- Email: [email protected]
1077 Four year results from the largest, prospective, randomized study of prostatic urethral lift (PUL)
1077
Four year results from the largest, prospective, randomized study of prostatic urethral lift (PUL) Eur Urol Suppl 2016;15(3);e1077
Print! Print!
Roehrborn C.1 , Gange S. 2 , Shore N.3 , Giddens J. 4 , Bolton D.5 , Cowan B. 6 , Cantwell A. 7 , McVary K. 8 , Chin P. 9 , Te A. 10 , Gholami S. 11 , Rashid P. 12 , Moseley W.13 , Tutrone R.14 , Freedman S. 15 , Incze P. 16 , Coffield K. 17 , Borges F.18 , Rukstalis D.19 1 University
of Texas Southwestern Medical Center, Dept. of Urology, Dallas, United States of America, 2 Western Urological Clinic, Dept. of
Urology, Salt Lake City, United States of America, 3 Carolina Urologic Research Center, Dept. of Urology, Myrtle Beach, United States of America, 4 Jonathan Giddens Medicine Professional Corporation, Dept. of Urology, Brampton, Canada, 5 Austin Health, Dept. of Urology, Heidelberg, Australia, 6 Urology Associates of Denver, Dept. of Urology, Englewood, United States of America, 7 Advanced Urology Institute, Dept. of Urology, Daytona Beach, United States of America, 8 Southern Illinois University School of Medicine, Dept. of Urology, Springfield, United States of America, 9 Illawarra Urology, Dept. of Urology, Figtree, Australia, 10 Weill Cornell Medical Center, Dept. of Urology, New York, United States of America, 11 Urology Associates of Silicon Valley, Dept. of Urology, San Jose, United States of America, 12 Urology Centre, Dept. of Urology, Port Macquarie, Australia, 13 Genesis Research LLC, Dept. of Urology, San Diego, United States of America, 14 Chesapeake
Urology Research Associates, Dept. of Urology, Baltimore, United States of America, 15 Sheldon J. Freedman, M.D., Ltd.,
Dept. of Urology, Las Vegas, United States of America, 16 The Fe/Male Health Centres, Dept. of Urology, Oakville, Canada, 17 Scott and White Healthcare, Dept. of Urology, Temple, United States of America, 18 Pinellas Urology Inc., Dept. of Urology, St. Petersburg, United States of America, 19 Wake Forest Baptist Health, Dept. of Urology, Winston Salem, United States of America INTRODUCTION & OBJECTIVES: The Prostatic Urethral Lift (PUL) has been shown to offer rapid, durable improvement in lower urinary tract symptoms (LUTS) with minimal adverse effects. We present the preliminary 4 year results of the pivotal, multi-center, randomized, blinded trial of the Prostatic Urethral Lift. MATERIAL & METHODS: At 19 centers in North America and Australia, 206 men with symptomatic LUTS secondary to benign prostatic hyperplasia (BPH) were randomized to PUL (N=140) or sham control (N=66). Enrollment criteria included age ≥ 50 years, IPSS (International Prostate Symptom Score) ≥ 13, peak flow (Qmax) ≤ 12 ml/s, and prostate volume 30 - 80 cc. PUL procedure entailed transurethral, endoscopically guided placement of small permanent metallic implants into the lateral lobes of the prostate. The implants held the lobes in a retracted position, opened the prostatic urethra, and reduced urinary obstruction. Through 3 months, patients and assessors were kept blinded to treatment arm. Assessments for the PUL participants continued through 4 years and included IPSS, quality of life on the IPSS form (QOL), BPH Impact Index (BPH II), Qmax, Sexual Health Inventory for Men (SHIM), and Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD). RESULTS: IPSS reduction was 44% by 1 month and sustained at 46% through 4 years (p < 0.0001). Adverse events were typically mild and transient, with the most frequent types being hematuria, dysuria, pelvic pain, urgency and urge incontinence. For those subjects who have reached their 4 year follow up, 19 subjects have undergone repeat PUL or other procedure. There were no reported de novo, sustained erectile or ejaculatory adverse events. Sexual function assessments (SHIM, MSHQ-EjD) show stable erectile function average score and statistically improved ejaculatory function and ejaculatory bother average scores.
IPSS
2 Wk
N Baseline Follow-Up Change % Change 95% CI p QoL
135 22.3±5.5 18.0±7.9 -4.3 -18% -23%, -12% <0.0001
N Baseline Follow-Up Change % Change 95% CI p BPH II N Baseline Follow-Up Change % Change 95% CI p Qmax (mL/s) N Baseline Follow-Up Change % Change 95% CI p
1 Mo
3 Mo
1 Yr
4 Yr
135 22.3±5.5 12.3±6.9 -9.99 -44% -49%, -39% <0.0001
136 22.3±5.5 11.2±7.7 -11.1 -50% -55%, -44% <0.0001
123 22.1±5.6 11.5±7.3 -10.6 -47% -53%, -42% <0.0001
48 21.7±6.7 11.7±6.5 -10.1 -46% -46%, -28% <0.0001
135 4.6±1.1 2.6±1.7 -2 -42% -49%, -36% <0.0001
136 4.6±1.1 2.4±1.7 -2.2 -47% -53%, -40% <0.0001
123 4.6±1.0 2.3±1.6 -2.3 -51% -57%, -44% <0.0001
48 4.5±1.0 1.9±1.2 -2.6 -57% -65%, -50% <0.0001
135 6.9±2.8 4.0±3.1 -2.9 -33% -46%, -20% <0.0001
136 6.9±2.8 2.9±3.0 -3.99 -56% -64%, -48% <0.0001
123 6.8±2.8 2.8±2.9 -4 -57% -66%, -49% <0.0001
48 6.2±2.9 2.1±2.1 -4.1 -61% -73%, -49% <0.0001
122 8.0±2.4 12.3±5.3 4.3 64% 50% – 79% <0.0001
103 8.0±2.4 12.1±5.3 4.1 59% 43% – 74% <0.0001
37 8.4±2.4 13.1±6.3 4.7 69% 31% – 108% <0.0001
136 4.6±1.1 3.6±1.7 -1 -18% -26%, -11% <0.0001 136 6.9±2.8 7.0±3.5 0.1 29% 8% – 50% 0.0054
CONCLUSIONS: The Prostatic Urethral Lift is a solution for patients. Patients suffer from little morbidity while on average achieving rapid, clinically meaningful LUTS relief. As demonstrated with this preliminary data from the largest and longest study of the PUL procedure, the relief can be sustained to 4 years. In addition, sexual function is preserved, both in terms of erection and ejaculation. Durability will be assessed through protocol driven follow up through 5 years.
Four year results from the largest, prospective, randomized study of prostatic urethral lift (PUL) Eur Urol Suppl 2016;15(3);e1077
Print! Print!
Roehrborn C.1 , Gange S. 2 , Shore N.3 , Giddens J. 4 , Bolton D.5 , Cowan B. 6 , Cantwell A. 7 , McVary K. 8 , Chin P. 9 , Te A. 10 , Gholami S. 11 , Rashid P. 12 , Moseley W.13 , Tutrone R.14 , Freedman S. 15 , Incze P. 16 , Coffield K. 17 , Borges F.18 , Rukstalis D.19 1 University
of Texas Southwestern Medical Center, Dept. of Urology, Dallas, United States of America, 2 Western Urological Clinic, Dept. of
Urology, Salt Lake City, United States of America, 3 Carolina Urologic Research Center, Dept. of Urology, Myrtle Beach, United States of America, 4 Jonathan Giddens Medicine Professional Corporation, Dept. of Urology, Brampton, Canada, 5 Austin Health, Dept. of Urology, Heidelberg, Australia, 6 Urology Associates of Denver, Dept. of Urology, Englewood, United States of America, 7 Advanced Urology Institute, Dept. of Urology, Daytona Beach, United States of America, 8 Southern Illinois University School of Medicine, Dept. of Urology, Springfield, United States of America, 9 Illawarra Urology, Dept. of Urology, Figtree, Australia, 10 Weill Cornell Medical Center, Dept. of Urology, New York, United States of America, 11 Urology Associates of Silicon Valley, Dept. of Urology, San Jose, United States of America, 12 Urology Centre, Dept. of Urology, Port Macquarie, Australia, 13 Genesis Research LLC, Dept. of Urology, San Diego, United States of America, 14 Chesapeake
Urology Research Associates, Dept. of Urology, Baltimore, United States of America, 15 Sheldon J. Freedman, M.D., Ltd.,
Dept. of Urology, Las Vegas, United States of America, 16 The Fe/Male Health Centres, Dept. of Urology, Oakville, Canada, 17 Scott and White Healthcare, Dept. of Urology, Temple, United States of America, 18 Pinellas Urology Inc., Dept. of Urology, St. Petersburg, United States of America, 19 Wake Forest Baptist Health, Dept. of Urology, Winston Salem, United States of America INTRODUCTION & OBJECTIVES: The Prostatic Urethral Lift (PUL) has been shown to offer rapid, durable improvement in lower urinary tract symptoms (LUTS) with minimal adverse effects. We present the preliminary 4 year results of the pivotal, multi-center, randomized, blinded trial of the Prostatic Urethral Lift. MATERIAL & METHODS: At 19 centers in North America and Australia, 206 men with symptomatic LUTS secondary to benign prostatic hyperplasia (BPH) were randomized to PUL (N=140) or sham control (N=66). Enrollment criteria included age ≥ 50 years, IPSS (International Prostate Symptom Score) ≥ 13, peak flow (Qmax) ≤ 12 ml/s, and prostate volume 30 - 80 cc. PUL procedure entailed transurethral, endoscopically guided placement of small permanent metallic implants into the lateral lobes of the prostate. The implants held the lobes in a retracted position, opened the prostatic urethra, and reduced urinary obstruction. Through 3 months, patients and assessors were kept blinded to treatment arm. Assessments for the PUL participants continued through 4 years and included IPSS, quality of life on the IPSS form (QOL), BPH Impact Index (BPH II), Qmax, Sexual Health Inventory for Men (SHIM), and Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD). RESULTS: IPSS reduction was 44% by 1 month and sustained at 46% through 4 years (p < 0.0001). Adverse events were typically mild and transient, with the most frequent types being hematuria, dysuria, pelvic pain, urgency and urge incontinence. For those subjects who have reached their 4 year follow up, 19 subjects have undergone repeat PUL or other procedure. There were no reported de novo, sustained erectile or ejaculatory adverse events. Sexual function assessments (SHIM, MSHQ-EjD) show stable erectile function average score and statistically improved ejaculatory function and ejaculatory bother average scores.
IPSS
2 Wk
N Baseline Follow-Up Change % Change 95% CI p QoL
135 22.3±5.5 18.0±7.9 -4.3 -18% -23%, -12% <0.0001
N Baseline Follow-Up Change % Change 95% CI p BPH II N Baseline Follow-Up Change % Change 95% CI p Qmax (mL/s) N Baseline Follow-Up Change % Change 95% CI p
1 Mo
3 Mo
1 Yr
4 Yr
135 22.3±5.5 12.3±6.9 -9.99 -44% -49%, -39% <0.0001
136 22.3±5.5 11.2±7.7 -11.1 -50% -55%, -44% <0.0001
123 22.1±5.6 11.5±7.3 -10.6 -47% -53%, -42% <0.0001
48 21.7±6.7 11.7±6.5 -10.1 -46% -46%, -28% <0.0001
135 4.6±1.1 2.6±1.7 -2 -42% -49%, -36% <0.0001
136 4.6±1.1 2.4±1.7 -2.2 -47% -53%, -40% <0.0001
123 4.6±1.0 2.3±1.6 -2.3 -51% -57%, -44% <0.0001
48 4.5±1.0 1.9±1.2 -2.6 -57% -65%, -50% <0.0001
135 6.9±2.8 4.0±3.1 -2.9 -33% -46%, -20% <0.0001
136 6.9±2.8 2.9±3.0 -3.99 -56% -64%, -48% <0.0001
123 6.8±2.8 2.8±2.9 -4 -57% -66%, -49% <0.0001
48 6.2±2.9 2.1±2.1 -4.1 -61% -73%, -49% <0.0001
122 8.0±2.4 12.3±5.3 4.3 64% 50% – 79% <0.0001
103 8.0±2.4 12.1±5.3 4.1 59% 43% – 74% <0.0001
37 8.4±2.4 13.1±6.3 4.7 69% 31% – 108% <0.0001
136 4.6±1.1 3.6±1.7 -1 -18% -26%, -11% <0.0001 136 6.9±2.8 7.0±3.5 0.1 29% 8% – 50% 0.0054
CONCLUSIONS: The Prostatic Urethral Lift is a solution for patients. Patients suffer from little morbidity while on average achieving rapid, clinically meaningful LUTS relief. As demonstrated with this preliminary data from the largest and longest study of the PUL procedure, the relief can be sustained to 4 years. In addition, sexual function is preserved, both in terms of erection and ejaculation. Durability will be assessed through protocol driven follow up through 5 years.