CASE STUDY:Uretero-Vaginal Fistula ReconstructionMUTAHAR AHMED, MD NEW JERSEY CENTER FOR PROSTATE CANCER IN UROLOGY | HACKENSACK, NJ

CASE RELEVANCE

• Modulating inflammation• Promoting cell migration and proliferation• Enhance the potential for tissue regeneration4,5,6

Contained in greatest abundance in the umbilical cord, the critical signaling HC-HA complex is optimally preserved through our proprietary CryoTek™ process, allowing CLARIX CORD 1K to deliver concentrations of HC-HA and other key biological factors that are comparable to fresh tissue and superior to dehydrated tissue products.7

Available in 5 different sizes, CLARIX CORD 1K allows for optimal sizing without waste, and is ready to apply straight from the refrigerator.

Background

Complex urinary fistulas offer some of the most challenging urological indications to treat and manage1 | Figure 1. Furthermore, those resulting from radiation therapy are even more difficult reconstructions and often have concurrent issues of continence and strictures2,3. Therefore, the opportunity for adjunctive technologies offering enhanced repair and healing is tremendous. This case study describes the use of cryopreserved umbilical cord to enhance the healing environment and act as an adhesion barrier.

Technology

Placental tissues, which consist of Umbilical Cord and Amniotic Membrane have been proven to exhibit innate regenerative properties that can be preserved and transplanted to adult environments. As the first commercially available human Umbilical Cord technology, CLARIX CORD 1K tissue delivers more critical biology than Amniotic Membrane alone in the form of growth factors, cytokines and the critical signaling complex – HC-HA/PTX3 | Figure 2. The biological components of CLARIX CORD 1K have been shown to minimize post-surgical scarring and adhesions by orchestrating a regenerative environment conducive to restorative healing through:

CLARIX CORD 1K comprises key biological components found only in amniotic tissue that have anti-scarring capabilities. Observed in research as the suppression of TGFβ to fibroblast signaling, myofibroblastic scar production is directly deterred by cryopreserved amniotic matrices4.

FIGURE 1:Common urological fistulae

FIGURE 2.CLARIX CORD 1K.

FIGURE 3:CT scan showing voided bladder indicating leakage of contrast.

FIGURE 4:CLARIX CORD 1K applied to the anastomosis.

CONCLUSION

Clinical History

62-year old female with significant medical history of endometrial cancer treated with neoadjuvant radiation therapy and robot assisted total hysterectomy with bilateral salpingo-oophorectomy. Patient presented to urologist with continuous urinary leakage. CT scan revealed a large right uretero-vaginal fistula | Figure 3.

Procedure

The bladder was mobilized and the distal portion of the right ureter was transected enabling the removal of the fistula connection. The right ureter was then prepared for re-implantation. A double J stent was placed, and the vesico-ureteral anastomosis was completed. Following the repair, CLARIX CORD 1K graft was placed posteriorly as well as circumferentially wrapped around the anastomotic site to promote healing and limit fibrotic invasion | Figure 4.

EDU-CS-41 Rev A

Following the procedure, patient was discharged after two nights in the hospital. Eight days post-op, a cystogram was obtained and showed no extravasation therefore, the foley catheter was removed. At the 6 months follow-up, the patient was well healed and satisfied.

1.Brandes, SB Clinical Urology. (2013) p 351-371. 2.Hodges AM. Br J Obstet Gynaecol. 1999 Nov. 106(11):1227-8. 3.Kim JH, Moore C, Jones JS, et al. Int Urogynecol J Pelvic Floor Dysfunct. 2006 Sep. 17(5):531-5. 4.Tseng et al. Journal of Cellular Physiology (1999) Vol 179, p 325-335 5.He et al. J Biol Chem (2009) 284:20136-46 6.He et al. J Biol Chem (2013) 288:25792-803 7.Cooke et al. J Wound Care (2014) 23:465-74, 476

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CASE STUDY:Uretero-Vaginal Fistula ReconstructionMUTAHAR AHMED, MD NEW JERSEY CENTER FOR PROSTATE CANCER IN UROLOGY | HACKENSACK, NJ