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PubMed2006

Cutaneous complications of intravesical treatments for bladder cancer: granulomatous inflammation of the penis following BCG therapy and penile gangrene following mitomycin therapy.

Transitional cell carcinoma of the bladder is frequently treated with intravesical injection of immunotherapeutic (eg, BCG) or chemotherapeutic (eg, mitomycin C) agents. The aim of this study was to report cutaneous complications of intravesical therapy in 2 patients with transitional cell carcinoma of the bladder. A 69-year-old man had an ulceration at the base of the penis and papules involving the glans penis 1 month after injection of intravesical BCG. Biopsy findings showed granulomatous inflammation with foci of dermal necrosis suggestive of a BCG-related granulomatous reaction. The second patient was a 73-year-old man with penile gangrene. Erythema involving his penis and perineum had developed within 24 hours after intravesical administration of mitomycin C, which spilled onto his perineum during catheter removal. The resulting penile gangrene required penectomy 3 months after the injection. Mitomycin C patch testing showed a clear allergic contact reaction. Dermatologists should be aware of these potential cutaneous complications.

Administration, Intravesical↗

PubMed1992

Urodynamic effects of intravesical instillation of terodiline in healthy volunteers and in patients with detrusor hyperactivity.

The effects of intravesical instillation of terodiline on urodynamic parameters were investigated in 8 healthy volunteers (10(-4) M.) and in 34 patients with detrusor hyperactivity (10(-5) M.) of neurogenic (22) or nonneurogenic (12) origin. The volunteers were investigated with conventional medium-fill cystometry, while in the patients a modified cystometric technique with slow intermittent filling was used. The reproducibility of the procedure was verified in 17 patients. Instillation of terodiline had no effect on the normal bladders nor were any improvements found in the nonneurogenic patients. In 12 patients in the neurogenic group treated with terodiline instillation the bladder capacity increased significantly (p < 0.05) from 289 +/- 32 to 413 +/- 55 ml. Within this group 5 patients were responders. It is suggested that pathophysiological changes may explain the difference between the neurogenic and nonneurogenic groups, and that the number of responders within the neurogenic group may be increased by an optimal drug preparation and increased dosage. Intravesical administration of terodiline may offer an alternative treatment in selected patients with detrusor hyperreflexia.

Administration, Intravesical↗

PubMed1992

Hypersensitivity systemic reaction following intravesical bacillus Calmette-Guerin: successful treatment with steroids.

Intravesical bacillus Calmette-Guerin (BCG) is an effective treatment for superficial bladder carcinoma. Serious complications, including disseminated BCG infection, are infrequent. We report a case of granulomatous hepatitis with pneumonitis following intravesical administration of BCG. Cultures for mycobacteria were negative in sputum, bronchoalveolar lavage, liver and blood specimens. All symptoms disappeared within days after steroid therapy. Hypersensitivity reaction should be considered in patients with systemic symptoms after immunotherapy with BCG.

Administration, Intravesical↗

PubMed1989

Persistent acid-fast bacilli following intravesical bacillus Calmette-Guerin.

Intravesical bacillus Calmette-Guerin immunotherapy has great efficacy in the treatment of superficial transitional cell carcinoma of the bladder. We report a case of persistent acid-fast bacilli contained within granulomas of the bladder, prostate and epididymides 1 year after treatment with intravesical bacillus Calmette-Guerin. Although commonly encountered immediately after therapy, there are no reported cases of persistent acid-fast bacilli following intravesical administration of bacillus Calmette-Guerin.

Administration, Intravesical↗

PubMed1997

Intravesical hyaluronic acid in the treatment of refractory interstitial cystitis.

OBJECTIVES: On the assumption that interstitial cystitis (IC) is the result of a defective mucous lining of the bladder epithelium, a study was carried out to investigate the activity of hyaluronic acid (HA) in the treatment of IC. HA is an important glycosaminoglycan (GAG) present in all connective tissues, including the GAG layer of the vesical mucosa. It exhibits a variety of pharmacologic properties that enhance its appeal for the therapy of IC. METHODS: A total of 25 patients, with the characteristic picture of IC and refractory to other medical treatments, participated in a trial of HA. Patients received 40 mg of HA intravesically on a weekly basis for 4 weeks, then monthly. Response to therapy was evaluated by symptom score, voiding diaries, and visual analog scales. RESULTS: An initial positive (complete+partial) response of 56% at week 4 increased to 71% by week 12. This response was maintained until week 20; beyond week 24 there appears to be a moderate decrease in the effectiveness of the medication. There was no significant toxicity attributable to the presence of HA in the bladder. CONCLUSIONS: The response of refractory IC patients to the intravesical administration of HA was gratifying. In the past, many therapies for IC that were initially considered promising failed the test of a controlled study. Further studies will establish the effectiveness of this particular preparation of HA in the treatment of IC.

Administration, Intravesical↗

PubMed1999

Capsaicin pretreatment does not alter rat urinary bladder motor responses induced by a kinin B1 receptor agonist after endotoxin treatment.

The kinin B1 receptor is generally expressed after inflammation or tissue injury. Kinin B1 receptor stimulation induces excitatory motor responses in the urinary bladder and, in this preparation, the effect of many excitatory transmitters involves the stimulation of capsaicin-sensitive afferent nerves. In this study we have investigated the effect of capsaicin pretreatment on the bladder contractions induced by [Sar0, D-Phe8, des-Arg9]bradykinin (SDABK), a kinin B1 receptor agonist, by inducing the expression of B1 receptors via the intravesical administration of a bacterial endotoxin (LPS, 1 mg/ml) in urethane-anaesthetized rats. Three and half hours after LPS, the bladder was filled with saline until the micturition reflex was evoked, then 0.15 ml of saline was withdrawn, in order to avoid spontaneous reflex contractions. In LPS-pretreated rats the threshold volume for micturition was lower than in the control group (248 +/- 44 vs. 534 +/- 112 microl). After capsaicin pretreatment the bladder capacity was increased in both control and LPS-treated groups and the LPS-induced hyperreflexia was abolished (threshold volumes: 901 +/- 96 vs. 837 +/- 120 microl, respectively). The administration of SDABK (30 nmol/kg i.v., 4 h after LPS or saline application) produced a local, low amplitude tonic contraction (< 15 mmHg) or a tonic contraction with superimposed high amplitude (> or = 15 mmHg) reflex contractions but no effect of LPS or capsaicin pretreatment was observed in the incidence of these responses. The amplitude of the local response was increased by LPS treatment (1.4 +/- 0.3 vs. 4.0 +/- 0.7 mmHg) but capsaicin pretreatment did not modify this effect (2.3 +/- 0.4 vs. 4.3 +/- 0.6 mmHg). Likewise, the number of reflex contractions induced by SDABK was increased after LPS treatment (1.1 +/- 0.4 vs. 2.7 +/- 0.5) irrespective of capsaicin pretreatment (1.3 +/- 0.4 vs. 2.8 +/- 0.6). These results indicate that: (1) topical application of LPS induces a bladder hyperreflexia that is sensitive to capsaicin pretreatment; (2) B1 receptor-mediated motor responses (either reflex or local) are enhanced after LPS treatment; (3) capsaicin pretreatment does not modify B1 receptor-mediated motor response (either reflex or local).

Administration, Intravesical↗

PubMed2006

Efficacy of a single intravesical treatment with Ad-IFN/Syn 3 is dependent on dose and urine IFN concentration obtained: implications for clinical investigation.

There is a need to improve the treatment of superficial bladder cancer. One area which holds promise is intravesical gene therapy. Recently, studies undertaken by us have shown that marked tumor regression of bladder cancers occurred after two daily intravesical administrations of an adenovirus encoding human interferon alpha (Ad-IFNalpha) using a mouse superficial bladder cancer model in which human bladder tumors are growing. A dose of 1 x 10(11) particles/ml (P/ml) was used along with 1 mg/ml of Syn3, a gene transfer-enhancing agent. Since clinical studies are being planned using this approach, it became critical to determine if one exposure and lower particle number could be equally effective. We report that indeed a single dose of Ad-IFNalpha in Syn3 at doses of 1 x 10(10)-1 x 10(11) P/ml is highly effective in reducing the size of the tumors, whereas 1 x 10(9) P/ml was not. Efficacy was also correlated with the level of IFN produced in the urine after treatment. Based on the results of the present studies, a Phase I trial is being planned for superficial bladder cancer, which will involve a single initial treatment with Ad-IFNalpha/Syn3 and measurement of IFN in the urine over time as an indicator of adequate gene transfer and expression.

Administration, Intravesical↗

PubMed2006

Adenoviral-mediated interferon alpha overcomes resistance to the interferon protein in various cancer types and has marked bystander effects.

We have previously shown that intravesical administration of adenovirus encoding human interferon alpha-2b (Ad-IFN) induced a marked regression of superficial human bladder tumors derived from cells that are resistant to over 1 million units/ml of IFNalpha protein in vitro. In addition, Ad-IFN appeared to produce strong bystander effects. In this study, we show that Ad-IFN causes marked inhibition of cell growth and apoptosis in cells of various tumor types, all of which are resistant to IFNalpha protein. In addition, strong perinuclear IFN staining was seen in all cell lines following Ad-IFN transfection and was never observed after exposure to the IFN protein. Ad-IFN induced proteolytic processing of caspases 3, 8 and 9, indicative of enzymatic activation. However, the caspase-8-selective inhibitor, IETDfmk, blocked apoptosis only in the cell lines that were sensitive to the IFNalpha protein and had minimal effect on Ad-IFN-induced caspase-3 or -9 processing and cell death, indicating that death receptor-independent mechanism(s) were involved in the cytotoxic effects observed for cancer cell lines resistant to the IFNalpha protein. Moreover, we document that a yet to be identified soluble factor(s) is responsible for causing the bystander effect observed following Ad-IFN treatment in IFN protein-resistant cancer cells.

Adenoviridae↗

PubMed2000

[The staging of bladder tumors in MRT: the value of the intravesical application of an iron oxide-containing contrast medium in combination with high-resolution T2-weighted imaging].

AIM: To investigate superparamagnetic iron oxide (SPIO) particles as intravesically applied contrast material in combination with high-resolution T2-weighted MR imaging for the diagnostic assessment of urinary bladder tumors. METHODS: A prospective study was performed in 40 patients with suspected urinary bladder tumors who underwent MR imaging with a body phased-array coil at 1.5 T. Prior to imaging, a SPIO-containing solution (179.2 mg Fe/l) was instilled into the bladder. All patients were examined with T2-weighted, half-fourier acquired single shot turbo spin echo sequences and T1-weighted fast low angle shot sequences in 3 planes as well as a T2-weighted turbo spin echo sequence (TSE) using a 512 matrix. An additional gadolinium-enhanced dynamic study was performed in 33 patients. All patients underwent transurethral resection of the bladder or cystectomy. RESULTS: The combination of intravesically applied SPIO particles and a high-resolution T2-weighted TSE sequence depicted intravesical tumors as small as 4 mm. A reliable identification of the different layers of the bladder wall was possible in 5 cases only. The T2-weighted TSE sequence allowed the correct determination of the depth of infiltration in 29 of 36 patients with urothelial cancer by assessing the inner and outer boundary of the urinary bladder wall. This sequence had a diagnostic accuracy of 81% compared to 84% for the dynamic study (26/31). CONCLUSION: Even small tumors could be identified with the T2-weighted TSE sequence after intravesical administration of SPIO particles but it was not possible to reliably differentiate the layers of the bladder wall. The results suggest that a dynamic MR imaging study cannot be dispensed with in patients with urinary bladder cancer.

Administration, Intravesical↗

PubMed1993

Molecular confirmation of bacillus Calmette-Guérin as the cause of pulmonary infection following urinary tract instillation.

Instillation into the urinary tract of the bacillus Calmette-Guérin (BCG), a strain of Mycobacterium bovis, is associated only rarely with severe side effects. We report here two cases of culture-proven pulmonary infection due to therapy with BCG. The first patient, who was seropositive for the human immunodeficiency virus, developed bilateral interstitial pneumonitis after instillation of BCG into the bladder. The second patient developed a right-lower-lobe infiltrate and empyema after instillation of BCG into the right renal pelvis. The clinical isolates from these two patients and from a third patient with a psoas abscess following intravesical instillation were analyzed with use of pulsed field gel electrophoresis (PFGE) to resolve chromosomal restriction fragment polymorphisms. The clinical isolates were confirmed to be BCG by comparison with known vaccine strains that differed from M. bovis isolates. We conclude that the potential for subsequent dissemination be considered prior to the intravesical administration of BCG. Analysis with PFGE may be useful for identifying species of the Mycobacterium tuberculosis complex.

Administration, Intravesical↗

PubMed2004

Urodynamic and immunohistochemical evaluation of intravesical capsaicin delivery using thermosensitive hydrogel and liposomes.

PURPOSE: Aqueous insolubility of the vanilloids such as capsaicin is a major disincentive in their intravesical therapy of detrusor hyperreflexia. We sought to overcome the delivery of this hydrophobic neurotoxin by entrapping it in a lipid bilayer of positively charged multilamellar lipid vesicles (liposomes) or in a hydrophobic polymer matrix of thermosensitive hydrogel. MATERIALS AND METHODS: Liposomes, hydrogel and 30% ethanol/normal saline were prepared with or without 1 mM capsaicin (0.5 ml) and administered intravesically for 30 minutes to 7 groups of age matched, normal female adult Sprague-Dawley rats under halothane anesthesia. At 48 hours after intravesical instillation cystometric studies were performed using urethane anesthesia (0.04 ml per minute). The animals were subsequently sacrificed and whole bladders were harvested for histology and immunohistochemistry. RESULTS: In normal urethane anaesthetized rats capsaicin in 30% ethanol and liposomes completely blocked micturition reflexes. Capsaicin in hydrogel did not completely block the micturition reflex but it significantly decreased bladder contraction frequency compared with vehicle controls. The results of cystometry with capsaicin in liposomes and capsaicin in 30% ethanol correlated with a significant decrease in calcitonin gene-related peptide staining of afferent nerves in the bladder wall. Photographs taken after hematoxylin and eosin staining of the bladder treated with liposomes and hydrogel in the absence of capsaicin did not reveal any adverse histological changes. There were significant histological changes in bladders treated with 30% ethanol alone. CONCLUSIONS: In comparison with 30% ethanol liposomes are a superior vehicle for the intravesical administration of capsaicin, producing comparable efficacy with less tissue damage. Hydrogel can also serve as safe alternative option for capsaicin delivery.

Administration, Intravesical↗

PubMed2005

Effects of tolterodine on an overactive bladder depend on suppression of C-fiber bladder afferent activity in rats.

PURPOSE: We determined whether the effects of antimuscarinics depend on the suppression of C-fiber bladder afferent nerves. We administered tolterodine intravenously or intravesically. MATERIALS AND METHODS: To induce C-fiber bladder afferent nerve desensitization resiniferatoxin (RTX) (0.3 mg/kg) was injected subcutaneously in female Sprague-Dawley rats 2 days prior to left middle cerebral artery occlusion (MCAO). As controls, we used rats treated with ethanol and saline vehicle (VEH). Insertion of a polyethylene catheter through the bladder dome and MCAO were performed using halothane anesthesia. The effects of intravenous (0.2 to 2000 nM/kg) or intravesical (0.2 or 2 nM) tolterodine, an antimuscarinic agent, on cystometrography were investigated in conscious rats with a cerebral infarct (CI). Tolterodine was instilled intravesically for 30 minutes and cystometry was repeated. RESULTS: Bladder capacity (BC) was markedly decreased after MCAO in RTX treated (RTX-CI) and VEH treated (VEH-CI) rats. Low tolterodine doses (0.2 or 2 nM/kg) significantly increased BC in VEH-CI rats without increasing residual volume but it had no effects on BC in RTX-CI rats. At the highest dose (2,000 nM/kg) the drug significantly decreased bladder contraction pressure and increased residual volume in RTX-CI and VEH-CI rats. Intravesical administration of tolterodine (0.2 or 2 nM) significantly increased BC in VEH-CI rats. However, tolterodine had no effect on BC in RTX-CI rats. CONCLUSIONS: These results suggest that at low doses tolterodine exerts an inhibitory effect on C-fiber bladder afferent nerves, thereby, improving BC during the storage phase.

Administration, Intravesical↗

PubMed1993

Iontophoresis of drugs in the bladder wall: equipment and preliminary studies.

Iontophoresis is the active transport of ions into tissues by means of an electric current: Ji = -D(i)delta Ci/delta chi + DizeECi/kT. Where Ji is the total ionic flux, D(i) the diffusion coefficient, Ci the concentration, z the valency, and E the electric field. The first expression on the right side of the equation is Fick's law of diffusion and approaches zero for bladder mucosa, which leads to uncertain results following intravesical administration of various therapeutic agents. The application of an electric field will potentially accelerate drug administration into the bladder wall in a controllable manner. To evaluate this concept, an appropriate source of electric current and electrodes was fabricated; then, studies were conducted in human cadaveric bladders and clinical trials in human subjects. Ionized dyes were applied in duplicate to 10 fresh cadaveric bladders. Electric currents (3.5-5.0 mA) were applied for 20 min to 10 solutions, and no current was used in 10 controls. Twenty-eight patients had 100 ml solutions of 1% mepivacaine or lidocaine with epinephrine infused into their bladders prior to endoscopic resections. Twenty-two patients received currents of 10-20 mA for 10-20 min, and 6 controls had either no drugs or a current of reverse polarity applied. Visually and on microscopy, the 10 control cadaveric bladder surfaces demonstrated only faint staining of the surface mucosa whereas the experimental surfaces showed full-thickness staining of the mucosa extending into the muscularis. The 6 control patients required supplemental anesthesia or abandonment of the operative procedure. Of the 22 experimental subjects, 16 tolerated procedures with up to 25 g of tissue removed by diathermic resection.

Administration, Intravesical↗

PubMed1989

Arthritis associated with adjuvant mycobacterial treatment for carcinoma of the bladder.

A patient who developed an inflammatory polyarthritis following intravesical administration of bacillus Calmette-Guérin (BCG) used in the treatment of bladder cancer is described. An inflammatory synovitis comprising predominantly T lymphocytes was demonstrated on synovial biopsy. The synovitis resolved spontaneously within 14 days in this 'human model' of adjuvant arthritis.

Administration, Intravesical↗

PubMed2003

Interferon-a2b reduces neo-microvascular density in the 'normal' urothelium adjacent to the tumor after transurethral resection of superficial bladder carcinoma.

BACKGROUND: As angiogenesis represents one of the hallmarks of cancer we investigated whether intravesically administered interferon-a (IFN-a2b) reduces neo-angiogenesis in the 'normal' urothelium adjacent to the tumor in patients with superficial bladder carcinoma after complete transurethral resection (TUR) of the tumor. PATIENTS AND METHODS: In the present study 47 patients after TUR of the tumor were examined. 10 patients (group A) received no further treatment (control group); 37 patients (group B) received intravesical treatment with IFN-a2b. The instillations started within 7 days after TUR, were performed weekly for 2 months, twice a month for the next 4 months, and thereafter monthly for 6 more months. Cold cup biopsies were taken before TUR of the transitional cell carcinoma (TCC): from the tumor (T), near tumor (NT) and from normal epithelium (N). Cold cup biopsies 'near tumor', were also taken during follow-up cystoscopy (C1, C2, and C3) 2, 6, and 12 months after TUR, respectively. Angiogenesis was estimated by counting the microvessels detected with CD31 immunostaining. RESULTS: Significant differences of microvascular density (MVD) between patients of group A and B appear after TUR (p < 0.005, Kruskal-Wallis and Wilcoxon test). The MVD difference was maximal 6 months after TUR (C2(A)-C2(B), second cystoscopy) and measured at 12.17 microvessels/ mm(2) (26.2%). CONCLUSION: Our results show that the intravesical administration of IFN-a2b after TUR significantly decreases the angiogenic potential of the 'healthy' urothelium adjacent to the tumor in patients with TCC. This observation could possibly explain, to a certain extent, the mechanism by which IFN-a2b reduces the recurrence rate of primary TCC.

Administration, Intravesical↗

PubMed1988

Treatment of superficial bladder tumors with intravesical recombinant interferon alpha-2a.

In a prospective study, the toxicity and efficacy of an instillation therapy with recombinant interferon alpha-2a (rIFN-alpha-2a) were evaluated in 12 patients with superficial bladder tumors. Treatment consisted of 8 weekly instillations of 54 X 10(6) IU rIFN-alpha-2a in 50 ml saline. Two weeks after completion of the instillation therapy, the tumor status was assessed with cystoscopy, biopsy and bladder wash-out cytology. Two partial responses, 1 no change and 2 progressive disease were seen in the 5 patients with TA tumors. In the 4 patients with carcinoma in situ, 1 complete response, 1 partial response and 2 no change were observed. Three patients suffered from carcinoma in situ and superficial papillary tumors, 1 showed complete response of the carcinoma in situ but no change of the TA tumor, the other 2 patients showed progressive disease. Three patients with partial response received a follow-up combination therapy with interferon intravesically and etretinate orally (25 mg/day). These patients presented progressive disease or no change 10 weeks after starting the follow-up combination therapy. During the treatment period, no side effects of interferon or changes of the serum interferon levels were observed. The treatment results are considered unsatisfactory; nevertheless, some activity after intravesical administration of interferon (mainly in patients with carcinoma in situ) could be demonstrated. Since the cytotoxic and antiproliferative effects seem to be dose-dependent, further studies might be done using higher interferon dosages and shorter treatment intervals.

Administration, Intravesical↗

PubMed1997

Results of treatment of refractory interstitial cystitis with intravesical hyaluronic acid.

Interstitial cystitis is a chronic benign disease of the bladder that causes bothersome and debilitating symptoms and mainly affects women. Since interstitial cystitis (IC) might result from a defective glycosaminoglycan layer of the bladder epithelium, we conducted a trial of hyaluronic acid (HA), used intravesically, to test its activity in the treatment of this disease. A total of 10 patients with typical findings of IC were included. Following bladder catheterisation, the patients received a dose of 40 mg, weekly for 6 weeks, and then monthly. Response to therapy was evaluated by comparing the pre-treatment and post-treatment symptom scores and voiding diaries. There was a 30% positive response rate at week 6, which was maintained until week 24. No significant local or general side-effects were noted during the course of treatment. Although we recorded a low incidence of success in our group of patients, the results of our limited study were satisfactory in the group of responsive patients (30%), who had no relapses during the observation period of 6 months. The intravesical administration of HA was well tolerated in all cases.

Administration, Intravesical↗

PubMed1989

Immunoprophylaxis with Calmette-Guérin bacillus in recurrent superficial bladder tumors.

26 patients with superficial bladder cancer underwent complete removal of tumors by transurethral resection and entered a prospective trial of immunoprophylaxis with Calmette-Guérin bacillus (BCG). The entire group had recurrent tumors that failed to respond to previous prophylaxis with thiotepa (13 patients) or other drugs (13 patients). Intravesical administration of BCG reduced the recurrence index and increased the disease-free interval. Side effects were mild and well tolerated. BCG seems to be effective in the prophylaxis of superficial bladder tumor recurrence after the failure of other drugs.

Administration, Intravesical↗