[Reiter syndrome after intravesical BCG therapy].
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Administration, Intravesical↗
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Intravesical drug delivery. Pharmacokinetic and clinical considerations.
Intravesical drug administration is widely used in the treatment of patients with superficial bladder cancer, and aims to optimise drug delivery in the vicinity of the tumour and reduce systemic availability. The most commonly employed intravesical agents in patients with superficial bladder cancer are mitomycin (mitomycin C), thiotepa, ethoglucid (ethoglucid), anthracyclines such as doxorubicin, bacille Calmette-Guérin (BCG) and, more recently, taxol and the new mitomycin derivative KW-2149. Recurrence rates in patients with superficial bladder cancer have been substantially reduced by combined transurethral resection and intravesical pharmacotherapy. The high concentration of cytotoxics in urine and tumour tissue explain the high efficacy rates. Furthermore, the low systemic availability of most intravesical agents is consistent with the low frequency of acute and delayed systemic adverse effects. Systemic toxicity is almost negligible, except in the case of thiotepa, and local toxicity is transient and tolerable. Pharmacokinetic models of drug absorption from the bladder have been developed, both in animals and humans. These have led to the identification of optimal intravesical treatment regimens.
Absorption↗
[Pulmonary fibrosis following instillation of mitomycin C in the urinary bladder].
Intravesical prophylaxis against recurrence of bladder carcinomas using mitomycin C has proved to be an effective treatment with few side effects. No side effects involving the lungs have so far been observed with systemic administration; with intravesical use, however, this is not the case. We report a 32-year-old man in whom pulmonary interstitial fibrosis occurred after intravesical instillation of mitomycin C. The clinical picture, including the therapy, and the differential diagnosis and practical consequences are all discussed.
Administration, Intravesical↗
Monoclonal antibodies for intravesical radioimmunotherapy of human bladder cancer.
Local administration of radioimmunoconjugates may allow successful tumor therapy. Bladder cancer appears well suited to this approach, because of its superficial and multifocal nature, and because it will allow direct intravesical administration of conjugates. Implantation of human bladder cancer cell lines in the bladder wall of nude rats results in tumor formation, providing an excellent model to test this. We have developed two murine monoclonal antibodies (MAbs), BLCA-8, IgG3, and BLCA-38, IgG1, both of which react with malignant cells and shed into voided urine of patients with transitional cell carcinoma (TCC) of the bladder, but not with normal bladder urothelial cells. Radioimmunoconjugates produced with 131Iodine (131I) or 125I have been used for biodistribution studies following administration directly into the bladder. Radioiodinated intact MAbs or Fabs administered intravesically into nontumor-bearing rats did not leak into the systemic circulation and were stable in urine for up to 100 h. Biodistribution studies carried out following intraperitoneal or intravesical administration of radioimmunoconjugates to tumor-bearing nude rats indicate good tumor uptake of both MAbs. Together with immunoreactivity assays, these studies demonstrate that 131I-labeled MAbs have considerable potential for intravesical radioimmunotherapy of human bladder tumors, and further studies are under way.
Administration, Intravesical↗
[Hematogenous contact dermatitis after intravesicular instillation of mitomycin C].
Mitomycin C is an alkylating chemotherapeutic agent which is instilled intravesically to prevent recurrence of superficial bladder carcinomas. After several cycles of mitomycin C, our patient developed a pruritic genital dermatitis and palmar desquamation. Following exclusion of a fungal infection, we performed patch tests using the standard series, the major basic ointment ingredients, disinfectants, and mitomycin C in concentrations of 0.001 to 0.1%; the resulting diagnosis was allergic contact dermatitis due to delayed-type hypersensitivity to mitomycin C. The skin rash rapidly resolved with application of topical steroids, and the intravesical chemotherapy was changed to doxorubicin. Eczematous skin reactions are quite common side effects after intravesical instillation of mitomycin C. In the majority of cases, they are caused by delayed-type hypersensitivity reactions, presumably elicited by hematogenous spread of the allergen, and not by irritation. The sensitization most likely occurs via the bladder mucosa. In order to differentiate between allergic and toxic contact dermatitis, patch tests with the above-mentioned mitomycin C concentrations are useful. In cases of mild allergic contact dermatitis the intravesical chemotherapy might be continued with concomitant topical steroids.
Administration, Intravesical↗
Intravesical dimethyl sulfoxide (DMSO) for interstitial cystitis--a practical approach.
OBJECTIVES: To provide a brief overview of intravesical dimethly sulfoxide (DMSO) therapy for interstitial cystitis and offer a practical approach to patient treatment. METHODS: A review of the literature and a summation of the experience with treatment of > 300 patients with DMSO at the Interstitial Cystitis Clinic, New England Medical Center. RESULTS: DMSO is helpful in a significant number of patients and it has acceptable morbidity and an excellent safety profile. CONCLUSIONS: Intravesical DMSO (singly or in combination) is one of the mainstays in the pharmacologic treatment of interstitial cystitis.
Administration, Intravesical↗
[A comparative clinical trial of UFT treatment and intravesical adriamycin instillation to prevent recurrence of superficial bladder cancer].
UFT was administered to 27 patients with superficial bladder cancer and adriamycin administered intravesically to 26 patients with the same cancer as a measure to prevent the recurrence of the tumor following transurethral resection, and the rate of recurrence was compared between the two groups of patients. There was no significant difference between the two groups in background factors (e.g., primary or recurrent, single or multiple), histological malignancy and degree of infiltration. The non-relapsers accounted for 88.9% of patients at one year, 64.3% at two years, and 64.3% at three years in the UFT group and 96.2%, 76.8%, and 65.5%, respectively, in the adriamycin group. There was no significant difference in the rate of non-recurrence between the two groups; nor was there significant difference in the non-recurrence rate between them with respect to any of the background factors. UFT showed results which compared with those of adriamycin administered intravesically, and UFT was considered useful for preventing recurrence of superficial bladder cancer.
Administration, Intravesical↗
Current strategies for managing interstitial cystitis.
Interstitial cystitis is a relatively common disorder that can be treated successfully in the majority of cases. Symptoms can be effectively controlled, and disease pathophysiology addressed, using a multimodal medical regimen based on heparinoid therapy. As appropriate to the individual patient, heparinoid therapy is supplemented by oral medications aimed at reversing neural upregulation and controlling any allergies. A new and promising adjunct to the multimodal regimen is an intravesical therapeutic solution that combines pentosan polysulfate or heparin with lidocaine and sodium bicarbonate. Preliminary results indicate this therapeutic solution provides immediate temporary relief of symptoms.
Administration, Intravesical↗
Treatment of patients with superficial bladder cancer by intravesical instillation of anticancer drugs plus oral chemotherapy following TUR-Bt: a randomized controlled trial.
We conducted a randomized controlled trial to compare local recurrence rate after transurethral resection of superficial bladder cancer treated by either intravesical instillation of an anticancer drug alone (method A) and the intravesical instillation plus oral chemotherapy (doxifluridine, 5'-DFUR, an intermediate metabolite of capecitabine) (method B). Results between groups showed no difference in recurrence-free survival curves in 196 patients subjected to primary analysis. However, patients subjected to secondary analysis (method B, over 3 months administration of 5'-DFUR) showed a significantly better prognosis than method A (p=0.0244, Wilcoxon). Regarding correlation between thymidine phosphorylase (TP, an enzyme to convert 5'-DFUR to 5-fluorouracil) level and prognosis, method A patients showed poorer prognosis in higher TP level cases than in lower TP levels. However, there was no significant difference in prognosis between those with higher and lower TP levels. In method B patients, there was no difference in prognosis between those with higher and lower TP levels. Method A patients tended to show a slightly better prognosis than those with lower TP levels, while method B patients tended to have a slightly better prognosis with higher TP levels, but no significant difference was observed. These findings suggested 5'-DFUR showed a mild efficacy in patients with higher TP levels and that patients with higher TP levels resulted in poorer prognosis.
Administration, Intravesical↗
[Prophylactic effect of UFT in combination with intravesical chemotherapy on the recurrence of superficial bladder tumor].
The influence of N1-(2-tetrahydrofuryl)-5-fluorouracil plus uracil (UFT) on the recurrence of superficial bladder tumors was evaluated in a randomized clinical study. Group A (n = 196) underwent transurethral resection (TUR) and the intravesical chemoprophylaxis, while group B (n = 193) received 400 mg per a day of UFT orally for 6 months in addition to the instillation therapy. These adjuvant therapy was started one week after TUR. Consequently, 30 patients in group B showed UFT-related toxicity and administration of UFT was discontinued in 10 of them. In addition, 87 patients in group B did not complete the 6-month course of UFT administration. Comparison of 2-year actuarial non-recurrence curves revealed no significant difference between groups A and B. However, UFT seemed to have a favorable prophylactic effect when recurrence rates were compared among those patients with recurrent tumors (generalized Wilcoxon: p = 0.1277), and those with recurrent multiple tumors (p = 0.0847).
Administration, Intravesical↗
The stability of lidocaine and epinephrine solutions exposed to electric current and comparative administration rates of the two drugs into pig bladder wall.
Intravesical electromotive administration of local anesthetics is clinically successful but electrochemistry, cost and effectiveness limit the choice of drugs to diluted lidocaine HCl 4% mixed with epinephrine. These studies address the stability of lidocaine and epinephrine both over time and when exposed to electric current, i.e. transport rates with passive diffusion and electromotive administration. The drug mixture used was 50 ml lidocaine 4%, 50 ml H2O and 1 ml epinephrine 1/1000. For stability, the solution was placed either in bowls for 7 days or in a two chamber cell with the donor compartment (drugs) separated from the receptor compartment (NaCl solution) by a viable pig bladder wall. This was subjected to 30 mA for 45 min. Stability was measured with mass spectrometry. The cell was also used to determine transport rates with passive diffusion and currents of 20 mA and 30 mA, over 20, 30 and 45 min. Drug measurements in both compartments and bladder were made with HPLC. Lidocaine remained stable throughout the 7 days, epinephrine on day 1 only and both drugs were stable with 30 mA for 45 min. Comparing 20 mA and 30 mA with passive diffusion, there were significant differences in 6/6 donor compartment lidocaine levels, 4/6 receptor compartment levels and 6/6 bladder tissue levels and also in 6/6 epinephrine donor levels and 6/6 tissue levels. The combination lidocaine and epinephrine remains stable for 1 day and when exposed to 30 mA for 45 min. Electric current accelerates the transport of lidocaine and epinephrine.
Anesthetics, Local↗
Intravesical bacillus Calmette-Guerin immunoprophylaxis of superficial bladder cancer: results of a controlled prospective trial with modified treatment schedule.
A controlled prospective trial on 94 patients evaluated the efficacy of intravesical Pasteur strain bacillus Calmette-Guerin (BCG) administration as prophylaxis against tumor recurrences after complete endoscopic resection of superficial bladder cancer. The treatment schedule, consisting of an initial 6-week course of instillations and a single quarterly maintenance dose to the responders, was modified to those of the latter who were at high risk for recurrence and who received an additional separate 4-week course of therapy. The percentage of the patients treated prophylactically with BCG and who remained free of recurrences (68%, mean followup 33.8 months) was significantly higher than that of the controls who underwent transurethral resection only (41%, mean followup 30.2 months). In terms of relative risk of recurrences, recurrence rate per 100 patient-months and disease-free interval, comparisons between the 2 groups of patients revealed a significant benefit for the BCG group overall as for those subjects having stages Ta and T1 tumors, multifocal tumors, a history of disease, and grades 2 and 3 carcinoma. Drug-induced toxicity was acceptable. Our study suggests that our modified treatment protocol is notably safe and effective against recurrent superficial bladder cancer.
Administration, Intravesical↗
Intravesical atropine compared to oral oxybutynin for neurogenic detrusor overactivity: a double-blind, randomized crossover trial.
PURPOSE: We tested the efficacy and side effect profiles of intravesical atropine compared to oxybutynin immediate release when used by individuals with multiple sclerosis. MATERIALS AND METHODS: We performed a study to determine the most effective dose of atropine. Eight participants used increasing doses of intravesical atropine during a 12-day period. Bladder diary data showed that the instillation of 6 mg atropine 4 times daily was most effective for increasing bladder capacity (voided/catheter volumes). We then did a randomized, double-blind crossover trial. Participants received 14 days of treatment with oral oxybutynin or with intravesical atropine, followed by 14 days of alternative treatment. Participants recorded a bladder diary and rated side effects and quality of life. The primary outcome variable was bladder capacity. RESULTS: A total of 57 participants with multiple sclerosis completed the study. Average change in bladder capacity was higher in the atropine arm. The mean +/- SD oxybutynin change was 55.5 +/- 67.2 ml, the mean atropine change was 79.6 +/- 89.6 ml and the mean difference between arms was 24.1 ml (95% CI -0.4, 49.7; p = 0.053). Changes in incontinence events and voiding frequency were not statistically different between the arms. Changes in total side effect and dry mouth scores were significantly better in the atropine treatment arm. CONCLUSIONS: Intravesical atropine was as effective as oxybutynin immediate release for increasing bladder capacity and it was probably better with less antimuscarinic side effects. We recommend that intravesical atropine should be made available to patients with neurogenic detrusor overactivity and voiding problems requiring intermittent catheterization as an alternative to oral therapy, which often has troublesome side effects.
Administration, Intravesical↗
A randomized prospective comparison of oral versus intravesical and percutaneous bacillus Calmette-Guerin for superficial bladder cancer.
Reports of a dramatic decrease in tumor recurrence and regression of muscle invasive disease with oral bacillus Calmette-Guerin prompted us to conduct a randomized prospective comparison of oral bacillus Calmette-Guerin with the standard intravesical plus percutaneous therapy. Oral therapy consisted of 200 mg. Tice bacillus Calmette-Guerin 3 times each week. Intravesical and percutaneous Tice bacillus Calmette-Guerin at a dose of 50 mg. was given weekly for 6 weeks, at 8, 10 and 12 weeks, then at 6 months and every 6 months thereafter. Minimal side effects confirmed the safety of oral bacillus Calmette-Guerin. Tumor recurrence was documented in 21 of 33 oral bacillus Calmette-Guerin patients (64%) and 18 of 55 (33%) who received intravesical plus percutaneous therapy (p less than 0.002, chi-square test). We were unable to demonstrate any antitumor activity of oral bacillus Calmette-Guerin in this study.
Administration, Intravesical↗
Combined intravesical and oral oxybutynin chloride in adult patients with spinal cord injury.
OBJECTIVES: Detrusor hyperreflexia with elevated storage pressures presents a major risk factor for renal damage in patients with neurogenic lower urinary tract dysfunction. If standard anticholinergic treatment is unsuccessful, surgical treatment must be considered. We evaluated the effects of intravesical oxybutynin treatment on detrusor hyperreflexia in patients in whom standard oral treatment had failed. METHODS: Twenty-five patients (mean age 36. 7 years) with storage pressures greater than 40 cm H(2)O despite standard anticholinergic treatment received intravesical (15 mg three times daily) and oral oxybutynin chloride treatment. The follow-up evaluations included urodynamic testing, renal ultrasound, urine examination (urinalysis and urine culture), and evaluation of side effects. RESULTS: The mean follow-up was 6 months. Intravesical treatment led to an increase in bladder storage volume from 349 to 420 mL. The mean maximum storage pressure was significantly reduced from 54 to 26.5 cm H(2)O. Detrusor storage pressures returned to values less than 40 cm H(2)O in 21 of 25 patients. Dysreflexia was treated successfully in 3 of 5 patients. No patient developed renal damage. No severe side effects or drug-related discontinuation of treatment were observed. CONCLUSIONS: Intravesical oxybutynin therapy seems to be a safe and effective treatment option for detrusor hyperreflexia in adults and avoids surgical treatment in most patients. Long-term observations concerning side effects, acceptance, and efficacy are needed.
Administration, Intravesical↗
[A comparative clinical trial of UFT medication and intravesical BCG in the recurrence of superficial bladder cancer. Study Group of UFT and BCG adjuvant therapy for bladder cancer].
In sixty-four patients who had TUR-bt for superficial bladder cancer, the effect of intravesical BCG and UFT medication were compared. Group A (n = 20) were treated with BCG, group B (n = 22) were treated with UFT and group C (n = 22) were treated with both agents. The patients were followed up for more than 12 months by cystoscopy at a interval of 3 months, urinary cytology and bladder cold cup biopsy, if necessary. Thirteen of the 20 patients in group A and 13 of the 22 patients in group B were free of tumors, compared to 5 of the 22 patients in group C. Although the recurrence-free-rate in each group does not differ significantly, the combination therapy of intravesical BCG and UFT medication seems to decrease the rate of tumor recurrence for superficial bladder cancer. Side effects of BCG and UFT were tolerated well.
Administration, Intravesical↗
[Superficial bladder neoplasia unresponsive to endocavitary treatment: when should the treatment approach be changed?].
PURPOSE: The appropriate treatment of superficial bladder neoplasm is still debated. The urologist must weigh the risk of tumor recurrence and progression against the possible side effects of conservative treatment (transurethral resection, intravesical therapy). Furthermore it is difficult to decide exactly when to abandon the conservative therapy and proceed with radical cystectomy and urinary diversion in order to prevent the potentially lethal sequelae of invasive bladder cancer. There are no certain scientific data on the appropriate therapeutic approach of recurrences of superficial bladder cancer after intravesical therapy and often the urologist takes a decision based on his personal experience ("art rather than science"). Based on these considerations, our aim was to evaluate applicable criteria to predict the risks of tumor recurrence and progression and so decide the best treatment for each patient. METHODS: 148 patients with multifocal, multirecurrent or persistent superficial bladder cancer (stage Ta-T1-Tis, G1-3) were treated with transurethral resection and/or two or more administration of intravesical chemo- (Mitomycin C, Doxorubicin, Epirubicin, Mitoxantron) or immuno-therapy (BCG) using common treatment schedule. Our first end point was the disease-free survival (DFS) evaluated by three different criteria: 1) "dynamic" stage (stage T1 diagnosed at the beginning, or during the follow-up or never); 2) "dynamic" grade (G3 tumor diagnosed at the beginning or during the follow-up or never); 3) "number of positive cystoscopies at the 3-year follow-up". Data were evaluated by a univariate statistical analysis (log-rank test) and a multivariate ones (MPLR stepwise procedure and L-ratio Cox's test). RESULTS: "Dynamic" stage: patients who never developed a T1 stage tumor have a better DFS than patients who developed a T1 stage tumor and even more than patients in which T1 was diagnosed from the beginning (p < 0.0001). "Dynamic" grade: patients who never developed a G3 tumor have a better DFS than patients who developed a G3 tumor and patients in which G3 tumor was diagnosed from the beginning (p < 0.0017). "Number of positive cystoscopies at the 3-year follow-up": patients with less than 3 positive cystoscopies have a better prognosis than patients with 3 or more positive cystoscopies at the three-year follow-up (p < 0.0380). DISCUSSION: We have found three independent predictive prognostic factors: "dynamic" stage, "dynamic" grade and number of positive cystoscopies at the 3-year follow-up. The statistical univariate and multivariate analyses allow us to define three risk categories for tumor progression (> or = T2): low, moderate, high.
Administration, Intravesical↗
Use of the lidocaine gel container for urethral dilation and intravesical drug delivery.
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Administration, Intravesical↗