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PubMed2005

Inhibitory effect of intravesically applied botulinum toxin A in chronic bladder inflammation.

PURPOSE: We evaluated a putative inhibitory effect of intravesical botulinum toxin A (BTX-A) on afferent pathways in conditions of chronic bladder inflammation. MATERIALS AND METHODS: Female Sprague-Dawley rats were divided into 4 groups, namely group 1-saline treated, group 2-BTX-A treated, group 3-cyclophosphamide (CYP) treated and group 4-BTX-A and CYP treated. At the beginning of the treatment period all animals received intravesical protamine sulfate (1%), followed by intravesical BTX-A or saline. Subsequently CYP or saline was injected intraperitoneally every 3 days for 10 days. The rats then underwent cystometrogram evaluation prior to spinal cord harvest. Sections from the L6 and S1 spinal cord segments were examined for the total number of Fos immunoreactive cells. RESULTS: Comparisons of the L6 and S1 sections showed a significant difference among groups (p <0.05). CYP treated animals had a significant increase in L6 and S1 (78% and 107%, respectively) c-fos expression compared with saline controls (p <0.001). Comparison of the CYP and BTX-A/CYP groups showed a significant decrease in L6 and S1 in c-fos expression (50% and 52%, respectively) in the BTX-A/CYP treated group (p <0.001). No significant difference was present between the saline and BTX-A alone groups. Cystometrogram studies revealed that the nonvoiding intercontractile interval increased by more than 10-fold in BTX-A/CYP treated animals compared with CYP treated rats (p <0.01). CONCLUSIONS: In a CYP model of chronic bladder inflammation intravesical BTX-A significantly inhibits the afferent neural response without impairing efferent bladder function.

Administration, Intravesical↗
PubMed2006

Transient anuria requiring nephrostomy after intravesical bacillus Calmette-Guérin instillations for superficial bladder cancer.

A 76-year-old man received intravesical bacillus Calmette-Guérin (BCG) instillations for recurrent superficial bladder cancer. He had undergone right nephroureterectomy for right renal pelvic cancer 9 months previously. He presented with anuria and left hydronephrosis after the fourth instillation, with serum creatinine increasing up to 15.7 mg/dL. Percutaneous nephrostomy was indwelled, and antegrade pyelography showed left vesicoureteral obstruction. There was no sign of recurrent bladder cancer or ureteral cancer. He started spontaneous voiding on day 4 and the nephrostomy was removed on day 8. Most of the side-effects of intravesical BCG therapy are minor, and major adverse reactions are rare. Life-threatening ureteral obstruction would be a rare complication of BCG immunotherapy. Although BCG intravesical instillation after nephroureterectomy is a common practice, special care should be taken of renal function in patients with unilateral kidney during BCG therapy.

Adjuvants, Immunologic↗
PubMed1990

Clinical study of prognostic factors of superficial bladder cancer treated with intravesical bacillus Calmette-Guerin.

Intravesical instillation of Tokyo 172 strain Bacillus Calmette-Guérin (BCG) was performed in 96 patients with initial superficial bladder cancer (Ta and T1) after transurethral resection (TUR) of tumour as a prophylaxis against tumour recurrence. The recurrence rate of tumours was estimated by the person-years method, comparing it with that of historical controls. There were statistically significant decreases in recurrent tumours following BCG therapy. To clarify the efficacy of intravesical BCG therapy, the prognostic significance of several factors was evaluated in patients with bladder cancer treated with TUR and instillation of BCG. The prophylactic effects were statistically better for those with multiple tumours, grade 3 lesions or Ta lesions than for control patients. No correlation between purified protein derivative (PPD) responsiveness and favourable results could be observed. Our results suggest that intravesical BCG instillation can alter the biological behaviour that affects the recurrence of superficial bladder cancer, especially for multiple, high grade or Ta tumours.

Administration, Intravesical↗
PubMed2001

Biphasic urethral sphincter responses to acetic acid infusion into the lower urinary tract in anesthetized cats.

PURPOSE: Varying the concentration of infused acetic acid produced bladder irritation and dose dependent increases in external urethral sphincter electromyography activity in cats. We further characterized acetic acid induced external urethral sphincter electromyography activity in intact and acute spinal cord injured animals. MATERIALS AND METHODS: Bladder cystometrography and external urethral sphincter electromyography were continuously recorded in chloralose anesthetized cats. Dilute 0.05% to 0.8% acetic acid was infused into the lower urinary tract through the bladder dome. Intravesical or intraurethral infusion was performed separately in bladder neck ligated preparations. In some animals the spinal cord was transected at L1 to L2 2 to 8 hours before the study. RESULTS: Acetic acid infusion into the lower urinary tract elicited dose dependent increases in tonic external urethral sphincter activity. However, a prolonged infusion of 0.7% to 0.8% acetic acid usually inhibited external urethral sphincter activity. The excitatory external urethral sphincter response was elicited by intraurethral but not by intravesical infusion. This response remained in acute spinal cord injured animals. The inhibition of tonic external urethral sphincter activity during 0.7% to 0.8% acetic acid infusion was observed when there was extreme bladder irritation characterized by continual contractions. Induced tonic external urethral sphincter activity was attenuated by intrathecal administration of prazosin or scopolamine and abolished by hexamethonium. CONCLUSIONS: Acetic acid infusion into the lower urinary tract elicits biphasic external urethral sphincter responses. The early excitatory response is a spinal urethrourethral reflex and the late inhibitory phase results from negative vesicourethral feedback control. Spinal muscarinic cholinergic and alpha-adrenergic receptors are involved in acetic acid induced excitatory external urethral sphincter responses.

Acetic Acid↗
PubMed1989

[An apparatus for intravesical chemotherapy].

To prevent spillage of cytostatic drugs when administering intravesical chemotherapy, a closed apparatus for preparation, instilling and disposal of the cytostatic drugs has been developed. After use, the apparatus is disposed of intact.

Administration, Intravesical↗
PubMed1996

The quality of life during intravesical bacillus Calmette-Guerin therapy.

PURPOSE: In the treatment of cancer the subjective evaluation of therapy induced side effects and quality of life must be considered. Adjuvant intravesical bacillus Calmette-Guerin (BCG) immunotherapy is regarded as highly effective but associated with significant side effects. To clarify whether these side effects significantly impact on patient satisfaction with life, a prospective survey of the health related quality of life and side effects was performed during an intravesical BCG treatment course. MATERIALS AND METHODS: Symptoms and side effects were recorded daily during the 6-week instillation period in 30 patients. The quality of life was determined before, during and after intravesical therapy with the assistance of a self-reported questionnaire. RESULTS: Due to a detailed subjective assessment of side effects, the course of local symptoms could be characterized with great reliability. Although side effects occurred, satisfaction with life in the patients studied was high and was not impaired during the treatment. The incidence of side effects correlated well with patient subjective evaluation of quality of life. CONCLUSIONS: Assessment of side effects and quality of life, as presented in this pilot study, can assist in the quantification of localized symptoms in intravesical therapy could contribute to the comparability of clinical studies. With regard to intravesical BCG immunotherapy, our results suggest that the specific side effects do not seriously impair satisfaction with life in these patients.

Adjuvants, Immunologic↗
PubMed1990

Intravesical mitomycin C for carcinoma in situ of the urinary bladder.

Mitomycin C was given intravesically over periods of 2-32 months to 34 patients with carcinoma in situ of the urinary bladder. Initial complete response was obtained in 17 patients, 14 of whom remained without evidence of disease during follow-up averaging 28 months from cessation of mitomycin therapy. In three responding patients malignant cells reappeared in the urine during follow-up, although no recurrence of carcinoma could be proven in bladder biopsy specimens. In eight of the 17 non-responders, muscle invasion and/or metastatic disease developed during or after mitomycin treatment. The prostatic urethra was involved in five cases. Chemotherapy had to be discontinued because of chemical cystitis in three cases. Mitomycin C appears to be effective for intravesical treatment of carcinoma in situ of the urinary bladder. Close surveillance of these patients is mandatory, however, and must include monitoring not only of the bladder, but also of the prostatic urethra and the upper urinary tract.

Administration, Intravesical↗
PubMed1990

Reduced bladder capacity in patients receiving intravesical chemoprophylaxis with mitomycin C.

After complete resection of superficial bladder carcinoma (Tis-2, G1-3), 75 patients were treated prophylactically with either 20 or 30 mg mitomycin C. Six patients developed a substantial reduction in bladder capacity (less than 200 ml). In 2 patients radical cystectomy of an otherwise tumour-free fibrotic bladder was necessary. The results of long-term treatment (2 years) suggest that reduced bladder capacity correlates with the cumulative dosage of mitomycin C.

Administration, Intravesical↗
PubMed2005

Long-term outcome of a low-dose intravesical bacillus Calmette-Guerin therapy for carcinoma in situ of the bladder: results after six successive instillations of 40 mg BCG.

BACKGROUND: In Japan, bacillus Calmette-Guerin (BCG: Tokyo 172 strain) instillation is generally performed at a dose of 80 mg once weekly for eight consecutive weeks; however, many adverse effects including severe ones have been reported. We employed a dose of 40 mg once a week for six consecutive weeks in principle for carcinoma in situ (CIS) of the bladder, and retrospectively evaluated its effectiveness and safety. METHODS: A total of 43 patients with CIS of the bladder were treated by this method and followed-up for a subsequent 12-79 months (median, 54 months). The patients consisted of 35 males and eight females aged 45-87 years (mean, 67.5 years). Intravesical BCG instillation at a dose of 40 mg was conducted once a week for six consecutive weeks. RESULTS: A complete response (CR) was achieved in 84% of the patients, in whom the recurrence-free rate was 72.4% after 3 years and 61.9% after 5 years. The median CR duration was 37.5 months. Two patients underwent total cystectomy, but none died of bladder cancer. As adverse effects, bladder irritation symptoms were observed in 48.8%, pyuria in 46.5%, macroscopic hematuria in 18.6% and fever (>37.5 degrees C) in 9.3%. There were no severe adverse effects requiring discontinuation of drug administration. CONCLUSION: Our present study corroborated both the effectiveness and safety of low-dose BCG therapy for CIS of the bladder. This therapy warrants further study by prospective randomized trials in the future.

Administration, Intravesical↗
PubMed1994

Diagnostic problems of urine cytology on initial follow-up after intravesical immunotherapy with Calmette-Guérin bacillus for superficial bladder cancer.

After transurethral resection or biopsy, patients with recurrent bladder cancer or in situ carcinoma were given topical immunotherapy with low-dose Calmette-Guérin bacillus (BCG). In the recurrence-free interval they were treated with BCG monthly for 1 year and then every 3 months for the next year. Cytological analysis was always performed concomitant with the administration of immunotherapy. In order to evaluate the therapeutic success, cystoscopy and biopsy were performed after the first cycle of BCG and then every 3 months. At the start of topical therapy with BCG, a great increase in the number of inflammatory cells was seen. In urothelial cells the nuclei were enlarged; they were hyperchromatic with sometimes increased and prominent nucleoli, anisocaryosis and a distorted nucleus-plasma ratio. These cytological findings were also made 1 year after initial therapy and slowly diminished in the 2nd year during immunotherapy at 3-month intervals. The accuracy of urine cytology for carcinoma in situ is 80%. Interpretation of cytology in the recurrence-free interval was impaired. When doubtful, the recurrence of a carcinoma in situ under maintenance therapy with BCG must be proved by biopsy.

Administration, Intravesical↗
PubMed1994

Single instillation of hydroxypropylcellulose-doxorubicin as treatment for superficial bladder carcinoma.

A single instillation of hydroxypropylcellulose (HPC)-doxorubicin (20 mg/20 ml) was performed in 20 patients with superficial bladder carcinoma. The therapeutic effect was assessed by cystoscopy at 14-30 days after the instillation, and the residual tumor tissue was resected by transurethral resection (TUR) when possible. The results obtained for the therapeutic effect were as follows: a complete response (CR), in 7 cases (35%); a reduction in size of more than 50% (partial response, PR), in 6 cases (30%); and a reduction of less than 25% in size (no change, NC), in 7 cases (35%). Combined intravesical instillation of HPC-doxorubicin and local hyperthermia using a Thermotron RF-8 was performed in 11 patients with recurrent superficial bladder carcinoma. The total number of treatment courses ranged from three to five per patient. The results obtained for the effect of this combined treatment were as follows: a CR, in 6 cases (54.5%); a PR, in 3 cases (27.3%); and NC, in 2 cases (18.2%). Therefore, the combination of intravesical instillation of HPC-doxorubicin and local hyperthermia was more effective against superficial bladder carcinoma than the single instillation of the chemotherapeutic agent alone.

Administration, Intravesical↗
PubMed1987

Superficial bladder cancer treated by intravesical bacillus Calmette-Guerin or adriamycin: multicenter study interim report.

One hundred sixteen patients with superficial bladder cancers (Stages Ta, T1, and TIS) were evaluated and treated with either intravesical bacillus Calmette-Guerin [Tice strain] (BCG) or doxorubicin hydrochloride (Adriamycin [ADR]), in a multicenter study. One hundred nine of these patients currently have follow-up. Of these, 54 were completely resected and 55 incompletely resected. For complete resections, based on recurrence rates per 100 patient months, both BCG (0.22) and ADR (0.91) worked well, although BCG had a slightly lower recurrence rate. However, for incomplete resections, BCG (0.20) had a markedly lower recurrence rate than ADR (2.52). Eighteen patients failed initial treatment, with either BCG or ADR. All have been placed on long-term therapy schedules. Of the 12 failures who currently have follow-up, 11 (92%) have either partially or completely responded with additional intravesical therapy. No patients in this study have yet required cystectomies.

Administration, Intravesical↗
PubMed1994

Intravesical therapy in superficial bladder cancer.

OBJECTIVE: To identify the appropriate characteristics of superficial bladder cancer that allow the physician to predict tumor behavior. METHODS: We analyzed 1,745 patients with primary superficial bladder cancer with regard to disease and patient characteristics. RESULTS: With the characteristics we found, the population can be described and prognostic factors can be found. Moreover, with the use of these factors, it appears to be possible to predict tumor behavior on a group level. Prediction on an individual level, however, remains far from ideal. CONCLUSIONS: Three treatment options can be chosen: follow-up after initial transurethral resection, additional instillations with intravesical chemotherapy, or instillations with bacillus Calmette-Guerin (BCG). In case instillations are indicated, most (but not all) superficial bladder cancer trials show superiority of BCG over intravesical chemotherapy, although at the cost of more side effects. However, with intravesical BCG, it seems possible to influence the natural history of superficial bladder cancer, which means that we can delay progression and improve survival.

Administration, Intravesical↗
PubMed2005

Effects of intravesical chemotherapy and immunotherapy on semen analysis.

OBJECTIVES: To study the effect of intravesical chemo-immunotherapy on the sperm parameters of young patients. METHODS: Twelve young male patients with superficial transitional cell carcinoma, all younger than 40 years old at surgery, were included in this prospective study. The mean patient age was 34.8 years (range 22 to 40). Of the 12 patients, 8 had superficial transitional cell carcinoma, grade 2-3, and 4 had proven invasion to the lamina propria; 1 patient had accompanying carcinoma in situ. Accordingly, adjuvant intravesical treatment with either bacille Calmette-Guérin (BCG; 6 patients) or mitomycin C (6 patients) was indicated on the basis of the initial stage and grade. Sperm analysis was performed before bladder irrigation and subsequently 3 months after completion of intravesical therapy. RESULTS: All 12 patients had normal follicle-stimulating hormone and luteinizing hormone levels after surgery. All 12 patients had normal-volume ejaculate, except for 1 who had undergone multiple prior transurethral tumor resections. Of the 6 patients who were treated with mitomycin C, only a few minor insignificant changes in the sperm quality were noted, and 2 of them later fathered healthy children. However, in 3 of the BCG-treated patients, remarkable changes in all sperm quality parameters were evident, with a statistically significant decrease in the sperm count (P = 0.0021). CONCLUSIONS: We suggest that potential adverse effects on spermatogenesis can be induced by intravesical therapy with BCG and that, consequently, routine pretreatment semen preservation should be considered as a precaution before instillation of intravesical BCG to prevent subsequent fertility difficulties in young men.

Adjuvants, Immunologic↗
PubMed1997

Urinary interleukin-8/creatinine level as a predictor of response to intravesical bacillus Calmette-Guerin therapy in bladder tumor patients.

PURPOSE: Our purpose was to determine whether urinary interleukin-8 (IL-8) levels could be used to predict a tumor-free response to intravesical bacillus Calmette-Guerin (BCG) therapy in bladder cancer patients. MATERIALS AND METHODS: A total of 46 patients with superficial bladder cancer underwent an initial 6-week course of intravesical BCG therapy after transurethral resection. Voided urine samples were collected immediately before BCG instillations 1 and 6. Urine samples were centrifuged at 1,500 rpm for 8 minutes, and the supernatant was stored at -20 C. An enzyme-linked immunosorbent assay technique was used to measure urinary IL-8 levels. The Jaffé method was used to measure urinary creatinine. Results were expressed as the IL-8/creatinine ratio. Patients were followed with cystoscopy and urinary cytology every 3 months to detect bladder tumor recurrence. RESULTS: IL-8/creatinine ratios were measured in 31 patients before BCG therapy and were undetectable in 15. After 5 weeks of intravesical BCG therapy, IL-8/creatinine ratios fell in 27 patients (59%), were unchanged in 10 (22%) and rose in 9 (19%). Mean followup was 20.9 months (range 3 to 48). There was no association between the direction of change in IL-8/creatinine ratio and response to intravesical BCG therapy (p = 0.5). CONCLUSIONS: Urinary IL-8 levels obtained before intravesical BCG therapy and after instillation 5 of BCG were not helpful in predicting tumor recurrences in bladder cancer patients.

Adjuvants, Immunologic↗
PubMed1994

Intravesical mitomycin C and doxorubicin sequential therapy for carcinoma in situ of the bladder: a longer followup result.

A total of 43 patients with carcinoma in situ of the bladder (primary in 26 and secondary in 17) who underwent intravesical mitomycin C and doxorubicin sequential therapy for 2 multicenter studies were followed for a median period of 45 months (range 10 to 84). Of the patients 32 (74%) achieved complete response after induction therapy and underwent maintenance therapy with either mitomycin C plus doxorubicin, mitomycin C alone or observation only. Of the complete responders 13 (41%) had a local recurrence, and subsequent repeat intravesical mitomycin C and doxorubicin sequential therapy as well as bacillus Calmette-Guerin was effective in a significant proportion (75% or greater). The maintenance therapy did not have a favorable effect on the recurrence rate. In 8 patients (19%) (3 of 32 complete responders and 5 of 11 nonresponders) progression developed, including invasive cancers in 4, metastatic disease in 2 and both conditions in 2. Initial complete responders had a significantly higher progression-free rate than initial nonresponders, although there was no difference in the sites of progression between them. At the last followup 35 patients (81%) remained free of disease with 31 (72%) having a normally functioning bladder. According to these results, intravesical mitomycin C and doxorubicin sequential therapy appears to be applicable as initial treatment for carcinoma in situ of the bladder.

Administration, Intravesical↗
PubMed2006

Bladder cancer.

PURPOSE OF REVIEW: This article will review the diagnosis and management of bladder cancer at each stage, from superficial to metastatic disease with an emphasis on recent developments over the last year. RECENT FINDINGS: Bacille Calmette-Guerin is the most effective therapy for carcinoma in situ. All patients who receive intravesical therapy with bacille Calmette-Guerin should be considered for ongoing maintenance therapy. The management of muscle invasive disease in the United States centers on radical cystectomy with bilateral pelvic lymphadenectomy. Areas of research include the optimal role for bladder preservation therapy, a growing experience in centers with laparoscopy, the effect of urinary diversion on quality of life, and the optimal standard for pelvic lymphadenectomy at surgery. The role of combination chemotherapy for advanced bladder cancer continues to evolve. Many questions remain unanswered including the relative value of neoadjuvant versus adjuvant chemotherapy for locally advanced disease and optimal chemotherapy regimen. SUMMARY: The detection of bladder cancer continues to rely on direct visualization with cystoscopy. Efforts are underway to improve the utility of urinary markers and cystoscopy through fluorescence endoscopy. The management of superficial bladder cancer is based on transurethral resection of the tumor with perioperative intravesical instillation of chemotherapy strongly suggested for most patients. Risk stratifying patients with high-risk superficial bladder cancer remain a challenge and area of future research.

Administration, Intravesical↗