Rezum induces durable surgical, sexual function outcomes in men with BPH

Utilizing the Rezum system led to preserved and/or improved sexual function and better lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) at 4 years after surgery, irrespective of erectile dysfunction (ED) and prostate volume (PV), according to 4-year, real-world analyses presented at the 24th Annual Fall Scientific Meeting of the Sexual Medicine Society of North America.^1-2

Previously, studies have shown that Rezum is effective in the alleviation of LUTS that is secondary to BPH, while preserving sexual function; however, long-term, real-world outcomes are limited among those with baseline ED who underwent surgery with the Rezum system. Therefore, the investigators retrospectively compared 4-year sexual function outcomes following treatment with Rezum among men with and without baseline ED.

The Rezum system–a minimally-invasive transurethral water vapor therapy that utilizes connective thermal energy to remove obstructive prostatic tissue–is currently indicated for men 50 years of age or older with a PV between 30 cc and 80 cc.

Sexual function

Among patients with ED, all functional domains across the International Index of Erectile Function (IIEF) domains (erectile function, orgasm function, sexual desire, intercourse satisfaction, and overall satisfaction), compared with baseline, remained preserved at 6 months post-surgery.¹ Orgasmic function (P = .02), sexual desire (P = .04), and overall satisfaction (P = .004) among men decreased at 12 months after the procedure, while erectile function and intercourse satisfaction were preserved. At 48 months, erectile function (P = .01), sexual desire (P = .02), intercourse satisfaction (P = .01), and overall satisfaction (P = .008) were improved, while orgasmic function was preserved following the procedure with Rezum.

Among patients without ED, investigators only found 1 significant finding: improved erectile function at 12 months (P = .04), compared with baseline. All other domains remained preserved across each of the follow-up time points.

“At long-term, Rezum preserved sexual function in patients with no baseline ED and improved sexual function in patients with baseline ED,” the study authors wrote. “However, patients with baseline ED may experience temporary decreases in sexual function at 12 months postoperatively.”

According to the study authors, BPH–which could lead to the development of LUTS and increases in prevalence and severity with age–affects nearly 70% of men between the ages of 60 to 69, and nearly 80% among those over 70 years. “Recent literature has shown that erectile dysfunction has been linked to LUTS/BPH, suggesting that patients with BPH or LUTS easily develop ED, and that LUTS/BPH symptoms often coexist with ED,” the authors wrote in their poster.

Previously, studies have shown that Rezum is effective in the alleviation of LUTS that is secondary to BPH, while preserving sexual function; however, long-term, real-world outcomes are limited among those with baseline ED who underwent surgery with the Rezum system.

Therefore, the investigators retrospectively compared 4-year sexual function outcomes following treatment with Rezum among 91 men with (n = 51) and without (n = 40) baseline ED, who were treated at a single center between 2017 and 2019.

They assessed sexual function using the validated 15-question IIEF questionnaire. In addition, they assessed erectile function, orgasm function, sexual desire, intercourse satisfaction, and overall satisfaction at baseline, as well as 6-, 12-, and 48-months after surgery.

Overall, mean age was 62.1 years. Half of patients with ED were taking medications for their condition. Between cohorts, there were no difference in age, prostate volume, and past medical history of hypertension or dyslipidemia; however, there was a larger number of patients in the ED cohort with diabetes mellitus (35% vs 15.7%; P = .048).

At baseline, according to the IIEF domains, the median scores across all patients for erectile function, orgasm function, sexual desire, intercourse satisfaction, and overall satisfaction were 16 (range, 9-25), 7 (range, 4-9), 6 (range, 4-8), 7 (range, 3-10), and 6 (range, 4-8), respectively. For those without ED and with ED, respectively, scores were 19 (range, 13-29) vs 13 (range, 8.3-17; P = .007); 8 (range, 5-10) vs 5 (range, 4-8; P = .03); 7 (range, 5-8) vs 6 (range, 4-7.8; P = .09); 9 (range, 3-11) vs 6 (range, 3-9; P = .03); and 8 (range, 4-10) vs 4 (range, 3-6; P = .002).

“Additional larger studies are warranted to further evaluate these real-world results,” the study authors wrote in their abstract.

Prostate volume

Rezum treatment led to significant improvements in International Prostate Symptom Score (IPSS) and quality of life among men with PV 30 cc or less, 30 to 80 cc, or 80 cc and larger

from baseline across all follow-up time periods (P < .05).² Importantly, there was no significant difference between cohorts.

Maximum urinary flow rate was only improved in the cohort of patients with a PV of 30 to 80 cc from baseline to all follow-up points; however, IIEF orgasmic function decreased at 12 months in the overall cohort, while IIEF erectile function was preserved.

Lastly, BPH medication usage decreased from baseline to all follow-ups among men with PVs of 30 cc or less and 30 to 80 cc; however, in men with PVs of 80 cc and larger, this was only durable to 6 months.

Postoperative adverse events (AEs) among all 3 cohorts included urinary tract infection (3.3%), surgical reoperation (4.3%), vasovagal (1.6%), gross hematuria (65.8%), penile burning (63.3%), penile pain (36.9%), dysuria (26.4%), sloughing (24.2%), and urinary retention (12.7%). The investigators observed no significant differences in postoperative AEs or decision regret scores between the cohorts.

“Rezum effectively improved LUTS secondary to BPH, irrespective of PV, with improvements being durable over 4 years,” the study authors wrote. “However, patients with PVs [larger than 80 cc] should be counseled on the possibility of continuing their BPH medications following treatment.”

The study authors noted that large PV can be associated with a higher incidence of LUTS in men with BPH, highlighting that the marker can be an important predictor of morbidity and the need for surgical intervention in patients. While the indication for the Rezum system was based on data from a randomized-controlled trial, it excludes men with larger and smaller PVs, who may also benefit from a reduction of excess prostatic tissue.

Therefore, the investigators evaluated 4-year outcomes stratified by PV (30 cc or less [n = 13.9%], 30 to 80 cc [n = 77.8%], or 80 cc and larger [n= 8.3%]) in a multiethnic cohort of men (n = 252) treated with Rezum from 2017 to 2019.

The investigators assessed IPSS, quality of life, IIEF erectile and orgasmic function, maximum urinary flow rate, and BPH medication usage at baseline, and compared with 1-, 3-, 6-, 12-, and 48-months’ follow-up.

The median PV volume was 42.5 cc (range, 35-59). Mean age was 63.4 years, and the study was comprised of ethnicities including Asian (33.7%), non-Hispanic Black (29.4%), Hispanic (23.4%), and non-Hispanic White (13.5%). In total, 225 patients received alpha blockers and/or 5-ARI, while 14.3% had mild LUTS, 46.0% had moderate LUTS, and 39.7% had severe LUTS.

References

1. Zhu M, Babar M, Schulz A, et al. Four-Year Real-World Sexual Function Outcomes of Rezum Therapy in Patients With and Without Erectile Dysfunction. Presented at: 24th Annual Fall Scientific Meeting SMSNA; November 16-18, 2023; San Diego, CA. Abstract 209.

2. Hawks-Ladds N, Zhu M, Babar M, et al. Long-Term Surgical and Sexual Function Outcomes of Rezum Therapy Across a Broad Range of Prostate Volumes. Presented at: 24th Annual Fall Scientific Meeting SMSNA; November 16-18, 2023; San Diego, CA. Abstract 210.