Category: Clinical Stones: Ureteroscopy

MP24-10 - Boston Scientific Navigator HD™ vs. Cook Flexor™ Ureteral Access Sheath insertion: A Prospective, Randomized Trial

Sun, Sep 23
10:00 AM - 12:00 PM

Introduction & Objective : To evaluate and compare the functional characteristics, safety profile and effectiveness of two commonly used ureteral access sheaths (UAS), the Boston Scientific Navigator HD and the Cook Flexor during flexible ureteroscopy.  


Methods :

After IRB approval, patients were enrolled in a prospective, randomized, clinical trial, between February 2017 and November 2017. Inclusion criteria were proximal ureteral and kidney stones requiring flexible ureteroscopy and UAS. Primary outcome observed is intraoperative complications. Secondary outcomes are the difficulty of UAS placement, length of procedure (LOP), post-operative complications, patient-reported complaints/phone calls/ED visits, postoperative hydronephrosis. All data were prospectively obtained and analyzed. Statistical analysis was performed using the appropriate methods. 


Results : Forty patients were enrolled in the study at the time of submission, sheath size was 12/14 FR in both cohorts, 20 patients in group (A) who had Boston Navigator HD, versus 16 patients in group (B) who had Cook Flexor. Four patients were excluded from the study since ureteral access sheaths were not used or did not proceed with surgery. All statistics were performed using the Fisher’s exact test or the Wilcoxon-Mann-Whitney test. Patients' demographics were comparable with no statistical significance between both cohorts. Laterality of stones: 10 bilateral, 7 rights, and 19 left. Mean stone size was 7.3 mm group (A) and 6.9 mm group (B) in both cohorts (p=0.59). Pre-stented patients were noted in 12 patients in group (A) vs. 7 in group (B) (p=0.33). No failure of insertion in both cohorts. Subjective resistance with insertion of the UAS was observed in 5 patients (A) vs. 4 patients (B) (p=1.0). Intraoperative ureteral injury was noted in 5 patients (A) vs. 4 patients (B) (p=1.0). Mean procedure time was 69 minutes (A) vs. 71.5 minutes (B) (p=0.67). Mean anesthesia time was 122 minutes (A) vs 115 minutes (B) (p=0.62). Post-operative pain requiring a phone call or a visit to the clinic was seen in 3 patients (A) vs. 2 patients (B) (p=0.15). Return to the ED was encountered in 1 patient (A) vs. 1 patient (B) (p=0.51). Temporary postoperative hydronephrosis was seen in one patient in each cohort (p=0.87). 


Conclusions : Both UAS were comparable regarding safety and efficacy in our preliminary data. There is no statistical significance between both cohorts. However, given the small cohort size, this ongoing clinical trial will require more patients before any final conclusions are made. 

Marawan M. El Tayeb

Assistant Professor
Baylor Scott and White Health
Temple, Texas

Kim H. Thai

Resident Physician
Baylor Scott and White Health
Temple, Texas

Amr Elmekresh

Research assistant
Temple, Texas

Kristofer R. Wagner

Baylor Scott and White Health
Temple, Texas

Belur Patel


Temple, Texas

Patrick Lowry

Urologist
Texas A&M University/Scott & White Memorial hospital
Temple, Texas