1. Method of high pressure intravesical drug delivery
Sandor Lovasz MD. PhD.
Dept. of Urology,
Jahn Ferenc South-Pest Teaching Hospital,
Budapest, Hungary

2. High pressure intravesical drug delivery
Local, intravesical treatment - the most 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.
Influencing factors
Concentration gradient
Pressure difference
Time of impact
Surface

3. 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.

4. 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 Institute 2001

5. High pressure intravesical drug delivery
This seems to be ideal!
COSTS !!!
20-40ml filling volume of intravesical drug
low intravesical pressure
small bladder surface
thick bladder mucosa
dilution by diuresis
ml filling volume of intravesical drug
high intravesical pressure (50-70cmH2O)
great bladder surface
thin bladder mucosa
no dilution by diuresis due to high pressure

6. 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

7. High pressure intravesical drug delivery
Balloon’s
characristics

8. High pressure intravesical drug delivery
Kept
continuously at
max. 70cmH2O
for 5-15minutes
Cystometry in a wide pressure-range:
Cysto-elastometry

9. High pressure intravesical drug delivery

10. High 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 delivery

11. High pressure intravesical drug delivery
Conclusions II The method optimizes all parameters of passive drug diffusion
concentration gradient
pressure difference
time of impact
size of surface
thickness of barrier
enhances efficacy of any intravesically used drugs

12. High pressure intravesical drug delivery
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.

13. High pressure intravesical drug delivery
Conclusions IV Computerized analysis of pressure-volume relation of the bladder let us measure novel physical characteristics of the bladder wall
Basic volume – independent of patient’s sensitivity
Distensibility – quantitative meaure of elastic properties
Software freely available to anybody !

14. High pressure intravesical drug delivery
Conclusions V
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.

15. Thank you for your attention Jahn Ferenc South-Pest Teaching Hospital,
  
Sandor Lovasz MD. PhD.
Dept. of Urology,
Jahn Ferenc South-Pest Teaching Hospital,
Budapest, Hungary