EAU 2017: Long Term (5 Year) Results From The Largest, Prospective, Randomized, Controlled Study Of The Minimally Invasive Prostatic Urethral Lift (Pul)

London, England (UroToday.com) Benign prostatic hyperplasia (BPH) is a common, age-related condition that clinically manifests as lower-urinary tract symptoms (LUTS). LUTS associated with BPH significantly increase with age, as does the need for intervention. Quality of life of patients with LUTS is significantly affected by these symptoms.
Prostatic urethral lift (PUL) is a minimally invasive procedure for the treatment of lower urinary tract symptoms secondary to BPH. The procedure may be performed under local, spinal, or general anesthesia. The PUL procedure involves the delivery of implants that retract obstructing prostate lobes. Unlike other benign prostatic hyperplasia treatment options including pharmacological therapy, and the current invasive gold-standard transurethral resection of the prostate, the PUL procedure achieves quantifiable improvements in functional outcomes and quality of life, in the absence of major adverse events.

Furthermore, improvement in LUTS may be attained while preserving erectile and ejaculatory function. Adverse effects associated with the PUL procedure are mild to moderate, and are transient in nature. The PUL procedure provides an alternative for men seeking treatment for bothersome LUTS, with fewer side-effects.

Roehrborn and colleagues performed the largest, prospective, multi-center, randomized, controlled trial on PUL to date and presented 5 year outcomes.
Between February and December of 2011, men with symptomatic LUTS secondary to benign prostatic hyperplasia (BPH) were randomized to PUL (N=140) or sham control (N=66) at 19 centers in North America and Australia. Enrollment criteria included age ≥ 50 years, IPSS (International Prostate Symptom Score) ≥ 13, peak flow rate ≤ 12 ml/s, and prostate volume 30 - 80 cc. Through 3 months, patients and assessors were kept blinded to treatment arm. Assessments for PUL subjects continued through 5 years with validated instruments including IPSS, IPSS quality of life (QoL), BPH Impact Index, Qmax, Sexual Health Inventory for Men, and Male Sexual Health Questionnaire for Ejaculatory Dysfunction.

The study demonstrated that the average symptom score improved for PUL patients by 1 month (IPSS: 44% and QoL: 42%, p<0.001) and remained improved through 5 years (IPSS: 38% and QoL: 54%, p<0.001). Peak flow rate remained improved 41% at 5 years. Adverse events such as hematuria, dysuria, pelvic pain, urgency and urge incontinence were typically mild and transient. There was no occurrence of de novo, sustained erectile or ejaculatory dysfunction. Sexual function was preserved in the PUL cohort, as assessments show stable erectile function average score and improved ejaculatory function and ejaculatory bother average scores (p<0.001).

Authors concluded that the 5 year data from the largest, longest study of the PUL procedure indicates that symptom relief and quality of life improvements can be durably sustained to 5 years. In addition, sexual function is preserved, both in terms of erection and ejaculation. The procedure can offer patients minimal morbidity with rapid, significant, durable symptom relief.

Authors: Roehrborn C., Gange S., Shore N., Giddens J., Bolton D., Cowan B., Cantwell A., McVary K., Chin P., Te A., Gholami S, Rashid P., Moseley W., Tutrone R., Freedman S, Incze P., Coffield K., Borges F., Rukstalis D.

at the #EAU17 - March 24-28, 2017- London, England