Preface
As the world's largest and most influential urology academic conference, the annual meeting of the American Urological Association (AUA) was held in San Antonio, USA from May 3 to 6 local time. The plenary session specially set up a Practice-changing, Paradigm-shifting (P2s) summary report session, in which the clinical studies that are about to break the pattern of clinical practice and bring breakthrough impact are displayed in a unified manner, which has attracted much attention! Yimaitong has compiled a summary of the breakthrough research on the treatment of benign prostatic hyperplasia (BPH) for you to take a look!
Results of the Phase III COURAGE trial: Efficacy and safety of vibegron in men with BPH and overactive bladder (OAB)[1]
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Background:
Current pharmacological treatment of BPH in men includes α-blockers and 5α-reductase inhibitors, however, patients treated with BPH may present with persistent OAB symptoms. Vibegron is a selective beta3 agonist approved for the treatment of OAB and is currently being investigated for the treatment of OAB in men with BPH who have been treated with medication. This report reports the efficacy and safety of Vibegron compared to placebo in male patients with persistent OAB after pharmacological treatment of BPH.
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Research Methods:
COURAGE (NCT03902080) is a phase III, multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of Vibegron (75 mg, p.o., qd) compared to placebo. Enrolled male BPH patients ≥ 45 years of age, with OAB symptoms, and who are receiving stable doses of α-blockers ± 5α-reductase inhibitors. Patients were randomized 1:1 to either Vibegron or placebo for 24 weeks. The primary endpoint is the change in the average number of urination and urgency episodes per day from baseline (CFB) to week 12. Secondary endpoints include the number of nocturia from baseline to week 12, the number of daily urge incontinence (UUI) episodes, the storage symptom score in the International Prostate Symptom Score (IPSS), and the change in urine output per void. Safety was assessed by adverse events (AEs) and standard urological assessments.
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Findings:
Of the 1105 patients randomized, 965 (87.3%) completed the full cycle of the trial, with a mean age of 67.1 years. Vibegron significantly reduced the average number of urination per day (minimum mean square error [LSMD], -0.74; p<0.0001) and the number of urinary urgency episodes (LSMD, -0.95; p<0.0001; figure 1) compared with placebo at week 12. Vibegron also significantly reduced nocturia frequency (LSMD, -0.22; p=0.0015), UUI episodes (LSMD, -0.80; p=0.0034), urinary storage symptom score in the International Prostate Symptom Score (IPSS, -0.9; p<0.0001), and significantly increased urination volume per void (LSMD, 15.07 mL; p<0.0001）。
Among patients treated with Vibegron and placebo, 45.0 percent and 39.0 percent, respectively, experienced at least one treatment-related AE, with the most common AEs (≥2 percent) including hypertension (9.0 versus 8.3 percent), COVID-19 (4.0 versus 3.1 percent), urinary tract infections (2.5 versus 2.2 percent), and hematuria (2.0 versus 2.5 percent).
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Conclusions of the study
In this phase III trial, Vibegron significantly outperformed placebo in all efficacy endpoints, with significant improvements in primary efficacy parameters observed at week 2 and maintained through week 24 with a favorable safety and tolerability profile.
Pilot analysis of the IMPACT study: minimally invasive surgery versus medical treatment of BPH-associated lower urinary tract symptoms (LUTS)[2]
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Background:
BPH and its associated LUTS are initially treated with medication or watchful waiting. However, due to low efficacy, sexual dysfunction, and adverse effects, patient adherence to medication is not high. Transurethral prostate suspension surgery (PUL) and other minimally invasive surgical treatments (MIST) provide more durable symptom relief, better patient experience, and a more favorable safety profile than transurethral resection of the prostate (TURP), while preserving bladder function better than α blockers or watchful waiting alone. This IMPACT randomized controlled trial (RCT) compared the patient experience and efficacy of the UroLift system-assisted PALL with pharmacological treatment for BPH over a three-month period.
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Research Methods:
IMPACT is a prospective, multicenter, two-arm, 1:1, unblinded RCT comparing the safety, efficacy, and patient experience of PUL or the drug (tamsulosin 0.4 mg, qd) in patients with BPH. The change in BPH symptoms (IPSS score) at 3 months was the primary endpoint, and the secondary endpoints were quality of life, achievement of treatment goals, satisfaction, sexual function, AEs, and medication adherence. This preliminary analysis reports on the key data collected to date.
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Findings:
Eighty-eight POL and 112 drug subjects were available for the initial analysis. Baseline demographic characteristics were similar between treatment groups. The improvement rates of IPSS scores at 1 and 3 months were 39.1% and 46.8%, respectively, in the PAL group, compared with 16.9% and 14.2% in the drug treatment group. Quality of life improved by 39.3% and 47.9% at 1 and 3 months, respectively, in the PUL group, while in the drug treatment group improved by 10.2% and 7.8%, respectively. The improvement in sexual function was greater in the PUL group compared to the medication group. More positive perception of treatment was reported in the PUL group at 1 and 3 months compared to the medication group. Baseline treatment goals were similar in both groups, and the overall goal achievement rate and high score rate of PUL were higher than those of drug therapy at 1 and 3 months.
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Conclusions of the study
The IMPACT study is the first head-to-head RCT to compare MIST with pharmacological treatment of BPH-related LUTS. Preliminary data suggest that PUL provides better improvements in quality of life, symptoms, and patient satisfaction.
Resources:
[1] https://www.auajournals.org/doi/10.1097/01.JU.0001015816.87470.c9.12
[2] https://www.auajournals.org/doi/10.1097/01.JU.0001015816.87470.c9.13
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