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At least 541 records · Page 30Linked to original sources
PubMed2006

Daily intravesical instillation of 1 mg nociceptin/orphanin FQ for the control of neurogenic detrusor overactivity: a multicenter, placebo controlled, randomized exploratory study.

PURPOSE: We studied the feasibility, safety and efficacy of daily intravesical instillation of 1 mg of the endogenous peptide nociceptin/orphanin FQ in a selected group of patients who perform clean intermittent self-catheterization for neurogenic detrusor overactivity incontinence. MATERIALS AND METHODS: A total of 18 patients with neurogenic detrusor overactivity incontinence and on clean intermittent self-catheterization were prospectively randomized to receive 1 mg nociceptin/orphanin FQ in 10 cc saline (9) or placebo (saline) solution (9) at the first morning catheterization for 10 days. All patients completed a voiding diary using a frequency/volume chart according to International Continence Society guidelines, and reported daily incontinence frequency. Mean changes in incontinence episode frequency and voiding diary mean bladder capacity from baseline throughout treatment were the primary outcome variables. Urodynamic parameters (cystomanometric bladder capacity, maximum bladder pressure) were also recorded at baseline and during the study. RESULTS: The 2 groups were well balanced and all patients completed the study. The urodynamic parameters recorded during the study showed an increase in cystomanometric bladder capacity and a decrease in maximum bladder pressure compared to baseline only in patients assigned to the nociceptin/orphanin FQ group. Mean daily urine leakage episodes during nociceptin/orphanin FQ treatment were 0.94 vs a pretreatment baseline of 2.18 (p < 0.05), while no significant changes were reported in the placebo group (2.06 vs 2.43 baseline). The total mean voiding diary bladder capacity increased from 171 +/- 70 to 294 +/- 107 ml in patients receiving nociceptin/orphanin FQ, while voiding diary mean bladder capacity remained unchanged in patients receiving placebo (from 182 +/- 55 to 178 +/- 23 ml). No significant problems related to feasibility of the procedure as well as significant side effects were reported by patients. CONCLUSIONS: This study showed that intravesical nociceptin/orphanin FQ but not placebo inhibited the micturition reflex in patients with neurogenic detrusor overactivity incontinence, and demonstrated the clinical efficacy of nociceptin/orphanin FQ during 10 days of treatment. These findings support the use of nociceptin/orphanin FQ peptide receptor agonists as an innovative therapeutic approach for controlling detrusor overactivity incontinence.

Administration, Intravesical↗
PubMed1988

Comparing the effects of different durations of the same therapy.

With clinical trials that compare different durations of the same therapy, particular problems arise when the main response criterion is time to an event, such as death or relapse. With such trials, we first discuss the appropriate time(s) for randomization in the context of both the two-treatment trial and the three-treatment trial, where one of the treatments is a control. We then propose a proportional hazards model with time-varying treatment effects for analysis of a three-treatment trial in which randomization occurs on entry to the study. We illustrate the methodology with a trial of intravesical chemotherapy for superficial bladder cancer.

Administration, Intravesical↗
PubMed1989

The effect of liposome encapsulated antineoplastic agents on transitional cell carcinoma in tissue culture.

Liposomes are microscopic vesicles composed of one or more phospholipid bilayers separated by an equal number of aqueous interspaces. These "capsules" are formed when dried lipid is combined with excess water, agitated, and warmed above the transition temperature of the lipid (the temperature at which the lipid changes from a gel state to a fluid state). If a chemical in solution is present when the vesicles form, the chemical will be trapped in either the aqueous interspaces (hydrophilic compounds), or the lipid bilayer (hydrophobic compounds). The urinary bladder is an attractive site for the topical application of liposome encapsulated compounds due to its accessibility and since the introduction of various agents, including antineoplastic compounds, into the bladder is a well established treatment option. Utilization of liposome technology may provide the means for a more effective intravesical treatment of transitional cell carcinoma.

Administration, Intravesical↗
PubMed1993

Incrusted cystitis after intravesical mitomycin C treatment.

Bladder wall calcification is a rare complication of intravesical therapy of superficial bladder cancer with Mitomycin C. A review of the literature revealed 2 other cases. We report a new case and discuss the pathogenic mechanism of this consequence of the intravesical treatment with Mitomycin C.

Administration, Intravesical↗
PubMed1994

Standard intravesical therapies for interstitial cystitis.

The treatment of interstitial cystitis is difficult and at time frustrating--both for the patient and for the physician. Treatment is hampered by the lack of a clear understanding of its pathophysiology, which makes it difficult to objectively assess disease severity and/or progression. Intravesical therapy appears to be the most successful approach to the relief of symptoms. Clearly, there are drawbacks to intravesical therapy, particularly Clorpactin lavage. Responses to intravesical lavage are variable in duration, unpredictable, and unamenable to objective measurement. Multiple treatments are frequently needed, as with DMSO, and multiple anesthetics may be required for Clorpactin therapy. There have been no double-blind, placebo-controlled studies comparing the mainstays--Clorpactin and DMSO--of intravesical treatment. It is hoped that current research into the pathogenesis and causation of interstitial cystitis will lead to an improved understanding of this disease or syndrome. The introduction of newer, more specific intravesical therapies will surely follow such advances.

Administration, Intravesical↗
PubMed1996

Alternating mitomycin C and bacillus Calmette-Guerin instillation prophylaxis for recurrent papillary (stages Ta to T1) superficial bladder cancer. Finnbladder Group.

PURPOSE: We attempted to prove if alternating chemoprophylactic and immunoprophylactic instillations improved efficacy and decreased toxicity in patients with recurrent superficial bladder cancer. MATERIALS AND METHODS: A total of 188 patients with rapidly recurring stage Ta or T1 cancer was randomly treated with mitomycin C (group 1) or alternating mitomycin C and Pasteur strain bacillus Calmette-Guerin (BCG) instillations (group 2) for 2 years. Mean followup was 34 months. RESULTS: Median times to initial recurrence were 12 months in group 1 and 7 months in group 2 (p = 0.976), and treatment failed in 21.5% and 18.9%, respectively. Recurrence rates during the instillation period were 1.01 in group 1 and 0.86 in group 2 (p = 0.376). There was no difference in the disease-free interval between the 2 groups (p = 0.976). Instillations were discontinued because of adverse effects in 6 cases (6%) in both groups. CONCLUSIONS: Efficacy of alternating mitomycin C and BCG was equal to mitomycin C monotherapy, and both methods were effective in prophylaxis of recurrent papillary bladder cancer. Less toxicity occurred in the alternating treatment group compared to earlier BCG monotherapy results.

Adjuvants, Immunologic↗
PubMed1994

Treatment of interstitial cystitis with intravesical heparin.

OBJECTIVE: To control the symptoms of interstitial cystitis with chronic self-administered intravesical heparin and determine whether the drug's continued use can sustain remission. PATIENTS AND METHODS: A total of 48 patients were selected to undergo intravesical heparin therapy, 10,000 units in 10 ml sterile water, three times per week for 3 months. For patients who attained a good clinical remission, therapy was available for up to a further 9 months. RESULTS: At 3 months 27 of 48 patients (56%) attained good clinical remissions. All were offered continuous therapy and 23 elected for an additional 3 months. Twenty of the 23 continued in remission. Sixteen of these patients elected to have a further 6 months of therapy (12 months total) and 15 of 16 remained in remission. CONCLUSION: In over half of the patients studied, intravesical heparin controls the symptoms of interstitial cystitis with continued improvement even after one year of therapy.

Administration, Intravesical↗