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PubMed2004

Sustained intravesical drug delivery using thermosensitive hydrogel.

PURPOSE: Direct instillation of drug solutions into the bladder through a urethral catheter (i.e., intravesical therapy) evades systemic adverse effects of drugs used for bladder diseases. However, conventional vehicles for these drugs fail to extend duration of drug exposure in the bladder beyond the first voiding of urine postinstillation. The current study seeks to overcome the aforementioned inherent limitation of intravesical drug administration by using thermosensitive hydrogel as a matrix for sustained intravesical drug delivery. METHODS: Under halothane anesthesia, normal adult female Sprague-Dawley rats were catheterized with PE-50 tubing to instill either 0.02% w/v solution of fluorescein isothiocyanate (FITC) or the same amount of FITC in a 30% w/v dispersion of thermosensitive [Poly(ethylene glycol)-Poly[lactic acid-co-glycolic acid]-Poly(ethylene glycol)) (PEG-PLGA-PEG) polymer in a 0.1 M phosphate buffer. After instillations, rats were kept in metabolic cages for urine collection. Fluorescence emanating from FITC was measured in the urine at various time points up to 24 h after instillation. A rat model of cyclophosphamide-induced cystitis was chosen for the efficacy study using misoprostol as a model drug entrapped in the thermosensitive hydrogel in place of FITC. Efficacy of hydrogel containing misoprostol was compared against rat groups instilled with saline, hydrogel, and misoprostol independently. RESULTS: Prolonged drug exposure to the bladder afforded by hydrogel was evident from the time course of FITC elimination in the urine and by the green fluorescence of FITC seen at the bladder surface when isolated 24 h after instillation. Rats instilled with free FITC voided almost all of the fluorescence in the urine within the first 8 h, whereas rats instilled with hydrogel encapsulated FITC showed sustained release up to 24 h after instillation. Using a cyclophosphamide-induced cystitis model, rats instilled with misoprostol, a synthetic PGE1 analog, showed significantly reduced frequency of urine voiding (p < 0.05) as compared to the rats instilled with saline. Histological examination of the urothelium showed near normal morphology in rats instilled with misoprostol in hydrogel, whereas extensive tissue damage was observed in rats instilled with saline. CONCLUSION: Our study showed that PEG-PLGA-PEG polymer could be used as a viable sustained drug delivery system for intravesical therapy of diseases of the bladder such as cystitis using misoprostol.

Animals↗
PubMed1990

Intravesical bacillus Calmette-Guérin administration in the prophylaxis of superficial bladder cancer.

A total of 68 patients received prophylactic/adjuvant intravesical Pasteur strain bacillus Calmette-Guérin (BCG) instillations following transurethral resection for superficial bladder carcinoma. An induction phase consisting of 6 weekly instillations was followed by a maintenance phase consisting of 1 instillation given every 3 months. A second 6-week course of BCG was administered to initial failure followed again by a quarterly maintenance therapy. The response rate for patients treated with one 6-week course was 56%, while complete response was achieved in 72% when both treatment courses were considered. Follow-up period lasted at least 2 years after each course of BCG. These results suggest that additional courses of BCG increase the prophylactic efficacy of intracavitary BCG. Regarding the purified protein derivative (PPD) skin test and granulomatous response in the bladder, it has been shown in the present study that, although favourable results occurred more frequently among patients with either PPD conversion from negative to positive or vesical granuloma formation, neither of these indices should be considered reliable prognostic indicators.

BCG Vaccine↗
PubMed1990

Bladder contracture following intravesical doxorubicin therapy: case report and a review of the literature.

Intravesical doxorubicin rarely has been implicated as a cause of bladder contracture. We present a case of severe bladder contracture, documented radiographically and urodynamically after 8 weekly intravesical instillations of doxorubicin. The patient subsequently underwent cystectomy because of voiding dysfunction and the specimen demonstrated marked fibrosis in the bladder wall. We postulate that a benign, recurrent bladder ulceration during doxorubicin therapy may have potentiated the fibrotic response in the bladder to the doxorubicin. Objective monitoring of bladder capacity should be considered in patients treated with intravesical chemotherapy.

Administration, Intravesical↗
PubMed2004

Vesicoureteral reflux after intravesical instillation of bacillus Calmette-Guérin against carcinoma in situ of the bladder.

We report a case of vesicoureteral reflux (VUR) 3 years after intravesical instillation of bacillus Calmette-Guérin (BCG, Tokyo 172 strain) against carcinoma in situ of the bladder. The present case suggests that a long-term careful follow-up is needed to detect not only tumor recurrences but also VUR as a late complication after intravesical BCG instillation.

Administration, Intravesical↗
PubMed1989

[Fundamental studies on intravesical instillation of interferons in the treatment of bladder cancer].

The cytotoxic effect of interferons on T24 cells, the established cell line from human urinary bladder cancer, the distribution of the drugs in blood, urine and tissues of various organs and histopathological change in the bladder mucosa in dogs following intravesical instillation of the drugs, were studied. These studies were conducted to investigate the possible application of each type of interferons to intravesical treatment of superfitial bladder cancer. 1) The cytotoxicity of Ro22-8181 (recombinant human interferon alpha), GKT-beta (recombinant human interferon beta) and KW2202 (recombinant human interferon gamma) on T24 cells was examined by colony formation method and growth inhibition assay. Cytocidal effects of interferons were dependent on dose and exposure time, and GKT-beta is most effective (GKT-beta greater than Ro22-8181 greater than KW2202). Cytostatic effects of GKT-beta were also dependent on dose and exposure time. 2) The interferon levels in blood, urine and tissues were measured by FL-Sindbis system following bladder instillation of GKT-beta or KW2202 in beagle dogs with bilateral cutaneous ureterostomy. No interferons were detected in blood and urine. Bladder mucosa and submucosal layer were observed through a microscope 6 and 10 hours after bladder instillation of GKT-beta or KW2202 in beagle dogs with bilateral cutaneous ureterostomy. Degeneration of bladder mucosa and submucosal layer was scarcely observed. The above results suggest that GKT-beta is a suitable drug for intravesical treatment of bladder cancer.

Administration, Intravesical↗
PubMed2001

Urodynamic effects induced by intravesical capsaicin in rats and hamsters.

This study compared the effect of acute intravesical capsaicin administration on transvesical cystometries in urethane-anesthetized rats and hamsters, and aimed to assess whether sensory neuropeptides (tachykinins; calcitonin gene-related peptide, CGRP) play a role in the urodynamic effects of capsaicin in these species. The following urodynamic parameters were evaluated: the mean micturition interval (MI), the pressure threshold for micturition (PT), and the mean amplitude of micturition contractions (MAC). Two concentrations of capsaicin (10 and 100 microM) were evaluated in both species. Here, we demonstrate that 10-microM capsaicin decreased the PT in both rats and hamsters, and 100-microM capsaicin decreased the PT in hamsters and decreased the MI in both species. In addition, 100-microM capsaicin increased the MAC in rats but decreased the MAC in hamsters. Administration of CGRP (10 nmol kg(-1) , i.v.) significantly decreased both MAC and PT in hamsters only, while capsaicin-induced desensitization of neuropeptide-containing afferents antagonized the urodynamic effects of intravesical capsaicin. In addition, administration of the tachykinin NK2 receptor antagonist, Nepadutant (100 nmol kg(-1), i.v.), reduced the effects of capsaicin (100 microM) only in rats. These results indicate that capsaicin induces bladder hyperactivity in both rats and hamsters, but the urodynamic characteristics of this hyperactivity markedly differ in these two species. The differences observed may be due to differential expression of sensory neuropeptides in capsaicin-sensitive bladder afferents or neuropeptide receptors in smooth muscle cells and in nerve fibers.

Animals↗
PubMed2001

Do bacteriostatic urethral lubricants affect the clinical efficacy of intravesical bacillus Calmette-Guérin therapy?

OBJECTIVES: To investigate the effect of a bacteriostatic urethral lubricant on the clinical efficacy of intravesical bacillus Calmette-Guérin (BCG) therapy. METHODS: Between July 1987 and August 1999, 389 patients with superficial urothelial carcinoma of the bladder (pTa [multilocular, size greater than 2 cm, recurrent tumor], pT1, pTis) were treated adjuvantly with BCG in a 6-week intravesical cycle after complete transurethral tumor resection of the bladder. Within the framework of a prospective study on recurrence and progression of superficial urothelial carcinoma of the bladder after transurethral resection and BCG therapy, we retrospectively studied the clinical value of the observation that the use of bacteriostatic urethral lubricants reduces the viability and thus the efficacy of BCG. If a lubricant induces a clinically relevant reduction in the viability of BCG, instillation without lubricant should lead to a lower rate of recurrence and possibly a lower rate of progression. Lubricant (11 mL) was used during catheterization in every male patient in our population (group 1, n = 317, 81.5%); no lubricant was used in the women serving as the control group (group 2, n = 72, 18.5%). The two groups were similar with respect to age, distribution of tumor stage and grade, multifocality, and frequency of previous bladder carcinoma (Levene test, P = 0.008). The median follow-up was 54 months (range 4 to 143). RESULTS: Of the 389 patients, 90 (23.1%) developed recurrence during the follow-up period: 73 (23%) in group 1 and 17 (23.6%) in group 2 (P value not significant). Progression occurred in 14 patients in group 1 (4.4%) and in 8 patients in group 2 (11%) (P = 0.043). In groups 1 and 2, 19.2% and 47.1%, respectively, of the recurrences were progressive (P = 0.026). CONCLUSIONS: The use of bacteriostatic lubricants in the usual dose before BCG instillation had no detectable adverse effect on the clinical efficacy of intravesical BCG immunotherapy. To avoid traumatic catheterization with possible systemic BCG administration, we therefore recommend, especially in men, the additional use of a sufficient quantity of urethral lubricant.

Adjuvants, Immunologic↗
PubMed2001

Intravesical oxybutynin affects bladder permeability.

To investigate the effects of intravesical application of oxybutynin chloride on bladder permeability we designed an animal model. Female Guinea pigs were given 3 different test solutions: phosphate buffered saline (PBS), 50% acetone and 1.27 x 10(-2) M oxybutynin chloride solution. Then 99mTc-DTPA 45 microCi in 2 ml normal saline was instilled into the bladder lumen in each animals and allowed to dwell for 30 minutes. At the end of exposure time, the net count data in each 1 ml serum sample were corrected for radioactive decay and converted to the total percentage of administered dose. 99mTc-DTPA absorption percentages of both acetone and oxybutynin groups were significantly higher than that of PBS group (mean 3.2 +/- 2.9% p < 0.001). Intravesical oxybutynin application increases bladder permeability 5 times compared with PBS administration. This observation can also explain how rapid absorption of oxybutynin through the bladder into the systemic circulation occurs.

Administration, Intravesical↗
PubMedDate not supplied

Treatment of superficial bladder cancer with intravesical chemotherapy.

Proper care of patients with superficial bladder cancer requires the assessment of multiple factors, including an understanding of the natural history of this disease, accurate clinical staging, and the expected efficacy of each drug. The pharmacology of intravesical mytomycin C is discussed in detail, as many of this drug's pharmacological principles are applicable to all intravesical chemotherapeutic agents, including doxorubicin, thiotepa, bacillus Calmette-Guérin, epirubicin, and ethoglucid. The bladder wall, bladder cavity, chemical properties of intravesical chemotherapeutic agents, and tumor considerations are discussed. Suggestions based on pharmacological studies are presented to optimize the efficacy of intravesical chemotherapy.

Administration, Intravesical↗
PubMed1993

Bladder contracture following intravesical BCG immunotherapy.

Intravesical BCG immunotherapy is commonly associated with irritative bladder symptoms. Bladder contracture as a result of this treatment is rare. Two cases of persistent small-capacity bladders occurring more than one year after intravesical BCG therapy are reported.

Administration, Intravesical↗