ABSTRACT
OBJECTIVE: To explore the optimal timing for placing an artificial urinary sphincter (AUS) postradiation therapy (RT). METHODS: A bi-institutional retrospective review of all patients who underwent their first (virgin) AUS placement after pelvic RT between January 1, 2011 and July 1, 2023. To determine the optimal timeline for device implantation 2-5years post-RT, we compared hazard ratios for device revision/explantation (Rev/Exp) using Kaplan-Meier curves for each year (earlier vs later than 2/3/4/5 years post-RT). The Pearson correlation coefficient identified trends in Rev/Exp reasons (erosion/infection vs other). RESULTS: Seventy-two patients met our inclusion criteria with a median age of 65.5years (interquartile range 70-81.25). Fifteen (20.8%) had undergone one or more previous urethral or bladder neck interventions (urethroplasty in 1 [1.4%], internal urethrotomy in 7 [9.7%], and bladder neck incision in 9 [12.5%]). After a median follow-up of 57.5months (interquartile range 13-107), a total of 36 (50%) devices were Rev/Exp, with mechanical failure in 14 (19.4%) and device erosion in 12 (16.7%) being the main reasons. Device survival analysis revealed no significant difference in the risk of device Rev/Exp when implanted earlier vs later than 2, 3, 4, or 5years post-RT, with P-values of .3, .3, .4, and .4, respectively. A constant trend toward higher infection/erosion rates as indication for device Rev/Exp the later the insertion was noticed: R2 = 0.98. CONCLUSION: Despite a small sample size, our study indicates that implanting an AUS within 5 years after RT shows comparable device lifespan. However, later insertions may have higher removal rates due to erosion/infection. CLINICAL TRIAL REGISTRATION: Not applicable.
ABSTRACT
PURPOSE: To compare the lifespan of first transcorporal cuff (TC) placement of an artificial urinary sphincter (AUS) versus standard placement (SP) in patients with prior radiotherapy (RT) for prostate cancer (PCa). METHODS: We reviewed first (virgin) AUS placements from two high-volume care centers between 1/2011 and 1/2021, including PCa patients with RT history. AUS lifespan was assessed via the hazard ratio of device explantation and/or revision within a ten-year timeframe for the TC vs. SP approaches. Chi-square, Fisher's exact, and t-tests compared clinicodemographic variables. Kaplan-Meier curve compared TC and SP lifespan. RESULTS: 85/314 men with AUS met inclusion criteria, with 38.8% (33/85) in the TC group and 61.2% (52/85) in the SP group. Median ages were 69.8 (IQR = 65.2-73.6) and 67.1 (61.6-72.9), respectively, p = 0.17. Over a median follow up of 51.9 (15.8-86.1) and 80.4 (28.1-128.3) months for the TC and SP, overall, 12 (36.4%) TC devices were removed (four [12.1%] due to mechanical failures; eight [24.2%] erosions, and two [6.1%] infections) vs. 29 (55.8%) in the SP group (14 [26.9%] mechanical failures; 11 [21.1%] erosions, and five [9.6%] infections). No statistically significant differences were observed between the two approaches, with HR = 0.717, 95% CI 0.37-1.44, p = 0.35. The calculated device survival probabilities for the TC vs. SP at one, five, and 10 years were 78.8% vs. 76.9%, 69.3% vs. 58.7%, and 62.1% vs. 46.7%, respectively. CONCLUSIONS: TC cuff insertion for the first AUS implantation in pre-radiated patients showed to be comparable to SP when it comes to device survival, with comparable complication rates. Current guidance for approach selection is primarily based on patient selection and surgeon preference.