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Method of high pressure intravesical drug delivery. Sandor Lovasz MD. PhD. Dept. of Urology, Jahn Ferenc South-Pest Teaching Hospital, Budapest, Hungary. Influencing factors. Concentration gradient Pressure difference Time of impact Surface.
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Method of highpressure intravesical drugdelivery Sandor Lovasz MD. PhD. Dept. of Urology, Jahn Ferenc South-Pest Teaching Hospital, Budapest, Hungary
Influencing factors Concentration gradient Pressure difference Time of impact Surface Highpressure intravesical drugdelivery Local, intravesical treatment -themost effective form of medical therapy in IC/PBS • Reduced side effect-profile • Higher concentration of the agent at bladder surface Intravesical drug is transferred by passive diffusion.
High pressure intravesical drug delivery Diuresis acts confusing in intravesical therapy. Concentration reduction (dilution) Reduction of time of exposure (urination) Both parameters are adversely influenced + diuresis is highly variable and unpredictable Efforts are made to reduce influence of diures.
High pressure intravesical drug delivery Using - higher concentration - minimized diuresis - alkalized urine Mitomycin C proved to be significantly more effective in a Phase III multicenter clinical trial. Au, Badalament, Wientjes et al.: Methods to Improve Efficacy of Intravesical Mitomycin C: Results of a Randomized Phase III Trial Journal of the National Cancer Institute2001
High pressure intravesical drug delivery This seems to be ideal! • 20-40ml filling volume of intravesical drug • low intravesical pressure • small bladder surface • thick bladder mucosa • dilution by diuresis COSTS !!! • 400-500ml filling volume of intravesical drug • high intravesical pressure (50-70cmH2O) • great bladder surface • thin bladder mucosa • no dilution by diuresis due to high pressure
High pressure intravesical drug delivery 1. Fill medication into empty bladder 2. Place special dilator balloon catheter 3. Blow up the balloon under continuous pressure control - measured inside the balloon 3. Drug is being pressed into the mucosa of the bladder
Highpressure intravesical drugdelivery Balloon’s characristics
High pressure intravesical drug delivery Kept continuously at max. 70cmH2O for 5-15minutes Cystometryin a widepressure-range: Cysto-elastometry
Highpressure intravesical drugdelivery Conclusions I Intravesical drug administration combined with Simultaneous balloon dilation of the bladder provides the basically new method of High pressure intravesical drug delivery
enhancesefficacy of anyintravesicallyuseddrugs Highpressure intravesical drugdelivery Conclusions II The method optimizes all parameters of passive drug diffusion concentrationgradient pressuredifference time of impact size of surface thickness of barrier
Highpressure intravesical drugdelivery Conclusions III All optimized parameters are standardized at the same time. Undisputed advantages for basic research in the field of topical treatment of IC/PBS.
Basic volume– independent of patient’ssensitivity Distensibility– quantitativemeaure of elasticproperties Highpressure intravesical drugdelivery Conclusions IV Computerized analysis of pressure-volume relation of the bladder let us measure novel physical characteristics of the bladder wall Software freelyavailabletoanybody !
Highpressure intravesical drugdelivery Conclusions V Ourbasicgoalwastoestablish an „opensource project” forresearch of efficacyenhencementof topical, intravesical medicaltreatment (notjust) forIC/PBS.
Thankyouforyourattention Sandor Lovasz MD. PhD. Dept. of Urology, Jahn Ferenc South-Pest Teaching Hospital, Budapest, Hungary