Method of treating dysfunctional bladder syndromes by electromotive drug administration

• US 5,779,661 A
• Filed: 12/11/1995
• Issued: 07/14/1998
• Est. Priority Date: 12/11/1995
• Status: Expired due to Term

• Current Assignee: Physion SRL
• Original Assignee: Physion SRL
• Inventors: Griffith, Donald P., Eruzzi, Silvio, Lugnani, Franco, Fontanella, Umberto, Stephen, Robert L., Rossi, Cino, Stohrer, Manfred
• Primary Examiner(s): Bockelman, Mark
• Assistant Examiner(s): Tao, Ellen S.
• Application Number:
  US08/570,507
• Time in Patent Office: 946 Days
• Field of Search: 604/21, 604/28, 604/49, 604/54-5, 604/264, 607/3, 607/40-41, 607/72, 607/75, 607/115-16, 607/143
• US Class Current: 604/21
• CPC Class Codes: A61N 1/306 Arrangements where at least part of the apparatus is introduced into the body
• CPC Class Codes: A61N 1/325 for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body electrodes for external use A61N1/0428

Abstract

An intravesical method of treating dysfunctional bladder syndromes by Electromotive Drug Administration (EMDA) of local anaesthetic drugs, anti muscarinic drugs and sympathomimetic agents. The administration of said drugs combined with hydraulic bladder dilatation causes relaxation of the detrusor muscle, reversing the hypertonicity associated with dysfunctional bladder syndromes.

Claims

1. A method of treating dysfunctional bladder syndromes by Electromotive Drug Administration of intravesically instilled drug into a bladder wall, said method comprising the steps of:

a) inserting a catheter via a urethra into a bladder and draining said bladder of urinary contents,

b) administering into said bladder via said catheter an electrically conductive aqueous solution comprising at least a local anaesthetic agent and an antimuscarinic agent to achieve both analgesia and relaxation of the detrusor muscle,

c) inserting into said catheter a tubular anodic electrode connected to an external controllable power source, so that the internal tip of said electrode resides within that section of said catheter which is within the bladder cavity,

d) placing in contact with an adapted skin location a cathodic electrode also connected to said external power source,

e) supplying an electrical current from said power source to said electrodes,

f) instituting a progressive active hydraulic dilatation of said bladder by infusing, portionwise, through said catheter, a solution to substantially achieve its maximum intravesical volume.

2. A method according to claim 1, wherein the solution of step f) is an electrically conductive aqueous solution including a local anaesthetic agent at a concentration of 0.3 to 2% by weight/volume.

3. A method according to claim 1, wherein said local anaesthetic agent is selected from the group consisting of lidocaine, mepivacaine, bupivacaine, and mixtures thereof.

4. A method according to claim 3, wherein said local anaesthetic agent is administered in the form of an aqueous solution at a concentration of 0.3% to 2.0% by weight/volume.

5. A method according to claim 1, wherein said electrically conductive aqueous solution further comprises a sympathomimetic agent.

6. A method according to claim 5, wherein said sympathomimethic agent is selected from the group consisting of epinephrine, ephedrine and mixture thereof.

7. A method according to claim 1, wherein a volume of from 50 to 150 ml of said electrically conductive aqueous solution is administered and an electrical current having an intensity of from 10 mA to 30 mA is supplied.

8. A method of treating dysfunctional bladder syndromes by Electromotive Drug Administration of intravesically instilled drug into a bladder wall, said method comprising the steps of:

a) inserting a catheter via a urethra into a bladder and draining said bladder of urinary contents,

b) administering into said bladder via said catheter an electrically conductive aqueous solution of at least one drug which causes relaxation of the detrusor muscle,

c) inserting into said catheter a tubular anodic electrode connected to an external controllable power source, so that the internal tip of said electrode resides within that section of said catheter which is within the bladder cavity,

d) placing in contact with an adapted skin location a cathodic electrode also connected to said external power source,

e) supplying an electrical current from said power source to said electrodes,

f) instituting a passive hydraulic dilatation of said bladder by clamping said catheter and thereby trapping inflowing urine within the bladder cavity and distending said bladder to substantially achieve its maximum intravesical volume.

9. A method according to claim 8, wherein the at least one drug which causes relaxation of the detrusor muscle comprises an antimuscarinic agent.

10. A method according to claim 9, wherein said antimuscarinic agent is selected from the group consisting of atropine, scopolamine, homatropine, dicyclomine, oxyphencyclamine, flavoxate, oxybutynin, methantheline, methscopolamine, octatrophine, parapenzolate, pentapiperide, pipenzolate, prifinium, propanteline, butylscopolamine, tiemonium, xenytropium, dihexyverine, propiverine, terodyline, diphemanile, emepronium, hexacyclium, fentonium, isopropamide, trospium, and mixtures thereof.

11. A method according to claim 9, wherein said antimuscarinic agent is administered in the form of an aqueous solution at a concentration of 0.001% to 0.2% by weight/volume.

12. A method according to claim 9, wherein said antimuscarinic agent is administered in the form of a sodium or potassium citrate solution at a concentration of 1.0% to 3.0% by weight.

13. A method according to claim 8, wherein the at least one drug which causes relaxation of the detrusor muscle is administered in the form of a physiological electrolyte solution having an osmolarity of from 150 to 310 milliosmols.

14. A method according to claim 8, wherein the at least one said drug which causes relaxation of the detrusor muscle comprises a local anaesthetic agent and an antimuscarinic agent.

15. A method according to claim 8, wherein a volume of from 50 to 150 ml of said electrically conductive aqueous solution is administered and an electrical current having an intensity of from 10 mA to 30 mA is supplied.