madman
Super Moderator
Introduction
Lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) is often initially treated with medical therapy, an approach marked by high non-adherence rates; minimally invasive surgical therapies(MISTs) like the Prostatic Urethral Lift (PUL) offer a favorable safety profile, superior early patient experience compared to TURP, durable symptom relief, and better bladder health preservation compared to watchful waiting or alpha blocker therapy. The IMPACT RCT compares efficacy and patient experience outcomes for subjects treated with PUL ormedical therapy; this analysis includes preliminary data through 3 months.
Methods
The IMPACT RCT is a prospective, two-arm, multicenter 1:1 study comparing efficacy, safety, and patient experience in BPH patients treated with PUL or medication (tamsulosin 0.4 mg daily). The primary endpoint was change in BPH symptom score (IPSS) at 3 months; additional endpoints included QoL, satisfaction, goal achievement, sexualfunction, adverse events, and medication adherence. Key outcomes to date are included in this preliminary analysis
Results
Preliminary analysis included 88 PUL and 112 medication subjects. Treatment group baseline demographics were similar (i.e., IPSS, QoL, Qmax, prostate volume, PSA, MSHQ, IIEF). IPSS improvements were greater for PUL subjects (39.1% and 46.8% at 1 and 3 months, respectively) compared to medication (16.9% and 14.2%). PUL patient QoL improved by 39.3% and 47.9% at 1 and 3 months compared to 10.2% and 7.8% for subjects on medication (Table 1). Compared to medication, PUL subject experienced greater improvements in sexual function (erectile and ejaculatory function, ejaculatory bother). PUL PPSM scores at 1 and 3 months were more positive than medication. Baseline treatment goals were similar between groups; highly-rated goals and overall goal achievement were higher for PUL than medication at 1 and 3 months.
Conclusion
IMPACT is the largest head-to-head RCT comparing any MIST to medication in the treatment of BPH associated LUTS. PUL appears to offer greater symptom and quality-of-life improvements, as well as patient satisfaction with treatment compared to medical therapy.
Lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) is often initially treated with medical therapy, an approach marked by high non-adherence rates; minimally invasive surgical therapies(MISTs) like the Prostatic Urethral Lift (PUL) offer a favorable safety profile, superior early patient experience compared to TURP, durable symptom relief, and better bladder health preservation compared to watchful waiting or alpha blocker therapy. The IMPACT RCT compares efficacy and patient experience outcomes for subjects treated with PUL ormedical therapy; this analysis includes preliminary data through 3 months.
Methods
The IMPACT RCT is a prospective, two-arm, multicenter 1:1 study comparing efficacy, safety, and patient experience in BPH patients treated with PUL or medication (tamsulosin 0.4 mg daily). The primary endpoint was change in BPH symptom score (IPSS) at 3 months; additional endpoints included QoL, satisfaction, goal achievement, sexualfunction, adverse events, and medication adherence. Key outcomes to date are included in this preliminary analysis
Results
Preliminary analysis included 88 PUL and 112 medication subjects. Treatment group baseline demographics were similar (i.e., IPSS, QoL, Qmax, prostate volume, PSA, MSHQ, IIEF). IPSS improvements were greater for PUL subjects (39.1% and 46.8% at 1 and 3 months, respectively) compared to medication (16.9% and 14.2%). PUL patient QoL improved by 39.3% and 47.9% at 1 and 3 months compared to 10.2% and 7.8% for subjects on medication (Table 1). Compared to medication, PUL subject experienced greater improvements in sexual function (erectile and ejaculatory function, ejaculatory bother). PUL PPSM scores at 1 and 3 months were more positive than medication. Baseline treatment goals were similar between groups; highly-rated goals and overall goal achievement were higher for PUL than medication at 1 and 3 months.
Conclusion
IMPACT is the largest head-to-head RCT comparing any MIST to medication in the treatment of BPH associated LUTS. PUL appears to offer greater symptom and quality-of-life improvements, as well as patient satisfaction with treatment compared to medical therapy.
