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    • Bu sitenin içeriği Türkiye'deki sağlık mesleği mensuplarına yöneliktir. 

       

      BOTOX ® indication: Neurogenic overactive detrusor

      Urinary incontinence in adults with neurogenic overactivity in the detrusor due to neurogenic bladder, due to stable subcervical spinal cord injury or multiple sclerosis.

      Patients with symptoms of overactive detrusor have poor results in tests that aim to capture health-related quality of life and productivity in working life. The same people have a high frequency of restlessness and depression, compared to those who have little or no symptoms of overactive bladder. The main goal of treatment is to improve the quality of life of these patients.


      Clinical efficacy and safety

      BOTOX ® : Statistically significant and sustained improvements in patients with NDO BOT, KEN13


      Treatment with BOTOX ® can relieve neurogenic overactive detrusor

      BOTOX ® counteracts the overactivity through presynaptic release of the transmitter substance acetylcholine. During impulse transmission, vesicles with acetylcholine flow into the presynaptic nerve cell. The vesicles bind to a protein complex, the so-called SNARE complex, on the inside of the cell membrane. The SNARE complex allows the vesicles to fuse with the cell membrane, enabling the release of acetylcholine from the nerve cell to the muscle cell via the synaptic cleft. In the muscle cell, acetylcholine binds to receptors and exerts its effect.

      Part of the SNARE complex is the protein SNAP-25. BOTOX ® works by being taken up by cholinergic nerve cells and cleaving SNAP-25. In this way, membrane fusion and thus acetylcholine release is blocked. In this way, the acetylcholine never reaches the receptors of the muscle cells where it would otherwise have had its effect. Following injection into the detrusor, the BOTOX ® activity of the detrusor's outward pathways affects by inhibiting acetylcholine release there. BOTOX ® can also inhibit the signaling substance in the introductory nerves and sensory pathways.

       


      Common side effects of BOTOX ® treatment

      In clinical trials of urinary incontinence due to neurogenic overactivity in the detrusor, the incidence was 32% for the first treatment and decreased to 18% after the second treatment. Several of the common side effects could be related to the injection procedure itself.


      Treatment with BOTOX ® Neurogenic overactive detrusor

       

      Dilution instructions for 2 vials of 100 Allergan units for the treatment of neurogenic overactive detrusor (NDO)

      * Sterile physiological sodium chloride solution without preservative (sodium chloride 0.9% solution for injection)

      Dilution instructions for 1 vial of 200 Allergan units for the treatment of neurogenic overactive detrusor (NDO)

      * Sterile physiological sodium chloride solution without preservative (sodium chloride 0.9% solution for injection)

      BOTOX ® is given through a cystoscope, after anesthesia or, in rare cases, anesthesia. There are 30 injection sites.

      The patient should not have a urinary tract infection at the time of treatment. Prophylactic antibiotics should be given 1-3 days before treatment, on the day of treatment, and 1-3 days after treatment.

      Patients are advised to discontinue antiplatelet therapy for at least 3 days before the injection procedure. During anticoagulation therapy, the patient must be closely monitored to reduce the risk of bleeding.

       


      After BOTOX ® treatment

      Immediately after the treatment, you can get more problems with urine leakage than before the treatment. Blood in the urine is not uncommon the first time. To get a good flow of urine and prevent it from being concentrated, it is good if the patient can drink a little extra afterwards. If the patient has not previously used a catheter and has difficulty urinating, the patient should start using a catheter (RIK) in accordance with the instructions given.

       


      Effect of BOTOX ® 

      The patient should be considered for reinjection when the clinical effect of the previous injection is reduced (mean duration of clinical trials is 256-295 days for 200-allergen units), based on the patient's request for repeated treatment, but not earlier than 3 months from the previous bladder injection.

      BOTOX ® is injected locally into the bladder and in very small doses, and therefore the risk of BOTOX ® spreading to other parts of the body is very small. In addition, the effect of BOTOX ® disappears from the body completely after a number of months if the treatment is not repeated. Side effects usually occur within the first few days after injection  and are usually transient, but in rare cases can last longer.

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      Prepared: July 2021