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PubMed1988

Intravesical BCG administration in the guinea pig. A histomorphological study.

Intravesical BCG administration is used as an adjuvant therapy after transurethral resection for superficial bladder cancer in man. The mechanisms of its antitumor activity are not known. The aim of this study was to characterize the histomorphological changes in various organs of the guinea pig after intravesical BCG administration. The BCG preparation used was BCG-RIVM, a Dutch BCG preparation. Instillations were performed in previously undamaged bladders weekly for 6 consecutive weeks and lasted 30 min or 1 h. Different doses were used ranging from 10(3) culturable particles (c.p.) to 5 x 10(7) c.p. of BCG. After 6 weeks, the animals were killed and postmortem examination was performed. The bladder wall, retroperitoneal lymph nodes, spleen, liver, lungs and distant lymph nodes were examined histologically. The BCG therapy, with a dose of 10(6) culturable particles and higher, induced an inflammatory reaction consisting of mononuclear infiltrates in the subepithelial tissue of the bladder wall. In approximately 50% of the animals investigated, the infiltrates were accompanied by non-caseating granulomatous lesions indicated by the presence of epithelioid cells. In general, the epithelial layer of the bladder showed no visible alterations. Similarly, a granulomatous inflammatory reaction was observed in the first retroperitoneal (iliac) lymph nodes draining the bladder. Granulomatous lesions were occasionally also present in liver and lung. In three of the 29 animals investigated, lesions were present both in liver and lungs, and in two of these three animals a granulomatous reaction was observed in the spleen and distant lymph nodes indicating a generalized inflammatory response induced by BCG.(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗

PubMed2000

Electromotive administration of intravesical bethanechol and the clinical impact on acontractile detrusor management: introduction of a new test.

PURPOSE: It is often difficult to determine the functional status of the detrusor muscle in patients with detrusor areflexia. We performed a clinical study to establish a test defining residual detrusor capacity in such patients. MATERIALS AND METHODS: In phase 1, 5 controls with detrusor areflexia were tested with an intravesical instillation of 20 mg. bethanechol in 150 cc of sodium chloride 0.3% with and without 20 mA. of pulsed current applied via an electrode catheter through the saline. Cystometry simultaneously recorded intravesical pressure changes. In phase 2, 45 patients with detrusor areflexia were tested with electromotive administration of intravesical bethanechol. In phase 3, 25 mg. bethanechol given orally once daily were prescribed for 15 patients and voiding control was assessed after 6 weeks of therapy. RESULTS: Neither bethanechol without current nor current through saline only led to increased intravesical pressure. However, we noted a mean pressure increase of 34 cm. water during the electromotive administration of bethanechol in 24 of 26 patients with areflexia and neurological disease compared to only 3 cm. water in 3 of 11 with a history of chronic bladder dilatation. Oral bethanechol restored spontaneous voiding in 9 of 11 patients who had had a positive response to the electromotive administration of bethanechol, whereas all 4 without a pressure increase during the electromotive administration of bethanechol did not void spontaneously. CONCLUSIONS: Electromotive administration of intravesical bethanechol identifies patients with an atonic bladder and adequate residual detrusor muscle function who are candidates for restorative measures, such as oral bethanechol and intravesical electrostimulation. Those who do not respond to the electromotive administration of bethanechol do not benefit from oral bethanechol and are candidates for catheterization.

Administration, Intravesical↗

PubMed2001

Intravesical electromotive administration of oxybutynin in patients with detrusor hyperreflexia unresponsive to standard anticholinergic regimens.

PURPOSE: About 15% to 20% of patients with detrusor hyperreflexia do not benefit from oral oxybutynin regimens, frequently because of unpleasant side effects. Several reports indicate that intravesical oxybutynin is effective in many of these patients but there are some who still fail to respond. MATERIALS AND METHODS: A select group of 10 adults with detrusor hyperreflexia unresponsive to standard oral and intravesical oxybutynin regimens were treated at weekly intervals with 5 mg. oxybutynin orally, or 5 mg. oxybutynin in 100 ml. intravesically for 60 minutes of passive diffusion and for 30 minutes with 5 mA. electrical current. Each treatment (plus oral placebo and 2 intravesical controls) was associated with an 8-hour, full urodynamic monitoring session, and periodic blood and bladder content sampling. RESULTS: There was no significant objective improvement with oral or intravesical passive diffusion oxybutynin. Conversely there was significant improvement in 5 of 6 objective urodynamic measurements with intravesical electromotive oxybutynin. Plasma profiles were a single peak and decay following oral oxybutynin and 2 distinct peaks with intravesical passive diffusion and electromotive oxybutynin. Area under the curve for intravesical passive diffusion were 709 ng. per 8 hours versus oral 1,485 (p <0.05) versus intravesical electromotive 2,781 (p <0.001). Bladder content samples confirmed oxybutynin absorption. Oral oxybutynin caused anticholinergic side effects in 7 of 10 patients. There were no side effects with intravesical passive diffusion or electromotive administrations. CONCLUSIONS: Accelerated intravesical administration results in greater bioavailability and increased objective benefits without side effects in previously unresponsive patients compared with oral and intravesical passive diffusion oxybutynin administration.

Administration, Intravesical↗

PubMed1992

Impaired immune response by isoniazid treatment during intravesical BCG administration in the guinea pig.

At present, isoniazid (INH) is being used prophylactically to reduce the side effects of intravesical BCG therapy for superficial bladder cancer, although it is not clear whether or not this reduces the antitumor efficacy of BCG. In this study the impact of INH treatment on the immune response after repeated intravesical BCG administration was investigated in guinea pigs. INH was given on the 3 days around each BCG instillation. We found that the administration of INH severely impaired the immunological effects of BCG. The induction of mononuclear cell infiltration in the bladder wall was reduced. Enlargement of the regional lymph nodes (weight and number of cells), and increase of MHC Class II expression on the lymph node cells, normally observed after intravesical BCG administration, were inhibited by INH. Systemic immunity, measured by the DTH reaction in the skin to PPD, was also diminished due to the combined treatment of BCG with INH. When INH was administered during the last 4 of 6 BCG instillations, the immune response to BCG was still impaired. A five-fold increase of the dose of BCG did not overcome the effect of INH. INH probably did not exert a direct suppression of the immune system of the guinea pig as the DNCB skin reactivity was not influenced. Although INH concentrations in the urine were high at the onset of the instillation, in vitro experiments indicated that the effect of INH may not be caused by killing of the BCG organisms shortly after application in the bladder. In conclusion, our data in guinea pigs suggest that the use of INH may impair the immune response to intravesical BCG. As this response may be important for the antitumor effect of BCG, urologists should be cautious with the prophylactic use of INH. The influence on the antitumor efficacy is now investigated in man.

Administration, Intravesical↗

PubMed1992

Impaired immune response by isoniazid treatment during intravesical BCG administration in the guinea pig.

At present, isoniazid (INH) is being used prophylactically to reduce the side effects of intravesical BCG therapy for superficial bladder cancer, although it is not clear whether or not this reduces the antitumor efficacy of BCG. In this study the impact of INH treatment on the immune response after repeated intravesical BCG administration was investigated in guinea pigs. INH was given during 3 days starting on the day prior to the BCG administration. It was found that the administration of INH severely impaired the immunological effects of BCG. The induction of mononuclear cell infiltration in the bladder wall was reduced. Enlargement of the regional lymph nodes (weight and number of cells), and increase of Major Histocompatibility Complex (MHC) class II expression on the lymph node cells, normally observed after intravesical BCG administration, were inhibited by INH. Systemic immunity, measured by the DTH reaction in the skin to PPD, was also diminished due to the combined treatment of BCG with INH. A five-fold increase of the dose of BCG did not overcome the effect of INH. INH probably did not exert a direct suppression of the immune system of the guinea pig as the DNCB skin reactivity was not influenced. Although INH concentrations in the urine were high at the onset of the instillation, in vitro experiments indicated that the effect of INH was probably not caused by killing of the BCG organisms shortly after application in the bladder. In conclusion, our data in guinea pigs suggest that the use of INH may impair the immune response to intravesical BCG. As this response may be important for the antitumor effect of BCG, urologists should be cautious with the prophylactic use of INH. The influence on the antitumor efficacy is now investigated in man.

Administration, Intravesical↗

PubMed2002

Pharmacokinetics, efficacy, and safety of intravesical formulation of oxybutynin in patients with detrusor overactivity.

OBJECTIVE: To determine the pharmacokinetics of oxybutynin and its main active metabolite, N-desethyloxybutynin, after multiple dosage (5 mg/30 ml three times daily) of intravesical oxybutynin formulation. Furthermore, to determine the efficacy and safety of intravesical oxybutynin in the symptomatic relief of urge incontinence or urgency in adult patients with detrusor hyperreflexia or instability. MATERIAL AND METHODS: Nine patients were randomly allocated to treatment with a special bladder instillation formulation of oxybutynin or placebo for two 14-day treatment periods in a double-blind, cross-over manner. The third, open study period was designed for pharmacokinetic purposes with all patients on the active drug. The pharmacokinetics was depicted by AUC0-24, Cmax, Cmin, and t(max), The efficacy was evaluated from the data collected from urinary voiding diaries and cystometries. The safety was measured by recording adverse events on questionnaires. Patients who were willing to continue with the intravesical oxybutynin treatment entered the 1-year extension part of the study. RESULTS: Oxybutynin was absorbed from the bladder with a geometric mean Cmax of 9.4 ng/ml and AUC0-24 of 92 ng x h/ml. For N-desethyloxybutynin, the geometric mean Cmax was 14.4 ng/ml and AUC0-24 186 ng x h/ml. Elimination of the drug was protracted, as there were detectable serum concentrations of both oxybutynin and N-desethyloxybutynin even 24 hours post-dose. The mean number of toilet visits/day decreased from the baseline value of 6.9 to 5.7 during oxybutynin treatment, whereas during the placebo period the value increased to 7.4 (p = 0.022). It remained at the same decreased level during the one-year follow-up period. CONCLUSIONS: Oxybutynin is readily absorbed from the bladder after intravesical administration. The serum concentrations of oxybutynin after single 5 mg intravesical doses are at least as high as those reported after oral drug intake, but the parent drug/metabolite ratio is much higher after intravesical administration. The elimination of oxybutynin as well as its metabolite is prolonged after intravesical administration compared with that reported after oral drug intake. The mean number of daily toilet visits decreased significantly in the oxybutynin group.

Administration, Intravesical↗

PubMed1993

Relief of pain following intravesical capsaicin in patients with hypersensitive disorders of the lower urinary tract.

We have extended our earlier observations on pain relief produced by intravesical instillation of capsaicin (10 microM in saline) in patients with hypersensitive disorders of the lower urinary tract. Patients in group A (n = 15) received intravesical capsaicin on days 0, 14 and 28: on each occasion the drug produced a warm or burning sensation, reduction in bladder capacity and a delayed, transient improvement or disappearance of symptoms. Patients in group B (n = 5) received intravesical capsaicin (10 microM at cystometry) 3 times on day 0. The initial sensation of warmth was experienced on each occasion, indicating that no significant desensitisation has been produced by the first instillation. Clinical improvement similar to that found in group A was observed. Three patients (group C) received warm saline (42 degrees C) at cystometry. This produced a pricking sensation, no change at cystometry and no subjective clinical improvement. Apart from the initial sensation of warmth, no patient in group A or B experienced side effects, either local or systemic. These findings confirm that intravesical instillation of capsaicin has a beneficial effect on patients with hypersensitive bladder disorders. Counter-irritation rather than desensitisation of primary afferents could be a possible mechanism of action. Further studies are needed to establish whether the intravesical administration of capsaicin or capsaicin-like agents represents a new form of treatment for relief of bladder pain.

Administration, Intravesical↗

PubMed1997

5-Aminolevulinic acid (ALA)-induced protoporphyrin IX fluorescence and photodynamic effects in the rat bladder: an in vivo study comparing oral and intravesical ALA administration.

BACKGROUND AND OBJECTIVE: Photodynamic therapy (PDT) using 5-aminolevulinic acid (ALA)-induced protoporphyrin IX (PpIX) for sensitization is a promising treatment for carcinoma in situ and diffuse premalignant changes of the bladder. We studied the biodistribution of PpIX in a range of tissues with oral and intravesical routes of administration of ALA and compared the photodynamic effects on bladder and skin. STUDY DESIGN/MATERIALS AND METHODS: Normal Wistar rats were given oral or intravesical ALA and PpIX levels in the liver, kidney, skin, and bladder measured by fluorescence microscopy on tissue sections. At the time of maximum PpIX levels, the bladder and skin on the back were illuminated with light at 630 nm and the PDT effects compared. RESULTS: PpIX fluorescence in the urothelium after 200 mg/kg given intravesically was comparable to that found after 100 mg/kg orally. The ratio of PpIX levels between the urothelium and the underlying muscle was the same for both routes of administration, although there appeared to be more selectivity of urothelial PDT necrosis after intravesical administration. Skin photosensitization was greater after oral ALA, the epidermal PpIX level being three times higher than after intravesical administration for comparable urothelial levels and the PDT effect being more marked. CONCLUSIONS: Intravesical instillation is preferable to oral administration of ALA for PDT ablation of the urothelium of the rat bladder without damage to the underlying tissue layers and for minimizing skin photosensitivity. The technique is now ready for clinical trials.

Administration, Intravesical↗

PubMed1992

Intravesical instillation of adriamycin in the presence or absence of verapamil for the treatment of superficial bladder cancer: preliminary report of a collaborative study.

A case-controlled collaborative study on the intravesical administration of Adriamycin in the presence or absence of verapamil, a calcium-channel blocker, as chemotherapy of superficial bladder cancer was carried out at two universities, Okayama and Kagoshima, and their affiliated hospitals. Although little is known about the expression of P-glycoprotein in superficial bladder cancer, it may be a cause of multidrug resistance (MDR). Verapamil was used as an inhibitor of P-glycoprotein. Arm A consisted of Adriamycin given at 50 mg/50 ml saline, and arm B constituted Adriamycin given at 50 mg/40 ml saline plus 5 ampules (10 ml) of injectable verapamil. The drugs were instilled into the bladder for 3 consecutive days in each of 3 consecutive weeks for a total of 9 instillations. No significant difference in antitumor effects was observed between arm A and arm B. Recurrent tumors responded better than did primary tumors to both arm-A and arm-B treatments (P = 0.012). In both treatment arms, significant differences (P = 0.031) in the response rate were found between tumors with diameters of less than 1 cm and those measuring 1-3 cm in diameter. Although the number of evaluable patients was limited, recurrent subjects who had previously received Adriamycin instillations responded in both treatment arms.

Administration, Intravesical↗

PubMed1997

Anti-neoplastic activity of paclitaxel on experimental superficial bladder cancer: in vivo and in vitro studies.

The effects of intravesical administration of paclitaxel (taxol) in a bladder tumor model in mice, as well as the drug's in vitro activity on the same tumor cells, have been studied. Two cell lines, derived from MBT-2 cells, were employed in these experiments. The T50 line (obtained by many passages in mice) was much more aggressive in vivo than the T5 line. In vivo paclitaxel treatment for 3 days after T5 implantation resulted in a considerable retardation of tumor growth, whereas under the same conditions the T50 line was much less, although still significantly, affected. When treatment was started 1 day after tumor implantation, both tumor variants were affected by paclitaxel to the same extent. The in vitro experiments utilized the MiCK assay, which allows continuous recording of the kinetics of cell growth. These studies revealed a 39.8% inhibition of cell growth by 2.10(-8)M paclitaxel in the T50 line and a 30-fold increase in concentration had only a small additional effect on the degree of inhibition. At 2.10(-8)M paclitaxel, growth of T5 was inhibited by 21.7%, which increased to 35.2% at 6.10(-7)M. The treated cells displayed bundles of microtubuli, as described for other paclitaxel-treated cells.

Administration, Intravesical↗

PubMed1989

Urinary interleukins in patients receiving intravesical Bacillus Calmette-Guerin therapy for superficial bladder cancer.

Intravesical administration of Bacillus Calmette-Guerin (BCG) causes a localized cell-mediated immune response. The intensity of this inflammatory response may be gauged by measuring the levels of both interleukin-2 (IL-2) and an inhibitor of interleukin-2 (IL-2-IN) activity in the urine during the hours after a BCG instillation. The levels of urinary IL-2 and IL-2-IN in the sixth week of BCG therapy predicted the subsequent clinical course in a group of 25 patients (P less than 0.01). Measurement of urinary IL-2 and IL-2-IN activity may be used to identify accurately those patients likely to develop a tumor recurrence, thereby sparing them the risk associated with inadequately treated bladder cancer. Since IL-2 and IL-2-IN are competitive with respect to biologic activity, and since relatively high urinary levels of either IL-2 or IL-2-IN activity correlated with a favorable clinical course, the authors conclude that the presence of bioactive IL-2 in urine is not required for the prevention of recurrent superficial bladder cancer.

Administration, Intravesical↗

PubMed1991

Characterization of cellular infiltrates in the rat urinary bladder following BCG and thiotepa intravesical therapy.

We examined rat urinary bladders following intravesical administration of BCG and thiotepa. BCG administration resulted in a relatively greater increase in the mucosal infiltration of mononuclear cells relative to polymorphonuclear cells (P less than 0.01) compared to the thiotepa treated bladders. This finding suggests that the mode of action of the therapeutic effects of these agents may be different. These results may also suggest that the mechanism of action of BCG might be immunologic in nature.

Administration, Intravesical↗

PubMed1987

Absorption of Adriamycin into the systemic circulation after intravesical instillation with or without Tween 80 in the rat.

The absorption of Adriamycin (ADM) into the systemic circulation after intravesical administration, using an experimental model in the rat, was closely related to the volume of the instilled solution and the concentration of the drug. The post instillation plasma concentration of ADM was increased after addition of Tween 80 to the instilled solution but the magnitude of the absorption was still discreet and, from a clinical point of view, negligible.

Absorption↗

PubMed1990

ThioTEPA pharmacokinetics during intravesical chemotherapy and the influence of Tween 80.

A pharmacokinetic study of randomised crossover design was carried out in which eight patients with recurrent stage pTa or pT1 transitional cell carcinoma of the bladder were given thioTEPA (30 mg) in distilled water or in 10% (v/v) Tween 80 (30 ml) intravesically for 2 h, followed 3 months later by the alternative treatment. ThioTEPA and its primary metabolite, TEPA, were measured in plasma and urine using a sensitive and specific chromatographic assay. Large differences between patients were observed in the proportion of thioTEPA absorbed, ranging from 20%-78%. Peak plasma levels of thioTEPA were observed within 1 h of intravesical administration. By 2 h after administration the plasma levels of TEPA were similar to those of thioTEPA and, in contrast to those of the parent compound, remained at a similar level over the next 4 h. The rate of absorption of thioTEPA was not influenced by Tween 80, but it did cause statistically significant increases in mean peak plasma levels (from 101 to 154 ng/ml) and mean AUC values (from 0.376 to 0.496 micrograms h per ml) and a decrease in the mean half-life (from 1.83 to 1.25 h). To obtain plasma levels similar to those achieved after instillation with thioTEPA alone, the dose should be reduced with Tween 80.

Absorption↗

PubMed1998

Desensitization of bladder sensory fibers by intravesical capsaicin or capsaicin analogs. A new strategy for treatment of urge incontinence in patients with spinal detrusor hyperreflexia or bladder hypersensitivity disorders.

Recent experimental studies have identified a category of unmyelinated type C bladder afferent fibers in the pelvic nerves which are extremely sensitive to capsaicin. Sensory input conveyed by these fibers triggers a spinal reflex which, in chronic spinalized animals, facilitates and controls micturition. In addition, bladder C fibers were also shown to have a role in bladder pain perception. In humans capsaicin-sensitive afferent fibers also innervate the bladder and contribute to the reflexogenic control of the detrusor muscle and to bladder pain perception. Desensitization of such fibers by intravesical administration of capsaicin, presumably by blocking sensory transmission, has been shown to reduce involuntary micturition and to increase bladder capacity in patients with detrusor hyperreflexia of spinal origin, and to reduce the intensity of bladder pain in patients with bladder hypersensitivity. Very recently, resiniferatoxin, an ultrapotent capsaicin analog, was shown to have a similar clinical effect in this subset of patients. However, unlike capsaicin, resiniferatoxin did not evoke acute irritative urinary symptoms during bladder instillation.

Administration, Intravesical↗

PubMed1994

Immunotargeting of urothelial cell carcinoma with intravesically administered Tc-99m labeled HMFG1 monoclonal antibody.

Ten patients with transitional cell carcinoma (TCC) of the bladder received 3-6 mCi of HMFG1 monoclonal antibody (MAb) intravesically. The antibody was labeled with Tc-99m using the 2-Iminothiolane method. All patients underwent transurethral resection of the bladder tumor within 12-20 h following intravesical administration of 99m-Tc-HMFG1. The presence of the radiolabeled MAb in the circulation was studied by measuring the radioactivity in the serum for a period up to 20 h. Three of 10 patients underwent immunoscintigraphy (SPECT) 2-3 h postadministration and cancerous areas could be easily localized. Biopsies were taken from the tumor sites as well as from normal bladder mucosa. Absolute uptake of the administered MAb expressed as percent administered dose/kg of tissue could be evaluated only in eight patients. Multiple specimen taken from various tumor sites in every patient gave a wide range of uptake values ranging from 0 to 9.29% adm. dose/kg, whereas normal tissue uptake values ranged from 0 to 1.63, respectively.

Administration, Intravesical↗

PubMed2006

Interindividual variability in the absorption of ciprofloxacin and hydrocortisone from continent ileal reservoir for urine.

OBJECTIVE: The neobladder created with a detubularized segment of ileum as standard treatment for the transitional cell carcinoma of the bladder may permit absorption of drugs. As a consequence, on the one hand the elimination of drugs excreted in the urine may be delayed and a change of dosage may be required, and on the other hand the intravesical administration of a drug may produce blood levels capable of inducing unwanted systemic effects. The purpose of the present study was to explore the possibility of drug absorption from a continent ileal reservoir for urine. METHODS: The possibility of drug re-absorption from a continent ileal reservoir for urine was studied in 12 patients with well functioning reservoirs after a time interval of 3 months from surgery and also, in 7 of them, 6 months later. Saline solutions of ciprofloxacin or hydrocortisone were instilled and maintained in the reservoir for 2 h, and drug concentrations in plasma were measured 1 and 2 h after instillation. RESULTS: Both ciprofloxacin and to a lower extent hydrocortisone were adsorbed from the reservoir, but with large interindividual variability. A comparison of the plasma concentrations produced by the two drugs 3 and 9 months after creation of the new bladder revealed that after 9 months the absorption was decreased in 3 patients, substantially unchanged in 2, and increased in 2. CONCLUSIONS: The results of this study show that both ciprofloxacin, chosen for its use as possible radiosensitizing agent in bladder cancer patients, and hydrocortisone, chosen as an example of lypofilic endogenous compound, can be absorbed through the intestinal mucosa of a continent ileal reservoir, but to a different extent and with high interindividual variability.

Administration, Intravesical↗

PubMed2002

Interaction of normal saline solution with ultrasound contrast medium: significant implication for sonographic diagnosis of vesicoureteral reflux.

The sonographic diagnosis of vesicoureteral reflux with intravesical administration of ultrasound contrast media is on the rise. In few cases did we encounter rapid dissolution of microbubbles in the bladder filled with normal saline. The aim of this study was to find out whether there is any interaction between normal saline and ultrasound contrast media and, if so, to elucidate the cause for the interaction. In an in vitro experimental setup the mixtures of various normal saline solutions and a galactose-based ultrasound contrast medium (Levovist) were scanned under pre-defined parameters. The duration of contrast was determined. Oxygen concentration of the solutions was measured (pO(2) and O(2) mg/l). The US contrast medium had significantly longer contrast duration when mixed with normal saline from plastic containers rather than glass containers. The contrast duration difference was even more between normal saline from containers sealed under vacuum and those not sealed under vacuum: 0.7 and 12 min, respectively. The oxygen concentration in normal saline from vacuum-sealed containers is one-third or less that from non-vacuum-sealed containers. The high concentration of dissolved oxygen in the normal saline seems to prevent the diffusion of air from the microbubbles into the solution and thus their collapse. Desaturated normal saline has detrimental effect on microbubbles of the galactose-based US contrast medium. For the purpose of filling the bladder during contrast-enhanced voiding urosonography only normal saline solution from non-vacuum-sealed containers should be used. For practical purposes, normal saline from plastic containers is safest.

Administration, Intravesical↗