Four years of real-world sexual function outcomes after Rezum therapy in men with and without baseline erectile dysfunction.

BACKGROUND: Rezum alleviates lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH) while preserving sexual function, but long-term sexual function outcomes are lacking in patients with baseline erectile dysfunction (ED). AIM: The study sought to analyze 4 years of real-world sexual function outcomes of Rezum using the International Index of Erectile Function (IIEF) questionnaire, stratified by baseline ED status. METHODS: Participants included multiethnic Rezum-treated patients from a single outpatient office. IIEF domains and BPH medication usage were compared at baseline and 6, 12, and 48 months using t tests, Mann-Whitney U tests, chi-square tests, and Wilcoxon signed rank tests. OUTCOMES: Primary outcomes over 4 years included the IIEF functional domains (erectile function [EF], orgasmic function [OF], sexual desire [SD], intercourse satisfaction [IS], overall satisfaction [OS]) and BPH medication usage. RESULTS: A total of 91 patients were included: 40 (44%) in the ED cohort and 51 (56%) in the no ED cohort. History of diabetes was more prevalent in the ED cohort (35% vs 15.7%; P = .048). Baseline scores in the EF, OF, IS, and OS domains were lower in the ED cohort. Compared with baseline, there were no significant changes in any IIEF domains in either cohort at 6 months. At 12 months, the ED cohort had significant percent decreases in OF (-25%; P = .02), SD (-22.2%; P = .04), and OS (-33.3%; P = .004); the no ED cohort had a significant percent increase in EF (5%; P = .04). At 48 months, the no ED cohort had no significant changes in any IIEF domains, while the ED cohort had significant percent increases in EF (30%; P = .01), SD (22.5%; P = .02), IS (20%; P = .01), and OS (58.3%; P = .008). Both cohorts significantly discontinued BPH medications at all follow-ups. At 48 months, there were no cases of de novo ED in the no ED cohort. CLINICAL IMPLICATIONS: As modern BPH therapies continue to demonstrate efficacy in alleviating lower urinary tract symptoms, the preservation or improvement of sexual function emerges as an increasingly important consideration for patients, with our study suggesting Rezum as a compelling option. STRENGTHS AND LIMITATIONS: Our study has the strength of long-term Rezum outcomes in an ethnically diverse patient population, stratified by the presence of baseline ED, but is limited by retrospective design, single-center nature, and small sample sizes at long-term follow-ups. CONCLUSION: Rezum preserved long-term sexual function in patients without baseline ED and improved sexual function in those with baseline ED; however, individuals with ED may experience temporary decreases in sexual function at 12 months.

Rezum water vapor therapy for patients with mild, moderate, or severe lower urinary tract symptoms: A retrospective study in a multiethnic population.

BACKGROUND: The Rezum System (Rezum) represents a novel, minimally invasive surgical therapy used to treat lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). We evaluated the safety and efficacy of Rezum in patients with mild, moderate, or severe LUTS. METHODS: A single office, retrospective study was conducted on patients from a multiethnic population treated with Rezum between 2017 and 2019. Patients were categorized into three cohorts based on baseline International Prostate Symptom Score (IPSS) LUTS severity: mild LUTS (IPSS ≤ 7), moderate LUTS (IPSS 8-19), or severe LUTS (IPSS ≥ 20) cohorts. Outcome measures, including IPSS, quality of life (QoL), maximum urinary flow rate (Qmax), postvoid residual (PVR), BPH medication usage, and adverse events (AEs) were collected and analyzed at baseline, 1-, 3-, 6-, and/or 12-months postoperatively. RESULTS: A total of 238 patients were included: 33 with mild LUTS, 109 with moderate LUTS, and 96 with severe LUTS. At 1-month follow-up, the moderate and severe LUTS cohorts saw significant improvements in IPSS (moderate LUTS: -3.0 [-6.0, 1.5], p < 0.001; severe LUTS: -10.0 [-16.0, -5.0], p < 0.001) and QoL (moderate LUTS: -1.0 [-3.0, 0.0], p < 0.001; severe LUTS: -1.0 [-3.0, 0.0], p < 0.001) and improvements remained durable up to 12-months (p < 0.001). The mild LUTS cohort saw significant worsening in IPSS by 2.0 (0.0, 12.0) at 1-month (p = 0.002) but returned to baseline at 3-months (p = 0.114). However, the mild LUTS cohort experienced significant improvements in QoL by -0.5 (-3.0, 0.0) at 3-months (p = 0.035) and nocturia by 0.0 (-1.0, 0.0) at 6-months (p = 0.002), both of which remained durable to 12-months (p < 0.05). Most AEs were transient and nonserious, with gross hematuria (66.5%) being most common. There were no significant differences in QoL point reduction, Qmax improvement, PVR reduction, and AE occurrence between the cohorts at 12-months (p > 0.05). At 12-months, 80.0%, 87.5%, and 66.0% of the patients in the mild, moderate, and severe LUTS cohorts discontinued their BPH medications, respectively. CONCLUSIONS: Rezum provides rapid and durable relief in LUTS in patients with moderate or severe LUTS and can be offered to patients with mild LUTS who have bothersome nocturia and wish to discontinue their BPH medications.

Real-world evidence with The Rezum System: A retrospective study and comparative analysis on the efficacy and safety of 12 month outcomes across a broad range of prostate volumes.

BACKGROUND: To provide 12-month unbiased outcomes with The Rezum System (Rezum), a convective water vapor thermal therapy for patients with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). Results from this retrospective, real-world evidence (RWE) study were compared to those of previous studies with the aim to evaluate the device's safety and efficacy in a real-world patient population. METHODS: Patients 45 years or older with an International Prostate Symptom Score (IPSS) score ≥8, prostate volume (PV) between 20cc and 120cc, who were 12 months posttreatment, and had at least one follow-up were included. Patients were broken into groups based on baseline PV; 30-80cc, <30cc, and >80cc. IPSS, PV, quality of life (QoL), maximum urinary flow rate (Qmax), adverse events (AE), postvoid residual, prostate-specific antigen, BPH medication usage, and International Index of Erectile Function were collected and analyzed at baseline, 1, 3, 6, and/or 12 months. RESULTS: A total of 179 patients were included in a retrospective study. IPSS, QoL, and Qmax significantly improved at follow-up time points (p < .05). There were no significant differences at 12 months in IPSS and QoL point reduction or Qmax improvement between the previous studies and any of the RWE groups. BPH medication reduction was seen at 3 months and remained durable up to 12 months. When compared to previous studies, the RWE study had similar rates of urinary retention, urinary tract infection, and dysuria but significantly higher rates of hematuria for the 30-80cc (71.7%), <30cc (58.8%), and >80cc (80.0%) groups (p < .001). CONCLUSIONS: The RWE study shows rapid and durable relief in LUTS, consistent with that observed in literature. Although Rezum had a reasonably acceptable AEs profile, patients should be counseled preoperatively for AEs. As a first line therapy, Rezum is an attractive option for men with BPH irrespective of their prostate size.

Long-Term Water Vapor Thermal Therapy Outcomes Across a Broad Range of Prostate Volumes.

INTRODUCTION: Water vapor thermal therapy (WVTT) is a minimally invasive therapy designed to treat lower urinary tract symptoms associated with benign prostatic hyperplasia. Long-term outcomes with large (>80 cc) and small (<30 cc) prostate volumes (PVs) remain limited. We report 48-month outcomes for a multiethnic cohort of WVTT-treated men, stratified by PV. METHODS: In this single-center retrospective study, patients were stratified by PV: < 30 cc, 30 to 80 cc, or > 80 cc. Outcome measures, including International Prostate Symptom Score, quality of life, International Index of Erectile Function, medication usage, and adverse events, were analyzed at baseline and at 1-, 3-, 6-, 12-, 24-, 36-, and/or 48-month follow-up. RESULTS: Two hundred fifty-two patients met inclusion; 35 (13.9%) had PVs < 30 cc, 196 (77.8%) had PVs 30 to 80 cc, and 21 (8.3%) had PVs > 80 cc. Most patients were Asian (33.7%) or non-Hispanic Black (29.4%). International Prostate Symptom Score and quality of life improved in all cohorts from baseline at all follow-ups (all P < .05), with no differences between cohorts. International Index of Erectile Function-Orgasmic Function and -Erectile Function domains improved in 30 to 80 cc patients at 48 months. Alpha blocker and/or 5-alpha reductase inhibitor usage decreased at all follow-ups in < 30 cc and 30 to 80 cc patients and remained durable to only 6 months for > 80 cc patients. No significant differences in adverse events or reoperation rates were observed between cohorts. CONCLUSIONS: Our study suggests WVTT to be efficacious, durable, and safe in managing lower urinary tract symptoms across PVs, although PV > 80 cc patients may require benign prostatic hyperplasia medication at long-term follow-up. Further research is desired to clarify WVTT's role regarding sexual function and in treating men with larger PVs.

Predictors of achieving a minimal clinically important difference in lower urinary tract symptoms 3 months after Rezum therapy.

Introduction: Gaining insight into patient characteristics to predict the success of procedures is crucial for improving outcomes and for preoperative counselling. We identified predictors of achieving a minimal clinically important difference (MCID) in lower urinary tract symptoms (LUTS) 3 months after Rezum. Material and methods: A retrospective study was conducted on patients treated with Rezum. Patients with moderate or severe LUTS and a recorded International Prostate Symptom Score (IPSS) at 3 months were included and categorised into 2 cohorts based on experiencing a MCID at 3 months (≥ 25% improvement in IPSS). Predictors were identified through multivariate logistic regression analysis. Results: Out of 174 patients, 134 (77%) achieved a MCID at 3 months, and those who did had a higher median baseline IPSS (20 [16-26] vs 15 [10-21], P <0.001) and were more likely to have severe LUTS at baseline (53.0% vs 35.0%, P = 0.046) when compared to those who did not experience a MCID at 3 months. Higher baseline IPSS (OR: 1.10, 95% CI 1.04-1.17) and larger baseline prostate volumes (OR: 1.03, 95% CI 1.0-1.05) were predictors of achieving a MCID at 3 months. More specifically, a significantly greater proportion of patients with severe LUTS (83.5 vs 70.8%, P = 0.046) and prostate volume ≥60 cc (94.6 vs 71.4%, P = 0.003) achieved MCID at 3 months when compared to patients with moderate LUTS and prostate volumes <60 cc, respectively. Conclusions: More than three-quarters of patients treated with Rezum achieved a MCID at 3 months. Patients with severe LUTS and prostate volumes ≥ 60 cc may be optimal candidates for experiencing early relief in LUTS following Rezum.

Real-world four-year functional and surgical outcomes of Rezum therapy in younger versus elderly men.

BACKGROUND: Management of urinary symptoms in elderly patients with benign prostatic hyperplasia (BPH) is complex given challenges with medications and invasive surgeries. Rezum, a minimally invasive water vapor therapy, is an emerging alternative. We compare real-world Rezum outcomes between young and elderly patients over 4 years. METHODS: We retrospectively analyzed a multiethnic population treated with Rezum at a single center between 2017-2019. Patients were stratified into young (<65 years) or elderly (≥65 years) cohorts. International Prostate Symptom Score (IPSS), Quality of Life (QoL), maximum urinary flow rate (Qmax), decisional regret scores, and adverse events (AEs) were assessed at baseline, 1-, 3-, 6-, 12-, and/or 48-months. Descriptive statistics were compared using t-tests, Chi-squared, or Mann-Whitney U tests. Changes in outcomes were assessed using Wilcoxon signed-rank tests, stratified by age. RESULTS: 256 patients - 146 (57%) young and 110 (43%) elderly - were included. The majority were Asian (33.2%) or non-Hispanic Black (28.9%). Significant improvements were observed in the combined cohort at 4-years in IPSS, QoL, and Qmax when compared to baseline (all p < 0.05). Between the age cohorts, there were no significant differences in IPSS, QoL, or Qmax at any follow-up. Within both cohorts, significant improvements in IPSS and QoL were found from baseline to all follow-ups. In the young cohort, Qmax was significantly improved from baseline to all follow-ups while in the elderly cohort, this was observed only at the 3-month follow-up. No significant differences in AEs or regret was found between cohorts. There was no significant difference in 4-year surgical retreatment rates between cohorts (elderly 4.0% vs young 4.4%, p = 0.86). CONCLUSIONS: There were no significant differences in IPSS, QoL, or AEs between elderly and younger men over 4 years following Rezum, suggesting comparable benefits and risks. Future research is warranted to clarify the impact of Rezum on Qmax in elderly men.

Rezum Outcomes in Relationship to Number of Injections: Is Less More?

Objectives: To assess efficacy and safety outcomes in relationship to the number of injections given during Rezum treatment. Methods: A retrospective study was conducted on patients with moderate to severe lower urinary tract symptoms (LUTS) treated with Rezum. Patients were stratified into cohorts based on the number of injections received per lateral prostatic lobe: 1, 2, 3, or 4 injections. International Prostate Symptom Score (IPSS), quality of life (QoL), maximum urinary flow rate (Qmax), postvoid residual (PVR), International Index of Erectile Function (IIEF)-Erectile Function, IIEF-Orgasmic Function, and adverse events were collected at baseline, 1, 3, 6, and/or 12 months postoperatively. Results: A total of 179 patients were included: 58, 91, 22, and 8 patients in the 1, 2, 3, and 4 injections cohorts, respectively. Baseline demographics significantly different across cohorts were age, history of urinary retention, prostate-specific antigen, prostate volume, prostatic urethral length, and presence of median lobe. At 3 months, all cohorts reported significant improvements in IPSS and QoL, which remained durable to 12 months. There were no significant differences in changes in IPSS, QoL, PVR, and IIEF-Erectile and Orgasmic Function between the cohorts at any follow-up. Multiple linear regression showed that the number of injections did not predict changes in IPSS, QoL, PVR, and IIEF-Erectile and Orgasmic Function at any follow-up (p > 0.05) but predicted change in Qmax at 3 months (ß = 5.7, p = 0.019). Multiple logistic regression showed that for each additional injection, the odds of gross hematuria, penile burning, penile pain, and dysuria increased by 3.8, 2.6, 2.2, and 3.0, respectively. Conclusions: Utilizing less injections represents a safe treatment strategy without compromising Rezum's efficacy in providing durable relief in LUTS.

Risk Factors and Real-World Short-Term Outcomes of a Failed Trial of Void After Rezum Therapy in a Multiethnic Population.

Background: Postoperative urinary retention is a common complication following surgery for benign prostatic hyperplasia. We aimed to identify risk factors for a failed trial of void (TOV) following treatment with the Rezum system and assess the impact of a failed TOV on short-term outcomes. Methods: A single-office retrospective study was conducted on patients treated with Rezum therapy between 2017 and 2019. A urinary catheter was placed in all patients following Rezum therapy. Demographic data and outcome measures, including the International Prostate Symptom Score (IPSS), quality of life (QoL), maximum urinary flow rate (Qmax), postvoid residual (PVR), and adverse events, were analyzed at baseline and 1, 3, and/or 6 months postoperatively. Risk factors were identified through multivariate logistic regression analysis. Results: A total of 289 patients were included. Thirty-five patients (12.1%) failed a TOV, while 254 (87.9%) had an effective TOV. All patients were given a TOV after a median of 5 days (4-5). Those who failed the TOV spent an additional mean of 13.7 ± 13.3 days with a catheter. Patients who failed the TOV were more likely to get a urinary tract infection compared with those who had an effective TOV (20.0% vs 4.7%, p < 0.001). All patients experienced significant improvements in IPSS, QoL, and Qmax at 1, 3, and/or 6 months. On multivariate analysis, a high baseline PVR was the only independent predictor of a failed TOV (odds ratio: 1.01, 95% confidence interval 1.00-1.01). A greater proportion of patients with a baseline PVR >200 mL failed the TOV (40.0%) compared with patients with a baseline PVR <200 mL (10.9%, p = 0.008). Conclusions: Approximately one in eight patients failed the TOV following Rezum therapy. Baseline PVR was the only independent risk factor for a failed TOV. Nevertheless, all patients experienced significant relief of urinary symptoms. Patients with high baseline PVR, particularly >200 mL, may require a catheter for an extended duration.