APPLICATION GUIDE FLO CLARIX FLO AFTER DVIU Manage Stricture Repair with CLARIX FLO Injectable Therapy for Prevention of Urethral Stricture Recurrence APPLIC ATION GUIDE The following is a general recommendation and is not intended to replace your standard technique: 1. Use a 22F optical urethrotome with a 12° lens and a semicircular knife for the DVIU 2. Suspend CLARIX FLO particulate by transferring up to 4.0mL of normal preservative- free saline into the vial with up to a 25 G needle. Shake vial to achieve a homologous mixture, noting that the particulate will not dissolve. Withdraw the suspension into a syringe for injection, and prepare the site for injection. Common needles used for injection include Sidekick™ Needle, 14.6 inch, 21 ga, Uroplasty Rigid Endoscopic Needle, or Injetak Botox Needle 3. Use a 21F urethroscope sheath and obturator with a 30° lens. 4. Slowly inject the CLARIX FLO suspension into the urethral wall along the length of the location where the stricture was excised. 5. Advise the patient on expectations post-injection: minor pain and discomfort for the first 24-48 hours at the injection site may be managed with heat/cold and ibuprofen. 6. Patients may resume full activities after a week. Any additional conservative measures or immobilization are at the discretion of the physician. CASE EXAMPLE by Samuel Lee, M.D. / Los Angeles, CA A 50-year-old male (5’7”, 21.9 kg/m2 BMI) presented with symptomatic urethral stricture disease, urinary retention, and right testicular and flank pain. Patient was currently taking oral Flomax 0.4mg once a day. Two years previously, patient underwent cystoscopy with direct visual internal urethrotomy for a urethral stricture in the proximal membranous urethra and right ureterocelectomy. Patient had a post-void residual volume of 143cc. Patient was taken to the operating room and given appropriate anesthesia. After prepping and draping the patient in the lithotomy position, a urethrotome was assembled and cold knife was used under direct vision to incise the 12 o’clock location of the 1-2cm stricture located in the bulbar urethra. To prevent stricture recurrence, 100mg CLARIX® FLO in 4cc preservative free saline was injected using a transurethral needle where the incisions were made. The cystoscope was then removed and 16F Foley catheter inserted. Post-operatively, the patient recovered without complications. It has been at least 3 months, patient has normal urinary function with no sign of stricture recurrence. 1. Djordjevic ML. Treatment of urethral stricture disease by internal urethrotomy, dilation, or stenting. European Association of Urology. 2016; 15: 7-12. 2. Osterberg EC, Murphy, G., Harris, C.R., Breyer, B.N. Cost-effective strategies for the management and treatment of urethral stricture disease. Urol Clin N Am. 2017; 7300 CORPORATE CENTER DR #700 MIAMI, FL 33126 44: 11-7. 3. Browne BM, Vanni, A.J. Use of alternative techniques and grafts in urethroplasty. 888-709-2140 | WWW.AMNIOXMEDICAL.COM Urol Clin N Am. 2017; 44: 127-40 US-CLF-1900002 Rev 01 10/19.
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