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PubMed1998

[Appropriate intravesical retention time of pirarubicin concentration based on its level in tumor tissue, anti-tumor effect and side effect in intravesical instillation therapy for bladder tumor].

The present study was designed to investigate the appropriate intravesical retention time of pirarubicin (THP) for the treatment of bladder tumor in terms of its anti-tumor effect and side effect. We administered THP to 22 patients with superficial bladder tumor intravesically and measured the THP concentration in the tumor tissues. Patients were divided into 3 groups by retention time; 8 for 30 minutes, 8 for 1 hour and 7 for 2 hours. Tumor tissues were obtained by transurethral resection 30 min., 1 or 2 hours after the intravesical instillation of THP at the fixed concentrations of 30 mg/30 ml. There was no significant difference in THP concentration between 3 groups. This indicates that the anti-tumor effect of intravesical instillation of the THP would be expected by only 30 min. of intravesical retention time at the THP concentration of 30 mg/30 ml. Then, we administered 30 mg/30 ml of THP solution for 30 min. to 10 patients intravesically 6 times every 48 hours to investigate its clinical anti-tumor effect and side effect. There were 2 complete responses, 3 partial responses and 5 cases with no changes for a total response rate of 50%. No side effect was observed. It is considered that 30 min. of intravesical retention time at the THP concentration of 30 mg/30 ml would be appropriate in terms of its anti-tumor effect and side effect.

Administration, Intravesical↗
PubMed2005

Critical appraisal of dimethyl sulfoxide treatment for interstitial cystitis: discomfort, side-effects and treatment outcome.

OBJECTIVE: To evaluate the discomfort and long-term efficacy associated with instillation of dimethyl sulfoxide (DMSO). MATERIAL AND METHODS: A total of 28 patients, 13 (11 females, 2 males) with classic interstitial cystitis (IC) and 15 (13 females, two males) with non-ulcer disease, who had received at least one series of six instillations of DMSO were studied. In addition to studying micturition diaries before and after the treatment, the evaluation included assessments of pain using a visual analog scale and of side-effects after each instillation in every series. Data were obtained by surveying the clinical records. A follow-up telephone interview was conducted for those patients who were treated with DMSO and in whom the treatment was considered successful. DMSO instillations were considered successful if the patient reported symptom amelioration and chose to continue with the treatment. RESULTS: Side-effects were not more common or pronounced in patients with classic compared to non-ulcer IC. For classic IC a significant difference could be seen when comparing side-effects experienced during the first three instillations and the three subsequent instillations. After DMSO instillations, a residual treatment effect lasting 16-72 months could be seen. CONCLUSIONS: Intravesical instillation therapy with DMSO appears to be a feasible treatment option for both subtypes of IC and is associated with a reasonably low degree of discomfort.

Administration, Intravesical↗
PubMed2002

[Classification, favorable characteristics, prevention and treatment of adverse side-effects associated with Bacillus Calmette-Guerin in the treatment of superficial bladder cancer].

The efficacy of Bacillus Calmette-Guérin (BCG) in the treatment of superficial bladder cancer was first reported by Morales in 1976. Several authors have since demonstrated the efficacy of BCG in the prophylaxis and treatment of high-risk superficial bladder tumors (pT1G3, CIS). Although BCG is now recommended as an adjunctive treatment for superficial bladder tumors, the optimal treatment schedule remains to be defined. Results reported by Lamm suggest that an initial induction cycle of six weekly intravesical BCG instillations is suboptimal unless maintenance therapy (three consecutive weekly instillations) is given 3, 6, 12, 18, 24, 30 and 36 months later. However, the use of maintenance therapy is hindered by troublesome adverse reactions. This article reviews adverse reactions associated with BCG treatment, proposed a classification and discusses their prevention and treatment.

Adjuvants, Immunologic↗
PubMed2000

Treatment of overactive bladder with modified intravesical oxybutynin chloride.

Intravesical oxybutynin chloride has been reported to be effective for overactive bladder, although sometimes the efficacy does not last long enough. To improve this deficiency, we report the effects of intravesical oxybutynin chloride with hydroxypropylcellulose (modified intravesical oxybutynin). Modified intravesical oxybutynin (5 mg/10 mL, twice a day) was administered to six overactive bladder patients for more than 1 year (two men and four women; average age, 56.5 years) who did not respond to oral anticholinergic agents and electric stimulation. Cystometography (CMG) was performed before, 2 hours, and 1 week after the start of modified intravesical oxybutynin. In addition, plasma levels of oxybutynin and its active metabolite, N-desethyl-oxybutynin (DEOB), were measured by high-performance liquid chromatography before, 1, 2, and 4 hours after the initial treatment of modified intravesical oxybutynin. CMG studies revealed that two of the six patients did not demonstrate uninhibited contractions 1 week after the treatment and that cystocapacity of before, 2 hours, and 1 week after the initial modified intravesical oxybutynin was 141.8+/-15.3, 210.0+/-35.5, and 305.0+/-21.3 mL, respectively. Plasma levels of oxybutynin and DEOB before, 1, 2, and 4 hours after the first instillation of modified intravesical oxybutynin were oxybutynin; not detected, 8.8+/-2.5, 6.8+/-1.1, 3.0+/- 1.0 ng/ml, and DEOB; not detected, 4.2+/-1.3, 6.4+/-1.7, 5.1+/- 1.4 ng/ml, respectively. No side effects were observed in any of the patients. Modified intravesical oxybutynin is an effective and safe therapy option for overactive bladder patients who do not respond to other treatments such as oral anticholinergic agents and electric stimulation.

Administration, Intravesical↗
PubMed1987

Intravesical chemotherapy: combination with Tween 80 increases cytotoxicity in vitro.

Tween 80 was shown to enhance significantly the cytotoxic activities of the four drugs (adriamycin, epodyl, mitomycin-c, thiotepa) most frequently administered intravesically to treat superficial bladder cancer. The colony forming ability of a human bladder cancer cell line, RT112, was measured following a 1 h exposure to each of the four drugs both alone and in combination with 0.1% and 0.3% Tween 80. Cell survival was not reduced by 0.1% Tween 80 alone. We conclude that the combination of Tween 80 with these drugs might increase the therapeutic index of intravesical chemotherapy.

Administration, Intravesical↗
PubMed1989

BCG vaccine therapy for treatment of superficial bladder cancer.

A total of 42 patients were involved in the study of the effectiveness of BCG vaccine on superficial bladder tumours. The new Bulgarian vaccine CALGEVAX was administered intravesically in consecutive instillations once weekly and then once monthly for a period of 11 months. For intradermal application the F-70 subcellular preparation was used. On the grounds of their initial experience in the treatment of superficial bladder tumours with unspecific immunotherapy the authors would like to express their confidence in the effectiveness of the intravesical application of BCG vaccine.

Administration, Intravesical↗
PubMed2006

[Intravesical treatment of overactive bladder syndrome].

Overactive bladder and urgency incontinence are common conditions generally treated with oral anticholinergic medication. Despite the development of new antimuscarinic substances, many patients are refractory to or cannot tolerate the oral therapy due to severe side effects. Intravesical instillation therapy can provide an alternative method to manage detrusor overactivity. Intravesical instillation of anticholinergics such as oxybutynin and trospium chloride can achieve cholinergic blockade without producing systemic side effects. Botulinum toxin type A injections into the detrusor have been shown to increase bladder capacity and to decrease detrusor overactivity for 6 or more months. Intravesical local anesthetics such as lidocaine and bupivacaine block the conduction of unmyelinated C fibers which results in an increase of functional bladder capacity. Intravesical capsaicin and resiniferatoxin also affect the afferent C fiber innervation of the bladder, leading to a decrease in detrusor overactivity and also an increased bladder capacity. The use of intravesical anticholinergics and of local anesthetic medications, both known for their short-term efficacy, is limited due to the necessity of daily intermittent catheterization. In conclusion, intravesical therapies can provide an alternative treatment for the management of overactive bladder.

Administration, Intravesical↗
PubMed2005

Intravesical therapy for overactive bladder.

Overactive bladder and urgency incontinence are common conditions generally treated with oral anticholinergic therapy. Despite the development of new antimuscarinic agents, many patients do not tolerate or fail to respond to oral therapy. Intravesical instillation therapy can provide an alternative method of managing bladder overactivity. Intravesical instillation of anticholinergics such as oxybutynin and atropine can achieve cholinergic blockade without producing systemic side effects. Botulinum A toxin injected directly into the detrusor has been shown in preliminary studies to increase bladder capacity and decrease uncontrolled bladder contractility for up to 6 months. Intravesical local anesthetics such as lidocaine and bupivacaine block the conduction of unmyelinated C fibers and when administered into the bladder, lead to an increase in functional bladder capacity. Intravesical capsaicin and resiniferatoxin also affect afferent innervation by blocking C-fiber afferents, leading to decreased bladder contractility and increased bladder capacity. Intravesical instillation therapy can provide an alternative treatment for the management of overactive bladder.

Administration, Intravesical↗
PubMed1994

Detection of urinary interleukin-2, interleukin-2 receptor, and tumor necrosis factor levels in patients with superficial bladder tumors after intravesical BCG immunotherapy.

OBJECTIVES: To investigate the presence of urinary cytokines, after bacillus Calmette-Guérin (BCG) therapy, in order to provide further insight into the mechanisms of action of intravesical BCG therapy. METHOD: Urine levels of interleukin-2 (IL-2), interleukin-2 receptor (IL-2R), and tumor necrosis factor alpha (TNF alpha) levels were determined in 34 patients with superficial bladder tumors after a six-week course of intravesical BCG therapy. The urine samples were obtained at the fifth hour following the sixth course of therapy and the determinations were made by using an (enzyme-linked immunosorbent assay (ELISA)) technique. RESULTS: The pre-BCG levels of IL-2, IL-2R, and TNF (32.1 ng/L, 21.1 ng/L, 37.6 micrograms/L, respectively) were increased significantly after therapy (175.2 ng/L, 54.4 ng/L, 625.9 micrograms/L, respectively). These levels remained significantly increased after all patients were stratified according to tumor and patient characteristics. CONCLUSION: The results of this study provide further evidence for the immunologic basis of the mechanism of action of intravesical BCG therapy.

Administration, Intravesical↗
PubMed1997

Urodynamic effects of intravesical resiniferatoxin in humans: preliminary results in stable and unstable detrusor.

PURPOSE: Resiniferatoxin, a substance isolated from some species of euphorbia, a cactus-like plant, presents pharmacological effects similar to those of capsaicin. We studied the urodynamic effects of intravesical resiniferatoxin* in normal subjects and patients with unstable detrusor contraction to provide insight into the action mechanism of the molecule on sensory neurons and possible future pharmacological and clinical use. MATERIALS AND METHODS: A total of 15 subjects with normal (8 patients) or unstable detrusor muscle (1 with detrusor instability and 6 with detrusor hyperreflexia) underwent urodynamic assessment during and after intravesical instillation of resiniferatoxin. Volume required to elicit the first desire to void, maximum bladder capacity and maximum bladder pressure were recorded during instillation of resiniferatoxin at a flow rate of 20 ml. per minute (normal subjects) or 15 minutes after instillation of 30 cc of a saline solution containing 10(-8) M. of resiniferatoxin and kept for 30 minutes in patients with unstable detrusor. The experiment was examined by the analysis of variance for repeated measures and post hoc comparisons were performed by Tukey-Kramer procedure. A p value <0.05 was accepted as significant. RESULTS: Resiniferatoxin did not decrease the volume required to elicit the first desire to void and did not produce warm or burning sensations at the suprapubic/urethral level during infusion in subjects with normal detrusor function. In patients with bladder hyperactivity mean bladder capacity increased from 175.28 ml. plus or minus standard deviation 36.05 to 280.85 ml. plus or minus standard deviation 93.33 (p <0.01) immediately after treatment, and no significant modification of bladder pressure was recorded. Four weeks after treatment, bladder capacity remained increased in 2 patients but mean capacity did not increase significantly from 175.28 ml. plus or minus standard deviation 36.053 to 216.71 plus or minus standard deviation 86.91. The 2 patients with stable increase of bladder capacity reported significant clinical improvement of frequency, nocturia and incontinence 4 weeks later. CONCLUSIONS: Our results suggest that in humans there may be substantial differences in urodynamic effects between resiniferatoxin and capsaicin when the drugs are instilled into the bladder. Further studies, in vitro and in vivo, are necessary to define the pharmacological and clinical effects of resiniferatoxin. Because resiniferatoxin did not produce warm or burning sensations at the suprapubic/urethral level during infusion and seems to have rapid desensitization, it could be an interesting alternative to intravesical capsaicin in the treatment of select cases of bladder hyperactivity.

Administration, Intravesical↗
PubMed1991

Intravesical bacillus Calmette-Guerin or mitomycin C in the treatment of carcinoma in situ of the bladder following prior pelvic radiation therapy.

A total of 20 patients received intravesical bacillus Calmette-Guerin (BCG) or mitomycin C for the treatment of carcinoma in situ following previous pelvic radiation therapy. Of the patients 14 (70%) responded completely after 1 or 2 courses of intravesical therapy. Mean followup from diagnosis of carcinoma in situ currently is 15.7 months. Complications of BCG and mitomycin C therapy were compared to the established complications of intravesical therapy with these agents. The incidences of fever greater than 103F, hematuria and bladder contracture were increased in patients receiving BCG following radiation therapy, although the cause of bladder contracture was probably multifactorial in our patient population. Our data suggest that BCG and mitomycin C are safe and biologically effective agents for the intravesical treatment of carcinoma in situ after pelvic radiation therapy.

Administration, Intravesical↗
PubMed1999

Systemic immune response after intravesical instillation of bacille Calmette-Guérin (BCG) for superficial bladder cancer.

The mechanism of anti-tumour activity by BCG is not known clearly. However, many studies suggest that immunological response is related to effectiveness of intravesical instillation of BCG in the therapy for superficial bladder carcinoma. Peripheral blood mononuclear cells (PBMC), urine and serum were obtained from patients with superficial carcinoma at various times during the course of BCG instillation. Urine of patients showed increased levels of IL-1beta, IL-2, IL-6, tumour necrosis factor-alpha (TNF-alpha), interferon-gamma (IFN-gamma) and macrophage colony-stimulating factor (M-CSF) after BCG instillation. Levels of IL-2 and IFN-gamma in the serum also increased after BCG instillation, but IL-1beta, IL-6, TNF-alpha and M-CSF were not detectable. Maximal levels of IL-2 and IFN-gamma in the urine or serum were shown after the fourth instillation. BCG-induced killer cell activity in PBMC increased significantly after the third BCG instillation. These results suggest that BCG instillation involved not only local immunological efforts but also systemic immune responses. Tumour-free patients produced higher BCG-induced killer cell activity than tumour recurrence patients. BCG-induced killer cell activity may be useful for monitoring the effectiveness of intravesical BCG instillation.

Administration, Intravesical↗
PubMed2004

Intravesical resiniferatoxin versus botulinum-A toxin injections for neurogenic detrusor overactivity: a prospective randomized study.

PURPOSE: We investigated the effectiveness and safety of intravesical resiniferatoxin (Sigma Chemical Co., St. Louis, Missouri) and botulinum-A toxin injections into the detrusor muscle in a group of spinal cord injured patients with neurogenic detrusor overactivity unresponsive to conventional anticholinergic therapy. MATERIALS AND METHODS: A total of 25 patients were randomly assigned to receive intravesically 0.6 microM resiniferatoxin in 50 ml of 0.9% NaCl or injections into the detrusor muscle of 300 units botulinum A-toxin diluted in 30 ml 0.9% NaCl. Clinical evaluation and urodynamics were performed at baseline, and at 6, 12 and 18 months after treatment. RESULTS: In both arms there was a significant decrease in catheterization and incontinent episodes, and a significant increase in first detrusor contraction and maximum bladder capacity at 6, 12 and 18-month followup. There were no local side effects with either treatment. Botulinum-A toxin induced a significant decrease in the frequency of daily incontinence episodes (p <0.05), a significant increase in first uninhibited detrusor contraction (p <0.01) in maximum bladder capacity (p <0.01), and a significant decrease in maximum pressure of uninhibited detrusor contractions (p <0.01) compared to resiniferatoxin at 6, 12 and 18-month followup. CONCLUSIONS: In spinal cord injured patients with refractory neurogenic detrusor overactivity, intravesical resiniferatoxin and botulinum-A toxin injections into the detrusor muscle provided beneficial clinical and urodynamic results with decreases in detrusor overactivity and restoration of urinary continence in a large proportion of patients. Botulinum-A toxin injections provided superior clinical and urodynamic benefits compared to those of intravesical resiniferatoxin.

Administration, Intravesical↗
PubMed2003

Distal ureteral stenosis after early adjuvant intravesical mitomycin C application for superficial bladder cancer.

We report a case of distal ureteral stenosis after transurethral resection of a small bladder tumor near the left ureteral orifice and early postoperative mitomycin C instillation for prevention of recurrence. The patient developed late recurrent stenosis of the ureteral orifice with histologic evidence of localized, severe benign inflammatory reaction. The recurrent stenosis was successfully managed by transurethral resection of the scar tissue and ureteric stenting. Although ureteral stenosis does occur after transurethral resection, the severity and time course of the stenosis in this case suggest an influence of the intravesical chemoprophylaxis used.

Administration, Intravesical↗
PubMed1995

BCG treatment of existing Ta, T1 tumours or carcinoma in situ of the bladder.

There are theoretical limits to the efficacy of intravesical instillation of anticancer agents as a method to prevent recurrence of superficial bladder cancer. Studies on the direct efficacy of intravesical instillation of bacillus Calmette-Guérin (BCG) to treat existing papillary tumours (Ta, T1) have shown a complete response rate of 66.4% and a partial response rate of 20.8%. These figures represent potent efficacy similar to that of BCG in the treatment of carcinoma in situ (CIS). Moreover, this efficacy was found to persist over a long period of time, and the subsequent recurrence rate was markedly reduced. In cases with multiple tumours, or in subjects where concurrent CIS is strongly suspected, these findings suggest that intravesical instillation of BCG might best be performed prior to transurethral resection of bladder tumours.

Administration, Intravesical↗