Botulinum Toxin Treatment Of Spastic Bladder

Abstract

The invention relates to the use of a liquid or semi-solid formulation of botulinum toxin for the preparation of a medicament intended to treat a disorder characterised by bladder spasms (e.g. urinary incontinence due to unstable bladder or unstable detrusor sphincter, voiding complications due to detrusor overactivity or unstable detrusor sphincter, urinary retention secondary to spastic sphincter or hypertrophied bladder neck and neurogenic bladder dysfunction secondary to Parkinson's disease, spinal cord injury, stroke or multiple sclerosis or characterised by a spasm reflex), wherein said medicament is for administration by infusion into the bladder or by other methods that do not involve injection into the bladder wall.

1 . A use of a solid, semi-solid or liquid formulation of botulinum toxin for the preparation of a medicament intended to treat a disorder characterised by bladder spasms wherein said medicament is for administration without using an injection into the bladder wall.  
   
   
       2 . The use according to  claim 1 , wherein the disorder characterised by bladder spasms is selected from the group consisting of urinary incontinence due to unstable bladder or unstable detrusor sphincter, voiding complications due to detrusor overactivity or unstable detrusor sphincter, urinary retention secondary to spastic sphincter or hypertrophied bladder neck and neurogenic bladder dysfunction secondary to Parkinson's disease, spinal cord injury, stroke or multiple sclerosis or characterised by a spasm reflex.  
   
   
       3 . The use according to  claim 1 , wherein the medicament prepared is in the form of a liquid or semi-solid formulation intended to be administered through infusion into the bladder or a solid, a gel formulation intended to be deposited at the appropriate location of the patient's bladder, a spray formulation intended to be administered through spraying at the appropriate location of the patient's bladder or a solid, semi-solid or liquid botulinum toxin formulation spread on the outer wall of a balloon intended to be inflated inside the bladder.  
   
   
       4 . The use according to  claim 3 , wherein the medicament prepared is a liquid or semi-solid formulation for administration through infusion into the bladder.  
   
   
       5 . The use according to  claim 4 , wherein the liquid or semi-solid formulation has a volume of 20 to 80 ml.  
   
   
       6 . The use according to  claim 3 , wherein the liquid or semi-solid formulation contains from 100 to 2500 units of botulinum toxin type A.  
   
   
       7 . The use according to  claim 3 , wherein the liquid or semi-solid formulation contains from 4,000 to 50,000 units of botulinum toxin type B.  
   
   
       8 . The use according to  claim 3 , wherein the medicament prepared is in the form of a gel formulation.  
   
   
       9 . The use according to  claim 3 , wherein the medicament prepared is in the form of a spray formulation.  
   
   
       10 . The use according to  claim 3 , wherein the medicament prepared is in the form of a solid, semi-solid or liquid botulinum toxin formulation spread on the outer wall of a balloon intended to be inflated inside the bladder.  
   
   
       11 . A method of treatment of a disorder characterised by bladder spasms, wherein the disorder characterised by bladder spasms is selected from the group consisting of urinary incontinence due to unstable bladder or unstable detrusor sphincter, voiding complications due to detrusor overactivity or unstable detrusor sphincter, urinary retention secondary to spastic sphincter or hypertrophied bladder neck and neurogenic bladder dysfunction secondary to Parkinson's disease, spinal cord injury, stroke or multiple sclerosis or characterised by a spasm reflex: wherein a patient requiring said treatment is administered with a therapeutically effective dose of a solid, semi-solid or liquid formulation of botulinum toxin, wherein said formulation is administered without using an injection into the bladder wall.