Intravesical Therapy blog

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Pros and cons of radical cystectomy in the treatment of T1G3 bladder cancer.

Indian J Urol. 2008 Jan;24(1):77-83

Authors: Agarwal PK, Kamat AM

The management of T1G3 (or high-grade T1) bladder cancer poses a challenging clinical dilemma to the urologist. There are good data supporting bladder conservative therapy with repeat transurethral resection and administration of Bacille Calmette-Guérin (BCG) intravesical therapy but this must include maintenance regimens since only maintenance BCG has been shown to decrease tumor recurrence and progression. Concern over worse survival with a delay in definitive therapy has prompted many to recommend immediate cystectomy for T1G3 disease. Ultimately, the decision needs to be individualized and although certain pathologic factors (T1b disease, early recurrence or progression within three months of BCG therapy, lymphovascular invasion and variant histology) are prognostic of progressive disease, no definitive risk factors for tumor progression have been identified.

PMID: 19468365 [PubMed - in process]

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Bladder contracture: review for intravesical bacillus Calmette-Guerin complication.

Can J Urol. 2007 Dec;14(6):3745-9

Authors: Hameed A, Sezian N, Thwaini A

INTRODUCTION: We are reporting a case of bladder contracture post intravesical bacillus Calmette-Guerin (BCG) therapy; to our knowledge only two cases were reported. We present the clinical history/presentation investigation and the outcome of the treatment. Approximately 75%-85% of patients with bladder cancer present with disease confined to the mucosa (stage Ta-CIS) or submucosa (stage T1). The management of non-muscle invasive bladder cancer has become more complex with regard to initial investigation, treatment and follow-up. In high-grade tumors, BCG therapy has proven to be superior to intravesical chemotherapy. BCG therapy prevents, or at least delays, tumor progression. METHODS AND RESULTS: A case of high grade superficial bladder caner treated with intravesical BCG which has successfully cleared her bladder cancer nevertheless has lead to bladder contracture for which case she may need bladder reconstruction/augmentation surgery if she remained disease free added to her psychological and social effects on her life. CONCLUSION: Although BCG is considered a very effective treatment; consensus exists that not every patient with superficial bladder cancer should be treated with BCG due to its increased risk of toxicity. Ultimately, the choice of treatment will depend upon the patient's risk of recurrence and progression. Assuming that maintenance therapy is necessary for optimal efficacy, the issue of BCG toxicity becomes more relevant. Due to the more pronounced side effects of BCG compared to intravesical chemotherapy, reluctance still exists about BCG use. However, with increased experience in applying BCG, the side effects now appear to be less prominent and few. Serious side effects are encountered in less than 5% of patients and this case carries one of the rarest, yet drastic, side effects of intravesical BCG.

PMID: 18163926 [PubMed - indexed for MEDLINE]

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Phase III prevention trial of fenretinide in patients with resected non-muscle-invasive bladder cancer.

Clin Cancer Res. 2008 Jan 1;14(1):224-9

Authors: Sabichi AL, Lerner SP, Atkinson EN, Grossman HB, Caraway NP, Dinney CP, Penson DF, Matin S, Kamat A, Pisters LL, Lin DW, Katz RL, Brenner DE, Hemstreet GP, Wargo M, Bleyer A, Sanders WH, Clifford JL, Parnes HL, Lippman SM

PURPOSE: The study aims to evaluate the efficacy and toxicity of fenretinide in preventing tumor recurrence in patients with transitional cell carcinoma (TCC) of the bladder. EXPERIMENTAL DESIGN: We conducted a multicenter phase III, randomized, placebo-controlled trial of fenretinide (200 mg/day orally for 12 months) in patients with non-muscle-invasive bladder TCC (stages Ta, Tis, or T1) after transurethral resection with or without adjuvant intravesical Bacillus Calmette-Guerin (BCG). Patients received cystoscopic evaluation and bladder cytology every 3 months during the 1-year on study drug and a final evaluation at 15 months. The primary endpoint was time to recurrence. RESULTS: A total of 149 patients were enrolled; 137 were evaluable for recurrence. The risk of recurrence was considered to be "low" in 72% (no prior BCG) and intermediate or high in 32% (prior BCG) of the evaluable patients. Of the lower-risk group, 68% had solitary tumors and 32% had multifocal, low-grade papillary (Ta, grade 1 or grade 2) tumors. The 1-year recurrence rates by Kaplan-Meier estimate were 32.3% (placebo) versus 31.5% (fenretinide; P = 0.88 log-rank test). Fenretinide was well tolerated and had no unexpected toxic effects; only elevated serum triglyceride levels were significantly more frequent on fenretinide (versus placebo). The Data Safety and Monitoring Board recommended study closure at 149 patients (before reaching the accrual goal of 160 patients) because an interim review of the data showed a low likelihood of detecting a difference between the two arms, even if the original accrual goal was met. CONCLUSIONS: Although well tolerated, fenretinide did not reduce the time-to-recurrence in patients with Ta, T1, or Tis TCC of the bladder.

PMID: 18172274 [PubMed - indexed for MEDLINE]

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Prevention of adverse effects of BCG immunotherapy in bladder cancer.

South Med J. 2008 Jan;101(1):17-8

Authors: Naoe M, Ogawa Y

PMID: 18176285 [PubMed - indexed for MEDLINE]

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Four cases of disseminated Mycobacterium bovis infection following intravesical BCG instillation for treatment of bladder carcinoma.

South Med J. 2008 Jan;101(1):91-5

Authors: Nadasy KA, Patel RS, Emmett M, Murillo RA, Tribble MA, Black RD, Sutker WL

Intravesical BCG (bacillus Calmette-Guérin) instillation is a first-line treatment for superficial transitional cell carcinoma of the bladder. A rare but severe complication of BCG immunotherapy is the development of disseminated BCG disease, which can result in miliary pneumonitis, granulomatous hepatitis, soft tissue infections, bone marrow involvement, and sepsis. Symptoms can present as early as a few hours or as late as several months following the BCG therapy. The key finding in disseminated BCG disease is the formation of caseating granulomas in distant organs; detection of BCG organisms from tissue samples can be difficult. Recommended treatment for disseminated BCG disease includes a combination of antituberculous medications (with the exception of pyrazinamide, to which BCG is typically resistant) and a tapering course of steroids. We present the cases of four patients who developed granulomatous infection consistent with disseminated disease after intravesical BCG treatment and provide a summary of current clinical management recommendations.

PMID: 18176300 [PubMed - indexed for MEDLINE]

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[Anticholinergic drugs in overactive bladder]

Gynecol Obstet Fertil. 2008 Jan;36(1):90-6

Authors: Muhlstein J, Deval B

The overactive bladder syndrome (OAB) associates urgency, frequency, nycturia, more or less associated with urinary incontinence. Its frequency is between 16 to 45 %, in the general population; the number of affected people in the USA being estimated at 34 million. Symptomatology is primarily marked by the abrupt, irrepressible need to urinate, impossible to defer, but also by a diurnal and night high mictional frequency. This OAB is more frequent when patients age increases, and affects indifferently men and women. The OAB induces a known negative impact on the quality of life and can lead to depression, sexual disorders, sleep disorders and a professional absenteism. The OAB medical treatment is actively concerned by the research since the discovery of oxybutinine. Tolterodin, solifenacin, darifenacin, trospium chloride supplement the therapeutic arsenal. New formulations (immediate and extended releases), new administration mediums (intravesical, transdermic, vaginal, rectal), new active ingredients (botulinic toxin, capsaicine, resiniferatoxine) are currently tested. The therapeutic options multiply, aiming at reducing to the maximum symptomatology, as well as the induced side effects.

PMID: 18178506 [PubMed - indexed for MEDLINE]

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A role of intravesical capsaicin instillation in benign prostatic hyperplasia with overactive bladder symptoms: the first reported study in the literature.

J Med Assoc Thai. 2007 Sep;90(9):1821-7

Authors: Mahawong P, Chaiyaprasithi B, Soontrapa S, Tappayuthapijarn P

OBJECTIVE: To study the efficacy of capsaicin in treating overactive bladder symptoms in benign prostatic hyperplasia patients. MATERIAL AND METHOD: A prospective study of 20 benign prostatic hyperplasia patients whose overactive bladder symptoms were not improved by alpha1 blocker Alpha1 blocker was taken about 22.9 +/- 17.2 months before and continued throughout 6 months duration of the present study. All of them had undergone intravesical capsaicin instillation at the Faculty of Medicine Siriraj Hospital, Bangkok, from 2004 to 2006. Both clinical and urodynamic data were evaluated before and after treatment. RESULTS: Mean urgency decreased from 6.7 +/- 5.1 at baseline to 2.0 +/- 2.3 (p < 0.005), 1.4 +/- 2.4 (p < 0.005), 1.3 +/- 2.2 (p < 0.005) at 1, 3 and 6 months. Mean urge incontinence decreased from 1.7 +/- 3.5 at baseline to 0.5 +/- 1.3 (p = 0.148), 0.4 +/- 1.2 (p = 0.114), 0.3 + 1.1 (p = 0.085) at 1, 3 and 6 months. Mean urinary frequency decreased from 13.7 +/- 3.3 at baseline to 10.5 +/- 2.8 (p < 0.005), 9.6 +/- 2.0 (p < 0.005), 9.5 +/- 2.6 (p < 0.005) at 1, 3 and 6 months. Mean nocturia decreased from 4.7 +/- 2.4 at baseline to 3.1 +/- 2.2 (p < 0.005), 2.7 +/- 1.2 (p < 0.005), 2.9 +/- 1.6 (p < 0.005) at 1, 3 and 6 months. Mean first desire to void increased from 172.5 +/- 100.4 ml at baseline to 210.6 +/- 99.5 ml (p = 0.016) at 1 month. Mean maximal cystometric capacity increased from 350.3 +/- 165.9 ml at baseline to 397.4 +/- 165.7 ml (p = 0.012) at 1 month. Peak flow rate, detrusor pressure, and postvoid residual urine were not affected. No serious adverse effect occurred in the present study. CONCLUSION: Intravesical capsaicin instillation is an effective treatment for overactive bladder symptoms in benign prostatic hyperplasia patients.

PMID: 17957925 [PubMed - indexed for MEDLINE]

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