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PubMed1990

Effect of intravesical instillation of varying doses of verapamil (20 mg, 40 mg, 80 mg) upon urinary bladder function in chronic traumatic paraplegics with overactive detrusor function.

The effect of intravesical instillation of verapamil was studied in eight chronic, traumatic paraplegics. Cystometry was performed before and 2 h after intravesical instillation of 20 mg of verapamil. After a gap of 10 days, the study was performed with 40 mg of verapamil and after an interval of another 10 days, the effect of intravesical instillation of 80 mg of verapamil was studied. No side-effects were observed after the intravesical administration of 20 mg, 40 mg or 80 mg of verapamil. The intravesical volume at detrusor reflex activity or at first uninhibited detrusor contraction (IV-DR) showed no significant change after intravesical instillation of 20 mg; but IV-DR increased from 90 +/- 22 ml to 131 +/- 21 ml (p less than 0.001) after intravesical instillation of 40 mg of verapamil. There was a significant increase in IV-DR from 96 +/- 23 ml to 242 +/- 35 ml after intravesical instillation of 80 mg of verapamil (p less than 0.001). There was no significant change in detrusor pressure at detrusor reflex activity or at first uninhibited detrusor contraction after intravesical instillation of 20 mg, 40 mg or 80 mg of verapamil. The frequency of voiding recorded before and one day after intravesical instillation of either 20 mg or 40 mg of verapamil showed no significant change. But the frequency of voiding recorded before and one day after intravesical instillation of 80 mg of verapamil showed a significant decrease from 19 +/- 2 to 8 +/- 1 (p less than 0.001).

Administration, Intravesical↗

PubMed1997

Urodynamic effects of intravesical instillation of lidocaine in patients with overactive detrusor.

PURPOSE: We evaluated the effects of intravesical administration of lidocaine on the overactive detrusor in patients with spinal cord injury and cerebrovascular disease. MATERIALS AND METHODS: Cystometry was performed before and 15 minutes after intravesical instillation of 20 ml. of 1 and/or 4% lidocaine in 48 patients with spinal cord injury and 67 with cerebrovascular disease. RESULTS: A significant increase in bladder capacity was observed following administration of 1 and 4% lidocaine in patients tested longer than 1 year after spinal cord injury. However, no significant increase was noted even with 4% lidocaine in those tested within 1 year after injury. A significant increase in bladder capacity was observed in patients with cerebrovascular disease with 4 but not 1% lidocaine. When comparing the percent increase in bladder capacity obtained with 4% lidocaine in the 2 groups, patients with spinal cord injury showed a significantly greater increase than those with cerebrovascular disease (91.6 versus 31.9%, respectively). Detrusor contractions disappeared in 37.5 versus 5.4% of patients, respectively. CONCLUSIONS: Intravesical administration of lidocaine appears to be useful in differentiating detrusor hyperactivity caused by lesions of the spinal cord versus those of the brain.

Administration, Intravesical↗

PubMed1992

Systemic and local carcinogenesis by directly acting N-nitroso compounds given to rats by intravesicular administration.

A number of directly acting carcinogenic N-nitroso compounds were administered to female F344 rats intravesically, to assess their ability to induce tumors locally in the urinary bladder and systemically following absorption through the bladder mucosa. The compounds were alkylnitosoureas and alkylnitrosocarbamates and could be formed by interaction of amides with bacterially produced nitrite in infected bladders. Methylnitrosourethane was very toxic: doses of 1-2 mg caused death of some rats. A total dose of 0.15 mmol of ethylnitrosourethane, which was much less toxic, was administered to each rat and almost all developed bladder tumors. Ethylnitrosourea also gave rise to bladder tumors following intravesical treatment, and induced some tumors systemically, whereas methylnitrosourea, 2-methoxyethylnitrosourea and 2-hydroxypropylnitrosourea induced bladder tumors in high incidence and few tumors systemically. Nitrosooxazolidone was quite toxic and induced few bladder tumors. The dialkylnitrosoureas were more stable and some induced more tumors systemically than the monoalkylnitrosoureas. 1,3-Dimethylnitrosourea induced no bladder tumors and 1,3-diethylnitrosourea very few, but both induced tumors systemically that were similar to those induced by gavage treatment of rats. 1-Ethyl-1-nitroso-3-hydroxyethylurea, 1-hydroxyethyl-1-nitroso-3-ethylurea and 1-(2-hydroxypropyl)-1-nitroso-3-(2-chloroethyl)-urea induced bladder tumors in a majority of rats treated intravesically; the first induced many tumors systemically. Most of the bladder tumors were transitional cell papillomas and carcinomas, but there were a few squamous cell tumors, smooth muscle tumors, sarcomas and carcinosarcomas. The effects of intravesical administration of the directly acting alkylating compounds are compared with the effects of similar doses given to rats by gavage.

Administration, Intravesical↗

PubMedDate not supplied

Biodistribution of an adenoviral vector carrying the luciferase reporter gene following intravesical or intravenous administration to a mouse.

The biodistribution and resulting pattern of transgene expression were determined following intravesical administration of an adenoviral vector carrying the luciferase reporter gene (AdLuc). Female BALB/c mice were subjected to intravesical instillation of 1 x 10(9) or 5 x 10(9) plaque-forming units of AdLuc. After sacrifice, transgene expression was detected in tissues using luciferase assays; vector DNA was detected by vector-specific polymerase chain reaction. These experiments showed very little vector dissemination outside of the bladder by this route of administration. High-level expression of the vector transgene in the bladder was found to diminish by severalfold after 3 days. In a supporting study, vector dissemination and resulting transgene expression were determined following tail vein injection of 5 x 10(9) plaque-forming units of AdLuc. Vector was distributed to and expressed in every organ analyzed, with the highest concentration and level of expression observed in the liver.

Adenoviridae↗

PubMed2002

The fluorescence biodistribution and kinetics of aminolevulinic acid induced protoporphyrin IX in the bladder of a rat model with orthotopic urothelial carcinoma.

PURPOSE: Photodynamic therapy is an alternative intravesical therapy modality for superficial bladder cancer. Aminolevulinic acid (ALA) induces the production of the endogenous photosensitizer protoporphyrin IX (PpIX). We compared intravenous versus intravesical administration of ALA and established the proper timing and dose of ALA for photodynamic therapy. To characterize the distribution of ALA in rat bladder tumor and normal bladder layers a cooled charge coupled device camera was used. MATERIALS AND METHODS: A total of 40 female Fisher F344 rats were used as test animals, including 36 inoculated with AY-27 tumor cells intravesically. PpIX accumulation was investigated by fluorescence microscopy comparing 100 and 300 mg./kg. intravenous administration with a 100 mg./ml. intravesical dose of ALA. Three areas of urothelium, submucosa and muscularis of the bladder wall were chosen for analysis. The software used allowed semiquantitative analysis by calculating the mean fluorescence count plus or minus standard error of mean within any chosen area on the fluorescence image. RESULTS: In this study the highest fluorescence difference in PpIX accumulation in tumor and the normal epithelium to the muscularis layer was achieved at 2 hours with intravenous administration (7:1 to 50:1). The highest absolute fluorescence levels were observed at 2 hours with the 100 mg./kg. intravenous dose and at 4 hours with the higher 300 mg./kg. dose. The difference in fluorescence intensity in tumor tissue to normal urothelium was 2:1 to 3:1 at 2 hours. At 4 hours it was less than 2:1. After intravesical administration no difference in PpIX accumulation in tumor and normal urothelium was observed. However, there was a 7:1 ratio in regard to the muscularis layer at 4 hours. CONCLUSIONS: According to the results of this study a difference in PpIX accumulation in urothelial carcinoma or normal urothelium and the muscular layer of the bladder can be achieved by each route of ALA administration. Although intravesical installation provided tumor and normal urothelium labeling comparable to the intravenous route, it lost the selectivity of PpIX accumulation in tumor and normal urothelium. The effect of this finding on clinical therapy results remains to be resolved in the future.

Administration, Intravesical↗

PubMed1994

Early cystometrograms can predict the response to intravesical instillation of oxybutynin chloride in myelomeningocele patients.

Recent reported experiences with intravesical medications in neurogenic bladder patients prompted us to evaluate this form of therapy in 28 myelomeningocele patients who could not tolerate oral anticholinergic agents or did not have adequate control on these agents. A pretreatment cystometrogram was performed followed by intravesical administration of oxybutynin chloride, with a repeat cystometrogram 3 hours later. Patients then began twice daily intravesical oxybutynin for a minimum of 4 months. The mean bladder capacity increased by 41%, the mean intravesical pressure decreased by 47% and compliance improved. Five patients achieved continence and 62% had less wetting while on intravesical therapy. The immediate posttreatment cystometrogram was predictive of the response to intravesical therapy on followup studies. Unfortunately, patient compliance was poor, with only 13 of the 28 patients remaining on therapy for the duration of the study.

Administration, Intravesical↗

PubMed2002

Intravesical morphine analgesia is not effective after bladder surgery in children: results of a randomied double-blind study.

PURPOSE: Intravesical morphine was recently recommended to reduce postoperative pain after reimplantation surgery for vesicoureteral reflux in children. The efficacy of such treatment, so far solely evaluated by open study, needed to be confirmed. MATERIALS AND METHODS: After parental informed consent was obtained, 80 children requiring Cohen cross-trigonal reimplantation were considered for inclusion in a double-blind study. On the day of surgery patients were randomly assigned to receive either 0.04 mg./kg. morphine per hour or placebo (normal saline) at a constant intravesical infusion rate of 0.08 ml./kg. per hour. Postoperative pain was assessed every 3 hours using a pain score adapted to patient age. If the score was above a predefined limit, patients received intravenous acetaminophen and nalbuphine alternately every 3 hours. Bladder infusion was discontinued after 48 hours. RESULTS: Mean and maximum pain scores as well as the number of scores above the limit were not statistically different when comparing the morphine and placebo groups. There was no difference in the number of doses of analgesics administered. Urine output, voiding frequency and the number of painful voiding episodes were not significantly different between the 2 groups. Plasma morphine concentrations were 3.0 +/- 2.7 and 1.9 +/- 1.9 ng./ml. at 24 and 48 hours in the morphine group and undetectable in the placebo group. CONCLUSIONS: Intravesical administration of morphine is not effective for relieving postoperative pain during the first 48 hours after intravesical ureteral reimplantation. This study emphasizes the importance of controlled studies in evaluating the effectiveness of a new drug or procedure before recommending its use for all patients.

Acetaminophen↗

PubMed1988

[Current status of the treatment of urothelial tumors].

Cancer of the urinary bladder, renal pelvis and ureter is usually transitional cell carcinoma. One third of cases of urethral cancer are also transitional cell carcinoma. In planning the treatment for these urothelial cancers, the anatomic stage (Ta-T4), the histologic grade (1-3), tumor multiplicity and tumor size are generally taken into account. Superficial and low-grade tumors can usually be treated by transurethral resection. However, such patients run the risk of subsequent tumor recurrence in the bladder. This risk may be reduced by intravesical administration of anti-neoplastic agents and BCG. Diffuse carcinoma in situ (CIS) should be treated intravesically before deciding on surgical extirpation of the bladder. Patients with tumors showing deep muscle invasion are usually managed by surgery. The role of adjuvant chemotherapy and/or radiation therapy is currently under investigation. Patients with unresectable cancer and/or metastases are candidates for systemic chemotherapy. This form of therapy is now resulting in an increased number of complete and partial remissions. However, there is still no evidence that systemic chemotherapy prolongs the duration of survival, especially in patients showing partial remission.

Administration, Intravesical↗

PubMed1999

Toxicology and pharmacokinetics of intravesical gemcitabine: a preclinical study in dogs.

More active and well-tolerated agents are needed for the treatment of superficial bladder cancer. This study investigated intravesical gemcitabine to establish the toxicology and pharmacokinetics necessary for clinical trials. Beagle dogs (in groups of 2; n = 6) received 100 mg, 350 mg, or 1 g of drug by intravesical administration on alternate days three times/week for 4 weeks. Animals were observed for clinical signs of toxicity; gemcitabine levels and peripheral blood counts were taken three times weekly. The dogs were euthanized, and a full necropsy was performed at days 1 and 14 after the last dose. Intravesical gemcitabine was given at 100 mg (n = 2), 350 mg (equivalent to the 1000 mg/m2 human dose; n = 3), and 3.5 g (n = 1). i.v. gemcitabine was given at 350 mg (n = 2). Plasma samples drawn at time points up to 8 h were analyzed for systemic absorption and clearance of drug. Doses of 100 and 350 mg were well tolerated with no clinical side effects. Necropsies revealed normal bone marrow cellularity and normal bladder histology. At 1 g, signs of severe clinical toxicity were evident, and after only three doses, necropsies demonstrated severe bone marrow hypoplasia, cystitis, and intestinal necrosis. At all intravesical doses, significant systemic absorption was seen. The T1/2 (+/- SD) for intravesical and i.v. administration of 350 mg was 328 (+/-6.8) min and 99.3 (+/-5.2) min, respectively (P<0.001). Intravesical gemcitabine is well tolerated and has no direct bladder toxicity at doses up to 1000 mg/m2. Higher doses result in gastrointestinal, bladder, and bone marrow toxicity.

Absorption↗

PubMed1999

Effects of intravesical capsaicin and resiniferatoxin on distension-induced bladder contraction in conscious rats with and without chronic spinal cord injury.

PURPOSE: To compare conscious, normal rats and rats with chronic spinal cord injury (CSI) in terms of the rhythmic bladder contractions (RBCs) induced by intravesical infusion of saline, and to determine how these contractions are influenced by intravesical capsaicin and resiniferatoxin. MATERIALS AND METHODS: Female Sprague-Dawley rats, normal or with spinal transection at the level of Th8-Th9, were investigated cystometrically under isovolumetric conditions before and after intravesical administration of capsaicin or resiniferatoxin. RESULTS: Spinal transection induced a significant increase in bladder weight. In both control and CSI animals, intravesical saline instillation induced reproducible RBCs that could be blocked by hexamethonium. Four weeks after the transection, the CSI animals had a significantly larger threshold volume than the controls, even after correction for bladder weight. The mean amplitude and duration of the RBCs did not differ between the two groups, but the frequency was significantly lower in CSI animals. Both capsaicin (0.1 and 1 mM) and resiniferatoxin (1 and 10 microM), instilled intravesically, were found to inhibit RBCs in both normal and CSI rats. There were no qualitative differences in the response to the drugs between the two groups. However, resiniferatoxin was approximately 100 times more potent than capsaicin. CONCLUSION: Capsaicin and resiniferatoxin inhibited RBCs in both normal and CSI rats, suggesting that activity in sensory fibers (C and Adelta), which are sensitive to the action of these drugs, is initiated by bladder filling in both types of rat.

Administration, Intravesical↗

PubMed2005

Mitomycin C and epirubicin: functional bladder damage in rats after repeat intravesical instillations.

PURPOSE: We studied functional damage in the bladder after intravesical administration of mitomycin C or epirubicin in rats. MATERIALS AND METHODS: A total of 40 rats were divided into 4 groups. Rats in 3 groups received intravesical instillations of mitomycin C, epirubicin or saline. Rats in group 4 received no intravesical instillations and served as normal controls. The doses of drugs administered were based on those used for therapeutic purposes. Changes in vesical capacity and bladder wall compliance were determined. Compliance was defined as the change in vesical volume induced by a given change in pressure. RESULTS: Weekly instillations of 1 mg/ml mitomycin C caused a statistically significant decrease in vesical volume and compliance, which persisted 3 weeks after the cessation of therapy. Epirubicin also induced changes in vesical volume and compliance but only that in bladder compliance achieved statistical significance. These changes were not seen in NaCl treated animals or in normal controls. CONCLUSIONS: Repeat intravesical instillations of mitomycin C have a prolonged effect on bladder function that is not seen after saline solution or epirubicin instillation.

Administration, Intravesical↗

PubMed2000

Transurethral resection and sequential chemo-immunoprophylaxis in primary T1G3 bladder cancer.

OBJECTIVES: T1G3 superficial bladder cancer is considered to be at high risk for progression, and in some institutions early cystectomy is advocated. Other authors and personal experience suggest that conservative treatment, such as TURBT followed by intravesical prophylaxis, may be adequate in the majority of cases. The purpose of the present phase II study was to assess the tolerability and efficacy of sequential intravesical administration of a chemotherapeutic agent, epirubicin, followed by BCG, after TURBT. MATERIALS AND METHODS: 81 patients with primary T1G3 superficial bladder cancer, without evidence of Tis or upper tract tumor, underwent TURBT and intravesical prophylaxis with weekly epirubicin 50 mg for 8 weeks followed by weekly BCG Connaught 120 mg for 6 weeks. A control cystoscopy with bladder mapping and/or TUR of suspicious areas was performed at 15-17 weeks. Then patients were followed-up with 3-month urinary cytology and cystoscopy. RESULTS: The sequential chemo-immunoprophylaxis was generally well tolerated. After a mean follow-up of 48 months recurrent tumors were found in 19 patients (23.4%) and progressive disease in 6 cases (7.4%). Of 6 progressions, 4 patients died (5%) of the disease. CONCLUSION: Sequential chemo-immunoprophylaxis with epirubicin followed by BCG is well tolerated and seems to be efficacious in primary T1G3 bladder cancer. The recurrence progression and disease-specific mortality rates were acceptable so that this study seems to confirm previous data which show that TURBT and intravesical prophylaxis are appropriate treatment for the majority T1G3 tumors.

Administration, Intravesical↗

PubMed1998

Follow-up of long-time treatment with intravesical oxybutynin for neurogenic bladder in children.

OBJECTIVE: Anticholinergic treatment for the hyperreflexic neurogenic bladder in childhood is an established method, together with clean intermittent catheterization (CIC), to promote continence and protect the upper urinary tract from deterioration. Recently, the use of oxybutynin, a compound with anticholinergic, smooth muscle relaxant and local anesthetic effects, has become widely used with both oral and intravesical administration. METHOD: In this study we report 39 children with myelodysplasia, neurogenic bladder disturbance with detrusor hyperreflexia and/or high bladder pressure treated with CIC to which intravesical oxybutynin 0.1 mg/kg twice daily was added and administered as a sterile pharmacy-produced solution. The follow-up period was 0.66-5 years (mean 2.25). RESULTS: Continence was clearly promoted and urodynamic parameters improved whereas an increased occurrence of asymptomatic bacteriuria and lower urinary tract infections was noted. Compliance was good, adverse reactions rare, and in some cases vesicoureteral reflux (VUR) resolved. Also infants and very young children were treated without complications. CONCLUSIONS: Intravesical oxybutynin is effective to diminish bladder pathophysiology and promote continence in this patient group and is also well tolerated. Attention should be paid to the occurrence of urinary tract infections and VUR may resolve.

Administration, Intravesical↗

PubMed2000

Fatal systemic reaction after multiple doses of intravesical bacillus Calmette-Guérin for polyposis.

OBJECTIVE: To report a case of fatal systemic reaction after intravesical administrations of bacillus Calmette-Guérin (BCG) for polyposis. CASE SUMMARY: A 72-year-old white man was treated by monthly injections of intravesical BCG immunotherapy for polyposis of the urinary bladder. He received a total of eight injections; four hours after the seventh injection, he presented with pyrexia associated with chills, sweating, headache, and vomiting, which quickly resolved. Four hours after the eighth injection, the patient presented with the same symptoms plus a left-hemisphere deficiency. Results of a cerebral scan performed at this time were normal. The clinical status of the patient quickly worsened, with the appearance of disseminated intravascular coagulation, acute anuric renal insufficiency, rhabdomyolysis, hemolysis, and cytolytic and cholestatic hepatitis. The patient required hemodialysis and symptomatic treatment. Lactic acidosis with hemolytic-uremic syndrome appeared, and he died as the result of a multivisceral (respiratory, renal, hepatic) deficiency. DISCUSSION: The patient presented with symptoms compatible with a severe systemic reaction to BCG therapy, a rare but possible adverse effect. CONCLUSIONS: BCG instillation is a valuable tool in the therapy of bladder carcinoma, but increasing reports of severe adverse reactions should continue to remind practicing urologists to be alert to the possibility of common and uncommon reactions after its use.

Adenomatous Polyposis Coli↗

PubMed2000

Interstitial cystitis: bladder training with intravesical oxybutynin.

PURPOSE: We assess the efficacy of intravesical administration of oxybutynin chloride in patients with interstitial cystitis. MATERIALS AND METHODS: The study included 36 women with a mean age of 45 years with a diagnosis of interstitial cystitis. Patients were treated with gradual intravesical instillation of saline oxybutynin solution (oxybutynin group) or gradual filling of simple saline (control group). Evaluation parameters consisted of symptom problem index, voids per day, volume per void, functional bladder capacity, volume at first sensation, cystometric bladder capacity and cystometric volume at first sensation. RESULTS: Statistically significant improvement of all evaluated parameters was found in both groups. When comparing the outcomes statistically significant improvement of parameters favored the oxybutynin group. CONCLUSIONS: Bladder training alone produces a satisfactory result by gradually expanding the bladder, and an additional statistically significant improvement is evident with intravesical oxybutynin.

Administration, Intravesical↗

PubMed1992

Recombinant tumor necrosis factor for superficial bladder tumors.

Twenty patients with histologically documented superficial bladder cancer (Ta, T1, Tis) were treated with intravesical administration of TNF 400-1800 micrograms. Of 18 patients with a marker lesion, 2 obtained a complete response for 8+ and 18 months. Two had a partial response and were given other intravesical therapies after 5 and 7 months. No or minimal systemic absorption of TNF was observed and documented in 4 of 20 patients by pharmacokinetic studies, and no patients developed antibodies to intravesically administered TNF. TNF was well tolerated in doses up to 1800 micrograms. No systemic or local side effects were observed. Modest activity was attained with intravesical TNF, even in pretreated patients.

Administration, Intravesical↗

PubMed1996

Biodistribution of protoporphyrin IX in rat urinary bladder after intravesical instillation of 5-aminolevulinic acid.

PURPOSE: Photodynamic therapy (PDT) has considerable potential for the treatment of superficial bladder neoplasia. Problems of detrusor muscle scarring and prolonged cutaneous photosensitivity with current photosensitizers may be reduced by using the new photosensitizer precursor, 5-aminolevulinic acid (ALA). We studied the fluorescence distribution of protoporphyrin IX (PpIX, the active derivative of ALA) in rat urinary bladder after intravesical administration of ALA as the first step to undertaking PDT using locally administered ALA. MATERIALS AND METHODS: Solutions of varying concentrations of ALA and pH were given intravesically to Wistar rats. The bladder was removed 1 to 24 hours later for measurement of the tissue levels of PpIX by fluorescence microscopy in the layers of the bladder wall. RESULTS: The stability of the ALA solution steadily decreased as the pH was increased from 2.1 to 7. The best value was pH 5.5, at which the stability of the solution and the urothelial tolerance were both acceptable. The maximum PpIX fluorescence intensity ratio between urothelium and the underlying muscle layer was 11 to 1. This was seen 5 hours after instillation of 1% ALA solution at pH 5.5. A 10% ALA solution gave higher levels of PpIX in the urothelium, but less selectivity between layers. CONCLUSIONS: Under appropriate conditions, intravesical instillation of ALA can be used to sensitize the bladder urothelium with a ratio between urothelial and muscle concentrations of PpIX of up to 11:1.

Administration, Intravesical↗

PubMed1990

Fatal sepsis following intravesical bacillus Calmette-Guerin administration for bladder cancer.

Intravesical administration of bacillus Calmette-Guerin has been shown to be highly effective treatment of superficial bladder cancer. Complications from bacillus Calmette-Guerin therapy are usually minor but serious and even fatal reactions can occur. Five recent cases illustrate the gravity of bacillus Calmette-Guerin sepsis. One man with severe debility and the organic brain syndrome died acutely with a fever of 40 C. Two men had frank sepsis that progressed to multiorgan failure and death. Sepsis progressed despite the use of isoniazid, rifampin and streptomycin. Two men who had equally progressive sepsis with intravesical bacillus Calmette-Guerin survived with the use of cycloserine for the first 72 hours of treatment. Triple antituberculous antibiotics, including cycloserine, may be lifesaving. Sepsis resulted from intravenous absorption through inflamed or disrupted urothelium. Bacillus Calmette-Guerin treatment should not be administered in the presence of severe cystitis or after grossly traumatic catheterization.

Administration, Intravesical↗