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Dept. of Urology,
Jahn Ferenc South-Pest Teaching Hospital,
Budapest, Hungary
Sandor Lovasz MD. PhD.
High pressure intravesical drug deliveryHigh pressure intravesical drug delivery
Local, intravesical treatment - the most effective form of medical therapy in IC/PBSReduced side effect-profileHigher concentration of the agent at bladder surface
Intravesical drug is transferred by passive diffusion.
Influencing factors
Concentration gradient Pressure difference Time of impact Surface
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 deliveryHigh 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 Institute 2001
High pressure intravesical drug deliveryHigh pressure intravesical drug delivery
High pressure intravesical drug deliveryHigh pressure intravesical drug delivery
• 20-40ml filling volume of intravesical drug• low intravesical pressure• small bladder surface• thick bladder mucosa• dilution by diuresis
• 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
This seems to be ideal!COSTS !!!COSTS !!!
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
High pressure intravesical drug deliveryHigh pressure intravesical drug delivery
High pressure intravesical drug deliveryHigh pressure intravesical drug delivery
Balloon’scharacristics
High pressure intravesical drug deliveryHigh pressure intravesical drug delivery
Kept continuously at max. 70cmH2Ofor 5-15minutes
Cystometry in a wide pressure-range:
Cysto-elastometry
High pressure intravesical drug deliveryHigh pressure intravesical drug delivery
Conclusions I
Intravesical drug administration
combined with
Simultaneous balloon dilation of the bladder
provides the basically new method
of
High pressure intravesical drug deliveryHigh pressure intravesical drug delivery
High pressure intravesical drug delivery
Conclusions II
The method optimizes all parameters of passive drug diffusion
High pressure intravesical drug deliveryHigh pressure intravesical drug delivery
concentration gradient
pressure difference
time of impact
size of surface
thickness of barrierenhances efficacy of any intravesically used drugs
Conclusions III
All optimized parameters are standardized
at the same time.
High pressure intravesical drug deliveryHigh pressure intravesical drug delivery
Undisputed advantages
for basic research in the field of
topical treatment of IC/PBS.
Conclusions IV
Computerized analysis of pressure-volume relation of the bladder let us measure
novel physical characteristics of the bladder wall
High pressure intravesical drug deliveryHigh pressure intravesical drug delivery
Basic volume – independent of
patient’s sensitivity
Distensibility – quantitative meaure of
elastic propertiesSoftware freely available to anybody !Software freely available to anybody !
Conclusions V
High pressure intravesical drug deliveryHigh pressure intravesical drug delivery
Our basic goal was to establish an
„open source project”
for research of efficacy enhencement of
topical, intravesical medical treatment
(not just) for IC/PBS.
Dept. of Urology,
Jahn Ferenc South-Pest Teaching Hospital,
Budapest, Hungary
Sandor Lovasz MD. PhD.