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.