Second-line therapy for your adult overactive bladder (OAB) patients

BOTOX® for OAB —
Dosing and Administration

Pre-Treatment

Patient Counseling Before BOTOX® Treatment
Patient communication is crucial. Patients want to hear about your anecdotal experience utilizing BOTOX® in your practice. Once a patient is identified as an appropriate candidate for BOTOX®, setting expectations is important.

Patients may have misconceptions about use and safety, and patients should be counseled before a BOTOX® procedure, about the procedure itself and possible adverse events, including potential need for clean intermittent catheterization (CIC) to empty the bladder.

Review patient options for anesthesia:
local anesthesia with or without a sedative.4

The use of anesthesia during the injection procedure is based on the medical needs of the patient, taking into account factors such as tolerance to the procedure, medical needs, and preference of the patient.

Local anesthesia can be achieved by instillation of the bladder with 1% to 2% lidocaine (or similar-acting agent) for at least 20 minutes. The bladder should then by drained of lidocaine, rinsed with saline, and drained again before injection.

Confirm that the patient does not have a urinary tract infection (UTI).
Patients must not have a UTI at the time of treatment. Prophylactic antibiotics, except aminoglycosides, should be administered 1 to 3 days pre-treatment, on the treatment day, and 1 to 3 days post-treatment to reduce likelihood of procedure-related UTI.4

Discontinue anti-platelet therapy at least 3 days before procedure
and manage patients on anticoagulant therapy.

Patients should discontinue anti-platelet therapy at least 3 days before the injection procedure. Patients on anticoagulation therapy need to be managed appropriately to decrease the risk of bleeding.4

Talk to patients about the possibility of urinary retention
and CIC.

Due to the risk of urinary retention, treat only patients who are willing and able to initiate catheterization post-treatment, if required, for urinary retention. Advise patients that if they experience signs of urinary retention, they may need to begin CIC to empty the bladder.4

The Equipment Procedure Guide contains additional information and suggestions on how to communicate information about the BOTOX® procedure and possible adverse events, including treatment and safety concerns, to your BOTOX® for OAB patients.

Administering BOTOX® Treatment

BOTOX® Dosage for OAB Injection

Maximum Cumulative Dose
When adult patients are treated with BOTOX® for one or more indications, the maximum cumulative dose should generally not exceed 360 Units in a 3-month interval.4

Total dose recommendation for OAB treatment

  • 100 Units BOTOX® (10 mL) as 20 intradetrusor injections of 0.5 mL each

Reconstitute BOTOX® per label

  • Reconstitution protocols vary depending on the indication. See the
    BOTOX® Reconstitution Procedure on this website or "Dilution Technique" in the Dosing and Administration section of the full Prescribing Information for details.
  • BOTOX® should be administered within 24 hours after reconstitution in the vial. During this time, reconstituted BOTOX® injectable should be stored in a refrigerator (2°C–8°C).
  • BOTOX® should be used immediately after reconstitution in the syringe. Do not store reconstituted BOTOX® in the syringe.

Injection Procedure

BEFORE ADMINISTERING BOTOX®
CONFIRM THAT THE PATIENT DOES NOT HAVE A UTI AT THE TIME OF TREATMENT AND HAS TAKEN THEIR PROPHYLACTIC ANTIBIOTICS (EXCEPT AMINOGLYCOSIDES) 3 DAYS PRIOR TO TREATMENT AND ON THE DAY OF TREATMENT. PATIENTS SHOULD DISCONTINUE ANTIPLATELET THERAPY AT LEAST 3 DAYS BEFORE THE INJECTION PROCEDURE. PATIENTS ON ANTI-COAGULATION THERAPY NEED TO BE MANAGED APPROPRIATELY TO DECREASE THE RISK OF BLEEDING. APPROPRIATE CAUTION SHOULD BE EXERCISED WHEN PERFORMING A CYSTOSCOPY.


Using a flexible or rigid cystoscope, BOTOX® can be administered in the office, ambulatory surgical center, or outpatient operating room.

For rigid scopes: • 30-degree lens prefered • 17-21F sheath preferred

1
Instilling the bladder with saline before BOTOX® (onabotulinumtoxinA) reconstitution

Instill the bladder with enough saline to achieve adequate visualization.4
Over-distension should be avoided. Before reconstituting BOTOX®, perform cystoscopy to determine whether the patient has a condition that would prevent BOTOX® administration.

2

Reconstitute BOTOX® per label.4

Keep unopened vials of BOTOX® refrigerated (2°C–8°C) until ready to use.

Dosage Information for OAB
Indication OAB: For the treatment of OAB with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic (AC) medication
Units 100 U
Dose 100 U of reconstituted BOTOX®
(5 U per 0.5 mL)
Reconstitution 100 U BOTOX® in 10 mL sterile, non-preserved 0.9% saline as well as 1 mL syringe of saline for final flush
Number of Injections 20
Storage Administer BOTOX® within 24 hours of reconstitution in the vial. During this time, reconstituted BOTOX® should be stored in a refrigerator(2°C–8°C)
3
Loading injection needle into cystoscope

Load the needle into the injection port.
After removing the needle from its sterile packaging, load it through the working channel of the flexible or rigid cystoscope. You should not load the needle into a flexible cystoscope without taking precautions against damaging the working channel. The precautions you take will depend on the specific type or brand of needle (see "Precautions for Flexible Cystoscopes," shown in sidebar, or needle information guide).

4
Inserting cystoscope and priming BOTOX® (onabotulinumtoxinA) injection needle

Prepare for injection into the destrusor.
Lubricate patient's urethral meatus and insert flexible or rigid cystoscope. Attach the syringe of reconstituted BOTOX® to the injection needle. Prime the needle with reconstituted BOTOX® injectable. This will remove the air bubbles inside the needle.

5
Injecting BOTOX® (onabotulinumtoxinA) into detrusor muscle

Distribute the injections evenly across the detrusor walls and dome.
Under direct visulization, inject reconstituted BOTOX® into the detrusor muscle, avoiding the trigone.4*

  • Insert the needle approximately 2 mm into the detrusor after penetrating the uromucosa4
  • Space the injections approximately 1 cm apart, avoiding the trigone4
  • Distribute the injections evenly across the detrusor walls as far laterally as possible
  • If you encounter a small amount of bleeding from an injection site, it should not interfere with the procedure. Any bleeding should be managed per local site practice.

Look for a "bleb" in the bladder epithelium at each injection site.
6
Final injection with saline

For the final injection, approximately 1 mL of sterile normal saline should be injected so the remaining BOTOX® in the needle is delivered to the bladder.4

7
Removing cystoscope and draining bladder of saline

Remove the cystoscope and drain.
After the final injection, remove the cystoscope. The saline used for bladder wall visualization should be drained.4

8
Observe patient after BOTOX® (onabotulinumtoxinA) injections

Observe the patient for at least 30 minutes post-injection.
During this period, safety monitoring and assessments should be done according to local site practice. This might include monitoring of blood pressure and pulse rate, and ensuring that the patient has demostrated his or her ability to void spontaneously before leaving the site.

9
Two weeks after BOTOX® (onabotulinumtoxinA) injections, test post-void residual urine volume

Assess post-void residual (PVR) urine volume within 2 weeks post-treatment.4

  • Assess PVR urine volume within 2 weeks of the injection
  • Continue to assess PVR urine volume for up to 12 weeks, as medically appropriate, particularly in patients with multiple sclerosis or diabetes mellitus

Instruct your patients to contact you if they experience burning sensation upon voiding or difficulties in voiding, as catheterization may be required. Also instruct them to continue taking prophylactic antibiotics for 1 to 3 days post-injection to prevent UTI.

10
Scheduling additional follow-up appointments

Consider re-injection upon diminishing clinical effect of the previous BOTOX® injection but no sooner than 12 weeks from the prior bladder injection.4

  • Schedule additional follow-up appointments at an appropriate interval
  • Median time until patients qualified for re-treatment with BOTOX® in the double-blind, placebo-controlled clinical studies was 169 days (24 weeks) for BOTOX® 100 Units, but no sooner than 12 weeks from the prior bladder injection
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Urology Essentials Program

Receive Essential Tools and Resources

The Urology Essentials program will provide ongoing support and educational resources including:

  • Featured listing in the BOTOX® Urology Directory
  • Training videos
  • Clinical updates
  • Office set-up guidance
  • Patient education
  • Help with reimbursement

It's free to join. Sign up today!

Already registered for the BOTOX® Urology Directory?
Click here
to access your profile.

Precautions for Flexible Cystoscopes to Help Prevent Damage to the Working Channel

In general, make sure your flexible cystoscope is in a neutral position (not flexed) when inserting the needle.

If the needle has a protective covering or cap: Leave the cap on as you pass the needle through the working channel. Once the covered tip of the needle is past the tip of the scope, in view, the cap is removed and the needle is withdrawn so that the tip is just inside the end of the scope. This would be performed outside the bladder as the protective covering or cap must be removed before entering the bladder.

If the needle is inserted through a protective sheath: Place the protective sheath through the working port of the cystoscope; then pass the needle through the sheath. When you use a protective sheath, the needle can be inserted into the working channel either before or after the scope is passed into the bladder.

If the needle is retractable: Ensure that your needle is properly retracted before loading it through the working channel. Before removal, confirm that the needle is no longer retracted. Then pull the needle straight back out of the working channel with a consistent motion.

Appearance of Bladder Epithelium at Each Injection Site

Look for a "bleb" in the bladder epithelium at each injection site.

BLEB
Bleb at injection site indicates proper BOTOX® (onabotulinumtoxinA) needle insertion

"Bleb," or subtle rise in the
bladder epithelium, indicates
proper needle insertion.

BLISTER
Blister at injection site may indicate improper BOTOX® (onabotulinumtoxinA) needle insertion

Thin, transparent, blister-like rise
in the bladder epithelium may
indicate incorrect needle insertion.

 
Second-line therapy for your adult overactive bladder (OAB) patients

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