Treatment durability is an important element for urologists and patients when considering optimal treatments for BPH, including minimally invasive therapies. Five-year durability of the minimally invasive UroLift PUL system has been demonstrated in the LIFT pivotal trial, and real-world data has revealed favorable outcomes in various BPH populations. Here, we present results from an analysis evaluating how baseline characteristics corresponded to PUL durability in the real world.

The international Real-World Retrospective (RWR) database consists of 3,226 PUL subjects, 2,714 of which who were not in urinary retention at baseline. A successful response for these non-retention subjects is defined as a lack of subsequent BPH surgery through the point at which 90% of the population was censored or follow up data was no longer available. The likelihood of success for real-world subjects was calculated by evaluating uni- and multivariate predictive assessments for baseline parameters including age, comorbidities, medical history and markers of BPH disease severity (e.g. IPSS, QoL, Qmax). Univariate predictive assessments were conducted for subjects from the pivotal LIFT trial (LIFT, n=140). A stepwise selection procedure was used to determine which predictors to include in the multivariate logistic regression model used for the overall RWR group. An odds ratio > 1 indicated a higher probability of intervention for failure to cure with increased values of the covariate.

Durability of PUL was not influenced by patients’ baseline characteristics of age, duration of LUTS prior to PUL, or the presence of comorbidities or medical conditions at baseline (e.g. diabetes, incontinence, obstructive median lobe). There was a significantly higher likelihood of retreatment for subjects with higher IPSS and subjects with higher QoL at baseline in both the overall RWR population and in LIFT patients. Having a prostate volume of >100cc (only applicable to the RWR group) was not a predictor of retreatment. Lower Qmax was a predictor in the LIFT group only. Odds ratios for all significant predictors were close to 1 – the highest magnitude odds ratio for significant predictors was for QoL with a ratio of 1.2. When QoL was entered into a multivariate model, no other baseline covariates added significantly to the prediction, and a stepwise selection procedure selected baseline QoL as more predictive than baseline IPSS. Based on the density of available data, the analysis included 1070 days of follow-up, during which time 158 patients were retreated.

Of the many baseline covariates analyzed for potential predictive value for a surgical retreatment after PUL, only IPSS and QoL were identified as significant predictors. According to this analysis, this indicates that a patient undergoing PUL with any of the baseline characteristics investigated, apart from elevated IPSS or QoL, would not necessarily be at increased risk of incurring a surgical retreatment. As elevated values of IPSS and QoL were identified as significant predictors of retreatment after PUL, this suggests that patients with more severe symptoms at baseline may have a slightly higher probability of undergoing a subsequent surgical retreatment after PUL. Significant predictors were similar between RWR and LIFT populations.

The only baseline characteristics found to be possible predictors of retreatment following PUL were IPSS and QoL, suggesting that a patient with a more severe disease state at baseline may have an elevated likelihood of subsequent BPH surgery. Urologists may utilize these findings as support for improving patient selection and to discuss BPH interventions with patients earlier in the disease process.