Predictors of Rectourethral Fistula Formation After Primary Whole-Gland Cryoablation for Prostate Cancer: Results from the Cryo On-Line Database Registry

Alireza Aminsharifi, Thomas J. Polascik, Ariel Schulman, Kae Jack Tay, Ghalib Jibara, Christina Sze, Efrat Tsivian, Ahmed Elshafei, J. Stephen Jones

To define the incidence and risk factors associated with rectourethral fistula (RUF) formation following primary whole-gland cryosurgery using a multicenter, centralized registry. The Cryo On-Line Data (COLD) registry was queried for men undergoing primary whole-gland cryotherapy between 1990 and 2014 who developed a RUF. Patient factors and disease parameters were correlated with RUF using Chi-square test and the t-test. Variables with P<0.25 were entered into a binary logistic regression with stepwise backward elimination to determine the factors associated with RUF formation. A total of 4,102 men underwent primary whole-gland cryotherapy, in the COLD registry at the time of analysis. Postoperative RUF was documented in 50 out of 4102 cases (1.21%). Patients with RUF had similar demographic data, prostate volume, preoperative prostate-specific antigen level and clinical stage in comparison to those without fistula. On both univariate and multivariate analyses, postoperative urinary retention (OR: 6.30; 95% CI 3.43-11.58, P<0.001), preoperative Gleason score of ≥7 (OR: 1.92; 95% CI 1.08-3.43, P=0.027) and preoperative incontinence (OR: 2.95, 95% CI 1.12-7.76, P=0.028) were the most signifiant risk factors associated with RUF formation. Primary whole-gland cryotherapy for prostate cancer is associated with a historically low rate (1.21%) of postoperative RUF formation. The rate decreased further to 0.55% over the last several years, suggesting better patient selection and technical improvement. Postoperative urinary retention, Gleason score > 7 and preoperative urinary incontinence were the key demographic, clinical and pathological features associated with RUF formation in this study.