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PubMed2006

Effect of intravesical Resiniferatoxin (RTX) on lower urinary tract symptoms, urodynamic parameters, and quality of life of patients with urodynamic increased bladder sensation.

OBJECTIVES: Intravesical resiniferatoxin (RTX) has been used with variable efficacy in the treatment of detrusor overactivity (DO). Patients with interstitial cystitis (IC) failed to benefit from this treatment, but a single placebo-controlled study in patients with non-IC painful bladders showed that RTX was effective in the short-term. We investigated the efficacy of intravesical RTX in patients with urgency and frequency due to increased bladder sensation. METHODS: Patients with intractable urgency and frequency, with or without urgency incontinence or bladder pain/discomfort, and with no urodynamic evidence of DO were recruited. After a single intravesical instillation of 100ml 50 nM RTX solution, patients were followed at 1, 3, and 6 mo for changes in urodynamics, bladder diary, the King's Health Questionnaire (KHQ), and degree of bladder pain. RESULTS: Fifteen patients (mean age, 52.5 yr) were treated. RTX significantly improved maximum cystometric capacity, volume at first desire to void, mean micturition volume, 24-h frequency, and daytime frequency for up to 6 mo after treatment. The overall KHQ score improved at all time points, with sustained improvements in the Symptom Severity, Incontinence Impact, and Personal Relationships domains. A >50% decrease in pain was reported by five of seven patients with painful bladders at 1 mo, but only one of seven at 6 mo. CONCLUSIONS: In our small open-label study, a single administration of intravesical RTX in patients with frequency and urgency due to increased bladder sensation significantly improved lower urinary tract symptoms, urodynamic parameters, and quality of life for up to 6 mo.

Administration, Intravesical↗
PubMed1992

A prospective randomized study of prophylaxis of tumor recurrence following transurethral resection of superficial bladder cancer--intravesical thio-TEPA versus oral UFT.

The long-term prophylactic effect of chemotherapy following transurethral electroresection of bladder tumors (TUR-Bt) was investigated using three different modalities: no prophylactic treatment (group C); oral UFT given at 1296 mg/day for 2 years (group U); and intravesical thio-TEPA at 30 mg/30 ml physiological saline, instilled 32 times over 2 years (group T). Patients newly diagnosed as having superficial bladder cancer (stage, less than or equal to pT1b; grade, less than or equal to G2) who had undergone TUR-Bt at Nara Medical University and its affiliated hospitals between November 1986 and March 1990 were allocated to one of the three groups by the envelope method. The initial treatment was maintained until the third recurrence or disease progression, except for TUR-Bt which was performed at the time of recurrence. The registered cases included 51 patients in group C, 50 in group U, and 52 in group T, and the number of evaluable cases in each group were 48, 47, and 45, respectively. The non-recurrence rates at 3 years were 54% in group C, 67% in group U, and 85% in group T, and the difference between groups T and C was significant. In terms of the tumor grade and stage, No significant difference was observed among the groups in the category of G1 or Ta tumors, but the non-recurrence rates determined in group T for G2 or T1 tumors were significantly higher than those obtained in group C. Moreover, no significant difference was found among the groups in relation to solitary tumors, but the non-recurrence rate obtained in group T for multiple tumors was significantly higher than that determined in group C. The overall cumulative recurrence rate in each group was 3.07 in group C, 1.95 in group U, and 0.70 in group T, and that determined according to tumor grade, stage, and multiplicity was also highest in group C, followed by group U and group T. The main adverse effects encountered were upper gastrointestinal (GI) symptoms (8.5%) in group U and irritable bladder (11.1%) in group T. Intravesical instillation of thio-TEPA tended to produce greater preventive efficacy than did oral UFT during the early postoperative period, but the prophylactic efficacy of thio-TEPA and UFT should be elucidated over a longer observation period.

Administration, Intravesical↗
PubMed1999

Importance of pharmacological and physicochemical properties for tolerance of antimuscarinic drugs in the treatment of detrusor instability and detrusor hyperreflexia--chances for improvement of therapy.

BACKGROUND: Antimuscarinic side-effects are relatively frequent problems in oral pharmacotherapy of detrusor instability and neurogenic dysfunction of the urinary bladder. Results of recent clinical trials demonstrate differences in tolerance between antimuscarinic drugs. It is the purpose of this paper to relate the available clinical data to the pharmacological and physicochemical properties of the different antimuscarinic drugs, in order to discuss the reasons for this enhanced tolerance and to make possible modes for improvement of antimuscarinic therapy plainly visible. METHODS: Therefore, we reviewed the available literature using among others the computerized library systems Medline (National Library of Medicine, Bethesda, Maryland, USA) and Embase (Excerpta Medica, Amsterdam, the Netherlands). Differences in tolerance of oral antimuscarinic drugs may result from muscarine-receptor selectivity, organ selectivity, and pharmacokinetic as well as physicochemical properties. While the roles of m-receptor and organ selectivity need more detailed clarification, influences of differences in bioavailability and physicochemical properties on the tolerance of antimuscarinic drugs are more sufficiently investigated. RESULTS: Generally, tolerance as well as efficacy of antimuscarinic drugs seem to be a complex result of a combination of various pharmacological properties distinguishing the individual substances. The enhancement of tolerance of propiverine hydrochloride, tolterodine tartrate and trospium chloride compared to oxybutynin chloride seems to be reached by different modes, from which the molecular structure -- propiverine and tolterodine are tertiary amines, trospium chloride possesses a quarternary ammonium structure -- may be of great importance. First investigations with alternative transdermal and intravesical application routes show interesting possibilities for further improvement of antimuscarinic therapy in urological indications. CONCLUSION: In conclusion, from pharmacological and clinical data it becomes obvious that there are significant differences between antimuscarinic drugs, which are of clinical relevance and include possible starting points for the development of new drugs and application forms.

Administration, Cutaneous↗
PubMed1989

[Short-term versus long-term chemoprevention of recurrence with Epodyl following transurethral resection of superficial urinary bladder cancer].

This investigation compares the short and long-term administration of intravesical Epodyl (etoglucid), following transurethral bladder tumor resection. This chemoprophylactic agent was used specifically in the treatment of bladder tumors that displayed different associated tumor risk factors: solitary versus multiple tumors, grade(s) I-III, primary versus recurrent tumors, and the presence of associated dysplasia. Within this study, 114 patients with carcinoma of the bladder underwent primary transurethral resection (TUR), followed in 10 days by short-term intravesical therapy (STIT) or long-term intravesical therapy (LTIT). Short-term intravesical therapy was administered to 56 patients. The therapy consisted of a 1% solution of Epodyl, which was given once per week for 6 weeks. Long-term intravesical therapy was given to 58 patients. This consisted of the short-term intravesical therapy protocol, followed by an additional dose once a month during an observation period of 2 years. The follow-up in both groups was for a minimum of 2 years. When the total number of recurrences in patients receiving (STIT) or (LTIT) was compared, no marked differences were noted (39% vs 38%). However, there was a difference when the individual tumor risk features were compared, e.g. for solitary tumors, the recurrence rate was 67% within the (STIT) group and 43% within the (LTIT). These results demonstrate that the decision of whether superficial bladder carcinomas are to be treated with short- or long-term Epodyl should be based on tumor-associated risk factors. Furthermore, if multiple tumor risk factors are present, maximal therapy is require; in the absence of risk factors TUR alone may be sufficient.

Administration, Intravesical↗
PubMed2006

Pharmacotherapy for neurogenic detrusor overactivity.

Chancellor MB, Anderson RU, Boone TB: Pharmacotherapy for neurogenic detrusor overactivity. Am J Phys Med Rehabil 2006;85:536-545. Patients with neurogenic detrusor overactivity are a heterogeneous group with voiding dysfunction secondary to neurologic injury or disease. The neurogenic detrusor overactivity syndrome, which may include urinary frequency, urgency, and incontinence, frequently contributes to a loss of independence, or even institutionalization. Urodynamic assessment provides the best method of quantifying and classifying neurogenic detrusor overactivity dysfunction in patients with primary diagnoses as diverse as Parkinson's disease, cerebral palsy, multiple sclerosis, spinal cord injury, and spina bifida. For many patients, management of urinary symptoms includes pharmacotherapy with an anticholinergic agent. Several novel approaches to managing neurogenic detrusor overactivity, including intravesical instillation of anticholinergic agents, vanilloids, and neurotoxins, are being investigated. For most patients, however, flexible dosing with an anticholinergic agent, with clean intermittent catheterization when indicated, has been shown to reduce the risks of urologic complications, improve levels of continence, and enhance patient quality of life in both children and adults.

Administration, Intravesical↗
PubMed1991

A prospective randomised trial of radiation with or without oral and intravesical misonidazole for bladder cancer.

Patients with T2 grade 3 and T3 bladder cancer were randomised to be treated with radiation alone (NO MISO) or with radiation and misonidazole (PLUS MISO). Patients in both groups initially received 40 Gy in 2 Gy fractions (5/week). Patients in the NO MISO arm received a further 20 Gy in 2 Gy fractions (5/week). Patients in the PLUS MISO arm received a further 12 Gy in 6 Gy fractions (1/week). MISO was administered orally (3.0 g m-2) and intravesically (1.0 g in 35 ml of solvent) 4 h and 2 h respectively prior to each fraction of 6 Gy. Fifty-eight patients were randomized of whom 53 are evaluable. There is a minimum follow-up of 5 years in the surviving patients. In the NO MISO and PLUS MISO arms, the complete response rate at cystoscopy at 6 months was 63% and 69%, the 5-year survival rate was 41% and 48% and the 5-year local control rate with bladder preservation was 46% and 36% respectively (censored for death from metastases while locally clear). These differences are not statistically significant. Two patients had grade 3 RTOG late bowel complications. Both patients were in the PLUS MISO arm, had undergone salvage cystectomy and subsequently required colostomies for bowel obstruction for a 5-year late complication rate (RTOG grade 3) of 9%. In addition, two patients in the PLUS MISO arm developed wound sepsis post cystectomy. We were not able to demonstrate improved results from the use of oral and intravesical MISO in this study. The number of patients entered are relatively low and large differences would have been required to be detected with a power of 0.80. The use of an unconventional radiation fractionation schedule may have resulted in increased bowel morbidity in patients in the PLUS MISO arm who subsequently underwent cystectomy.

Administration, Intravesical↗
PubMed1999

[Late phase II clinical study for bropirimine (U-54461S) in situ carcinoma of the bladder: follow-up investigation. Bropirimine Study Group].

A follow-up investigation was conducted on a Late Phase II clinical study of bropirimine for carcinoma in situ (CIS) of the bladder. We previously reported that 48 patients were enrolled and 17 patients achieved complete remission (CR) in the Late Phase II study. Of the 17 CR patients, 5 had recurrence, but 9 were recurrence free for a year and 5 have remained so for more than 2 years (median follow-up: 29.1 +/- 4.2 months). The 1-year and 2-year recurrence-free rates calculated using the Kaplan-Meier method were 70.3% and 61.5% respectively. Of all the 47 bropirimine-treated patients, 11 underwent total cystectomy (median follow-up: 31.8 +/- 5.2 months). The rates of bladder preservation after 1 year, 2 years, and 3 years calculated using the Kaplan-Meier method were 87.2%, 80.7%, and 74.0% respectively. Of the 39 patients who did not respond to bropirimine or suffered from recurrence after bropirimine treatment, 19 received subsequent intravesical bacillus Calmette-Guerin (BCG) therapy and 13 achieved CR (68.4%). This suggests that bropirimine does not decrease the efficacy of BCG therapy. In the present study, the prognosis was confirmed to be favorable after bropirimine therapy. Bropirimine would thus seem to be a useful oral anticancer agent for bladder CIS.

Administration, Intravesical↗
PubMed1994

Prophylactic chemotherapy with intravesical instillation of adriamycin and oral administration of 5-fluorouracil after surgery for superficial bladder cancer. The Japanese Urological Cancer Research Group for Adriamycin.

The Japanese Urological Cancer Research Group for Adriamycin has conducted a series of clinical trials to investigate the efficacy and safety of prophylactic intravesical chemotherapy for superficial bladder cancer. In the third trial, reported herein, patients with recurrent bladder cancer or multiple primary cancer were selected and randomized to one of four groups using the envelope method after complete resection of the original tumors. Group A was given Adriamycin alone, group B received oral 5-fluorouracil (5-FU), group C was given Adriamycin and oral 5-FU, and group D served as the control group. Of the 544 patients registered, 331 were evaluable for the purpose of this study. The administration of 5-FU (group B) failed to prevent the recurrence of bladder tumors. Although group C (both Adriamycin and 5-FU) did not fare better than group A (Adriamycin only), Adriamycin was effective in preventing the recurrence of tumors, especially in high-risk patients with recurrent and multiple tumors. The risk of recurrence was reduced to 0.21 (95% confidence interval, 0.10-0.44) relative to the control group. There was no indication of a synergistic effect between 5-FU and Adriamycin. As side effects, cystitis syndrome was observed in 23%-30% of the patients in the Adriamycin groups and mild myelosuppression was observed in the 5-FU groups.

Administration, Intravesical↗
PubMed2005

Randomized phase II marker lesion study evaluating effect of scheduling on response to intravesical gemcitabine in recurrent Stage Ta urothelial cell carcinoma of the bladder.

OBJECTIVES: To evaluate the response rate for intravesical gemcitabine given in three different schedules to patients with recurrent multiple carcinoma of the urinary bladder Stage Ta, grade 1-2, in whom all but one marker lesion was removed. Furthermore, we sought to define the safety profile. METHODS: This was a multicenter, open-label, randomized, Phase II study in which gemcitabine 2000 mg in 100 mL of unbuffered saline was instilled as a single dose (n = 11), two doses per week for 3 weeks (n = 11), or once weekly for 6 weeks (n = 10). Efficacy was evaluated using cystoscopy after 9 weeks. Toxicity was evaluated by assessing the liver, kidney, bone marrow, and coagulation function at defined intervals and by questionnaire. RESULTS: A total of 32 patients were included, 2 of whom were subsequently excluded because of protocol violations. The overall complete remission rate was 31%. The respective subgroup response rate was 10% in the single-dose group, 44% in the once-weekly group, and 40% in the twice-weekly group. The most common side effect was nausea. One patient withdrew because of nausea and fever, and an additional 2 patients had reversible hematologic toxicity (mild thrombocytopenia causing delayed instillation and mild anemia). The side effects were generally in the multiple-dose groups, with an overrepresentation in women. Ten patients were unable to retain the drug intravesically for the full hour. CONCLUSIONS: The results of our study have shown that gemcitabine has a tumor ablative effect when given intravesically for bladder cancer. A single dose seemed ineffective, and the multiple dosing regimens seemed effective. The side effects were generally mild.

Administration, Intravesical↗
PubMed1992

When intravesical measures fail. Indications for cystectomy in superficial disease.

The indications for intravesical therapy for superficial bladder cancer include multifocal or recurrent tumors, lamina propria invasion, CIS, and superficial involvement of the prostatic urethra. Tumor-free success rates approach 70% in most series. Intravesical therapy is usually administered as a 6-week course with a re-evaluation of the bladder at the 3-month interval. If disease persists, a second 6-week course of therapy is administered. If tumor recurs or persists at the 6-month evaluation, treatment is considered to have failed, and another form of therapy is instituted (Fig. 1). In the 30% of patients failing an adequate course of intravesical therapy, cystectomy may be indicated for uncontrollable superficial disease not amenable to transurethral resection, persistent grade III lesions, lamina propria invasion, persistent CIS, persistent involvement of the prostatic urethra, and persistence of tumor in a nonfunctioning bladder. Rarely, cystectomy may be indicated because of severe adverse effects related to intravesical therapy.

Administration, Intravesical↗
PubMed2003

[Oral tegafur plus mitomycin versus intravesical mitomycin alone in the prevention of recurrence in stage Ta bladder tumors].

OBJECTIVE: The aim of this study is to know if the use of oral Tegafur associated to intravesical mitomycin is effective in the prevention of the relapses of Ta bladder tumors. METHOD: This is a prospective study in which we compare the recurrence rate and the disease-free interval of 2 groups of 40 patients each one, the first of them treated after the TUR with oral Tegafur and intravesical mitomycin, and the second with intravesical mitomycin alone. Tolerance of Tegafur was also studied. RESULTS: The group of the Tegafur presented a descent of the relapse rate and a continuation of the time free of illness; but it was not statistically significant. The tolerance to the drug was good, without important adverse effects. CONCLUSIONS: Tegafur seems an useful drug in the prevention of the recurrence of superficial bladder tumors, although it will be necessary bigger studies to reach statistically valid conclusions.

Administration, Intravesical↗