1,136 patient-months compared to 55% of the controls who were followed for a total of 436 months, a difference that was not statistically significant (p greater than 0.05). However, examining the results in another manner, the control patients demonstrated a significantly shorter mean interval to recurrence and higher recurrent tumor rate per 100 patient-months. To clarify further the efficacy of epirubicin therapy, comparisons of the treatment outcome according to several tumor factors were done. These comparisons revealed a significant benefit for those who received epirubicin with respect to history of tumor recurrences and multiplicity at presentation. Drug-induced toxicity was acceptable. Our study suggests that epirubicin is safe and effective against the recurrence of superficial bladder cancer.

Administration, Intravesical↗
PubMed1996

Mycobacterial sepsis following intravesical instillation of bacillus Calmette-Guérin.

Intravesical bacillus Calmette-Guérin (BCG) administration for bladder cancer may lead to BCG dissemination in the compromised host. A case of a 63-year-old man with shock secondary to BCG sepsis is reported. The recognition and treatment of disseminated BCG infection are discussed. In addition to standard therapy for urosepsis, early therapy with steroids and coverage with antitubercular medications should be initiated for patients with this condition. In general, the author recommends that all febrile patients who have received BCG immunotherapy within three years, and who have no obvious source for their fever, have acid-fast bacilli blood cultures done for Mycobacterium bovis, and that these patients be admitted to the hospital for further evaluation.

Administration, Intravesical↗
PubMed1990

Intravesical Bacillus Calmette-Guérin prophylactic treatment for superficial bladder tumors: results of a controlled prospective study.

A controlled prospective study in 100 patients evaluated the efficacy of intravesical bacillus Calmette-Guérin (BCG) administration as prophylactic treatment on tumor recurrence and tumor progression rate after endoscopic resection of superficial transitional cell carcinoma of the bladder. There were 27 recurrences in 22 of 67 evaluable patients (33%) who received BCG, compared to 27 recurrences in 19 of 33 control patients (58%) (p less than 0.05). The mean follow-up periods for the tumor-free patients in the BCG and control groups were 29 and 30 months, respectively, while the mean times to tumor recurrences for the above groups were 13.36 +/- 6 and 9.94 +/- 5 months, respectively (p less than 0.05). The recurrence rates per 100 patient months for the BCG and control patients were 1.69 and 4.41 recurrences, respectively (p less than 0.05), while 7 patients of the BCG group showed recurrent tumors of higher stage or grade, compared to 13 of the controls (p less than 0.05). This study confirms that Pasteur strain BCG is safe and efficacious in the prevention of superficial bladder tumor recurrence and tumor progression.

Administration, Intravesical↗
PubMed1995

Intravesical application of oxybutynine: mode of action in controlling detrusor hyperreflexia. Preliminary results.

Topical oxybutynine (Oxy) has been used successfully in neurogenic bladder patients who remained wet on oral anticholinergics or could not tolerate oral medication. However, little is known about the pharmacokinetics of intravesical Oxy. The aim of this study was to evaluate the resorption rate of intravesically given Oxy in the bladder in comparison with oral intake, and to find out which pharmacological properties of the drug are responsible for its effect when given intravesically. Our results indicate that peak plasma levels of intravesical Oxy appear later, are lower and stay longer compared to oral intake. Cystometries before, 20 min and 2 h after intravesical application of Oxy indicate that the main effect of intravesical Oxy on the detrusor is systemic due to its resorption. Our findings confirm the clinical experience that intravesical Oxy is well tolerated, very efficacious and better than oral medication.

Administration, Intravesical↗
PubMed1990

[Immunohistochemical studies on bladder tumours. Immunohistochemical evaluation on intravesical therapy for bladder tumours].

The focus of my study was the immunohistochemical studies of tumour cells induced by ADM intravesical instillation therapy when stained by several antigens, those being; Carcinoembryonic antigen (CEA), Ferritin, Beta 2 Microglobulin (beta 2-MG), Keratin and Glycogen before and after the therapy. Then I discussed as to their value in indicating therapeutic efficacy. There were 18 cases of bladder cancer studied using the Peroxidase-antiperoxidase technique (PAP) of staining. Data indicated a 44.4% response rate following therapy with intravesical ADM. Immunohistochemical evaluation showed improvement as indicated by not staining with CEA. Also observed was no change and slightly diffuse staining with Keratin: and a decrease in all layers of Glycogen expression: However this could not be observed with the Ferritin or beta 2-MG. It is believed this demonstrates that immunohistochemical expressions of staining with CEA, Keratin, and Glycogen may be a sensitive indicator of a therapeutic response to intravesical ADM.

Administration, Intravesical↗